Sample records for pro instrument development

  1. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument.

    PubMed

    Patrick, Donald L; Burke, Laurie B; Gwaltney, Chad J; Leidy, Nancy Kline; Martin, Mona L; Molsen, Elizabeth; Ring, Lena

    2011-12-01

    The importance of content validity in developing patient reported outcomes (PRO) instruments is stressed by both the US Food and Drug Administration and the European Medicines Agency. Content validity is the extent to which an instrument measures the important aspects of concepts that developers or users purport it to assess. A PRO instrument measures the concepts most significant and relevant to a patient's condition and its treatment. For PRO instruments, items and domains as reflected in the scores of an instrument should be important to the target population and comprehensive with respect to patient concerns. Documentation of target population input in item generation, as well as evaluation of patient understanding through cognitive interviewing, can provide the evidence for content validity. Developing content for, and assessing respondent understanding of, newly developed PRO instruments for medical product evaluation will be discussed in this two-part ISPOR PRO Good Research Practices Task Force Report. Topics include the methods for generating items, documenting item development, coding of qualitative data from item generation, cognitive interviewing, and tracking item development through the various stages of research and preparing this tracking for submission to regulatory agencies. Part 1 covers elicitation of key concepts using qualitative focus groups and/or interviews to inform content and structure of a new PRO instrument. Part 2 covers the instrument development process, the assessment of patient understanding of the draft instrument using cognitive interviews and steps for instrument revision. The two parts are meant to be read together. They are intended to offer suggestions for good practices in planning, executing, and documenting qualitative studies that are used to support the content validity of PRO instruments to be used in medical product evaluation. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  2. A concept taxonomy and an instrument hierarchy: tools for establishing and evaluating the conceptual framework of a patient-reported outcome (PRO) instrument as applied to product labeling claims.

    PubMed

    Erickson, Pennifer; Willke, Richard; Burke, Laurie

    2009-01-01

    To facilitate development and evaluation of a PRO instrument conceptual framework, we propose two tools--a PRO concept taxonomy and a PRO instrument hierarchy. FDA's draft guidance on patient reported outcome (PRO) measures states that a clear description of the conceptual framework of an instrument is useful for evaluating its adequacy to support a treatment benefit claim for use in product labeling the draft guidance, however does not propose tools for establishing or evaluating a PRO instrument's conceptual framework. We draw from our review of PRO concepts and instruments that appear in prescription drug labeling approved in the United States from 1997 to 2007. We propose taxonomy terms that define relationships between PRO concepts, including "family,"compound concept," and "singular concept." Based on the range of complexity represented by the concepts, as defined by the taxonomy, we propose nine instrument orders for PRO measurement. The nine orders range from individual event counts to multi-item, multiscale instruments. This analysis of PRO concepts and instruments illustrates that the taxonomy and hierarchy are applicable to PRO concepts across a wide range of therapeutic areas and provide a basis for defining the instrument conceptual framework complexity. Although the utility of these tools in the drug development, review, and approval processes has not yet been demonstrated, these tools could be useful to improve communication and enhance efficiency in the instrument development and review process.

  3. Patient-reported Outcomes for Assessment of Quality of Life in Refractive Error: A Systematic Review.

    PubMed

    Kandel, Himal; Khadka, Jyoti; Goggin, Michael; Pesudovs, Konrad

    2017-12-01

    This review has identified the best existing patient-reported outcome (PRO) instruments in refractive error. The article highlights the limitations of the existing instruments and discusses the way forward. A systematic review was conducted to identify the types of PROs used in refractive error, to determine the quality of the existing PRO instruments in terms of their psychometric properties, and to determine the limitations in the content of the existing PRO instruments. Articles describing a PRO instrument measuring 1 or more domains of quality of life in people with refractive error were identified by electronic searches on the MEDLINE, PubMed, Scopus, Web of Science, and Cochrane databases. The information on content development, psychometric properties, validity, reliability, and responsiveness of those PRO instruments was extracted from the selected articles. The analysis was done based on a comprehensive set of assessment criteria. One hundred forty-eight articles describing 47 PRO instruments in refractive error were included in the review. Most of the articles (99 [66.9%]) used refractive error-specific PRO instruments. The PRO instruments comprised 19 refractive, 12 vision but nonrefractive, and 16 generic PRO instruments. Only 17 PRO instruments were validated in refractive error populations; six of them were developed using Rasch analysis. None of the PRO instruments has items across all domains of quality of life. The Quality of Life Impact of Refractive Correction, the Quality of Vision, and the Contact Lens Impact on Quality of Life have comparatively better quality with some limitations, compared with the other PRO instruments. This review describes the PRO instruments and informs the choice of an appropriate measure in refractive error. We identified need of a comprehensive and scientifically robust refractive error-specific PRO instrument. Item banking and computer-adaptive testing system can be the way to provide such an instrument.

  4. Systematic literature review and assessment of patient-reported outcome instruments in sickle cell disease.

    PubMed

    Sarri, Grammati; Bhor, Menaka; Abogunrin, Seye; Farmer, Caroline; Nandal, Savita; Halloway, Rashid; Revicki, Dennis A

    2018-05-21

    Sickle cell disease (SCD) is a chronic condition associated with high mortality and morbidity. It is characterized by acute clinical symptoms such as painful vaso-occlusive crises, which can impair health-related quality of life (HRQL). This study was conducted to identify validated patient-reported outcome (PRO) instruments for use in future trials of potential treatments for SCD. A systematic literature review (SLR) was performed using MEDLINE and EMBASE to identify United States (US)-based studies published in English between 1997 and 2017 that reported on validated PRO instruments used in randomized controlled trials and real-world settings. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was used to assess the quality of PRO instruments. The SLR included 21 studies assessing the psychometric properties of 24 PRO instruments. Fifteen of those instruments were developed and validated for adults and 10 for children (one instrument was used in both children and young adults aged up to 21 years). Only five of the 15 adult instruments and three of the 10 pediatric instruments were developed specifically for SCD. For most instruments, there were few or no data on validation conducted in SCD development cohorts. Of the 24 PRO instruments identified, 16 had strong internal reliability (Cronbach's α ≥0.80). There was often insufficient information to assess the content validity, construct validity, responsiveness, or test-retest reliability of the instruments identified for both child and adult populations. No validated PRO instruments measuring caregiver burden in SCD were identified. The evidence on the psychometric properties of PRO instruments was limited. However, the results of this SLR provide key information on such tools to help inform the design of future clinical trials for patients with SCD in the US.

  5. Patient-Reported Outcome Instruments for Surgical and Traumatic Scars: A Systematic Review of their Development, Content, and Psychometric Validation.

    PubMed

    Mundy, Lily R; Miller, H Catherine; Klassen, Anne F; Cano, Stefan J; Pusic, Andrea L

    2016-10-01

    Patient-reported outcomes (PROs) are of growing importance in research and clinical care and may be used as primary outcomes or as compliments to traditional surgical outcomes. In assessing the impact of surgical and traumatic scars, PROs are often the most meaningful. To assess outcomes from the patient perspective, rigorously developed and validated PRO instruments are essential. The authors conducted a systematic literature review to identify PRO instruments developed and/or validated for patients with surgical and/or non-burn traumatic scars. Identified instruments were assessed for content, development process, and validation under recommended guidelines for PRO instrument development. The systematic review identified 6534 articles. After review, we identified four PRO instruments meeting inclusion criteria: patient and observer scar assessment scale (POSAS), bock quality of life questionnaire for patients with keloid and hypertrophic scarring (Bock), patient scar assessment questionnaire (PSAQ), and patient-reported impact of scars measure (PRISM). Common concepts measured were symptoms and psychosocial well-being. Only PSAQ had a dedicated appearance domain. Qualitative data were used to inform content for the PSAQ and PRISM, and a modern psychometric approach (Rasch Measurement Theory) was used to develop PRISM and to test POSAS. Overall, PRISM demonstrated the most rigorous design and validation process, however, was limited by the lack of a dedicated appearance domain. PRO instruments to evaluate outcomes in scars exist but vary in terms of concepts measured and psychometric soundness. This review discusses the strengths and weaknesses of existing instruments, highlighting the need for future scar-focused PRO instrument development. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to Table of Contents or the online Instructions to Authors www.springer.com/00266 .

  6. Development and validation of a primary sclerosing cholangitis-specific patient-reported outcomes instrument: The PSC PRO.

    PubMed

    Younossi, Zobair M; Afendy, Arian; Stepanova, Maria; Racila, Andrei; Nader, Fatema; Gomel, Rachel; Safer, Ricky; Lenderking, William R; Skalicky, Anne; Kleinman, Leah; Myers, Robert P; Subramanian, G Mani; McHutchison, John G; Levy, Cynthia; Bowlus, Christopher L; Kowdley, Kris; Muir, Andrew J

    2017-11-20

    Primary sclerosing cholangitis (PSC) is a chronic liver disease associated with inflammation and biliary fibrosis that leads to cholangitis, cirrhosis, and impaired quality of life. Our objective was to develop and validate a PSC-specific patient-reported outcome (PRO) instrument. We developed a 42-item PSC PRO instrument that contains two modules (Symptoms and Impact of Symptoms) and conducted an external validation. Reliability and validity were evaluated using clinical data and a battery of other validated instruments. Test-retest reliability was assessed in a subgroup of patients who repeated the PSC PRO after the first administration. One hundred two PSC subjects (44 ± 13 years; 32% male, 74% employed, 39% with cirrhosis, 14% with a history of decompensated cirrhosis, 38% history of depression, and 68% with inflammatory bowel disease [IBD]) completed PSC PRO and other PRO instruments (Short Form 36 V2 [SF-36], Chronic Liver Disease Questionnaire [CLDQ], Primary Biliary Cholangitis - 40 [PBC-40], and five dimensions [5-D Itch]). PSC PRO demonstrated excellent internal consistency (Cronbach alphas, 0.84-0.94) and discriminant validity (41 of 42 items had the highest correlations with their own domains). There were good correlations between PSC PRO domains and relevant domains of SF-36, CLDQ, and PBC-40 (R = 0.69-0.90; all P < 0.0001), but lower (R = 0.31-0.60; P < 0.001) with 5-D Itch. Construct validity showed that PSC PRO can differentiate patients according to the presence and severity of cirrhosis and history of depression (P < 0.05), but not by IBD (P > 0.05). Test-retest reliability was assessed in 53 subjects who repeated PSC PRO within a median (interquartile range) of 37 (27-47) days. There was excellent reliability for most domains with intraclass correlations (0.71-0.88; all P < 0.001). PSC PRO is a self-administered disease-specific instrument developed according to U.S. Food and Drug Administration guidelines. This preliminary validation study suggests good psychometric properties. Further validation of the instrument in a larger and more diverse sample of PSC patients is needed. (Hepatology 2017). © 2017 by the American Association for the Study of Liver Diseases.

  7. Patient-reported outcomes to support medical product labeling claims: FDA perspective.

    PubMed

    Patrick, Donald L; Burke, Laurie B; Powers, John H; Scott, Jane A; Rock, Edwin P; Dawisha, Sahar; O'Neill, Robert; Kennedy, Dianne L

    2007-01-01

    This article concerns development and use of patient-reported outcomes (PROs) in clinical trials to evaluate medical products. A PRO is any report coming directly from patients, without interpretation by physicians or others, about how they function or feel in relation to a health condition and its therapy. PRO instruments are used to measure these patient reports. PROs provide a unique perspective on medical therapy, because some effects of a health condition and its therapy are known only to patients. Properly developed and evaluated PRO instruments also have the potential to provide more sensitive and specific measurements of the effects of medical therapies, thereby increasing the efficiency of clinical trials that attempt to measure the meaningful treatment benefits of those therapies. Poorly developed and evaluated instruments may provide misleading conclusions or data that cannot be used to support product labeling claims. We review selected major challenges from Food and Drug Administration's perspective in using PRO instruments, measures, and end points to support treatment benefit claims in product labeling. These challenges highlight the need for sponsors to formulate desired labeling claim(s) prospectively, to acquire and document information needed to support these claim(s), and to identify existing instruments or develop new and more appropriate PRO instruments for evaluating treatment benefit in the defined population in which they will seek claims.

  8. Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report.

    PubMed

    Rothman, Margaret; Burke, Laurie; Erickson, Pennifer; Leidy, Nancy Kline; Patrick, Donald L; Petrie, Charles D

    2009-01-01

    Patient-reported outcome (PRO) instruments are used to evaluate the effect of medical products on how patients feel or function. This article presents the results of an ISPOR task force convened to address good clinical research practices for the use of existing or modified PRO instruments to support medical product labeling claims. The focus of the article is on content validity, with specific reference to existing or modified PRO instruments, because of the importance of content validity in selecting or modifying an existing PRO instrument and the lack of consensus in the research community regarding best practices for establishing and documenting this measurement property. Topics addressed in the article include: definition and general description of content validity; PRO concept identification as the important first step in establishing content validity; instrument identification and the initial review process; key issues in qualitative methodology; and potential threats to content validity, with three case examples used to illustrate types of threats and how they might be resolved. A table of steps used to identify and evaluate an existing PRO instrument is provided, and figures are used to illustrate the meaning of content validity in relationship to instrument development and evaluation. RESULTS & RECOMMENDATIONS: Four important threats to content validity are identified: unclear conceptual match between the PRO instrument and the intended claim, lack of direct patient input into PRO item content from the target population in which the claim is desired, no evidence that the most relevant and important item content is contained in the instrument, and lack of documentation to support modifications to the PRO instrument. In some cases, careful review of the threats to content validity in a specific application may be reduced through additional well documented qualitative studies that specifically address the issue of concern. Published evidence of the content validity of a PRO instrument for an intended application is often limited. Such evidence is, however, important to evaluating the adequacy of a PRO instrument for the intended application. This article provides an overview of key issues involved in assessing and documenting content validity as it relates to using existing instruments in the drug approval process.

  9. A Stereomicroscopic Evaluation of Dentinal Cracks at Different Instrumentation Lengths by Using Different Rotary Files (ProTaper Universal, ProTaper Next, and HyFlex CM): An Ex Vivo Study

    PubMed Central

    Shankarappa, Pushpa; Misra, Abhinav; Sawhney, Asheesh; Sridevi, Nandamuri; Singh, Anu

    2016-01-01

    Introduction. The aim of the present study was to evaluate the dentinal cracks after root canal preparation with rotary files: Gates Glidden, ProTaper Universal, ProTaper Next, and HyFlex CM at different instrumentation lengths. Methodology. Sixty-five mandibular premolars were mounted in the acrylic tube with simulated periodontal ligaments and the apex was exposed. The root canals were instrumented with different rotary files, namely, ProTaper Universal, ProTaper Next, and HyFlex CM, to the major apical foramen (AF), short AF, and beyond AF. The root apex was stained with 1% methylene blue dye and digital images of apical surface of every tooth were taken and development of dentinal defects was determined by using stereomicroscope. Multinomial logistic regression test was performed to identify influencing factors. Results. Instrumentation with rotary files terminated 2 mm short AF and did not cause any cracks. Significantly less cracks were seen when instrumentation with rotary files terminated 1 mm short apical foramen when compared with the instrumentation terminated at or beyond apical foramen (p < 0.05). Conclusion. ProTaper Universal rotary files caused more dentinal cracks than ProTaper Next and HyFlex CM. Instrumentation short AF reduced the risk of dentinal defects. PMID:27446636

  10. Methods to Develop the Eye-tem Bank to Measure Ophthalmic Quality of Life.

    PubMed

    Khadka, Jyoti; Fenwick, Eva; Lamoureux, Ecosse; Pesudovs, Konrad

    2016-12-01

    There is an increasing demand for high-standard, comprehensive, and reliable patient-reported outcome (PRO) instruments in all the disciplines of health care including in ophthalmology and optometry. Over the past two decades, a plethora of PRO instruments have been developed to assess the impact of eye diseases and their treatments. Despite this large number of instruments, significant shortcomings exist for the measurement of ophthalmic quality of life (QoL). Most PRO instruments are short-form instruments designed for clinical use, but this limits their content coverage often poorly targeting any study population other than that which they were developed for. Also, existing instruments are static paper and pencil based and unable to be updated easily leading to outdated and irrelevant item content. Scores obtained from different PRO instruments may not be directly comparable. These shortcomings can be addressed using item banking implemented with computer-adaptive testing (CAT). Therefore, we designed a multicenter project (The Eye-tem Bank project) to develop and validate such PROs to enable comprehensive measurement of ophthalmic QoL in eye diseases. Development of the Eye-tem Bank follows four phases: Phase I, Content Development; Phase II, Pilot Testing and Item Calibration; Phase III, Validation; and Phase IV, Evaluation. This project will deliver technologically advanced comprehensive QoL PROs in the form of item banking implemented via a CAT system in eye diseases. Here, we present a detailed methodological framework of this project.

  11. Updating the OMERACT filter: implications for patient-reported outcomes.

    PubMed

    Kirwan, John R; Bartlett, Susan J; Beaton, Dorcas E; Boers, Maarten; Bosworth, Ailsa; Brooks, Peter M; Choy, Ernest; de Wit, Maarten; Guillemin, Francis; Hewlett, Sarah; Kvien, Tore K; Landewé, Robert B; Leong, Amye L; Lyddiatt, Anne; March, Lyn; May, James; Montie, Pamela Lesley; Nikaï, Enkeleida; Richards, Pam; Voshaar, Marieke M J H; Smeets, Wilma; Strand, Vibeke; Tugwell, Peter; Gossec, Laure

    2014-05-01

    At a previous Outcome Measures in Rheumatology (OMERACT) meeting, participants reflected on the underlying methods of patient-reported outcome (PRO) instrument development. The participants requested proposals for more explicit instrument development protocols that would contribute to an enhanced version of the "Truth" statement in the OMERACT Filter, a widely used guide for outcome validation. In the present OMERACT session, we explored to what extent these new Filter 2.0 proposals were practicable, feasible, and already being applied. Following overview presentations, discussion groups critically reviewed the extent to which case studies of current OMERACT Working Groups complied with or negated the proposed PRO development framework, whether these observations had a more general application, and what issues remained to be resolved. Several aspects of PRO development were recognized as particularly important, and the need to directly involve patients at every stage of an iterative PRO development program was endorsed. This included recognition that patients contribute as partners in the research and not merely as subjects. Correct communication of concepts with the words used in questionnaires was central to their performance as measuring instruments, and ensuring this understanding crossed cultural and linguistic boundaries was important in international studies or comparisons. Participants recognized, endorsed, and were generally already putting into practice the principles of PRO development presented in the plenary session. Further work is needed on some existing instruments and on establishing widespread good practice for working in close collaboration with patients.

  12. Content Validity of Patient-Reported Outcome Instruments used with Pediatric Patients with Facial Differences: A Systematic Review.

    PubMed

    Wickert, Natasha M; Wong Riff, Karen W Y; Mansour, Mark; Forrest, Christopher R; Goodacre, Timothy E E; Pusic, Andrea L; Klassen, Anne F

    2018-01-01

    Objective The aim of this systematic review was to identify patient-reported outcome (PRO) instruments used in research with children/youth with conditions associated with facial differences to identify the health concepts measured. Design MEDLINE, EMBASE, CINAHL, and PsycINFO were searched from 2004 to 2016 to identify PRO instruments used in acne vulgaris, birthmarks, burns, ear anomalies, facial asymmetries, and facial paralysis patients. We performed a content analysis whereby the items were coded to identify concepts and categorized as positive or negative content or phrasing. Results A total of 7,835 articles were screened; 6 generic and 11 condition-specific PRO instruments were used in 96 publications. Condition-specific instruments were for acne (four), oral health (two), dermatology (one), facial asymmetries (two), microtia (one), and burns (one). The PRO instruments provided 554 items (295 generic; 259 condition specific) that were sorted into 4 domains, 11 subdomains, and 91 health concepts. The most common domain was psychological (n = 224 items). Of the identified items, 76% had negative content or phrasing (e.g., "Because of the way my face looks I wish I had never been born"). Given the small number of items measuring facial appearance (n = 19) and function (n = 22), the PRO instruments reviewed lacked content validity for patients whose condition impacted facial function and/or appearance. Conclusions Treatments can change facial appearance and function. This review draws attention to a problem with content validity in existing PRO instruments. Our team is now developing a new PRO instrument called FACE-Q Kids to address this problem.

  13. Comparison of apical transportation between ProFile and ProTaper NiTi rotary instruments.

    PubMed

    Iqbal, M K; Firic, S; Tulcan, J; Karabucak, B; Kim, S

    2004-06-01

    To use a newly developed radiographic technique to compare apical transportation and loss of working length (WL) between.06 taper ProFile Series 29 and ProTaper nickel-titanium (NiTi) rotary instruments in vitro. Mesio-buccal canals of 40 extracted mandibular molars were randomly divided into two groups. Group 1 was instrumented with ProFile and group 2 with ProTaper instruments according to the manufacturers' directions. A specially constructed radiographic jig with a Schick digital radiographic system (Schick Technologies Inc., Long Island City, NY, USA) was used to take pre- and postoperative radiographs of the samples at predetermined angulations. Using AutoCAD 2000 (Autodesk Inc., San Rafael, CA, USA), the central axes of initial and final instruments were radiographically superimposed to determine the loss of WL and degree of transportation at D(0), D(1), D(2) and D(4) from the WL. Data were analysed using repeated-measures anova. A statistically significant difference in apical transportation was found at the D(4) level between the two groups (P = 0.05). There was no statistical significance regarding postinstrumentation change in WL between groups. Spearman's Bivariate Correlation analysis indicated no statistically significant relationship between the radius of curvature and transportation. The results indicate that both ProTaper and ProFile instruments are comparable to each other in regards to their ability to optimally enlarge root canal with minimal transportation and loss of WL in vitro.

  14. Development of a Symptom-Based Patient-Reported Outcome Instrument for Functional Dyspepsia: A Preliminary Conceptual Model and an Evaluation of the Adequacy of Existing Instruments.

    PubMed

    Taylor, Fiona; Reasner, David S; Carson, Robyn T; Deal, Linda S; Foley, Catherine; Iovin, Ramon; Lundy, J Jason; Pompilus, Farrah; Shields, Alan L; Silberg, Debra G

    2016-10-01

    The aim was to document, from the perspective of the empirical literature, the primary symptoms of functional dyspepsia (FD), evaluate the extent to which existing questionnaires target those symptoms, and, finally, identify any missing evidence that would impact the questionnaires' use in regulated clinical trials to assess treatment efficacy claims intended for product labeling. A literature review was conducted to identify the primary symptoms of FD and existing symptom-based FD patient-reported outcome (PRO) instruments. Following a database search, abstracts were screened and articles were retrieved for review. The primary symptoms of FD were organized into a conceptual model and the PRO instruments were evaluated for conceptual coverage as well as compared against evidentiary requirements presented in the FDA's PRO Guidance for Industry. Fifty-six articles and 16 instruments assessing FD symptoms were reviewed. Concepts listed in the Rome III criteria for FD (n = 7), those assessed by existing FD instruments (n = 34), and symptoms reported by patients in published qualitative research (n = 6) were summarized in the FD conceptual model. Except for vomiting, all of the identified symptoms from the published qualitative research reports were also specified in the Rome III criteria. Only three of the 16 instruments, the Dyspepsia Symptom Severity Index (DSSI), Nepean Dyspepsia Index (NDI), and Short-Form Nepean Dyspepsia Index (SF-NDI), measure all seven FD symptoms defined by the Rome III criteria. Among these three, each utilizes a 2-week recall period and 5-point Likert-type scale, and had evidence of patient involvement in development. Despite their coverage, when these instruments were evaluated in light of regulatory expectations, several issues jeopardized their potential qualification for substantiation of a labeling claim. No existing PRO instruments that measured all seven symptoms adhered to the regulatory principles necessary to support product labeling. As such, the development of a new FD symptom PRO instrument is supported.

  15. Assessment of Patient-Reported Outcome Instruments to Assess Chronic Low Back Pain.

    PubMed

    Ramasamy, Abhilasha; Martin, Mona L; Blum, Steven I; Liedgens, Hiltrud; Argoff, Charles; Freynhagen, Rainer; Wallace, Mark; McCarrier, Kelly P; Bushnell, Donald M; Hatley, Noël V; Patrick, Donald L

    2017-06-01

     To identify patient-reported outcome (PRO) instruments that assess chronic low back pain (cLBP) symptoms (specifically pain qualities) and/or impacts for potential use in cLBP clinical trials to demonstrate treatment benefit and support labeling claims.  Literature review of existing PRO measures.  Publications detailing existing PRO measures for cLBP were identified, reviewed, and summarized. As recommended by the US Food & Drug Administration (FDA) PRO development guidance, standard measurement characteristics were reviewed, including development history, psychometric properties (validity and reliability), ability to detect change, and interpretation of observed changes.  Thirteen instruments were selected and reviewed: Low Back Pain Bothersomeness Scale, Neuropathic Pain Symptom Inventory, PainDETECT, Pain Quality Assessment Scale Revised, Revised Short Form McGill Pain Questionnaire, Low Back Pain Impact Questionnaire, Oswestry Disability Index, Pain Disability Index, Roland-Morris Disability Questionnaire, Brief Pain Inventory and Brief Pain Inventory Short Form, Musculoskeletal Outcomes Data Evaluation and Management System Spine Module, Orebro Musculoskeletal Pain Questionnaire, and the West Haven-Yale Multidimensional Pain Inventory Interference Scale. The instruments varied in the aspects of pain and/or impacts that they assessed, and none of the instruments fulfilled all criteria for use in clinical trials to support labeling claims based on recommendations outlined in the FDA PRO guidance.  There is an unmet need for a validated PRO instrument to evaluate cLBP-related symptoms and impacts for use in clinical trials. © 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  16. Patient perspective workshop: moving towards OMERACT guidelines for choosing or developing instruments to measure patient-reported outcomes.

    PubMed

    Kirwan, John R; Fries, James F; Hewlett, Sarah E; Osborne, Richard H; Newman, Stanton; Ciciriello, Sabina; van de Laar, Mart A; Dures, Emma; Minnock, Patricia; Heiberg, Turid; Sanderson, Tessa C; Flurey, Caroline A; Leong, Amy L; Montie, Pamela; Richards, Pam

    2011-08-01

    The workshop Choosing or Developing Instruments held at the Outcome Measures in Rheumatology (OMERACT) 10 meeting was designed to help participants think about the underlying methods of instrument development. Conference pre-reading material and 3 brief introductory presentations elaborated the issues, and participants broke into discussion groups before reconvening to share insights, engage in a more general discussion of the issues, and vote on recommendations. Tradeoffs between using current imperfect measures and the long and complex process of developing new instruments were considered, together with the need for rigor in patient-reported outcome (PRO) instrument development. The main considerations for PRO instrument development were listed and a research agenda for action produced. As part of the agenda for action, it is recommended that researchers and patient partners work together to tackle these issues, and that OMERACT bring forward proposals for acceptable instrument development protocols that would meet an enhanced "Truth" statement in the OMERACT Filter.

  17. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.

    PubMed

    2006-10-11

    This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably and validly measure the specific concepts at issue. The glossary defines many of the terms used in this guidance. In particular, the term instrument refers to the actual questions or items contained in a questionnaire or interview schedule along with all the additional information and documentation that supports the use of these items in producing a PRO measure (e.g., interviewer training and instructions, scoring and interpretation manual). The term conceptual framework refers to how items are grouped according to subconcepts or domains (e.g., the item walking without help may be grouped with another item, walking with difficulty, within the domain of ambulation, and ambulation may be further grouped into the concept of physical ability). FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended but not required. First publication of the Draft Guidance by the Food and Drug Administration--February 2006.

  18. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance

    PubMed Central

    2006-01-01

    This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably and validly measure the specific concepts at issue. The glossary defines many of the terms used in this guidance. In particular, the term instrument refers to the actual questions or items contained in a questionnaire or interview schedule along with all the additional information and documentation that supports the use of these items in producing a PRO measure (e.g., interviewer training and instructions, scoring and interpretation manual). The term conceptual framework refers to how items are grouped according to subconcepts or domains (e.g., the item walking without help may be grouped with another item, walking with difficulty, within the domain of ambulation, and ambulation may be further grouped into the concept of physical ability). FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended but not required. First publication of the Draft Guidance by the Food and Drug Administration- February 2006. PMID:17034633

  19. Voice-Related Patient-Reported Outcome Measures: A Systematic Review of Instrument Development and Validation

    PubMed Central

    Daniero, James J.; Hovis, Kristen L.; Sathe, Nila; Jacobson, Barbara; Penson, David F.; Feurer, Irene D.; McPheeters, Melissa L.

    2017-01-01

    Purpose The purpose of this study was to perform a comprehensive systematic review of the literature on voice-related patient-reported outcome (PRO) measures in adults and to evaluate each instrument for the presence of important measurement properties. Method MEDLINE, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument databases were searched using relevant vocabulary terms and key terms related to PRO measures and voice. Inclusion and exclusion criteria were developed in consultation with an expert panel. Three independent investigators assessed study methodology using criteria developed a priori. Measurement properties were examined and entered into evidence tables. Results A total of 3,744 studies assessing voice-related constructs were identified. This list was narrowed to 32 PRO measures on the basis of predetermined inclusion and exclusion criteria. Questionnaire measurement properties varied widely. Important thematic deficiencies were apparent: (a) lack of patient involvement in the item development process, (b) lack of robust construct validity, and (c) lack of clear interpretability and scaling. Conclusions PRO measures are a principal means of evaluating treatment effectiveness in voice-related conditions. Despite their prominence, available PRO measures have disparate methodological rigor. Care must be taken to understand the psychometric and measurement properties and the applicability of PRO measures before advocating for their use in clinical or research applications. PMID:28030869

  20. Preliminary Results for the PAR-PRO: A Measure of Home and Community Participation

    PubMed Central

    Ostir, Glenn V.; Granger, Carl V.; Black, Terrie; Roberts, Pamela; Burgos, Laura; Martinkewiz, Paula; Ottenbacher, Kenneth J.

    2007-01-01

    Objective To develop a measure of home and community participation related to the World Health Organization’s International Classification of Functioning, Disability and Health. Design Cross-sectional analysis of survey data. Setting Nine medical inpatient rehabilitation facilities from 6 states. Participants A total of 594 patients of mixed impairment type admitted for inpatient rehabilitation in 2002. Mean age was 74.0 years and 61.4% were women. Interventions Not applicable. Main Outcome Measures Reliability and validity of the participation instrument. Results A 20-item instrument of home and community participation was developed (PAR-PRO). The instrument showed good internal consistency and good Rasch person and item fit statistics. Four subfactors were identified beyond the unidimensional construct of participation including domestic management, socialization, physical vigor, and generative activities. The PAR-PRO total participation score correlated inversely with age (r=−.31, P<.001) but did not differ by sex. Conclusions The 20-item PAR-PRO instrument of home and community participation displayed good psychometric characteristics. The instrument shows promise as a broad measure of home and community involvement for persons with disabilities. Further work is needed to support its application for people without disability. PMID:16876548

  1. Development of the Flu-PRO: a patient-reported outcome (PRO) instrument to evaluate symptoms of influenza.

    PubMed

    Powers, John H; Guerrero, M Lourdes; Leidy, Nancy Kline; Fairchok, Mary P; Rosenberg, Alice; Hernández, Andrés; Stringer, Sonja; Schofield, Christina; Rodríguez-Zulueta, Patricia; Kim, Katherine; Danaher, Patrick J; Ortega-Gallegos, Hilda; Bacci, Elizabeth Dansie; Stepp, Nathaniel; Galindo-Fraga, Arturo; St Clair, Kristina; Rajnik, Michael; McDonough, Erin A; Ridoré, Michelande; Arnold, John C; Millar, Eugene V; Ruiz-Palacios, Guillermo M

    2016-01-05

    To develop content validity of a comprehensive patient-reported outcome (PRO) measure following current best scientific methodology to standardize assessment of influenza (flu) symptoms in clinical research. Stage I (Concept Elicitation): 1:1 telephone interviews with influenza-positive adults (≥18 years) in the US and Mexico within 7 days of diagnosis. Participants described symptom type, character, severity, and duration. Content analysis identified themes and developed the draft Flu-PRO instrument. Stage II (Cognitive Interviewing): The Flu-PRO was administered to a unique set of influenza-positive adults within 14 days of diagnosis; telephone interviews addressed completeness, respondent interpretation of items and ease of use. Samples: Stage I: N = 46 adults (16 US, 30 Mexico); mean (SD) age: 38 (19), 39 (14) years; % female: 56%, 73%; race: 69% White, 97% Mestizo. Stage II: N = 34 adults (12 US, 22 Mexico); age: 37 (14), 39 (11) years; % female: 50%, 50%; race: 58% White, 100% Mestizo. Symptoms identified by >50%: coughing, weak or tired, throat symptoms, congestion, headache, weakness, sweating, chills, general discomfort, runny nose, chest (trouble breathing), difficulty sleeping, and body aches or pains. No new content was uncovered during Stage II; participants easily understood the instrument. Results show the 37-item Flu-PRO is a content valid measure of influenza symptoms in adults with a confirmed diagnosis of influenza. Research is underway to evaluate the suitability of the instrument for children and adolescents. This work can form the basis for future quantitative tests of reliability, validity, and responsiveness to evaluate the measurement properties of Flu-PRO for use in clinical trials and epidemiology studies.

  2. Development of the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT®) questionnaire: a new patient-reported outcome instrument for PAH.

    PubMed

    McCollister, Deborah; Shaffer, Shannon; Badesch, David B; Filusch, Arthur; Hunsche, Elke; Schüler, René; Wiklund, Ingela; Peacock, Andrew

    2016-06-14

    Regulators and clinical experts increasingly recognize the importance of incorporating patient-reported outcomes (PROs) in clinical studies of therapies for pulmonary arterial hypertension (PAH). No PAH-specific instruments have been developed to date in accordance with the 2009 FDA guidance for the development of PROs as endpoints in clinical trials. A qualitative research study was conducted to develop a new instrument assessing PAH symptoms and their impacts following the FDA PRO guidance. A cross-sectional study was conducted at 5 centers in the US in symptomatic PAH patients aged 18-80 years. Concept elicitation was based on 5 focus group discussions, after which saturation of emergent concepts was reached. A PRO instrument for PAH symptoms and their impacts was drafted. To assess the appropriateness of items, instructions, response options, and recall periods, 2 rounds of one-on-one cognitive interviews were conducted, with instrument revisions following each round. Additional interviews tested the usability of an electronic version (ePRO). PRO development considered input from an international Steering Committee, and translatability and lexibility assessments. Focus groups comprised 25 patients (5 per group); 20 additional patients participated in cognitive interviews (10 per round); and 10 participated in usability interviews. Participants had a mean ± SD age of 53.1 ± 15.8 years, were predominantly female (93 %), and were diverse in race/ethnicity, WHO functional class (FC I/II: 56 %, III/IV: 44 %), and PAH etiology (idiopathic: 56 %, familial: 2 %, associated: 42 %). The draft PRO instrument (PAH-SYMPACT®) was found to be clear, comprehensive, and relevant to PAH patients in cognitive interviews. Items were organized in a draft conceptual framework with 16 symptom items in 4 domains (respiratory symptoms, tiredness, cardiovascular symptoms, other symptoms) and 25 impact items in 5 domains (physical activities, daily activities, social impact, cognition, emotional impact). The recall period is the past 24 h for symptoms, and the past 7 days for impacts. The PAH-SYMPACT® was shown to capture symptoms and their impacts relevant to PAH patients, demonstrating content saturation, concept validity, and ePRO usability. Final content and psychometric validation of the instrument will be based on the results of an ongoing Phase IIIb clinical trial in PAH patients.

  3. Capturing the Patient’s Experience: Using Qualitative Methods to Develop a Measure of Patient-Reported Symptom Burden: An Example from Ovarian Cancer

    PubMed Central

    Williams, Loretta A.; Agarwal, Sonika; Bodurka, Diane C.; Saleeba, Angele K.; Sun, Charlotte C.; Cleeland, Charles S.

    2013-01-01

    Context Experts in patient-reported outcome (PRO) measurement emphasize the importance of including patient input in the development of PRO measures. Although best methods for acquiring this input are not yet identified, patient input early in instrument development ensures that instrument content captures information most important and relevant to patients in understandable terms. Objectives The M. D. Anderson Symptom Inventory (MDASI) is a reliable, valid PRO instrument for assessing cancer symptom burden. We report a qualitative (open-ended, in-depth) interviewing method that can be used to incorporate patient input into PRO symptom measure development, with our experience in constructing a MDASI module for ovarian cancer (MDASI-OC) as a model. Methods Fourteen patients with ovarian cancer (OC) described symptoms experienced at the time of the study, at diagnosis, and during prior treatments. Researchers and clinicians used content analysis of interview transcripts to identify symptoms in patient language. Symptoms were ranked on the basis of the number of patients mentioning them and by clinician assessment of relevance. Results Forty-two symptoms were mentioned. Eight OC-specific items will be added to the 13 core symptom items and six interference items of the MDASI in a test version of the MDASI-OC based on the number of patients mentioning them and clinician assessment of importance. The test version is undergoing psychometric evaluation. Conclusion The qualitative interviewing process, used to develop the test MDASI-OC, systematically captures common symptoms important to patients with ovarian cancer. This methodology incorporates the patient experience recommended by experts in PRO instrument development. PMID:23615044

  4. Development of the Autosomal Dominant Polycystic Kidney Disease Impact Scale: A New Health-Related Quality-of-Life Instrument.

    PubMed

    Oberdhan, Dorothee; Cole, Jason C; Krasa, Holly B; Cheng, Rebecca; Czerwiec, Frank S; Hays, Ron D; Chapman, Arlene B; Perrone, Ronald D

    2018-02-01

    The impact of autosomal dominant polycystic kidney disease (ADPKD) on health-related quality of life (HRQoL) is not well understood due to a lack of instruments specific to the condition. Content for a new self-administered patient-reported outcome (PRO) questionnaire to assess ADPKD-related HRQoL was developed through clinical expert and patient focus group discussions. The new PRO instrument was administered to study patients with ADPKD to evaluate its reliability and validity. 1,674 adult patients with ADPKD participated in this research: 285 patients in focus groups to generate questionnaire content, 15 patients in debriefing interviews to refine the PRO questionnaire, and 1,374 patients to assess the performance and measurement properties of the PRO questionnaire. A new PRO questionnaire. The ADPKD Impact Scale (ADPKD-IS), consisting of 14 items representing 3 conceptual domains (physical, emotional, and fatigue) plus 4 additional questions, was developed. The instrument's reliability (regarding internal consistency and test-retest consistency) and validity (content and construct) were supported. Need for more responsiveness testing when more data from clinical use become available over time. Complex concepts such as ADPKD-related pain and impact on a patient's HRQoL need further evaluation. The ADPKD-IS is a new patient-centric tool that reliably and validly provides a standardized method for assessing HRQoL and overall disease burden in patients with ADPKD. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  5. Apically extruded debris with three contemporary Ni-Ti instrumentation systems: an ex vivo comparative study.

    PubMed

    Logani, Ajay; Shah, Naseem

    2008-01-01

    To comparatively evaluate the amount of apically extruded debris when ProTaper hand, ProTaper rotary and ProFile systems were used for the instrumentation of root canals. Thirty minimally curved, mature, human mandibular premolars with single canals were randomly divided into three groups of ten teeth each. Each group was instrumented using one of the three instrumentation systems: ProTaper hand, ProTaper rotary and ProFile. Five milliliters of sterile water were used as an irrigant. Debris extruded was collected in preweighed polyethylene vials and the extruded irrigant was evaporated. The weight of the dry extruded debris was established by comparing the pre- and postinstrumentation weight of polyethylene vials for each group. The Kruskal-Wallis nonparametric test and Mann-Whitney U test were applied to determine if significant differences existed among the groups ( P< 0.05). All instruments tested produced a measurable amount of debris. No statistically significant difference was observed between ProTaper hand and ProFile system ( P > 0.05). Although ProTaper rotary extruded a relatively higher amount of debris, no statistically significant difference was observed between this type and the ProTaper hand instruments ( P > 0.05). The ProTaper rotary extruded significantly more amount of debris compared to the ProFile system ( P< 0.05). Within the limitations of this study, it can be concluded that all instruments tested produced apical extrusion of debris. The ProTaper rotary extruded a significantly higher amount of debris than the ProFile.

  6. Micro-computed tomographic comparison of nickel-titanium rotary versus traditional instruments in C-shaped root canal system.

    PubMed

    Yin, Xingzhe; Cheung, Gary Shun-Pan; Zhang, Chengfei; Masuda, Yoshiko Murakami; Kimura, Yuichi; Matsumoto, Koukichi

    2010-04-01

    The purpose of this study was to assess the efficacy of instrumentation of C-shaped canals with ProTaper rotary system and traditional instruments by using micro-computed tomography (micro-CT). Twenty-four mandibular molars with C-shaped canals were selected in pairs and sorted equally into 2 groups, which were assigned for instrumentation by ProTaper rotary system (ProTaper group) or by K-files and Gates-Glidden burs (Hand Instrument group). Three-dimensional images were constructed by micro-CT. The volume of dentin removed, uninstrumented canal area, time taken for instrumentation, and iatrogenic error of instrumentation were investigated. Hand Instrument group showed greater amount of volumetric dentin removal and left less uninstrumented canal area than ProTaper group (P < .01). The time needed for instrumentation was shorter for ProTaper group than for Hand Instrument group (P < .05). No instrument breakage occurred in both groups, but more conspicuous procedural errors were detected in Hand Instrument group than for ProTaper group. It was concluded that ProTaper rotary system maintained the canal curvature with speediness and few procedural errors, whereas traditional instrumentation can clean more canal surface. Copyright (c) 2010 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  7. Comparison of the cleaning capacity of Mtwo and Pro Taper rotary systems and manual instruments in primary teeth

    PubMed Central

    Azar, Mohammad Reza; Safi, Laya; Nikaein, Afshin

    2012-01-01

    Background: Root canal cleaning is an important step in endodontic therapy. In order to develop better techniques, a new generation of endodontic instruments has been designed. The aim of this study was to compare the effectiveness of manual K-files (Mani Co, Tokyo, Japan) and two rotary systems–Mtwo (Dentsply-Maillefer, Ballaigues, Switzerland) and ProTaper (VDW, Munich, Germany)–for root canal preparation in primary molars. Materials and Methods: India ink was injected to 160 mesiobuccal and distal root canals of mandibular primary molars. The teeth were randomly divided into three experimental groups and one control group. In each experimental group, either manual instruments (K-files) or rotary instruments (Mtwo or ProTaper) were used to prepare root canals. After cleaning the canals and clearing the teeth, ink removal was evaluated with a stereomicroscope. Statistical analysis was done with Kruskal–Wallis and Friedman tests. Results: There were no significant differences in cleaning efficiency between manual and rotary instruments. Only ProTaper files performed significantly better in the coronal and middle thirds than in the apical third of the root canal. Conclusion: Manual K-files and the Mtwo and ProTaper rotary systems showed equally acceptable cleaning ability in primary molar root canals. PMID:22623929

  8. Advising on Preferred Reporting Items for patient-reported outcome instrument development: the PRIPROID.

    PubMed

    Hou, Zheng-Kun; Liu, Feng-Bin; Fang, Ji-Qian; Li, Xiao-Ying; Li, Li-Juan; Lin, Chu-Hua

    2013-03-01

    The reporting of patient-reported outcomes (PRO) instrument development is vital for both researchers and clinicians to determine its validity, thus, we propose the Preferred Reporting Items for PRO Instrument Development (PRIPROID) to improve the quality of reports. Abiding by the guidance published by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network, we had performed 6 steps for items development: identified the need for a guideline, performed a literature review, obtained funding for the guideline initiative, identified participants, conducted a Delphi exercise and generated a list of PRIPROID items for consideration at the face-to-face meeting. Twenty three items subheadings under 7 topics were included: title and structured abstract, rationale, objectives, intention, eligibility criteria, conceptual framework, items generation, response options, scoring, times, administrative modes, burden assessment, properties assessment, statistical methods, participants, main results, and additional analysis, summary of evidence, limitations, clinical attentions, and conclusions, item pools or final form, and funding. The PRIPROID contains many elements of the PRO research, and this assists researchers to report their results more accurately and to a certain degree use this instrument to evaluate the quality of the research methods.

  9. Quality of life of pediatric oncology patients: Do patient-reported outcome instruments measure what matters to patients?

    PubMed

    Anthony, Samantha J; Selkirk, Enid; Sung, Lillian; Klaassen, Robert J; Dix, David; Klassen, Anne F

    2017-02-01

    The assessment of quality of life (QOL) is key within pediatric oncology and requires a clearly defined construct of QOL. The purpose of our study was: (1) to conduct a qualitative study to inform the theoretical underpinnings of QOL and (2) to determine the appropriateness of patient-reported outcome (PRO) instruments to assess and evaluate QOL in pediatric cancer patients and survivors. The study used an interpretative description approach. Children diagnosed with childhood cancer, aged 8-18 years, were recruited from four Canadian hospitals. Semi-structured interviews were completed, transcribed verbatim and coded through methods of constant comparison. In-depth analysis facilitated a comparison between emerging themes and the content of commonly used PRO instruments. Thirty-seven children (19 females; 51 %) participated. The mean age was 13 years, and 19 (51 %) participants were post-treatment. Participant experiences reflected notions of positive and negative duality, including: maintaining physical functioning but longing for the ability to participate in activities; experiencing a new level of intimacy with family and friends amidst isolation; and developing positivity amidst anger, sadness and lingering worry. Analysis showed that existing PRO instruments are missing concerns specific to this population and contain content not reflective of the QOL experiences of childhood cancer patients and survivors. Our research highlights important problems with content validity of existing PRO scales, indicating that the tools we have to date have limited utility in research and clinical practice. The development of a new PRO instrument should be considered to ensure that content validity is achieved.

  10. Considering quality of life for children with cancer: a systematic review of patient-reported outcome measures and the development of a conceptual model.

    PubMed

    Anthony, Samantha J; Selkirk, Enid; Sung, Lillian; Klaassen, Robert J; Dix, David; Scheinemann, Katrin; Klassen, Anne F

    2014-04-01

    An appraisal of pediatric cancer-specific quality-of-life (QOL) instruments revealed a lack of clarity about what constitutes QOL in this population. This study addresses this concern by identifying the concepts that underpin the construct of QOL as determined by a content analysis of all patient-reported outcome (PRO) instruments used in childhood cancer research. A systematic review was performed of key databases (i.e., MEDLINE, CINAHL, PsychINFO) to identify studies of QOL in children with cancer. A content analysis process was used to code and categorize all items from generic and cancer-specified PRO instruments. Our objective was to provide clarification regarding the conceptual underpinnings of these instruments, as well as to help inform the development of theory and contribute to building a conceptual framework of QOL for children with cancer. A total of 6,013 English language articles were screened, identifying 148 studies. Ten generic and ten cancer-specific PRO instruments provided 957 items. Content analysis led to the identification of four major domains of QOL (physical, psychological, social, and general health), with 11 subdomains covering 98 different concepts. While all instruments reflected items relating to the broader domains of QOL, there was substantial heterogeneity in terms of the content and variability in the distribution of items. This systematic review and the proposed model represent a useful starting point in the critical appraisal of the conceptual underpinnings of PRO instruments used in pediatric oncology and contribute to the need to place such tools under a critical, yet reflective and analytical lens.

  11. Incorporating development of a patient-reported outcome instrument in a clinical drug development program: examples from a heart failure program.

    PubMed

    Wiklund, Ingela; Anatchkova, Milena; Oko-Osi, Hafiz; von Maltzahn, Robyn; Chau, Dina; Malik, Fady I; Patrick, Donald L; Spertus, John; Teerlink, John R

    2016-09-15

    Patient-reported outcome (PRO) measures can be used to support label claims if they adhere to US Food & Drug Administration guidance. The process of developing a new PRO measure is expensive and time-consuming. We report the results of qualitative studies to develop new PRO measures for use in clinical trials of omecamtiv mecarbil (a selective, small molecule activator of cardiac myosin) for patients with heart failure (HF), as well as the lessons learned from the development process. Concept elicitation focus groups and individual interviews were conducted with patients with HF to identify concepts for the instrument. Cognitive interviews with HF patients were used to confirm that no essential concepts were missing and to assess patient comprehension of the instrument and items. During concept elicitation, the most frequently reported HF symptoms were shortness of breath, tiredness, fluid retention, fatigue, dizziness/light-headedness, swelling, weight fluctuation, and trouble sleeping. Two measures were developed based on the concepts: the Heart Failure Symptom Diary (HF-SD) and the Heart Failure Impact Scale (HFIS). Findings from cognitive interviews suggested that the items in the HF-SD and HFIS were relevant and well understood by patients. Multiple iterations of concept elicitation and cognitive interviews were needed based on FDA request for a broader patient population in the qualitative study. Lessons learned from the omecamtiv mecarbil PRO/clinical development program are discussed, including challenges of qualitative studies, patient recruitment, expected and actual timelines, cost, and engagement with various stakeholders. Development of a new PRO measure to support a label claim requires significant investment and early planning, as demonstrated by the omecamtiv mecarbil program.

  12. Accounting for the effect of GERD symptoms on patients' health-related quality of life: supporting optimal disease management by primary care physicians.

    PubMed

    Flook, N W; Wiklund, I

    2007-12-01

    To review, from a primary care physician (PCP) perspective, the use of patient-reported outcome (PRO) instruments for assessment of gastro-oesophageal reflux disease (GERD) symptoms, their impact on health-related quality of life (HRQL) and the effectiveness of therapy. While generic and disease-specific PRO instruments have been used in the assessment of GERD, the latter can be considered to be more appropriate as they focus only on problems relevant to the disease in question (and therefore tend to be more responsive to change). Such instruments include the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire and the Gastrointestinal Symptom Rating Scale and the Reflux Disease Questionnaire (RDQ). Their use indicates that GERD symptoms are troublesome and significantly reduce patients' HRQL, and that effective treatment of GERD improves HRQL. The GERD Impact Scale (GIS) questionnaire, primarily developed for use within primary care, can also help to determine the impact of symptoms on patients' everyday lives and, in turn, the benefit of appropriately targeted therapy. Notably, these PRO instruments were developed from focus groups of GERD patients, and only aspects rated of highest importance are used in the final instruments. Consequently, PCPs can feel confident that these questionnaires encompass the most relevant points that they are likely to ask in terms of how symptoms affect patients' everyday lives. Primary care physicians are encouraged to make wider use of PRO instruments within routine practice to improve communication with their GERD patients that, in turn, could lead to improved clinical outcomes and greater patient satisfaction.

  13. [Deformation evaluation of ProTaper nickel-titanium rotary instruments in curved canals instrumentation in vitro].

    PubMed

    Yan, Hong; Ren, Min; Yin, Xing-Zhe; Zhao, Shu-Yan; Zhang, Cheng-Fei

    2008-04-01

    To evaluate the deformation of ProTaper rotary instruments using in root canals of different curvature in vitro. Extracted first mandibular molars were divided into two experimental groups according to the curvature of mesial buccal canals: group A with moderate curvature and group B with severe curvature. Only the mesial buccal canals of all these teeth were prepared with 6 sets of new ProTaper rotary instruments individually. Additionally, the control group was established with a set of new ProTaper rotary instruments. After finishing each canal preparation, the instruments accompanied by control were examined under the stereomicroscope by an inspector without knowing the group. If distortion, unwinding, abrasion or fracture occurred within one set of instruments, then the whole set was disposed. The sets without problems were in use until 30 times. After 5, 10, 20 times canal preparation, S1, F1 files without deformation under stereomicroscope were examined under scanning electron microscope (SEM). Deformation of ProTaper rotary instruments happened after 12 times in group A and after 7 times in group B. In these two experimental groups, microcracks were found increasing with the times of use under SEM in the instruments without deformation under stereomicroscope. The microcracks on tip of instruments were deep in the early use and became smoother after 10 times. Similar changes happened on knife-edge of instruments, and the microcracks extended over the edge after 20 times use. Root canals with severe curvature tend to damage ProTaper rotary instruments more frequently than moderately curved canals. ProTaper rotary instruments are appropriate to treat less than 7 root canals with severe curvature or 12 root canals with moderate curvature. Stereomicroscope is recommended to detect early damages on Ni-Ti rotary instruments, for preventing instruments fracture in clinic.

  14. Patient-Reported Outcome (PRO) Consortium translation process: consensus development of updated best practices.

    PubMed

    Eremenco, Sonya; Pease, Sheryl; Mann, Sarah; Berry, Pamela

    2017-01-01

    This paper describes the rationale and goals of the Patient-Reported Outcome (PRO) Consortium's instrument translation process. The PRO Consortium has developed a number of novel PRO measures which are in the process of qualification by the U.S. Food and Drug Administration (FDA) for use in clinical trials where endpoints based on these measures would support product labeling claims. Given the importance of FDA qualification of these measures, the PRO Consortium's Process Subcommittee determined that a detailed linguistic validation (LV) process was necessary to ensure that all translations of Consortium-developed PRO measures are performed using a standardized approach with the rigor required to meet regulatory and pharmaceutical industry expectations, as well as having a clearly defined instrument translation process that the translation industry can support. The consensus process involved gathering information about current best practices from 13 translation companies with expertise in LV, consolidating the findings to generate a proposed process, and obtaining iterative feedback from the translation companies and PRO Consortium member firms on the proposed process in two rounds of review in order to update existing principles of good practice in LV and to provide sufficient detail for the translation process to ensure consistency across PRO Consortium measures, sponsors, and translation companies. The consensus development resulted in a 12-step process that outlines universal and country-specific new translation approaches, as well as country-specific adaptations of existing translations. The PRO Consortium translation process will play an important role in maintaining the validity of the data generated through these measures by ensuring that they are translated by qualified linguists following a standardized and rigorous process that reflects best practice.

  15. Efficacy of ProTaper universal retreatment files in removing filling materials during root canal retreatment.

    PubMed

    Giuliani, Valentina; Cocchetti, Roberto; Pagavino, Gabriella

    2008-11-01

    The aim of this study was to evaluate the efficacy of the ProTaper Universal System rotary retreatment system and of Profile 0.06 and hand instruments (K-file) in the removal of root filling materials. Forty-two extracted single-rooted anterior teeth were selected. The root canals were enlarged with nickel-titanium (NiTi) rotary files, filled with gutta-percha and sealer, and randomly divided into 3 experimental groups. The filling materials were removed with solvent in conjunction with one of the following devices and techniques: the ProTaper Universal System for retreatment, ProFile 0.06, and hand instruments (K-file). The roots were longitudinally sectioned, and the image of the root surface was photographed. The images were captured in JPEG format; the areas of the remaining filling materials and the time required for removing the gutta-percha and sealer were calculated by using the nonparametric one-way Kruskal-Wallis test and Tukey-Kramer tests, respectively. The group that showed better results for removing filling materials was the ProTaper Universal System for retreatment files, whereas the group of ProFile rotary instruments yielded better root canal cleanliness than the hand instruments, even though there was no statistically significant difference. The ProTaper Universal System for retreatment and ProFile rotary instruments worked significantly faster than the K-file. The ProTaper Universal System for retreatment files left cleaner root canal walls than the K-file hand instruments and the ProFile Rotary instruments, although none of the devices used guaranteed complete removal of the filling materials. The rotary NiTi system proved to be faster than hand instruments in removing root filling materials.

  16. A systematic review of patient-reported outcome measures in clinical vestibular research

    PubMed Central

    Fong, Eric; Li, Carol; Aslakson, Rebecca; Agrawal, Yuri

    2014-01-01

    Objective To identify the most commonly-used patient-reported outcome (PRO) measures in clinical vestibular research, and assess their test characteristics and applicability to study age-related vestibular loss (ARVL) in clinical trials. Data Sources We performed a systematic review of the PubMed, CINAHL, and PsycINFO databases from 1950 to August 13, 2013. Study Selection PRO measures were defined as outcomes that capture the subjective experience of the patient, such as symptoms, functional status, health perceptions, and quality of life. Two independent reviewers selected studies that used PRO measures in clinical vestibular research. Disparities were resolved with consensus between the reviewers. Of 2260 articles initially found on literature search, 255 full-text articles were retrieved for assessment. One-hundred and four studies met inclusion criteria for data collection. Data Extraction PRO measures were identified by two independent reviewers. The four most commonly used PROs were evaluated for their applicability to the condition of ARVL. Specifically, for these four PROs, data were collected pertaining to instrument test-retest reliability, item domains, and target population of the instrument. Data Synthesis A total of 50 PRO instruments were identified. The four most frequently utilized PROs were the Dizziness Handicap Inventory (DHI), the Activities-specific Balance Confidence (ABC) scale, the Vertigo Symptom Scale (VSS), and the Visual Analogue Scale (VAS). Of these four PROs, three were validated for use in patients with vestibular disease, and one was validated in community-dwelling older individuals with balance impairments. Items across the four PROs were categorized into three domains based on the International Classification of Functioning, Disability and Health: Activity, Participation, and Body Functions and Structures. Conclusions None of the most commonly-used PRO instruments were validated for use in community-dwelling older adults specifically with ARVL. Nevertheless, the three common domains of items identified across these four PRO instruments may be generalizable to older adults and provide a basis for developing a PRO instrument designed to evaluate the effectiveness of interventions targeted to ARVL. PMID:25305629

  17. ProFile Vortex and Vortex Blue Nickel-Titanium Rotary Instruments after Clinical Use.

    PubMed

    Shen, Ya; Zhou, Huimin; Coil, Jeffrey M; Aljazaeri, Bassim; Buttar, Rene; Wang, Zhejun; Zheng, Yu-feng; Haapasalo, Markus

    2015-06-01

    The aim of this study was to analyze the incidence and mode of ProFile Vortex and Vortex Blue instrument defects after clinical use in a graduate endodontic program and to examine the impact of clinical use on the instruments' metallurgical properties. A total of 330 ProFile Vortex and 1136 Vortex Blue instruments from the graduate program were collected after each had been used in 3 teeth. The incidence and type of instrument defects were analyzed. The lateral surfaces and fracture surfaces of the fractured files were examined by using scanning electron microscopy. Unused and used instruments were examined by full and partial differential scanning calorimetry. No fractures were observed in the 330 ProFile Vortex instruments, whereas 20 (6.1%) revealed bent or blunt defects. Only 2 of the 1136 Vortex Blue files fractured during clinical use. The cause of fracture was shear stress. The fractures occurred at the tip end of the spirals. Only 1.8% (21 of 1136) of the Vortex Blue files had blunt tips. Austenite-finish temperatures were very similar for unused and used ProFile Vortex files and were all greater than 50°C. The austenite-finish temperatures of used and unused Vortex Blue files (38.5°C) were lower than those in ProFile Vortex instruments (P < .001). However, the transformation behavior of Vortex Blue files had an obvious 2-stage transformation, martensite-to-R phase and R-to-austenite phase. The trends of differential scanning calorimetry plots of unused Vortex Blue instruments and clinically used instruments were very similar. The risk of ProFile Vortex and Vortex Blue instrument fracture is very low when instruments are discarded after clinical use in the graduate endodontic program. The Vortex Blue files have metallurgical behavior different from ProFile Vortex instruments. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  18. Development and Validation of the ACSI: Measuring Students' Science Attitudes, Pro-Environmental Behaviour, Climate Change Attitudes and Knowledge

    ERIC Educational Resources Information Center

    Dijkstra, E. M.; Goedhart, M. J.

    2012-01-01

    This article describes the development and validation of the Attitudes towards Climate Change and Science Instrument. This 63-item questionnaire measures students' pro-environmental behaviour, their climate change knowledge and their attitudes towards school science, societal implications of science, scientists, a career in science and the urgency…

  19. Cultural adaptation: translatability assessment and linguistic validation of the patient-reported outcome instrument for irritable bowel syndrome with diarrhea.

    PubMed

    Delgado-Herrera, Leticia; Lasch, Kathryn; Popielnicki, Ana; Nishida, Akito; Arbuckle, Rob; Banderas, Benjamin; Zentner, Susan; Gagainis, Ingrid; Zeiher, Bernhardt

    2016-01-01

    Following a 2009 US Food and Drug Administration guidance, a new patient-reported outcome (PRO) instrument was developed to support end points in multinational clinical trials assessing irritable bowel syndrome with diarrhea (IBS-D) symptom severity. Our objective was to assess the translatability of the IBS-D PRO instrument into ten languages, and subsequently perform a cultural adaptation/linguistic validation of the questionnaire into Japanese and US Spanish. Translatability assessments of the US English version of the IBS-D PRO were performed by experienced PRO translators who were native speakers of each target language and currently residing in target-language countries. Languages were Chinese (People's Republic of China), Dutch (the Netherlands), French (Belgium), German (Germany), Japanese (Japan), Polish (Poland), Portuguese (Brazil), Russian (Russia), Spanish (Mexico), and Spanish (US). The project team assessed the instrument to identify potential linguistic and/or cultural adaptation issues. After the issues identified were resolved, the instrument was translated into Spanish (US) and Japanese through a process of two forward translations, one reconciled translation, and one backward translation. The project team reviewed the translated versions before the instruments were evaluated by cognitive debriefing interviews with samples of five Spanish (US) and five Japanese IBS-D patients. Linguistic and cultural adaptation concerns identified during the translatability assessment required minor revisions, mainly the presentation of dates/times and word structure. During the cognitive debriefing interviews, two of five Spanish respondents misunderstood the term "bowel movement" to mean only diarrhea in the Spanish version. Consequently, the term was changed from "movimiento intestinal" to "evacuaciones". None of the Japanese respondents identified issues with the Japanese version. The translatability of the IBS-D PRO instrument into ten target languages was confirmed, with only minor changes made to the translations of the instrument. The translation and linguistic validation into Spanish (US) and Japanese provide evidence that this instrument can be used in multinational trials and clinical settings.

  20. Comparison of cyclic fatigue resistance of three different rotary nickel-titanium instruments designed for retreatment.

    PubMed

    Inan, Ugur; Aydin, Cumhur

    2012-01-01

    A number of rotary nickel-titanium (NiTi) systems have been developed to provide better, faster, and easier cleaning and shaping of the root canal system, and recently, rotary NiTi systems designed for root canal retreatment have been introduced. Because the main problem with the rotary NiTi files is fracture, the aim of this study was to compare the cyclic fatigue resistance of 3 different rotary NiTi systems designed for root canal retreatment. Total of 60 instruments of 3 different rotary NiTi systems designed for root canal retreatment were used in this study. Twenty R-Endo R3, 20 ProTaper D3, and 20 Mtwo R (Retreatment) 25.05 instruments were tested. Cyclic fatigue testing of instruments was performed by using a device that allowed the instruments to rotate freely inside an artificial canal. Each instrument was rotated until fracture occurred, and the number of cycles to fracture for each instrument was calculated. Representative samples were also evaluated under a scanning electron microscope to confirm the fracture was flexural. Data were analyzed by using 1-way analysis of variance test. R-Endo R3 instruments showed better cyclic fatigue resistance than ProTaper D3 and Mtwo R 25.05 instruments, and the difference was statistically significant (P < .05). There was no significant difference between ProTaper D3 and Mtwo R 25.05 groups. The R-Endo R3 instruments were more resistant to fatigue failure than ProTaper D3 and Mtwo R 25.05. Copyright © 2012 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  1. Development and validation of the pro-environmental behaviour scale for women's health.

    PubMed

    Kim, HyunKyoung

    2017-05-01

    This study was aimed to develop and test the Pro-environmental Behavior Scale for Women's Health. Women adopt sustainable behaviours and alter their life styles to protect the environment and their health from environmental pollution. The conceptual framework of pro-environmental behaviours was based on Rogers' protection motivation theory and Weinstein's precaution adoption process model. The cross-sectional design was used for instrument development. The instrument development process consisted of a literature review, personal depth interviews and focus group interviews. The sample comprised 356 adult women recruited in April-May 2012 in South Korea using quota sampling. For construct validity, exploratory factor analysis was conducted to examine the factor structure, after which convergent and discriminant validity and known-group comparisons were tested. Principal component analysis yielded 17 items with four factors, including 'women's health protection,' 'chemical exposure prevention,' 'alternative consumption,' and 'community-oriented behaviour'. The Cronbach's α was 0·81. Convergent and discriminant validity were supported by performing correlations with other environmental-health and health-behaviour measures. Nursing professionals can reliably use the instrument to assess women's behaviours, which protect their health and the environment. © 2016 John Wiley & Sons Ltd.

  2. Application of nondestructive testing in cyclic fatigue evaluation of endodontic Ni-Ti rotary instruments.

    PubMed

    Li, Uei-Ming; Shin, Chow-Shing; Lan, Wan-Hong; Lin, Chun-Pin

    2006-06-01

    The purpose of this study was to investigate the application of nondestructive testing in cyclic fatigue evaluation of endodontic ProFile nickel-titanium (NiTi) rotary instruments. As-received ProFile instruments were made to rotate freely in sloped metal blocks by a contra-angle handpiece mounted on a testing machine. Rotation was interrupted periodically, and the instrument removed and engaged onto a device to monitor its stiffness by using two strain gauges in four different directions. This monitoring method has the potential to be developed into a convenient, nondestructive turnkey system that allows in situ assessment of the integrity of NiTi instruments in the clinic. Upon fracture, which was indicated by a change in instrument stiffness, the fractured surface would be examined under a scanning electron microscope. Microscopic evaluation indicated a small area of fatigue fracture with a large area of final ductile fracture, whereby the latter was the major cyclic failure mode. Based on the results of this study, we concluded that a potential nondestructive integrity assessment method for NiTi rotary instruments was developed.

  3. Qualitative modification and development of patient- and caregiver-reported outcome measures for iron chelation therapy.

    PubMed

    Horodniceanu, Erica G; Bal, Vasudha; Dhatt, Harman; Carter, John A; Huang, Vicky; Lasch, Kathryn

    2017-06-23

    Compliance, palatability, gastrointestinal (GI) symptom, and treatment satisfaction patient- and observer-reported outcome (PRO, ObsRO) measures were developed/modified for patients with transfusion-dependent anemias or myelodysplastic syndrome (MDS) requiring iron chelation therapy (ICT). This qualitative cross-sectional observational study used grounded theory data collection and analysis methods and followed PRO/ObsRO development industry guidance. Patients and caregivers of patients with transfusion-dependent anemias or MDS were individually interviewed face-to-face to cognitively debrief the Compliance, Palatability, GI Symptom Diary, and Modified Satisfaction with Iron Chelation Therapy (SICT) instruments presented electronically. Interviews were conducted in sets. Interviews began open-endedly to spontaneously elicit ICT experiences. Item modifications were debriefed during the later interviews. Interviews were audio recorded, transcribed, and coded. Data was analyzed using ATLAS.ti qualitative research software. Twenty-one interviews were completed (Set 1: 5 patients, 6 caregivers; Set 2: 6 patients, 4 caregivers) in 6 US cities. Mean age was 43 years for patients and 9 years for children of caregivers. Conditions requiring ICT use across groups included transfusion-dependent anemias (85.7%) and MDS (14.3%). Concepts spontaneously reported were consistent with instruments debriefed. Interview analysis resulted in PRO and ObsRO versions of each instrument: Compliance (2 items), Palatability (4 items), GI Symptom Diary (6 items), and Modified SICT (PRO = 13, ObsRO = 17 items). Qualitative research data from cognitive interviews supports the content validity and relevance of the instruments developed/modified. Quantitative validation of these PRO and ObsRO measures is needed testing for validity, reliability, and responsiveness for future research use with new formulations of oral ICT.

  4. Development of the PRO-SDLS: A Measure of Self-Direction in Learning Based on the Personal Responsibility Orientation Model

    ERIC Educational Resources Information Center

    Stockdale, Susan L.; Brockett, Ralph G.

    2011-01-01

    The purpose of this study was to develop a reliable and valid instrument to measure self-directedness in learning among college students based on an operationalization of the personal responsibility orientation (PRO) model of self-direction in learning. The resultant 25-item Personal Responsibility Orientation to Self-Direction in Learning Scale…

  5. The efficacy of ProTaper Universal rotary retreatment instrumentation to remove single gutta-percha cones cemented with several endodontic sealers.

    PubMed

    Ersev, H; Yilmaz, B; Dinçol, M E; Dağlaroğlu, R

    2012-08-01

    To evaluate residual root filling material following removal of three newly developed root canal sealers used with a matched-taper single-cone root filling technique and to compare the efficacy of ProTaper Universal rotary retreatment instruments with that of a conventional manual technique. The canals of 120 palatal roots in maxillary molar teeth were instrumented with EndoWave nickel-titanium rotary instruments and filled using Hybrid Root SEAL, EndoSequence BC Sealer, Activ GP system or AH Plus with matched-taper single gutta-percha cones. The root fillings were then removed with ProTaper Universal retreatment rotary instruments or a manual technique. Buccolingual and proximal digital radiographs of the roots were exposed to determine the area of remaining filling material in the coronal, middle and apical thirds. The area percentages of remaining filling material in each third and total canal area were calculated. Data were analysed statistically with Kruskal-Wallis and Mann-Whitney U-tests. The level of significance was set at P<0.05. Irrespective of the sealer type and retreatment technique, filling material could not be removed completely from the root canals. Significantly, more remaining filling material was observed in the apical third (P<0.05). When comparing the sealers, the only significant difference was detected between AH Plus/manual and Activ GP/manual groups with respect to residual material in the total canal area (P<0.05). There were no significant differences between manual and ProTaper groups. When using gross radiographic criteria, the Activ GP was more effectively removed from root canals than AH Plus with hand instrumentation. Hybrid Root SEAL, EndoSequence BC Sealer and AH Plus were removed to a similar extent. ProTaper Universal retreatment instruments were as safe and effective as hand instruments in reaching the working length. © 2012 International Endodontic Journal.

  6. Shaping ability and safety of five different rotary nickel-titanium instruments compared with stainless steel hand instrumentation in simulated curved root canals.

    PubMed

    Schirrmeister, Jörg F; Strohl, Christian; Altenburger, Markus J; Wrbas, Karl-Thomas; Hellwig, Elmar

    2006-06-01

    To compare the shaping ability and safety of engine-driven FlexMaster, GT Rotary, ProFile, ProTaper, and RaCe rotary instrumentation and Hedström hand instrumentation in simulated root canals. One hundred fifty simulated colored root canals with a curvature of 20 degrees and a radius of 10 mm were randomly distributed among 6 groups of 25 specimens each. After preparation to apical size 30 the area of remaining color on the canal wall indicating unprepared areas was measured in mm2 using image analyzer software. Specimens treated with RaCe left least areas of remaining color compared to all other groups (P < .001), followed by ProTaper. Preparation with ProFile left behind the highest amount of unprepared areas. The ProFile group revealed significantly more remaining color than ProTaper, GT Rotary, and FlexMaster (P < .05). Four FlexMaster files separated. RaCe rotary files were safe and more effective compared to the other instruments.

  7. The development of a patient-reported outcome measure for assessing nighttime symptoms of chronic obstructive pulmonary disease.

    PubMed

    Hareendran, Asha; Palsgrove, Andrew C; Mocarski, Michelle; Schaefer, Michael L; Setyawan, Juliana; Carson, Robyn; Make, Barry

    2013-06-25

    The assessment of symptoms of chronic obstructive pulmonary disease (COPD) is important for monitoring and managing the disease and for evaluating outcomes of interventions. COPD patients experience symptoms during the day and night, and symptoms experienced at night often disturb sleep. The aim of this paper is to describe methods used to develop a patient-reported outcome (PRO) instrument for evaluating nighttime symptoms of COPD, and to document evidence for the content validity of the instrument. Literature review and clinician interviews were conducted to inform discussion guides to explore patients' nighttime COPD symptom experience. Data from focus groups with COPD patients was used to develop a conceptual framework and the content of a new PRO instrument. Patient understanding of the new instrument was assessed via cognitive interviews with COPD patients. The literature review confirmed that there is no instrument with evidence of content validity currently available to assess nighttime symptoms of COPD. Additionally, the literature review and clinician interviews suggested the need to understand patients' experience of specific symptoms in order to evaluate nighttime symptoms of COPD. Analyses of patient focus group data (N = 27) supported saturation of concepts and aided in development of a conceptual framework. Items were generated using patients' terminology to collect data on concepts in the framework including the occurrence and severity of COPD symptoms, use of rescue medication at night, and nocturnal awakening. Response options were chosen to reflect concepts that were salient to patients. Subsequent cognitive interviewing with ten COPD patients demonstrated that the items, response options, recall period, and instructions were understandable, relevant, and interpreted as intended. A new PRO instrument, the Nighttime Symptoms of COPD Instrument (NiSCI), was developed with documented evidence of content validity. The NiSCI is ready for empirical testing, including item reduction and evaluation of psychometric properties.

  8. Development and Validation of a Symptom-Based Activity Index for Adults with Eosinophilic Esophagitis

    PubMed Central

    Schoepfer, Alain M.; Straumann, Alex; Panczak, Radoslaw; Coslovsky, Michael; Kuehni, Claudia E.; Maurer, Elisabeth; Haas, Nadine A.; Romero, Yvonne; Hirano, Ikuo; Alexander, Jeffrey A.; Gonsalves, Nirmala; Furuta, Glenn T.; Dellon, Evan S.; Leung, John; Collins, Margaret H.; Bussmann, Christian; Netzer, Peter; Gupta, Sandeep K.; Aceves, Seema S.; Chehade, Mirna; Moawad, Fouad J.; Enders, Felicity T.; Yost, Kathleen J.; Taft, Tiffany H.; Kern, Emily; Zwahlen, Marcel; Safroneeva, Ekaterina

    2015-01-01

    BACKGROUND & AIMS Standardized instruments are needed to assess the activity of eosinophilic esophagitis (EoE), to provide endpoints for clinical trials and observational studies. We aimed to develop and validate a patient-reported outcome (PRO) instrument and score, based on items that could account for variations in patients’ assessments of disease severity. We also evaluated relationships between patients’ assessment of disease severity and EoE-associated endoscopic, histologic, and laboratory findings. METHODS We collected information from 186 patients with EoE in Switzerland and the US (69.4% male; median age, 43 years) via surveys (n = 135), focus groups (n = 27), and semi-structured interviews (n = 24). Items were generated for the instruments to assess biologic activity based on physician input. Linear regression was used to quantify the extent to which variations in patient-reported disease characteristics could account for variations in patients’ assessment of EoE severity. The PRO instrument was prospectively used in 153 adult patients with EoE (72.5% male; median age, 38 years), and validated in an independent group of 120 patients with EoE (60.8% male; median age, 40.5 years). RESULTS Seven PRO factors that are used to assess characteristics of dysphagia, behavioral adaptations to living with dysphagia, and pain while swallowing accounted for 67% of the variation in patients’ assessment of disease severity. Based on statistical consideration and patient input, a 7-day recall period was selected. Highly active EoE, based on endoscopic and histologic findings, was associated with an increase in patient-assessed disease severity. In the validation study, the mean difference between patient assessment of EoE severity and PRO score was 0.13 (on a scale from 0 to 10). CONCLUSIONS We developed and validated an EoE scoring system based on 7 PRO items that assesses symptoms over a 7-day recall period. Clinicaltrials.gov number: NCT00939263. PMID:25160980

  9. University Students' Conceptual Knowledge of Randomness and Probability in the Contexts of Evolution and Mathematics.

    PubMed

    Fiedler, Daniela; Tröbst, Steffen; Harms, Ute

    2017-01-01

    Students of all ages face severe conceptual difficulties regarding key aspects of evolution-the central, unifying, and overarching theme in biology. Aspects strongly related to abstract "threshold" concepts like randomness and probability appear to pose particular difficulties. A further problem is the lack of an appropriate instrument for assessing students' conceptual knowledge of randomness and probability in the context of evolution. To address this problem, we have developed two instruments, Ra ndomness and Pro bability Test in the Context of Evo lution (RaProEvo) and Ra ndomness and Pro bability Test in the Context of Math ematics (RaProMath), that include both multiple-choice and free-response items. The instruments were administered to 140 university students in Germany, then the Rasch partial-credit model was applied to assess them. The results indicate that the instruments generate reliable and valid inferences about students' conceptual knowledge of randomness and probability in the two contexts (which are separable competencies). Furthermore, RaProEvo detected significant differences in knowledge of randomness and probability, as well as evolutionary theory, between biology majors and preservice biology teachers. © 2017 D. Fiedler et al. CBE—Life Sciences Education © 2017 The American Society for Cell Biology. This article is distributed by The American Society for Cell Biology under license from the author(s). It is available to the public under an Attribution–Noncommercial–Share Alike 3.0 Unported Creative Commons License (http://creativecommons.org/licenses/by-nc-sa/3.0).

  10. Evaluation of Root Canal Cleaning and Shaping Efficacy of Three Engine-driven Instruments: SafeSider, ProTaper Universal and Lightspeed LSX.

    PubMed

    Wigler, Ronald; Koren, Tal; Tsesis, Igor

    2015-11-01

    To compare the cleaning effectiveness and shaping ability of SafeSider, ProTaper Universal and Lightspeed rotary instruments during the preparation of curved root canals in extracted human teeth. A total of 63 roots with curved root canals were divided into three groups. Canals were prepared using SafeSider, ProTaper Universal or Lightspeed LSX. Using pre- and post-instrumentation radiographs, straightening of the canal curvatures and loss of working length were determined with a computer image analysis program. The amounts of debris at the apical 5 mm were quantified on the basis of a numerical evaluation scale. The data were analyzed statistically using the two-way analysis of variance (ANOVA). There was significantly more transportation among the Lightspeed LSX group compared to the SafeSider and ProTaper Universal groups only at the 4 mm level (p < 0.05). The ProTaper Universal instruments performed significantly faster than other groups. No significant differences were observed between the three engine-driven instruments with regards to debris removal. SafeSider, ProTaper Universal and Lightspeed LSX rotary instruments maintained the original canal curvature well at the apical 3 mm and were safe to use. No difference was found in cleaning efficacy and none rendered the apical part of the canal free of debris. SafeSider, ProTaper Universal and Lightspeed LSX rotary instruments are safe to use in curved root canals.

  11. Efficacy of Twisted File Adaptive, Reciproc and ProTaper Universal Retreatment instruments for root-canal-filling removal: A cone-beam computed tomography study.

    PubMed

    Akbulut, Makbule Bilge; Akman, Melek; Terlemez, Arslan; Magat, Guldane; Sener, Sevgi; Shetty, Heeresh

    2016-01-01

    The aim of this study was to evaluate the efficacy of Twisted File (TF) Adaptive, Reciproc, and ProTaper Universal Retreatment (UR) System instruments for removing root-canal-filling. Sixty single rooted teeth were decoronated, instrumented and obturated. Preoperative CBCT scans were taken and the teeth were retreated with TF Adaptive, Reciproc, ProTaper UR, or hand files (n=15). Then, the teeth were rescanned, and the percentage volume of the residual root-canal-filling material was established. The total time for retreatment was recorded, and the data was statistically analyzed. The statistical ranking of the residual filling material volume was as follows: hand file=TF Adaptive>ProTaper UR=Reciproc. The ProTaper UR and Reciproc systems required shorter periods of time for retreatment. Root canal filling was more efficiently removed by using Reciproc and ProTaper UR instruments than TF Adaptive instruments and hand files. The TF Adaptive system was advantageous over hand files with regard to operating time.

  12. Cultural adaptation: translatability assessment and linguistic validation of the patient-reported outcome instrument for irritable bowel syndrome with diarrhea

    PubMed Central

    Delgado-Herrera, Leticia; Lasch, Kathryn; Popielnicki, Ana; Nishida, Akito; Arbuckle, Rob; Banderas, Benjamin; Zentner, Susan; Gagainis, Ingrid; Zeiher, Bernhardt

    2016-01-01

    Background and objective Following a 2009 US Food and Drug Administration guidance, a new patient-reported outcome (PRO) instrument was developed to support end points in multinational clinical trials assessing irritable bowel syndrome with diarrhea (IBS-D) symptom severity. Our objective was to assess the translatability of the IBS-D PRO instrument into ten languages, and subsequently perform a cultural adaptation/linguistic validation of the questionnaire into Japanese and US Spanish. Materials and methods Translatability assessments of the US English version of the IBS-D PRO were performed by experienced PRO translators who were native speakers of each target language and currently residing in target-language countries. Languages were Chinese (People’s Republic of China), Dutch (the Netherlands), French (Belgium), German (Germany), Japanese (Japan), Polish (Poland), Portuguese (Brazil), Russian (Russia), Spanish (Mexico), and Spanish (US). The project team assessed the instrument to identify potential linguistic and/or cultural adaptation issues. After the issues identified were resolved, the instrument was translated into Spanish (US) and Japanese through a process of two forward translations, one reconciled translation, and one backward translation. The project team reviewed the translated versions before the instruments were evaluated by cognitive debriefing interviews with samples of five Spanish (US) and five Japanese IBS-D patients. Results Linguistic and cultural adaptation concerns identified during the translatability assessment required minor revisions, mainly the presentation of dates/times and word structure. During the cognitive debriefing interviews, two of five Spanish respondents misunderstood the term “bowel movement” to mean only diarrhea in the Spanish version. Consequently, the term was changed from “movimiento intestinal” to “evacuaciones”. None of the Japanese respondents identified issues with the Japanese version. Conclusion The translatability of the IBS-D PRO instrument into ten target languages was confirmed, with only minor changes made to the translations of the instrument. The translation and linguistic validation into Spanish (US) and Japanese provide evidence that this instrument can be used in multinational trials and clinical settings. PMID:27382346

  13. Comparative study of ProTaper gold, reciproc, and ProTaper universal for root canal preparation in severely curved root canals

    PubMed Central

    Arslan, Hakan; Yildiz, Ezgi Doganay; Gunduz, Hicran Ates; Sumbullu, Meltem; Bayrakdar, Ibrahim Sevki; Karatas, Ertugrul; Sumbullu, Muhammed Akif

    2017-01-01

    Aim: The aim of this study is to evaluate the root canal transportation, centering ability, and instrumentation times with the ProTaper Gold (Dentsply Tulsa Dental, Tulsa, OK, USA), Reciproc (VDW, Munich, Germany), and ProTaper Universal (Dentsply Maillefer, Ballaigues, Switzerland) using cone-beam computed tomography (CBCT). Materials and Methods: Thirty mesial root canals of mandibular first molars with curvature angles of 35°–70° and radii of 2–6 mm were included in the study. Root canal instrumentation was performed up to F2 or R25. The instrumentation times were recorded. CBCT scanning was performed both pre- and post-instrumentation. Root canal transportation and the centering ratio were calculated for groups, and the data were analyzed using a one-way ANOVA and least significant difference post hoc tests for the instrumentation time, root canal transportation, and centering ratio at the 95% confidence level (P = 0.05). Results: At 3, 5, and 7 mm levels, there was no significant difference in the root canal transportation and centering ratio among the groups (P > 0.05). There were significant differences between the Reciproc and ProTaper Universal groups in the instrumentation times (P < 0.05). Conclusion: Root canal transportation and the centering ratio with the ProTaper Gold were similar to those obtained with the ProTaper Universal and Reciproc. PMID:29259355

  14. University Students’ Conceptual Knowledge of Randomness and Probability in the Contexts of Evolution and Mathematics

    PubMed Central

    Fiedler, Daniela; Tröbst, Steffen; Harms, Ute

    2017-01-01

    Students of all ages face severe conceptual difficulties regarding key aspects of evolution—the central, unifying, and overarching theme in biology. Aspects strongly related to abstract “threshold” concepts like randomness and probability appear to pose particular difficulties. A further problem is the lack of an appropriate instrument for assessing students’ conceptual knowledge of randomness and probability in the context of evolution. To address this problem, we have developed two instruments, Randomness and Probability Test in the Context of Evolution (RaProEvo) and Randomness and Probability Test in the Context of Mathematics (RaProMath), that include both multiple-choice and free-response items. The instruments were administered to 140 university students in Germany, then the Rasch partial-credit model was applied to assess them. The results indicate that the instruments generate reliable and valid inferences about students’ conceptual knowledge of randomness and probability in the two contexts (which are separable competencies). Furthermore, RaProEvo detected significant differences in knowledge of randomness and probability, as well as evolutionary theory, between biology majors and preservice biology teachers. PMID:28572180

  15. Pediatric patient-reported outcome instruments for research to support medical product labeling: report of the ISPOR PRO good research practices for the assessment of children and adolescents task force.

    PubMed

    Matza, Louis S; Patrick, Donald L; Riley, Anne W; Alexander, John J; Rajmil, Luis; Pleil, Andreas M; Bullinger, Monika

    2013-06-01

    Patient-reported outcome (PRO) instruments for children and adolescents are often included in clinical trials with the intention of collecting data to support claims in a medical product label. The purpose of the current task force report is to recommend good practices for pediatric PRO research that is conducted to inform regulatory decision making and support claims made in medical product labeling. The recommendations are based on the consensus of an interdisciplinary group of researchers who were assembled for a task force associated with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). In those areas in which supporting evidence is limited or in which general principles may not apply to every situation, this task force report identifies factors to consider when making decisions about the design and use of pediatric PRO instruments, while highlighting issues that require further research. Five good research practices are discussed: 1) Consider developmental differences and determine age-based criteria for PRO administration: Four age groups are discussed on the basis of previous research (<5 years old, 5-7 years, 8-11 years, and 12-18 years). These age groups are recommended as a starting point when making decisions, but they will not fit all PRO instruments or the developmental stage of every child. Specific age ranges should be determined individually for each population and PRO instrument. 2) Establish content validity of pediatric PRO instruments: This section discusses the advantages of using children as content experts, as well as strategies for concept elicitation and cognitive interviews with children. 3) Determine whether an informant-reported outcome instrument is necessary: The distinction between two types of informant-reported measures (proxy vs. observational) is discussed, and recommendations are provided. 4) Ensure that the instrument is designed and formatted appropriately for the target age group. Factors to consider include health-related vocabulary, reading level, response scales, recall period, length of instrument, pictorial representations, formatting details, administration approaches, and electronic data collection (ePRO). 5) Consider cross-cultural issues. Additional research is needed to provide methodological guidance for future studies, especially for studies involving young children and parents' observational reports. As PRO data are increasingly used to support pediatric labeling claims, there will be more information regarding the standards by which these instruments will be judged. The use of PRO instruments in clinical trials and regulatory submissions will help ensure that children's experience of disease and treatment are accurately represented and considered in regulatory decisions. Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  16. A comparative scanning electron microscopic study of the effect of three different rotary instruments on smear layer formation.

    PubMed

    Shahi, Shahriar; Yavari, Hamid R; Rahimi, Saeed; Reyhani, Mohammad F; Kamarroosta, Zahra; Abdolrahimi, Majid

    2009-03-01

    The aim of this study was to evaluate the effect of RaCe, FlexMaster and ProFile rotary instruments on smear layer formation by scanning electron microscopy. Eighty-four caries-free freshly extracted human single-rooted teeth were selected and divided into three groups, each containing 28 teeth. The teeth were instrumented with rotary instruments sequentially: Group A: ProFile Rotary Instruments; Group B: FlexMaster Rotary Instruments; and Group C: RaCe Rotary Instruments. Instrumentation was performed by the crown-down method and according to the manufacturer's instructions. The specimens were then examined with SEM according to Hülsmann's classification. One-way ANOVA and a post hoc Tukey test were used for statistical analysis. The results showed that there were no statistically significant differences among the three groups in the coronal third (P = 0.39), but at the apical and middle thirds there were statistically significant differences between the RaCe group and the other groups (P < 0.05). Smear layer in the RaCe group was less than that in the ProFile and FlexMaster groups, but the difference between the ProFile group and FlexMaster group was not statistically significant (P > 0.05). It was concluded that RaCe Rotary Instruments produce less smear layer than FlexMaster and ProFile Rotary Instruments.

  17. A comparative evaluation of cleaning efficacy (debris and smear layer removal) of hand and two NiTi rotary instrumentation systems (K3 and ProTaper): a SEM study.

    PubMed

    Reddy, K Balakoti; Dash, Shreemoy; Kallepalli, Sowmya; Vallikanthan, Sangeetha; Chakrapani, N; Kalepu, Vamsi

    2013-11-01

    The present study was conducted to compare the cleaning efficacy (debris and smear layer removal) of hand and two NiTi rotary instrumentation systems (K3 and ProTaper). Sixty single rooted human maxillary anterior teeth decoronated at the cementoenamel junction were used. All the specimens were divided into four groups of 15 teeth each, group I--ProTaper rotary instrumentation done, group II--K3 rotary instrumentation done, group III--Stainless steel K-file instrumentation done, group IV--root canal irrigation without instrumentation. Root canal preparation was done in a crown down manner and 3% sodium hypochlorite was used as irrigant after each file followed by final rinse with 5 ml of 17% EDTA solution, then specimens were scanning electron microscopic (SEM) examination. Statistical analysis was done using one-way ANOVA followed by post hoc Tukey's HSD test. Group I showed highly statistical significant difference compared to other groups. There was no statistically significant difference considering smear layer at any levels among the groups with no smear layer formation in group IV. ProTaper rotary instrumentation showed the maximum cleaning efficacy followed by K3 rotary instrumentation in the coronal, middle and apical thirds of the root canal. ProTaper rotary instruments are more efficient than hand and K3 rotary instruments during root canal treatment.

  18. Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier.

    PubMed

    Revicki, Dennis A; Gnanasakthy, Ari; Weinfurt, Kevin

    2007-05-01

    The Food and Drug Administration (FDA) and European Medicines Agency (EMEA) are willing to consider including information on patient reported outcomes (PROs) in product labeling and advertising. Pharmaceutical industry researchers must provide sufficient evidence supporting PRO benefit before an approval may be granted. This report describes the purpose and content of a PRO Evidence Dossier, which consists of important information supporting PRO claims. The dossier should be completed by pharmaceutical industry or other researchers to document the planning of the PRO assessment strategy, psychometric evidence, desired target labeling statements, and the clinical trial evidence of PRO benefits. The systematic reporting and documentation of information on the rationale for including PROs, rationale for the selection of specific PRO instruments, evidence on the psychometric qualities of the PRO measures, and guidelines for interpreting PRO findings will facilitate achieving a PRO labeling or promotional claim. Combining all the relevant information into a single document will facilitate the review and evaluation process for clinical and regulatory reviewers. The PRO Evidence Dossier may also be helpful to industry and academic researchers in identifying further information that will need to be developed to support the clinical development program and the PRO endpoints.

  19. [Comparison of the shaping ability of three Ni-Ti rotary instruments in the preparation of simulated curved root canals].

    PubMed

    Qiu, Ning; Wang, Chu-yu; Liu, Yu-fei; Yu, Xiao-qing; Xue, Ming

    2016-04-01

    To compare the shaping ability of three rotary Ni-Ti instruments in simulated root canals. A total of 30 simulated resin blocks were divided randomly into 3 groups: ProTaper Universal, ProTaper Next and TF Adaptive. Each group consisted of 10 root canals. The preparation time and changes in canal curvature were measured. Pre- and post-instrumentation photograghs were taken by precise camera and superimposed through Photoshop. The material removed from the inner and outer canal walls at 9 points beginning at 0 mm from the foramen were measured with Image Pro Plus. Centering ability was determined accordingly. The data was analyzed with SPSS13.0 software package. During root canal preparation, no instruments fractured. ProTaper Next was much faster than ProTaper Universal(P<0.05). At the apical curvature, transportation was the least with TF Adaptive, followed by Protaper Next (P<0.05). There were no significant differences in 3 groups with respect to coronal curvature transportation (P>0.05). Under the conditions of this study, ProTaper Next was the most efficient instrument. TF Adaptive and Protaper Next showed better shaping ability. In general, all the instruments respected original canal curvature well and were safe to be used.

  20. Patient-Reported Outcome Measures in Dysphagia: A Systematic Review of Instrument Development and Validation

    PubMed Central

    Patel, Dhyanesh A.; Sharda, Rohit; Hovis, Kristen L.; Nichols, Erin E.; Sathe, Nila; Penson, David F.; Feurer, Irene D.; McPheeters, Melissa L.; Vaezi, Michael F.; Francis, David O.

    2017-01-01

    Objective Patient-reported outcome (PRO) measures are commonly used to capture patient experience with dysphagia and to evaluate treatment effectiveness. Inappropriate application can lead to distorted results in clinical studies. A systematic review of the literature on dysphagia-related PRO measures was performed to 1) identify all currently available measures and 2) to evaluate each for the presence of important measurement properties that would affect their applicability. Design MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument database were searched using relevant vocabulary terms and key terms related to PRO measures and dysphagia. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed multiple domains: 1) conceptual model, 2) content validity, 3) reliability, 4) construct validity, 6) scoring and interpretation, and 7) burden and presentation. Results Of 4950 abstracts reviewed, a total of 34 dysphagia-related PRO measures (publication year 1987 – 2014) met criteria for extraction and analysis. Several PRO measures were of high quality (MADS for achalasia, SWAL-QOL and SSQ for oropharyngeal dysphagia, PROMIS-GI for general dysphagia, EORTC-QLQ-OG25 for esophageal cancer, ROMP-swallowing for Parkinson’s disease, DSQ-EoE for eosinophilic esophagitis, and SOAL for total laryngectomy-related dysphagia). In all, 17 met at least one criterion per domain. Thematic deficiencies in current measures were evident including: 1) direct patient involvement in content development, 2) empirically justified dimensionality, 3) demonstrable responsiveness to change, 4) plan for interpreting missing responses, and 5) literacy level assessment. Conclusion This is the first comprehensive systematic review assessing developmental properties of all available dysphagia-related PRO measures. We identified several instruments with robust measurement properties in multiple diseases including achalasia, oropharyngeal dysphagia, post-surgical dysphagia, esophageal cancer, and dysphagia related to neurological diseases. Findings herein can assist clinicians and researchers in making more informed decisions in selecting the most fundamentally sound PRO measure for a given clinical, research, or quality initiative. PMID:28375450

  1. Failure of ProTaper rotary Ni-Ti instruments used by undergraduate students

    PubMed Central

    Duran-Sindreu, Fernando; Morello-Castro, Sergio; Mercade-Bellido, Montserrat; Bueno-Martínez, Rufino; Roig-Cayón, Miguel

    2012-01-01

    Objective: To evaluate the effect of number of uses, angle and radius of curvature and type of instrument on the fracture of ProTaper rotary instruments when used by undergraduate students. Study Design: Three hundred and seventy-six molars, with a total of 1114 root canals, extracted were instrumented by undergraduate students using ProTaper instruments according to the manufacturer´s recommendations. When fracture occurred, data were collected concerning the number of uses, type of instrument, level of fracture, angle and radius of curvature. ANOVA test were used to determine the influence of type of instrument in the incidence of instrument fracture. Logistic regression model was used to determine the influence of number of uses, angle and radius of curvature in the incidence of instrument fracture. Significance was set at p< 0.05. Results: A total of 37 Ni-Ti rotary instruments fractured during the treatment. Fracture occurred in 9.84% (37/376) of the teeth treated and 3.32% of the canals prepared with Ni-Ti rotary instruments (37/1114). A decrease in the radius of curvature of the canal significantly increased the likelihood of fracture (p=0.0001). Instrument fracture significantly increased as the number of uses increased (p=0.0037). No significant differences were found between the 6 types of ProTaper instruments (p=0.8). A reduction in the angle of curvature did not produce a significant decrease in the incidence of instrument separation (p=0.08). Conclusions: The results of this study imply that instrument fracture is linked to radius of curvature and number of uses. Key words:Fracture, ProTaper ®, root canal preparation, undergraduate students. PMID:24558555

  2. Analysis of defects in ProTaper hand-operated instruments after clinical use.

    PubMed

    Shen, Ya; Bian, Zhuan; Cheung, Gary Shun-pan; Peng, Bin

    2007-03-01

    The purpose of this study was to analyze the type and location of defects observed in ProTaper for Hand Use (PHU) instruments after routine clinical use. We analyzed a total of 401 PHUs discarded from an endodontic clinic over a 17-month period. Those failed instruments were examined on the lateral and fractographic surface by scanning electron microscope. Of the 86 PHUs that showed discernible defects, 28 were intact but partially unwound, and 58 were fractured (36 because of shear and 22 from fatigue failure). The primary characteristic of shear failure was the presence of a skewed dimple and/or tear ridge, a typical pattern developed because of a combination of various loads. Nearly 74% of the instruments with defects exhibited shear damage. About three-quarters of the instrument fractures occurred in the apical one-third of the canal, mostly in molars. The results of this study indicated that most PHU instruments fail because of either shear or fatigue.

  3. Comparative evaluation of the shaping ability of two different nickel-titanium rotary files in curved root canals of extracted human molar teeth.

    PubMed

    Ferrara, Giulia; Taschieri, Silvio; Corbella, Stefano; Ceci, Caterina; Del Fabbro, Massimo; Machtou, Pierre

    2017-02-01

    The aim of the present study was to compare the shaping ability of two different nickel-titanium rotary files in the curved root canals of extracted human molar teeth. Thirty root canals of 17 extracted human molars teeth were randomly assigned to two experimental groups (n = 15): ProTaper Next and ProTaper Universal (PTU), on the basis of the rotary files system used. The final size of all apical foramina was 0.25 mm in diameter. Standardized digital radiographs were taken before and after instrumentation in both clinical and proximal views, with a size 10 K-file inserted into the canal for the determination of the angle of curvature and apical transportation. Preparation time and fractured or deformed instruments were also recorded. The unpaired Student's t-test was used to compare results. There was no significant difference between the two instruments with respect to canal straightening and apical transportation before and after instrumentation (P > 0.05). The use of both instruments resulted in a significant reduction in the angle of curvature after instrumentation (P < 0.05). Instrumentation time was significantly greater for PTU (P < 0.05). The ProTaper Universal and ProTaper Next systems performed similarly with regard to the straightening of curved root canals and apical transportation. ProTaper Next was significantly faster than ProTaper Universal. © 2015 Wiley Publishing Asia Pty Ltd.

  4. Cyclic fatigue resistance of R-Pilot, WaveOne Gold Glider, and ProGlider glide path instruments.

    PubMed

    Keskin, Cangül; İnan, Uğur; Demiral, Murat; Keleş, Ali

    2018-02-17

    The aim of the present study was to compare the cyclic fatigue resistance of R-Pilot (VDW; Munich, Germany) with ProGlider (Denstply Sirona; Ballaigues, Switzerland) and WaveOne Gold Glider (Denstply Sirona; Ballaigues, Switzerland) glide path instruments. R-Pilot, ProGlider, and WaveOne Gold Glider instruments were collected (n = 15) and tested in a dynamic cyclic fatigue test device, which has an artificial canal with 60° angle of curvature and a 5-mm radius of curvature. All instruments were operated until fracture occurred, and both time to fracture (TF) and the lengths of the fractured fragments were recorded. Mean and standard deviations of TF and fragment length were calculated for each reciprocating system. TF data and fractured fragment length data were subjected to one-way ANOVA and post-hoc Tukey tests (P < 0.05). Also a Weibull analysis was performed on TF data. The cyclic fatigue resistance values of the WaveOne Gold Glider and R-Pilot were significantly higher than those of the ProGlider (P < 0.05), with no significant difference between them (P > 0.05). Weibull analysis revealed that WaveOne Gold Glider showed the highest predicted TF value for 99% survival rate, which was followed by R-Pilot and ProGlider. Regarding the length of the fractured tips, there were no significant differences among the instruments (P > 0.05). The reciprocating WaveOne Gold Glider and R-Pilot instruments had significantly higher cyclic fatigue resistance than rotary ProGlider instruments. This study reported that novel reciprocating glide path instruments exhibited higher cyclic fatigue resistance than rotating glide path instrument.

  5. Application of Bother in patient reported outcomes instruments across cultures

    PubMed Central

    2014-01-01

    Background The objective of this study was to determine the applicability of the term bother, as used in Patient Reported Outcomes (PRO) instruments that will be translated into foreign languages from English for the United States. Bother is versatile in English for the U.S., in that it can describe negative mental states and physical sensations, as well as social disturbances. Bother has many different meanings across cultures, due to this versatility. Alternatives for bother were explored for future PRO instrument development. Methods A PRO instrument used to evaluate the degree of bother resulting from psoriasis was analyzed. This disease can negatively impact patients physically, emotionally and socially. Translations of bother were analyzed to determine its meaning when translated into other languages. Cognitive debriefing was conducted on psoriasis patients with the instrument containing bother. Following cognitive debriefing, a questionnaire was distributed to linguists and cognitive debriefing subjects to collect definitions of bother in each target language, and detail any difficulty with translation. To establish alternatives to bother and demonstrate the breakdown of concepts within bother, translations of the Dermatology Quality of Life Index (DLQI) were analyzed. This instrument was selected for its focus on psoriasis and use of terminology that lacks the ambiguity of bother. Results An analysis of back-translations revealed that bother yielded a back-translation that was conceptually different from the source 20% of the time (5/26). Analysis of alternative terminology found in the DLQI revealed much greater conceptual equivalence when translated into other languages. Conclusion When developing the wording of PRO instruments, the terminology chosen should be applicable across languages to allow for international pooling and comparison of data. While all linguists and subjects of cognitive debriefing understood bother to have a negative connotation, a large variety of definitions and synonyms provided across languages showed a lack of conceptual equivalence. Ambiguity of the term across cultures may result in variation in translation, impacting subsequent international data pooling. Analysis of alternatives revealed that measurement of unambiguous terminology produces the greatest conceptual equivalency across languages and cultures. PMID:24520950

  6. Cyclic fatigue resistance of ProTaper Universal instruments when subjected to static and dynamic tests.

    PubMed

    Lopes, Hélio P; Britto, Izabelle M O; Elias, Carlos N; Machado de Oliveira, Julio C; Neves, Mônica A S; Moreira, Edson J L; Siqueira, José F

    2010-09-01

    This study evaluated the number of cycles to fracture of ProTaper Universal S2 instruments when subjected to static and dynamic cyclic fatigue tests. ProTaper Universal S2 instruments were used until fracture in an artificial curved canal under rotational speed of 300 rpm in either a static or a dynamic test model. Afterward, the length of the fractured segments was measured and fractured surfaces and helical shafts analyzed by scanning electron microscopy (SEM). The number of cycles to fracture was significantly increased when instruments were tested in the dynamic model (P<.001). Instrument separation occurred at the point of maximum flexure within the artificial canals, i.e., the midpoint of the curved canal segment. SEM analysis revealed that fractured surfaces exhibited characteristics of the ductile mode. Plastic deformation was not observed in the helical shaft of fractured instruments. The number of cycles to fracture ProTaper Universal S2 instruments significantly increased with the use of instruments in a dynamic cyclic fatigue test compared with a static model. These findings reinforce the need for performing continuous pecking motions during rotary instrumentation of curved root canals. Copyright (c) 2010 Mosby, Inc. All rights reserved.

  7. Mechanical reduction of the intracanal Enterococcus faecalis population by Hyflex CM, K3XF, ProTaper Next, and two manual instrument systems: an in vitro comparative study.

    PubMed

    Tewari, Rajendra K; Ali, Sajid; Mishra, Surendra K; Kumar, Ashok; Andrabi, Syed Mukhtar-Un-Nisar; Zoya, Asma; Alam, Sharique

    2016-05-01

    In the present study, the effectiveness of three rotary and two manual nickel titanium instrument systems on mechanical reduction of the intracanal Enterococcus faecalis population was evaluated. Mandibular premolars with straight roots were selected. Teeth were decoronated and instrumented until 20 K file and irrigated with physiological saline. After sterilization by ethylene oxide gas, root canals were inoculated with Enterococcus faecalis. The specimens were randomly divided into five groups for canal instrumentation: Manual Nitiflex and Hero Shaper nickel titanium files, and rotary Hyflex CM, ProTaper Next, and K3XF nickel titanium files. Intracanal bacterial sampling was done before and after instrumentation. After serial dilution, samples were plated onto the Mitis Salivarius agar. The c.f.u. grown were counted, and log10 transformation was calculated. All instrumentation systems significantly reduced the intracanal bacterial population after root canal preparation. ProTaper Next was found to be significantly more effective than Hyflex CM and manual Nitiflex and Hero Shaper. However, ProTaper Next showed no significant difference with K3XF. Canal instrumentation by all the file systems significantly reduced the intracanal Enterococcus faecalis counts. ProTaper Next was found to be most effective in reducing the number of bacteria than other rotary or hand instruments. © 2014 Wiley Publishing Asia Pty Ltd.

  8. Radiological evaluation of the morphological changes of root canals shaped with ProTaper for hand use and the ProTaper and RaCe rotary instruments.

    PubMed

    Aguiar, Carlos M; Câmara, Andréa C

    2008-12-01

    This study evaluated, by means of the radiography examination, the occurrence of deviations in the apical third of root canals shaped with hand and rotary instruments. Sixty mandibular human molars were divided into three groups. The root canals in group 1 were instrumented with ProTaper (Dentsply/Maillefer, Ballaigues, Switzerland) for hand use, group 2 with ProTaper and group 3 with RaCe. The images obtained by double superimposition of the pre- and postoperative radiographs were evaluated by two endodontists with the aid of a magnifier-viewer and a fivefold magnifier. Statistical analysis was performed using the Fisher-Freeman-Halton. The instrumentation using the ProTaper for hand use showed 25% of the canals with a deviation in the apical third, as did the ProTaper, while the corresponding figure for the RaCe (FKG Dentaire, La-Chaux-de-Fonds, Switzerland) was 20%, but these results were not statistically significant. There was no correlation between the occurrence of deviations in the apical third and the systems used.

  9. Geometric and dimensional characteristics of simulated curved canals prepared with proTaper instruments

    PubMed Central

    MARTINS, Renata de Castro; BAHIA, Maria Guiomar de Azevedo; BUONO, Vicente Tadeu Lopes

    2010-01-01

    Objective This study identified which regions of ProTaper instruments work during curved root canal instrumentation. Material and methods Twelve ProTaper instruments of each type, S1, S2, F1, and F2, were assessed morphometrically by measuring tip angle, tip length, tip diameter, length of each pitch along the cutting blades, and instrument diameter at each millimeter from the tip. Curved canals in resin blocks were explored with manual stainless steel files and prepared with ProTaper instruments until the apical end following four distinct sequences of instrumentation: S1; S1 and S2; S1, S2, and F1; S1, S2, F1, and F2. Image analysis was employed for measuring canal diameters. The diameters of the canals and diameters of the instruments were compared. Data were analyzed by one-way ANOVA and Tukey’s test. Results No statistically significant difference was found between the canals and instrument diameters (p>0.05). The largest diameters in the end-point of the instrumented canals were obtained with F1 and F2 instruments and in the initial and middle thirds with S1 and S2 instruments. Conclusions All instruments worked at the tip and along their cutting blades, being susceptible to fail by torsion, fatigue, or the combination of these two mechanisms. PMID:20379681

  10. Hand-operated and rotary ProTaper instruments: a comparison of working time and number of rotations in simulated root canals.

    PubMed

    Pasqualini, Damiano; Scotti, Nicola; Tamagnone, Lorenzo; Ellena, Federica; Berutti, Elio

    2008-03-01

    The aim of this study was to compare the effective shaping time and number of rotations required by an endodontist working with hand and rotary ProTaper instruments to completely shape simulated root canals. Eighty Endo Training Blocks (curved canal shape) were used. Manual preflaring was performed with K-Flexofiles #08-10-12-15-17 and #20 Nitiflex at a working length of 18 mm. Specimens were then randomly assigned to 2 different groups (n = 40); group 1 was shaped by using hand ProTaper and group 2 with ProTaper rotary. The number of rotations made in the canal and the effective time required to achieve complete canal shaping were recorded for each instrument. Differences between groups were analyzed with the nonparametric Mann-Whitney U test (P < .05). Hand ProTaper required significantly fewer rotations (P < .001) than rotary ProTaper, whereas the effective working time to fully shape the simulated canal was significantly higher (P < .001) with hand ProTaper.

  11. Histological analysis of cleaning efficacy of hand and rotary instruments in the apical third of the root canal: A comparative study.

    PubMed

    Arya, Ashtha; Bali, Dildeep; Grewal, Mandeep S

    2011-07-01

    To compare the cleaning efficiency of manual and rotary instrumentation in the apical third of the root canal system. In group 1 (n=10), instrumentation was performed with stainless steel K-file; in group 2 (n=10), it was done with hand ProTaper files; and in group 3 (n=10), instrumentation was done with ProTaper rotary. Distilled water was used for irrigation. The apical third was sectioned transversally and histologically processed. The cross sections were examined under optic microscope and debris was measured using Motic software. Instrumentation with stainless steel K-files showed minimum amount of debris, followed by ProTaper hand files, and rotary ProTaper files were least effective with maximum amount of debris; however, there were no significant differences between the three experimental groups. Both the manual and rotary instrumentation are relatively efficient in cleaning the apical third of the root canal system and the choice between manual and rotary instrumentation should depend on case to case basis.

  12. Development and content validation of a patient-reported endometriosis pain daily diary.

    PubMed

    van Nooten, Floortje E; Cline, Jennifer; Elash, Celeste A; Paty, Jean; Reaney, Matthew

    2018-01-04

    Endometriosis is a common gynecological disorder that causes inflammation and pelvic pain. Endometriosis-related pain is best captured with patient-reported outcome (PRO) measures, however, assessment of endometriosis-related pain in clinical trials has been difficult in the absence of a reliable and valid PRO instrument. We describe the development of the Endometriosis Pain Daily Diary (EPDD), an electronic PRO developed as a survey instrument to assess endometriosis-related pain and its impact on patients' lives. The EPDD was initially developed on the basis of an existing Endometriosis Pain and Bleeding Diary, a targeted review of relevant literature, clinical expert interviews, and open-ended (concept elicitation) patient interviews in the United States (US) and Japan which captured patients' experience with endometriosis. Cognitive interviews of patients with endometriosis were conducted to evaluate patient comprehension of the EPDD items. A conceptual model of endometriosis was developed, and meetings with US and European regulatory authorities provided feedback for validating the EPDD in the context of clinical trials. Translatability assessments of the EPDD were conducted to confirm its appropriate interpretation and ease of completion across 17 languages. The iterative development progressed through three versions of the instrument. The EPDDv1 included 18 items relating to dysmenorrhea/pelvic pain, dyspareunia and sexual activity, bleeding, hot flashes, daily activities, and use of rescue medication. The EPDDv2 was a larger 43-item survey tested in cognitive interviews and subsequently revised to yield the current 11-item EPDDv3, consisting of five core items relating to dysmenorrhea, non-menstrual pelvic pain, and dyspareunia, and six extension items relating to sexual activity, daily activities, and use of rescue medication. The EPDD is a PRO for the evaluation of endometriosis-related pain and its associated impacts on patients' lives. The EPDD represents an important step in providing a PRO that is relevant to patients with endometriosis-related pain in the context of a clinical study setting (ie, fit-for-purpose), designed to evaluate pain associated with endometriosis, including regulatory agency support for its further exploration in clinical trials.

  13. Influence of axial movement on fatigue of ProFile Ni-Ti rotary instruments: an in vitro evaluation.

    PubMed

    Avoaka, Marie-Chantal; Haïkel, Youssef

    2010-05-01

    The aim of this study was to evaluate the influence of the axial movement and the angle of curve (in degrees) on fatigue of nickel-titanium (Ni-Ti) ProFile rotary endodontic instruments. Ni-Ti ProFile rotary instruments (Maillefer SA, Ballaigues, Switzerland), 25 mm long in the range of ISO size 15 to 40 with two tapers (0.4 and 0.6) were evaluated. They are divided in two groups: the instruments with axial movement and those without axial movement. The system used to test the fatigue is maintained in mechanical conditions as close as possible to the clinical situation. The axial movement is in the order of 2 mm in corono-apical direction with a frequency of 1 Hz. The concave radii incorporating a notched V-form for guiding the instruments were: 5; 7,5 and 10 mm. The rotary system is mounted on an electric handpiece and rotated at 350 rpm speed as recommended by the manufacturers. The instruments are rotated until their separation, and the time, in seconds, is recorded. Statistical evaluation is undertaken using a two-way t-test to identify significant differences between variables in the study (p <0.05). We found significant statistical difference (p<0.05) between Ni-Ti engine drive ProFile instruments incorporating an axial movement and the instruments without axial movement with the same radius of curvature, size and taper.The incorporation of the axial movement increases significantly the life-span of the ProFile rotary instruments. This should reduce the risk of the instrument separation during the endodontic treatment.

  14. Influence of multiple clinical use on fatigue resistance of ProTaper rotary nickel-titanium instruments.

    PubMed

    Vieira, E P; França, E C; Martins, R C; Buono, V T L; Bahia, M G A

    2008-02-01

    To examine the influence of clinical use on the occurrence of deformation and fracture and on the fatigue resistance of ProTaper rotary instruments. Root canal treatments were performed on patients using the ProTaper rotary system. Ten sets of instruments were used by an experienced endodontist, each set in five molars. Another 10 sets of instruments were used by the same operator, each set in eight molars. In addition, 10 sets of instruments were used, each set in five molars, by undergraduate students with no clinical experience with the system. After clinical use, S1, S2, F1 and F2 instruments were analysed for damage by optical and scanning electron microscopy. The used sets, along with a control group of 12 sets of new instruments, were then tested in a bench device for fatigue resistance. The use of the ProTaper rotary instruments by an experienced endodontist allowed for the cleaning and shaping of the root canal system of up to eight molars without fracture. During the students work, six instruments fractured. Fatigue resistance decreased upon clinical use for all instruments analysed. Fatigue resistance of used instruments was reduced, but no significant change was observed amongst the instruments used for shaping the canals of five and eight molars. Operator experience affected the occurrence of fracture and plastic deformation during shaping.

  15. Montreal Accord on Patient-Reported Outcomes (PROs) use series-Paper 7: modern perspectives of measurement validation emphasize justification of inferences based on patient reported outcome scores.

    PubMed

    Sawatzky, Richard; Chan, Eric K H; Zumbo, Bruno D; Ahmed, Sara; Bartlett, Susan J; Bingham, Clifton O; Gardner, William; Jutai, Jeffrey; Kuspinar, Ayse; Sajobi, Tolulope; Lix, Lisa M

    2017-09-01

    Obtaining the patient's view about the outcome of care is an essential component of patient-centered care. Many patient-reported outcome (PRO) instruments for different purposes have been developed since the 1960s. Measurement validation is fundamental in the development, evaluation, and use of PRO instruments. This paper provides a review of modern perspectives of measurement validation in relation to the followings three questions as applied to PROs: (1) What evidence is needed to warrant comparisons between groups and individuals? (2) What evidence is needed to warrant comparisons over time? and (3) What are the value implications, including personal and societal consequences, of using PRO scores? Measurement validation is an ongoing process that involves the accumulation of evidence regarding the justification of inferences, actions, and decisions based on measurement scores. These include inferences pertaining to comparisons between groups and comparisons over time as well as consideration of value implications of using PRO scores. Personal and societal consequences must be examined as part of a comprehensive approach to measurement validation. The answers to these three questions are fundamental to the the validity of different types of inferences, actions, and decisions made on PRO scores in health research, health care administration, and clinical practice. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. Exploration, Development, and Validation of Patient-reported Outcomes in Antineutrophil Cytoplasmic Antibody–associated Vasculitis Using the OMERACT Process

    PubMed Central

    Robson, Joanna C.; Milman, Nataliya; Tomasson, Gunnar; Dawson, Jill; Cronholm, Peter F.; Kellom, Katherine; Shea, Judy; Ashdown, Susan; Boers, Maarten; Boonen, Annelies; Casey, George C.; Farrar, John T.; Gebhart, Don; Krischer, Jeffrey; Lanier, Georgia; McAlear, Carol A.; Peck, Jacqueline; Sreih, Antoine G.; Tugwell, Peter; Luqmani, Raashid A.; Merkel, Peter A.

    2016-01-01

    Objective Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a group of linked multisystem life- and organ-threatening diseases. The Outcome Measures in Rheumatology (OMERACT) vasculitis working group has been at the forefront of outcome development in the field and has achieved OMERACT endorsement of a core set of outcomes for AAV. Patients with AAV report as important some manifestations of disease not routinely collected through physician-completed outcome tools; and they rate common manifestations differently from investigators. The core set includes the domain of patient-reported outcomes (PRO). However, PRO currently used in clinical trials of AAV do not fully characterize patients’ perspectives on their burden of disease. The OMERACT vasculitis working group is addressing the unmet needs for PRO in AAV. Methods Current activities of the working group include (1) evaluating the feasibility and construct validity of instruments within the PROMIS (Patient-Reported Outcome Measurement Information System) to record components of the disease experience among patients with AAV; (2) creating a disease-specific PRO measure for AAV; and (3) applying The International Classification of Functioning, Disability and Health to examine the scope of outcome measures used in AAV. Results The working group has developed a comprehensive research strategy, organized an investigative team, included patient research partners, obtained peer-reviewed funding, and is using a considerable research infrastructure to complete these interrelated projects to develop evidence-based validated outcome instruments that meet the OMERACT filter of truth, discrimination, and feasibility. Conclusion The OMERACT vasculitis working group is on schedule to achieve its goals of developing validated PRO for use in clinical trials of AAV. (First Release September 1 2015; J Rheumatol 2015;42:2204–9; doi:10.3899/jrheum.141143) PMID:26329344

  17. Comparative evaluation of cyclic fatigue resistance of D-RaCe and ProTaper retreatment instruments in curved artificial canals.

    PubMed

    Topçuoğlu, H S; Topçuoğlu, G; Aktı, A

    2016-06-01

    To compare the cyclic fatigue resistance of D-RaCe and ProTaper rotary nickel-titanium (NiTi) retreatment files when used in curved artificial canals. A total of 120 new D-RaCe DR2 and ProTaper D3 retreatment files were tested in stainless steel artificial canals having 45° and 60° angles of curvature. Thirty instruments of each of the file systems were tested in both angles of curvature (n = 30). The retreatment instruments were rotated until fracture to calculate the number of cycles to failure. The length of each fractured fragment was recorded. Data were analysed by independent sample t-test. Fractured surfaces of the instruments were analysed by scanning electron microscopy. In the canal with 45° angle of curvature, no significant difference was observed between the retreatment systems (P > 0.05); on the other hand, in the canal with 60° angle of curvature, D-RaCe DR2 instruments had greater cyclic fatigue resistance than ProTaper D3 (P < 0.05). No difference was observed between the retreatment instruments regarding the lengths of fractured fragments (P > 0.05). The fracture surfaces of the instruments had morphologic characteristics of ductile fracture. D-RaCe DR2 instrument exhibited greater cyclic fatigue resistance than ProTaper D3 only in root canals with 60° angle of curvature. © 2015 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  18. Extended cyclic fatigue life of F2 ProTaper instruments used in reciprocating movement.

    PubMed

    De-Deus, G; Moreira, E J L; Lopes, H P; Elias, C N

    2010-12-01

    To evaluate the cyclic fatigue fracture resistance of engine-driven F2 ProTaper instruments under reciprocating movement. A sample of 30 NiTi ProTaper F2 instruments was used. An artificial canal was made from a stainless steel tube, allowing the instruments to rotate freely. During mechanical testing, different movement kinematics and speeds were used, which resulted in three experimental groups (n = 10). The instruments from the first group (G1) were rotated at a nominal speed of 250 rpm until fracture, whilst the instruments from the second group (G2) were rotated at 400 rpm. In the third instrument group (G3), the files were driven under reciprocating movement. The time of fracture for each instrument was measured, and statistical analysis was performed using parametric methods. Reciprocating movement resulted in a significantly longer cyclic fatigue life (P < 0.05). Moreover, operating rpm was a significant factor affecting cyclic fatigue life (P < 0.05); instruments used at a rotational speed of 400 rpm (approximately 95 s) failed more rapidly than those used at 250 rpm (approximately 25 s). Movement kinematics is amongst the factors determining the resistance of rotary NiTi instruments to cyclic fracture. Moreover, the reciprocating movement promoted an extended cyclic fatigue life of the F2 ProTaper instrument in comparison with conventional rotation.

  19. Understanding the Patient Perspective of Seizure Severity in Epilepsy: Development of a Conceptual Model.

    PubMed

    Borghs, Simon; Tomaszewski, Erin L; Halling, Katarina; de la Loge, Christine

    2016-10-01

    For patients with uncontrolled epilepsy, the severity and postictal sequelae of seizures might be more impactful than their frequency. Seizure severity is often assessed using patient-reported outcome (PRO) instruments; however, evidence of content validity for existing instruments is lacking. Our aim was to understand the real-life experiences of patients with uncontrolled epilepsy. A preliminary conceptual model was developed. The model was refined through (1) a targeted literature review of qualitative research on seizure severity; (2) interviews with four clinical epilepsy experts to evaluate identified concepts; and (3) qualitative interviews with patients with uncontrolled epilepsy, gathering descriptions of symptoms and impacts of epilepsy, focusing on how patients experience and describe "seizure severity." Findings were summarized in a final conceptual model of seizure severity in epilepsy. Twenty-five patients (12 who experienced primary generalized tonic-clonic seizures and 13 who experienced partial-onset seizures) expressed 42 different symptoms and 26 different impacts related to seizures. The final conceptual model contained a wide range of concepts related to seizure frequency, symptoms, and duration. Our model identified several new concepts that characterize the patient experience of seizure severity. A seizure severity PRO instrument should cover a wide range of seizure symptoms alongside frequency and duration of seizures. This qualitative work reinforces the notion that measuring seizure frequency is insufficient and that seizure severity is important in defining the patient's experience of epilepsy. This model could be used to assess the content validity of existing PRO instruments, or could support the development of a new one.

  20. Microtomography-based comparison of reciprocating single-file F2 ProTaper technique versus rotary full sequence.

    PubMed

    Paqué, Frank; Zehnder, Matthias; De-Deus, Gustavo

    2011-10-01

    A preparation technique with only 1 single instrument was proposed on the basis of the reciprocating movement of the F2 ProTaper instrument. The present study was designed to quantitatively assess canal preparation outcomes achieved by this technique. Twenty-five extracted human mandibular first molars with 2 separate mesial root canals were selected. Canals were randomly assigned to 1 of the 2 experimental groups: group 1, rotary conventional preparation by using ProTaper, and group 2, reciprocate instrumentation with 1 single ProTaper F2 instrument. Specimens were scanned initially and after root canal preparation with an isotropic resolution of 20 μm by using a micro-computed tomography system. The following parameters were assessed: changes in dentin volume, percentage of shaped canal walls, and degree of canal transportation. In addition, the time required to reach working length with the F2 instrument was recorded. Preoperatively, there were no differences regarding root canal curvature and volume between experimental groups. Overall, instrumentation led to enlarged canal shapes with no evidence of preparation errors. There were no statistical differences between the 2 preparation techniques in the anatomical parameters assessed (P > .01), except for a significantly higher canal transportation caused by the reciprocating file in the coronal canal third. On the other hand, preparation was faster by using the single-file technique (P < .01). Shaping outcomes with the single-file F2 ProTaper technique and conventional ProTaper full-sequence rotary approach were similar. However, the single-file F2 ProTaper technique was markedly faster in reaching working length. Copyright © 2011 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  1. A systematic review of patient reported outcomes in phase II or III clinical trials of myelodysplastic syndromes and acute myeloid leukemia.

    PubMed

    Bryant, Ashley Leak; Drier, Sarah W; Lee, Sejin; Bennett, Antonia V

    2018-06-07

    The purpose of this systematic literature review was to identify clinical trials of MDS and AML that included patient-reported outcome (PRO) instruments, and to summarize the symptom and other health related quality of life (HRQOL) concepts most frequently assessed and the PRO instruments that were used. Sixteen manuscripts describing 14 distinct trials met all criteria (i.e., phase 2 or 3 clinical trial for MDS or AML which included PRO assessment) and were published between 1996-2017. In trials evaluating anemia, PRO scores showed significant improvement in relevant domains (e.g. fatigue, function) among patients identified as responders. In trials evaluating the impact of anti-cancer therapies, improvements the baseline to end of treatment were observed in physical functioning and HRQOL, however the rates of missing data in many of the trials was high or unreported. PRO instruments have the ability to capture changes over time in patients' function and well-being, and PRO instruments and guidance documents are available to support the assessment of HRQOL in AML/MDS clinical trials. Copyright © 2018. Published by Elsevier Ltd.

  2. Overview of classical test theory and item response theory for the quantitative assessment of items in developing patient-reported outcomes measures.

    PubMed

    Cappelleri, Joseph C; Jason Lundy, J; Hays, Ron D

    2014-05-01

    The US Food and Drug Administration's guidance for industry document on patient-reported outcomes (PRO) defines content validity as "the extent to which the instrument measures the concept of interest" (FDA, 2009, p. 12). According to Strauss and Smith (2009), construct validity "is now generally viewed as a unifying form of validity for psychological measurements, subsuming both content and criterion validity" (p. 7). Hence, both qualitative and quantitative information are essential in evaluating the validity of measures. We review classical test theory and item response theory (IRT) approaches to evaluating PRO measures, including frequency of responses to each category of the items in a multi-item scale, the distribution of scale scores, floor and ceiling effects, the relationship between item response options and the total score, and the extent to which hypothesized "difficulty" (severity) order of items is represented by observed responses. If a researcher has few qualitative data and wants to get preliminary information about the content validity of the instrument, then descriptive assessments using classical test theory should be the first step. As the sample size grows during subsequent stages of instrument development, confidence in the numerical estimates from Rasch and other IRT models (as well as those of classical test theory) would also grow. Classical test theory and IRT can be useful in providing a quantitative assessment of items and scales during the content-validity phase of PRO-measure development. Depending on the particular type of measure and the specific circumstances, the classical test theory and/or the IRT should be considered to help maximize the content validity of PRO measures. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

  3. Patient-reported outcome measures in dysphagia: a systematic review of instrument development and validation.

    PubMed

    Patel, D A; Sharda, R; Hovis, K L; Nichols, E E; Sathe, N; Penson, D F; Feurer, I D; McPheeters, M L; Vaezi, M F; Francis, David O

    2017-05-01

    Patient-reported outcome (PRO) measures are commonly used to capture patient experience with dysphagia and to evaluate treatment effectiveness. Inappropriate application can lead to distorted results in clinical studies. A systematic review of the literature on dysphagia-related PRO measures was performed to (1) identify all currently available measures and (2) to evaluate each for the presence of important measurement properties that would affect their applicability. MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument database were searched using relevant vocabulary terms and key terms related to PRO measures and dysphagia. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed multiple domains: (1) conceptual model, (2) content validity, (3) reliability, (4) construct validity, (6) scoring and interpretation, and (7) burden and presentation. Of 4950 abstracts reviewed, a total of 34 dysphagia-related PRO measures (publication year 1987-2014) met criteria for extraction and analysis. Several PRO measures were of high quality (MADS for achalasia, SWAL-QOL and SSQ for oropharyngeal dysphagia, PROMIS-GI for general dysphagia, EORTC-QLQ-OG25 for esophageal cancer, ROMP-swallowing for Parkinson's Disease, DSQ-EoE for eosinophilic esophagitis, and SOAL for total laryngectomy-related dysphagia). In all, 17 met at least one criterion per domain. Thematic deficiencies in current measures were evident including: (1) direct patient involvement in content development, (2) empirically justified dimensionality, (3) demonstrable responsiveness to change, (4) plan for interpreting missing responses, and (5) literacy level assessment. This is the first comprehensive systematic review assessing developmental properties of all available dysphagia-related PRO measures. We identified several instruments with robust measurement properties in multiple diseases including achalasia, oropharyngeal dysphagia, post-surgical dysphagia, esophageal cancer, and dysphagia related to neurological diseases. Findings herein can assist clinicians and researchers in making more informed decisions in selecting the most fundamentally sound PRO measure for a given clinical, research, or quality initiative. © The Authors 2017. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  4. Apical root canal transportation of different pathfinding systems and their effects on shaping ability of ProTaper Next

    PubMed Central

    Türker, Sevinç-Aktemur

    2015-01-01

    Background This study aimed to compare glide path preparation of different pathfinding systems and their effects on the apical transportation of ProTaper Next (Dentsply Maillefer, Ballaigues, Switzerland) in mesial root canals of extracted human mandibular molars, using digital subtraction radiography. Material and Methods The mesial canals of 40 mandibular first molars (with curvature angles between 25° and 35°) were selected for this study. The specimens were divided randomly into 4 groups with 10 canals each. Glide paths were created in group 1 with #10, #15 and #20 K-type (Dentsply Maillefer, Ballaigues, Switzerland) stainless steel manual files; in group 2 with Path-File (Dentsply Maillefer) #1, #2, and #3 and in group 3 with #16 ProGlider (Dentsply Maillefer) rotary instruments; in group 4 no glide paths were created. All canals were instrumented up to ProTaper Next X2 to the working length. A double digital radiograph technique was used, pre and post-instrumentation, to assess whether apical transportation and/or aberration in root canal morphology occurred. Instrument failures were also recorded. The data were analyzed statistically using ANOVA and Tukey tests (p<0.05). Results No significant differences were found among groups regarding apical transportation (p>0.05). Two ProTaper Next instruments failed in-group 4. Conclusions Within the parameters of this study, there was no difference between the performance of path-finding files and ProTaper Next system maintained root canal curvature well and was safe to use either with path-finding files or alone. Key words:Glide path, PathFile, ProGlider, ProTaper Next, transportation. PMID:26330936

  5. Shaping ability of ProFile.04 Taper Series 29 rotary nickel-titanium instruments in simulated root canals. Part 1.

    PubMed

    Thompson, S A; Dummer, P M

    1997-01-01

    The aim of this study was to determine the shaping ability of ProFile.04 Taper Series 29 nickel-titanium instruments in simulated canals. A total of 40 simulated root canals made up of four different shapes in terms of angle and position of curvature were prepared by ProFile instruments using a step-down approach. Part 1 of this two-part report describes the efficacy of the instruments in terms of preparation time, instrument failure, canal blockages, loss of canal length and three-dimensional canal form. The time necessary for canal preparation was not influenced significantly by canal shape. No instrument fractures occurred but a total of 52 instruments deformed. Size 6 instruments deformed the most followed by sizes 5, 3 and 4. Canal shape did not influence significantly instrument deformation. None of the canals became blocked with debris and loss of working distance was on average 0.5 mm or less. Intracanal impressions of canal form demonstrated that most canals had definite apical stops, smooth canal walls and good flow and taper. Under the conditions of this study, ProFile.04 Taper Series 29 rotary nickel-titanium instruments prepared simulated canals rapidly and created good three-dimensional form. A substantial number of instruments deformed but it was not possible to determine whether this phenomenon occurred because of the nature of the experimental model or through an inherent design weakness in the instruments.

  6. Evaluation of surface preparation and maintenance of canal curvature following instrumentation with hand 'K' file and three different Ni-Ti rotary systems: A radiographic and SEM study.

    PubMed

    Bhatti, Namrata; Sroa, Renu; Sikri, Vimal K

    2010-04-01

    To determine the shaping ability and cleaning efficiency of hand K-flexofiles, ProTaper, LightSpeed and Mtwo instruments during the preparation of curved root canals in extracted human teeth. A total of 120 root canals of mandibular and maxillary molars with curvature more than 20° were divided into four groups of 30 each. In group A, canals were prepared using hand K-flexofiles following the crown down technique. In group B LightSpeed, in group C ProTaper, and in group D Mtwo rotary instruments were used to prepare the root canals. Using pre- and post-instrumentation radiographs, straightening of the canal curvature was determined with Corel Draw 9.0 software tools. The amount of debris and smear layer were quantified at three different areas (coronal, middle, and apical thirds) of root canal using SEM. The collected data were analyzed statistically using Student's paired 't' test. The mean change in curvature for hand K-files was 7.71°, for ProTaper files 6.03°, for Mtwo 5.43°, and for LightSpeed instruments were found to be 4.57°. The percentage change in the curvature for all the four groups was statistically highly significant (P< 0.01). LightSpeed instruments maintained the original canal curvature significantly (P< 0.01) better than the other instruments. For leftover debris, the minimum percentage was found to be associated with ProTaper (65.48%) followed by Mtwo (66.22%), LightSpeed (71.67%) and the maximum with hand K-files (74.16%). However, the difference in mean leftover debris between ProTaper and Mtwo was not significant. ProTaper and Mtwo resulted in good cleaning, and LightSpeed maintained the original canal curvature better than the ProTaper, Mtwo, or Hand K-files.

  7. OMERACT Endorsement of Patient-reported Outcome Instruments in Antineutrophil Cytoplasmic Antibody–associated Vasculitis

    PubMed Central

    Robson, Joanna C.; Tomasson, Gunnar; Milman, Nataliya; Ashdown, Sue; Boonen, Annelies; Casey, George C.; Cronholm, Peter F.; Cuthbertson, David; Dawson, Jill; Direskeneli, Haner; Easley, Ebony; Kermani, Tanaz A.; Farrar, John T.; Gebhart, Don; Lanier, Georgia; Luqmani, Raashid A.; Mahr, Alfred; McAlear, Carol A.; Peck, Jacqueline; Shea, Beverley; Shea, Judy A.; Sreih, Antoine G.; Tugwell, Peter S.; Merkel, Peter A.

    2018-01-01

    Objective The antineutrophil cytoplasmic antibody–associated vasculitides (AAV) are multiorgan diseases. Patients with AAV report impairment in their health-related quality of life (HRQOL) and have different priorities regarding disease assessment compared with physicians. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group previously received endorsement for a core set of domains in AAV. Two approaches to measure patient-reported outcomes (PRO) were presented at OMERACT 2016. Methods A novel 5-step tool was used to facilitate assessment of the instruments by delegates: the OMERACT Filter 2.0 Instrument Selection Algorithm, with a red-amber-green checklist of questions, including (1) good match with domain (face and content validity), (2) feasibility, (3) do numeric scores make sense (construct validity)?, (4) overall ratings of discrimination, and (5) can individual thresholds of meaning be defined? Delegates gave an overall endorsement. Three generic Patient-Reported Outcomes Measurement Information System (PROMIS) instruments (fatigue, physical functioning, and pain interference) and a disease-specific PRO, the AAV-PRO (6 domains related to symptoms and HRQOL), were presented. Results OMERACT delegates endorsed the use of the PROMIS instruments for fatigue, physical functioning, and pain interference (87.6% overall endorsement) and the disease-specific AAV-PRO instrument (89.4% overall endorsement). Conclusion The OMERACT Vasculitis Working Group gained endorsement by OMERACT for use of the PROMIS and the AAV-PRO in clinical trials of vasculitis. These instruments are complementary to each other. The PROMIS and the AAV-PRO need further work to assess their utility in longitudinal settings, including their ability to discriminate between treatments of varying efficacy in the setting of a randomized controlled trial. PMID:28864650

  8. Patient Reported Outcome (PRO) assessment in epilepsy: a review of epilepsy-specific PROs according to the Food and Drug Administration (FDA) regulatory requirements.

    PubMed

    Nixon, Annabel; Kerr, Cicely; Breheny, Katie; Wild, Diane

    2013-03-11

    Despite collection of patient reported outcome (PRO) data in clinical trials of antiepileptic drugs (AEDs), PRO results are not being routinely reported on European Medicines Agency (EMA) and Food and Drug Administration (FDA) product labels. This review aimed to evaluate epilepsy-specific PRO instruments against FDA regulatory standards for supporting label claims. Structured literature searches were conducted in Embase and Medline databases to identify epilepsy-specific PRO instruments. Only instruments that could potentially be impacted by pharmacological treatment, were completed by adults and had evidence of some validation work were selected for review. A total of 26 PROs were reviewed based on criteria developed from the FDA regulatory standards. The ability to meet these criteria was classified as either full, partial or no evidence, whereby partial reflected some evidence but not enough to comprehensively address the FDA regulatory standards. Most instruments provided partial evidence of content validity. Input from clinicians and literature was common although few involved patients in both item generation and cognitive debriefing. Construct validity was predominantly compromised by no evidence of a-priori hypotheses of expected relationships. Evidence for test-retest reliability and internal consistency was available for most PROs although few included complete results regarding all subscales and some failed to reach recommended thresholds. The ability to detect change and interpretation of change were not investigated in most instruments and no PROs had published evidence of a conceptual framework. The study concludes that none of the 26 have the full evidence required by the FDA to support a label claim, and all require further research to support their use as an endpoint. The Subjective Handicap of Epilepsy (SHE) and the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) have the fewest gaps that would need to be addressed through additional research prior to any FDA regulatory submission, although the NDDI-E was designed as a screening tool and is therefore unlikely to be suitable as an instrument for capturing change in a clinical trial and the SHE lacks the conceptual focus on signs and symptoms favoured by the FDA.

  9. Comparative study of 6 rotary nickel-titanium systems and hand instrumentation for root canal preparation in severely curved root canals of extracted teeth.

    PubMed

    Celik, Davut; Taşdemir, Tamer; Er, Kürşat

    2013-02-01

    Some improvements have been developed with new generations of nickel-titanium (NiTi) rotary instruments that led to their successful and extensive application in clinical practice. The purpose of this in vitro study was to compare the root canal preparations performed by using GT Series X and Twisted File systems produced by innovative manufacturing process with Revo-S, RaCe, Mtwo, and ProTaper Universal systems manufactured directly from conventional nitinol and with stainless steel K-Flexofile instruments. The mesiobuccal root canals of 140 maxillary first permanent molars that had between 30°-40° curvature angle and 4- to 9-mm curvature radius of the root canal were used. After root canal preparations made by using GT Series X, Twisted File, Revo-S, RaCe, Mtwo, and ProTaper Universal NiTi rotary systems and stainless steel K-Flexofile instruments, transportation occurred in the root canal, and alteration of working length (WL) was assessed by using a modified double-digital radiographic technique. The data were compared by the post hoc Tukey honestly significant difference test. NiTi rotary systems caused less canal transportation and alteration of WL than K-Flexofile instruments (P < .05). There was no significant difference between NiTi rotary system groups at any levels (P > .05) except 2.5 mm from the WL. At this level ProTaper Universal system caused significant canal transportation (P < .05). GT Series X and Twisted File rotary systems produced with innovative process were concluded to shape the curved canals to result in minimal canal transportation, similar to Revo-S, RaCe, Mtwo, and ProTaper Universal rotary systems manufactured by traditional methods. Copyright © 2013 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  10. Comparison of effects of ProTaper, HeroShaper, and Gates Glidden Burs on cervical dentin thickness and root canal volume by using multislice computed tomography.

    PubMed

    Mahran, Abeer H; AboEl-Fotouh, Mona M

    2008-10-01

    The purpose of this study was to compare the effects of 3 different instruments used to prepare curved root canals on the remaining cervical dentin thickness and total amount of dentin removed from root canals during instrumentation by using multislice computed tomography. Mesiobuccal canals of 45 mandibular first molars with curvature between 30-40 degrees were divided into 3 equal groups: ProTaper, Hero Shaper, and Gates Glidden Bur with Flex-R hand file. Cervical dentin thickness and canal volume were measured before and after instrumentation by using multislice computed tomography and image analysis software. The results indicated that ProTaper removed significantly less cervical dentin from distal wall of the root (dangerous zone) than HeroShaper and Gates Glidden Bur (P < .05). The total dentin removed during canal instrumentation was significantly more with ProTaper system (P < .05).

  11. The effects of autoclave sterilization on the cyclic fatigue resistance of ProTaper Universal, ProTaper Next, and ProTaper Gold nickel-titanium instruments.

    PubMed

    Özyürek, Taha; Yılmaz, Koray; Uslu, Gülşah

    2017-11-01

    It was aimed to compare the cyclic fatigue resistances of ProTaper Universal (PTU), ProTaper Next (PTN), and ProTaper Gold (PTG) and the effects of sterilization by autoclave on the cyclic fatigue life of nickel-titanium (NiTi) instruments. Eighty PTU, 80 PTN, and 80 PTG were included to the present study. Files were tested in a simulated canal. Each brand of the NiTi files were divided into 4 subgroups: group 1, as received condition; group 2, pre-sterilized instruments exposed to 10 times sterilization by autoclave; group 3, instruments tested were sterilized after being exposed to 25%, 50%, and 75% of the mean cycles to failure, then cycled fatigue test was performed; group 4, instruments exposed to the same experiment with group 3 without sterilization. The number of cycles to failure (NCF) was calculated. The data was statistically analyzed by using one-way analysis of variance and post hoc Tukey tests. PTG showed significantly higher NCF than PTU and PTN in group 1 ( p < 0.05). Sterilization significantly increased the NCF of PTN and PTG ( p < 0.05) in group 2. PTN in group 3 had significantly higher cyclic fatigue resistance than PTN group 4 ( p < 0.05). Also, significantly higher NCF was observed for PTG in group 2 than in groups 3 and 4 ( p < 0.05). PTG instrument made of new gold alloy was more resistant to fatigue failure than PTN and PTU. Autoclaving increased the cyclic fatigue resistances of PTN and PTG.

  12. Evaluation of conventional, protaper hand and protaper rotary instrumentation system for apical extrusion of debris, irrigants and bacteria- An in vitro randomized trial.

    PubMed

    Kalra, Pinky; Rao, Arathi; Suman, Ethel; Shenoy, Ramya; Suprabha, Baranya-Shrikrishna

    2017-02-01

    Endodontic instrumentation carries the risk of over extrusion of debris and bacteria. The technique used and the type of instrumentation influences this risk. The purpose of this study was to evaluate and compare the K-file, ProTaper hand and ProTaper rotary instrumentation systems for the amount of apically extruded debris, irrigant solution and intracanal bacteria. Experimental single blinded randomized type of in vitro study with sample of 30 single rooted teeth. Endodontic access cavities were prepared and the root canals were filled with the suspension of E. faecalis . Myers and Montogomery Model was used to collect apically extruded debris and irrigant. Canals were prepared using K files, Hand protapers and Protaper rotary files. Non Parametric test like Kruskal-Wallis and Mann-Whitney U test were applied to determine the significant differences among the group. Tests revealed statistically significant difference between the amount of debris and number of bacteria extruded by the ProTaper hand and the K-files. No statistically significant difference was observed between the amounts of irrigant extruded by the ProTaper hand and the K-file system. Statistically significant differences were observed between the amounts of bacteria and irrigant extruded by the ProTaper rotary and the Protaper hand. No statistically significant difference was observed between the amounts of debris extruded by the ProTaper hand and the K-file system. Amount of apical extrusion of irrigant solution, bacteria and debris are significantly greater with K File instruments and least with Protaper rotary instruments. Key words: Protaper, rotary, periapical extrusion.

  13. Voice-Related Patient-Reported Outcome Measures: A Systematic Review of Instrument Development and Validation

    ERIC Educational Resources Information Center

    Francis, David O.; Daniero, James J.; Hovis, Kristen L.; Sathe, Nila; Jacobson, Barbara; Penson, David F.; Feurer, Irene D.; McPheeters, Melissa L.

    2017-01-01

    Purpose: The purpose of this study was to perform a comprehensive systematic review of the literature on voice-related patient-reported outcome (PRO) measures in adults and to evaluate each instrument for the presence of important measurement properties. Method: MEDLINE, the Cumulative Index of Nursing and Allied Health Literature, and the Health…

  14. Apically-extruded debris using the ProTaper system.

    PubMed

    Azar, Nasim Gheshlaghi; Ebrahimi, Gholamreza

    2005-04-01

    The purpose of this in vitro study was to determine the quantity of debris and irrigant extruded apically using the ProTaper system compared to ProFiles and K-Flexofiles. Thirty-six mesio-buccal root canals of human mandibular molars were selected and divided into three groups of twelve canals. Two groups were instrumented with ProFiles and ProTapers according to the manufacturer's instructions. The other group was instrumented with K-Flexofiles using the step-back technique. A standard amount of irrigant was used for each canal. Apically-extruded debris and irrigant was collected in pre-weighed vials. The mean weight of extruded debris and irrigant for each group was statistically analysed using Student's t-test and one-way ANOVA. All instrumentation techniques produced extruded debris and irrigant. Although the mean amount of extrusion with the step-back technique was higher than the two rotary systems, there was no significant difference between the three groups (p > 0.05). NiTi rotary systems were associated with less apical extrusion, but were not significantly better than hand file instrumentation. All techniques extruded debris.

  15. Efficacy of D-RaCe and ProTaper Universal Retreatment NiTi instruments and hand files in removing gutta-percha from curved root canals - a micro-computed tomography study.

    PubMed

    Rödig, T; Hausdörfer, T; Konietschke, F; Dullin, C; Hahn, W; Hülsmann, M

    2012-06-01

    To compare the efficacy of two rotary NiTi retreatment systems and Hedström files in removing filling material from curved root canals. Curved root canals of 57 extracted teeth were prepared using FlexMaster instruments and filled with gutta-percha and AH Plus. After determination of root canal curvatures and radii in two directions, the teeth were assigned to three identical groups (n = 19). The root fillings were removed with D-RaCe instruments, ProTaper Universal Retreatment instruments or Hedström files. Pre- and postoperative micro-CT imaging was used to assess the percentage of residual filling material as well as the amount of dentine removal. Working time and procedural errors were recorded. Data were analysed using analysis of covariance and analysis of variance procedures. D-RaCe instruments were significantly more effective than ProTaper Universal Retreatment instruments and Hedström files (P < 0.05). Hedström files removed significantly less dentine than the rotary NiTi systems (P < 0.0001). D-RaCe instruments were significantly faster compared to both other groups (P < 0.05). No procedural errors such as instrument fracture, blockage, ledging or perforation were detected in the Hedström group. In the ProTaper group, four instrument fractures and one lateral perforation were observed. Five instrument fractures were recorded for D-RaCe. D-RaCe instruments were associated with significantly less residual filling material than ProTaper Universal Retreatment instruments and hand files. Hedström files removed significantly less dentine than both rotary NiTi systems. Retreatment with rotary NiTi systems resulted in a high incidence of procedural errors. © 2012 International Endodontic Journal.

  16. Comparison of defects in ProTaper hand-operated and engine-driven instruments after clinical use.

    PubMed

    Cheung, G S P; Bian, Z; Shen, Y; Peng, B; Darvell, B W

    2007-03-01

    To compare the type of defects and mode of material failure of engine-driven and hand-operated ProTaper instruments after clinical use. A total of 401 hand-operated and 325 engine-driven ProTaper instruments were discarded from an endodontic clinic over 17 months. Those that had fractured were examined for plastic deformation in lateral view and remounted for fractographical examination in scanning electron microscope. The mode of fracture was classified as 'fatigue' or 'shear' failure. The lengths of fractured segments in both instruments were recorded. Any distortion in hand instrument was noted. Data were analysed using chi-square, Fisher's exact or Student's t-test, where appropriate. Approximately 14% of all discarded hand-operated instruments and 14% of engine-driven instruments were fractured. About 62% of hand instruments failed because of shear fracture, compared with approximately 66% of engine-driven instruments as a result of fatigue (P < 0.05). Approximately 16% of hand instruments were affected by shear, and either remained intact or was fractured, compared with 5% of engine-driven instruments (P < 0.05). The length of the broken fragment was significantly shorter in hand versus engine-driven group (P < 0.05). Approximately 7% of hand instruments were discarded intact but distorted (rarely for engine-driven instruments); all were in the form of unscrewing of the flutes. The location of defects in hand Finishing instruments was significantly closer to the tip than that for Shaping instruments (P < 0.05). Under the conditions of this study (possibly high usage), the failure mode of ProTaper engine-driven and hand-operated instruments appeared to be different, with shear failure being more prevalent in the latter.

  17. Apical extrusion of intracanal bacteria following use of two engine-driven instrumentation techniques.

    PubMed

    Er, K; Sümer, Z; Akpinar, K E

    2005-12-01

    To evaluate the number of bacteria extruded apically from extracted teeth ex vivo after canal instrumentation using the two engine-driven techniques utilizing nickel-titanium instruments (ProTaper and System GT). Forty extracted single-rooted human mandibular premolar teeth were used. Access cavities were prepared and root canals were then contaminated with a suspension of Enterococcus faecalis and dried. The contaminated roots were divided into two experimental groups of 15 teeth each and one control group of 10 teeth. Group 1, ProTaper group: the root canals were instrumented using ProTaper instruments. Group 2, System GT group: the root canals were instrumented using System GT instruments. Group 3, control group: no instrumentation was attempted. Bacteria extruded from the apical foramen during instrumentation were collected into vials. The microbiological samples from the vials were incubated in culture media for 24 h. Colonies of bacteria were counted and the results were given as number of colony-forming units. The data obtained were analysed using the Kruskal-Wallis one-way analysis of variance and Mann-Whitney U-tests, with alpha = 0.05 as the level for statistical significance. There was no significant difference as to the number of extruded bacteria between the ProTaper and System GT engine-driven systems (P > 0.05). Both engine-driven nickel-titanium systems extruded bacteria through the apical foramen.

  18. A Comparative SEM Investigation of Smear Layer Remaining on Dentinal Walls by Three Rotary NiTi Files with Different Cross Sectional Designs in Moderately Curved Canals

    PubMed Central

    Kakkar, Pooja; Vats, Asit

    2015-01-01

    Objective: The objective of this study was to compare the smear layer formed on root canal walls during canal preparation of extracted human teeth by Twisted, Mtwo, and ProTaper rotary nickel titanium instruments. Materials and Methods: Sixty single rooted human premolar teeth with root curvature <250 were selected and randomly divided into three Groups (n= 20 teeth per Group). Three types of rotary nickel titanium instruments were used, Twisted (SybronEndo, Orange, CA, USA), Mtwo (VDW, Munich, Germany) and ProTaper (Dentsply Maillefer, Ballaigues, Switzerland) according to manufacturer’s instructions to instrument the root canals. Irrigation for all groups was performed after each instrument change with 3ml of 3% sodium hypochlorite followed by Glyde (File Prep, Dentsply, Maillefer, Ballaigues, Switzerland) as chelator paste and lubricant. Three different areas (coronal, middle and apical thirds) of the root canal were evaluated using scanning electron microscopy (SEM). The canal wall of each sample was assessed and compared using a predefined scale for the presence or absence of smear layer. Data were analysed statistically using ANOVA and Tukey HSD test Results: All three groups showed statistically significant more smear layer in the apical thirds of the canal as compared to the coronal and middle thirds (p<0.001). Mtwo rotary file system produced significantly less smear layer (p<0.001) compared to Twisted and ProTaper rotary instruments in the apical portion. Twisted Files resulted in less smear layer formation in the apical thirds of the canal compared to ProTaper rotary instruments but were statistically insignificant. Conclusion: Completely clean root canals were not found after instrumentation with any of the three instruments. Under the confines of this study Mtwo instruments produced significantly cleaner dentin wall surfaces throughout the canal length in comparison to Twisted and ProTaper rotary files. Twisted Files proved to be comparable to ProTaper rotary instruments with respect to canal cleanliness in the apical thirds of the root canal. PMID:25954704

  19. Patient-Reported Outcomes Are Changing the Landscape in Oncology Care: Challenges and Opportunities for Payers

    PubMed Central

    Zagadailov, Erin; Fine, Michael; Shields, Alan

    2013-01-01

    Background A patient-reported outcome (PRO) is a subjective report that comes from a patient without interpretation by a clinician. Because of the increasingly significant role of PROs in the development and evaluation of new medicines, the US Food and Drug Administration (FDA) issued a formal guidance to describe how PRO instruments will be reviewed and evaluated with respect to claims in approved medical product labeling. Meanwhile, PROs continue to appear in oncology clinical trials more frequently; however, it is unclear how payers and policymakers can use PRO data in the context of decision-making for cancer treatments. Objective The objective of this article is to discuss the challenges and opportunities of incorporating oncology-related PRO data into payer decision-making. Discussion Payer concerns with PRO instruments are often related to issues regarding measurement, relevance, quality, and interpretability of PROs. Payers may dismiss PROs that do not independently predict improved outcomes. The FDA guidance released in 2009 demonstrates, as evidenced by the case of ruxolitinib, how PRO questionnaires can be generated in a relevant, trustworthy, and meaningful way, which provides an opportunity for payers and policy decision makers to focus on how to use PRO data in their decision-making. This is particularly relevant in oncology, where a recent and sizable number of clinical trials include PRO measures. Conclusion As an increasing number of oncology medications enter the market with product labeling claims that contain PRO data, payers will need to better familiarize themselves with the opportunities associated with PRO questionnaires when making coverage decisions. PRO measures will continue to provide valuable information regarding the risk–benefit profile of novel agents. As such, PRO measures may provide evidence that should be considered in payers' decisions and discussions; however, the formal role of PROs and the pertinence of PROs in decision-making has yet to be understood. PMID:24991362

  20. Content Validity for the VVSymQ® Instrument: A New Patient-Reported Outcome Measure for the Assessment of Varicose Veins Symptoms.

    PubMed

    Paty, Jean; Elash, Celeste A; Turner-Bowker, Diane M

    2017-02-01

    Varicose veins are common and can impact patients' quality of life, but consensus regarding the evaluation of varicose vein symptoms is lacking and existing measures have limitations. This research aimed to develop and establish the content validity of a new electronic patient-reported outcome (PRO) measure, the VVSymQ ® instrument, to assess symptoms of superficial venous insufficiency (varicose veins) in clinical trials. The development of the VVSymQ ® instrument began with qualitative interviews with patients based on the symptom domain of the VEINES-QOL/Sym, an existing PRO instrument for chronic venous disorders of the leg. Three phases of qualitative research were conducted to examine the relevance and importance of the symptoms to patients with varicose veins, and the patients' ability to understand and use the VVSymQ ® instrument. The development included evaluating questions that had 1-week and 24-h recall periods, and paper and electronic versions of the new instrument. Five symptoms (heaviness, achiness, swelling, throbbing, and itching [HASTI™]) were consistently reported by patients across all sources of qualitative data. The final version of the VVSymQ ® instrument queries patients on the HASTI™ symptoms using a 24-h recall period and a 6-point duration-based response scale ranging from "None of the time" to "All of the time," and is administered daily via an electronic diary. Cognitive interviews demonstrated varicose vein patients' understanding of and their ability to use the final version of the VVSymQ ® instrument. Content validity was established for the VVSymQ ® instrument, which assesses the five HASTI™ symptoms of varicose veins daily via an electronic diary and has promise for use in research and practice.

  1. Introducing the Body-QoL®: A New Patient-Reported Outcome Instrument for Measuring Body Satisfaction-Related Quality of Life in Aesthetic and Post-bariatric Body Contouring Patients.

    PubMed

    Danilla, Stefan; Cuevas, Pedro; Aedo, Sócrates; Dominguez, Carlos; Jara, Rocío; Calderón, María E; Al-Himdani, Sarah; Rios, Marco A; Taladriz, Cristián; Rodriguez, Diego; Gonzalez, Rolando; Lazo, Ángel; Erazo, Cristián; Benitez, Susana; Andrades, Patricio; Sepúlveda, Sergio

    2016-02-01

    To develop a new patient-reported outcome instrument (PRO) to measure body-related satisfaction quality of life (QoL). Standard 3-phase PRO design was followed; in the first phase, a qualitative design was used in 45 patients to develop a conceptual framework and to create preliminary scale domains and items. In phase 2, large-scale population testing on 1340 subjects was performed to reduce items and domains. In phase 3, final testing of the developed instrument on 34 patients was performed. Statistics used include Factor, RASCH, and multivariate regression analysis. Psychometric properties measured were internal reliability, item-rest, item-test, and test-retest correlations. The PRO-developed instrument is composed of four domains (satisfaction with the abdomen, sex life, self-esteem and social life, and physical symptoms) and 20 items in total. The score can range from 20 (worst) to 100 (best). Responsiveness was 100 %, internal reliability 93.3 %, and test-retest concordance 97.7 %. Body image-related QoL was superior in men than women (p < 0.001) and decreased with increasing age (p = 0.004) and BMI (p < 0.001). Post-bariatric body contouring patients score lower than cosmetic patients in all domains of the Body-QoL instrument (p < 0.001). After surgery, the score improves by on average 21.9 ± 16.9 (effect size 1.8, p < 0.001). Body satisfaction-related QoL can be measured reliably with the Body-QoL instrument. It can be used to quantify the improvement in cosmetic and post-bariatric patients including non- or minimally invasive procedures, suction assisted lipectomy, abdominoplasty, lipoabdominoplasty, and lower body lift and to give an evidence-based approach to standard practice. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

  2. Comparative Evaluation of Stress developed on Rotary Retreatment Instruments during Retrieval of Gutta-percha.

    PubMed

    Sihivahanan, Dhanasekaran; Reddy, T Vinay Kumar; Thomas, Anchu Rachel; Senthilnathan, Natarajan; Sivakumar, Murali; Shivanna, Sushmita

    2017-06-01

    The aim of the study is to compare the maximum stress distribution on the rotary retreatment instruments within the root canal at cervical, middle, and the apical one-third during retreatment of gutta-percha. A human mandibular premolar was scanned, and three-dimensional geometry of the root was reconstructed using finite element analysis (FEA) software package (ANSYS). The basic model was kept unchanged; tooth models were created using the same dimensions and divided into two groups as follows: Group I: ProTaper Universal retreatment system and group II: Mtwo rotary retreatment system. The stress distribution on the surface and within the retreatment files was analyzed numerically in the FEA package (ANSYS). The FEA analysis revealed that the retreatment instruments received the greatest stress in the cervical third, followed by the apical third and the middle third. The stress generated on the ProTaper Universal retreatment system was less when compared with the Mtwo retreatment files. The study concludes that the retreatment instruments undergo higher stress in the cervical third region, and further in vivo and in vitro studies are necessary to evaluate the relationship between instrument designs, stress distribution, residual stresses after use, and the torsional fracture of the retreatment instrument. The stress developed on the rotary retreatment instruments during retrieval of gutta-percha makes the instrument to get separated. There is no instrument system, i.e., suitable for all clinical situations and it is important to understand how the structural characteristics could influence the magnitude of stresses on the instrument to prevent its fracture in use.

  3. Evaluation of the mechanical behaviour of PathFile and ProGlider pathfinding nickel-titanium rotary instruments.

    PubMed

    Elnaghy, A M; Elsaka, S E

    2015-09-01

    To assess and compare the resistance to cyclic fatigue, torsional stress, bending and buckling of ProGlider (PG; Dentsply Maillefer, Ballaigues, Switzerland) instruments with PathFile (PF; Dentsply Maillefer) pathfinding nickel-titanium rotary instruments. Size 16, .02 taper PG and PF instruments were rotated in simulated canals until failure, and the number of cycles to failure (NCF) was recorded to evaluate their cyclic fatigue resistance. Torsional strength was measured using a torsiometer after fixing rigidly the apical 5 mm of the instrument. A scanning electron microscope was used to characterize the topographic features of the fracture surfaces of the instruments. The instruments were evaluated for bending resistance using a cantilever-bending test. The buckling resistance was measured by recording the maximum load required to form a lateral elastic displacement along the file axis using a universal testing machine. Data were statistically analysed using independent t-tests. Statistical significance was set at P < 0.05. ProGlider instrument had a significantly higher flexibility, higher resistance to cyclic fatigue and torsional stress than PF instruments (P < 0.05). The fractured cross-sectional surfaces revealed typical features of cyclic fatigue and torsional fractures. There was no significant difference in the maximum load needed to buckle the two instruments tested (P = 0.082). ProGlider NiTi pathfinding instrument manufactured from M-Wire alloy had enhanced mechanical properties, including higher flexibility, higher resistance to cyclic fatigue and torsional stress compared with PathFile instrument made of conventional NiTi alloy. © 2014 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  4. Comparison of apical debris extrusion during root canal preparation using instrumentation techniques with two operating principles: An in vitro study

    PubMed Central

    Verma, Mudita; Meena, N.; Kumari, R. Anitha; Mallandur, Sudhanva; Vikram, R.; Gowda, Vishwas

    2017-01-01

    Aims: The aim of this study was to quantify the debris extruded apically from teeth using rotary and reciprocation instrumentation systems. Subjects and Methods: Eighty extracted human mandibular premolars with single canals and similar lengths were instrumented using ProTaper Universal (40, 06; Dentsply Maillefer, Ballaigues, Switzerland), ProTaper Next (40, 06; Dentsply Maillefer, Ballaigues, Switzerland), WaveOne (40, 06; Dentsply Maillefer, Ballaigues, Switzerland), and Reciproc (R40; VDW GmbH, Munich, Germany). Debris extruded during instrumentation was collected into preweighed Eppendorf tubes, which were then stored in an incubator at 70°C for 5 days. The final weight of the Eppendorf tubes with the extruded debris was calculated after obtaining the mean of three consecutive weights obtained for each tube. Statistical Analysis Used: Statistical analysis was performed using SPSS version 16.0 software. The groups were compared using the Kruskal–Wallis test for all variables. Results: There was no statistically significant difference between the groups (P = 0.1114). However, the ProTaper Universal group produced more extrusion and ProTaper Next produced least debris extrusion among the instrument groups (P > 0.05). Conclusions: All instrumentation techniques were associated with extruded debris. PMID:28855755

  5. Incidence of apical crack initiation and propagation during the removal of root canal filling material with ProTaper and Mtwo rotary nickel-titanium retreatment instruments and hand files.

    PubMed

    Topçuoğlu, Hüseyin Sinan; Düzgün, Salih; Kesim, Bertan; Tuncay, Oznur

    2014-07-01

    The aim of this study was to determine the incidence of crack initiation and propagation in apical root dentin after retreatment procedures performed by using 2 rotary retreatment systems and hand files with additional instrumentation. Eighty extracted mandibular premolars with single canals were selected. One millimeter from the apex of each tooth was ground perpendicular to the long axis of the tooth, and the apical surface was polished. Twenty teeth served as the control group, and no preparation was performed. The remaining 60 teeth were prepared to size 35 with rotary files and filled with gutta-percha and AH Plus sealer. Specimens were then divided into 3 groups (n = 20), and retreatment procedures were performed with the following devices and techniques: ProTaper Universal retreatment files, Mtwo retreatment files, and hand files. After retreatment, the additional instrumentation was performed by using size 40 ProTaper, Mtwo, and hand files. Digital images of the apical root surface were recorded before preparation, after instrumentation, after filling, after retreatment, and after additional instrumentation. The images were then inspected for the presence of any new apical cracks and propagation. Data were analyzed with the logistic regression and Fisher exact tests. All experimental groups caused crack initiation and propagation after use of retreatment instruments. The ProTaper and Mtwo retreatment groups caused greater crack initiation and propagation than the hand instrument group (P < .05) after retreatment. Additional instrumentation with ProTaper and Mtwo instruments after the use of retreatment instruments caused crack initiation and propagation, whereas hand files caused neither crack initiation nor propagation (P < .05). This study showed that retreatment procedures and additional instrumentation after the use of retreatment files may cause crack initiation and propagation in apical dentin. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  6. Comparative study of six rotary nickel-titanium systems and hand instrumentation for root canal preparation.

    PubMed

    Guelzow, A; Stamm, O; Martus, P; Kielbassa, A M

    2005-10-01

    To compare ex vivo various parameters of root canal preparation using a manual technique and six different rotary nickel-titanium (Ni-Ti) instruments (FlexMaster, System GT, HERO 642, K3, ProTaper, and RaCe). A total of 147 extracted mandibular molars were divided into seven groups (n = 21) with equal mean mesio-buccal root canal curvatures (up to 70 degrees), and embedded in a muffle system. All root canals were prepared to size 30 using a crown-down preparation technique for the rotary nickel-titanium instruments and a standardized preparation (using reamers and Hedströem files) for the manual technique. Length modifications and straightening were determined by standardized radiography and a computer-aided difference measurement for every instrument system. Post-operative cross-sections were evaluated by light-microscopic investigation and photographic documentation. Procedural errors, working time and time for instrumentation were recorded. The data were analysed statistically using the Kruskal-Wallis test and the Mann-Whitney U-test. No significant differences were detected between the rotary Ni-Ti instruments for alteration of working length. All Ni-Ti systems maintained the original curvature well, with minor mean degrees of straightening ranging from 0.45 degrees (System GT) to 1.17 degrees (ProTaper). ProTaper had the lowest numbers of irregular post-operative root canal diameters; the results were comparable between the other systems. Instrument fractures occurred with ProTaper in three root canals, whilst preparation with System GT, HERO 642, K3 and the manual technique resulted in one fracture each. Ni-Ti instruments prepared canals more rapidly than the manual technique. The shortest time for instrumentation was achieved with System GT (11.7 s). Under the conditions of this ex vivo study all Ni-Ti systems maintained the canal curvature, were associated with few instrument fractures and were more rapid than a standardized manual technique. ProTaper instruments created more regular canal diameters.

  7. Comparison of removed dentin thickness with hand and rotary instruments

    PubMed Central

    Shahriari, Shahriar; Abedi, Hasan; Hashemi, Mahdi; Jalalzadeh, Seyed Mohsen

    2009-01-01

    INTRODUCTION: The aim of this study was to evaluate the amount of dentine removed after canal preparation using stainless steel (SS) hand instruments or rotary ProFile instruments. MATERIALS AND METHODS: Thirty-six extracted human teeth with root canal curvatures less than 30º were embedded in clear polyester resin. The roots were cut horizontally at apical 2, 4 and 7 mm. Dentin thickness was measured at each section and the sections were accurately reassembled using a muffle. Root canals were randomly prepared by SS hand instruments or rotary ProFile instruments. Root sections were again separated, and the remaining dentin thickness was measured. Mann-Whitney U and t tests were performed for analytic comparison of the results. RESULTS: The thickness of removed dentin was significantly different between the two used methods (P<0.05). Significantly greater amounts of dentin was removed mesially in all sections in hand instrumentation group (P<0.001). CONCLUSION: ProFile rotary instrumentation prepares root canals with a greater conservation of tooth structure. PMID:23940489

  8. The Myelofibrosis Symptom Assessment Form (MFSAF): An Evidence-based Brief Inventory to Measure Quality of Life and Symptomatic Response to Treatment in Myelofibrosis

    PubMed Central

    Mesa, Ruben A.; Schwager, Susan; Radia, Deepti; Cheville, Andrea; Hussein, Kebede; Niblack, Joyce; Pardanani, Animesh D.; Steensma, David P.; Litzow, Mark R.; Rivera, Candido E.; Camoriano, John; Verstovsek, Srdan; Sloan, Jeffrey; Harrison, Claire; Kantarjian, Hagop; Tefferi, Ayalew

    2015-01-01

    Quality of life (QoL) in patients with myelofibrosis (MF) is severely compromised by severe constitutional symptoms (i.e. fatigue, night sweats, fever, weight loss), pruritus, and symptoms from frequently massive hepatosplenomegaly. Given that no current instrument of patient reported outcomes (PRO) exists that covers the unique spectrum of symptomatology seen in MF patients, we sought to develop a new PRO instrument for MF patients for use in therapeutic clinical trials. Utilizing data from an international internet based survey of 458 patients with MF we created a 20 item instrument (MFSAF: Myelofibrosis Symptom Assessment Form) which measures the symptoms reported by >10% of MF patients, and includes a measure of QoL. We subsequently validated the MFSAF in a prospective trial of MF patients involving patient and provider feedback, as well as comparison to other validated instruments used in cancer patients. The MFSAF results were highly correlated with other instruments, judged comprehensive and understandable by patients, and should be considered for evaluation of MF symptoms in therapeutic trials. PMID:19250674

  9. Cyclic fatigue resistance of D-RaCe, ProTaper, and Mtwo nickel-titanium retreatment instruments after immersion in sodium hypochlorite.

    PubMed

    Topçuoğlu, Hüseyin Sinan; Pala, Kanşad; Aktı, Ahmet; Düzgün, Salih; Topçuoğlu, Gamze

    2016-07-01

    The aim of this study was to investigate the effect of immersion in sodium hypochlorite (NaOCl) on cyclic fatigue resistance of three different rotary nickel-titanium (NiTi) retreatment files. A total of 90 new ProTaper, D-RaCe, and Mtwo retreatment files were tested. Thirty files of the same brand were randomly assigned to two groups (n = 15). Group 1 was no immersion (control group) and 16 mm of group 2 instruments were immersed in 5 % NaOCl at 37 °C for 5 min. All instruments were then tested for cyclic fatigue. Resistance to cyclic fatigue was determined by counting the numbers of cycles to failure in a 60° curve with a 5-mm radius, recording the time in seconds to fracture. Data were analyzed by two-way analysis of variance. Resistance to cyclic fatigue decreased significantly for D-RaCe retreatment files after immersion in NaOCl. ProTaper and Mtwo retreatment files were not affected from immersion to NaOCl. D-RaCe retreatment instruments showed better cyclic fatigue resistance than ProTaper and Mtwo retreatment instruments, and the difference was statistically significant (p < 0.05). There was no significant difference between ProTaper and Mtwo retreatment instrument groups (p > 0.05). D-RaCe retreatment instruments had the highest cyclic fatigue resistance among retreatment files tested in this study, but immersion to NaOCl decreased the cyclic fatigue resistance of D-RaCe retreatment instrument. It should be considered that cyclic fatigue resistance of D-RaCe can decrease in contact with NaOCl during the removal of canal filling material.

  10. The effects of autoclave sterilization on the cyclic fatigue resistance of ProTaper Universal, ProTaper Next, and ProTaper Gold nickel-titanium instruments

    PubMed Central

    2017-01-01

    Objectives It was aimed to compare the cyclic fatigue resistances of ProTaper Universal (PTU), ProTaper Next (PTN), and ProTaper Gold (PTG) and the effects of sterilization by autoclave on the cyclic fatigue life of nickel-titanium (NiTi) instruments. Materials and Methods Eighty PTU, 80 PTN, and 80 PTG were included to the present study. Files were tested in a simulated canal. Each brand of the NiTi files were divided into 4 subgroups: group 1, as received condition; group 2, pre-sterilized instruments exposed to 10 times sterilization by autoclave; group 3, instruments tested were sterilized after being exposed to 25%, 50%, and 75% of the mean cycles to failure, then cycled fatigue test was performed; group 4, instruments exposed to the same experiment with group 3 without sterilization. The number of cycles to failure (NCF) was calculated. The data was statistically analyzed by using one-way analysis of variance and post hoc Tukey tests. Results PTG showed significantly higher NCF than PTU and PTN in group 1 (p < 0.05). Sterilization significantly increased the NCF of PTN and PTG (p < 0.05) in group 2. PTN in group 3 had significantly higher cyclic fatigue resistance than PTN group 4 (p < 0.05). Also, significantly higher NCF was observed for PTG in group 2 than in groups 3 and 4 (p < 0.05). Conclusions PTG instrument made of new gold alloy was more resistant to fatigue failure than PTN and PTU. Autoclaving increased the cyclic fatigue resistances of PTN and PTG. PMID:29142878

  11. Evaluation of conventional, protaper hand and protaper rotary instrumentation system for apical extrusion of debris, irrigants and bacteria- An in vitro randomized trial

    PubMed Central

    Kalra, Pinky; Suman, Ethel; Shenoy, Ramya; Suprabha, Baranya-Shrikrishna

    2017-01-01

    Background Endodontic instrumentation carries the risk of over extrusion of debris and bacteria. The technique used and the type of instrumentation influences this risk. Aim The purpose of this study was to evaluate and compare the K-file, ProTaper hand and ProTaper rotary instrumentation systems for the amount of apically extruded debris, irrigant solution and intracanal bacteria. Design Experimental single blinded randomized type of in vitro study with sample of 30 single rooted teeth. Endodontic access cavities were prepared and the root canals were filled with the suspension of E. faecalis. Myers and Montogomery Model was used to collect apically extruded debris and irrigant. Canals were prepared using K files, Hand protapers and Protaper rotary files. Statistical analysis Non Parametric test like Kruskal-Wallis and Mann-Whitney U test were applied to determine the significant differences among the group. Results Tests revealed statistically significant difference between the amount of debris and number of bacteria extruded by the ProTaper hand and the K-files. No statistically significant difference was observed between the amounts of irrigant extruded by the ProTaper hand and the K-file system. Statistically significant differences were observed between the amounts of bacteria and irrigant extruded by the ProTaper rotary and the Protaper hand. No statistically significant difference was observed between the amounts of debris extruded by the ProTaper hand and the K-file system. Conclusions Amount of apical extrusion of irrigant solution, bacteria and debris are significantly greater with K File instruments and least with Protaper rotary instruments. Key words:Protaper, rotary, periapical extrusion. PMID:28210445

  12. Content Validity of the Hypogonadism Impact of Symptoms Questionnaire (HIS-Q): A Patient-Reported Outcome Measure to Evaluate Symptoms of Hypogonadism.

    PubMed

    Gelhorn, Heather L; Vernon, Margaret K; Stewart, Katie D; Miller, Michael G; Brod, Meryl; Althof, Stanley E; DeRogatis, Leonard R; Dobs, Adrian; Seftel, Allen D; Revicki, Dennis A

    2016-04-01

    Hypogonadism, or low testosterone, is a common disorder. There are currently no patient-reported outcome (PRO) instruments designed to comprehensively evaluate the symptoms of hypogonadism and to detect changes in these symptoms in response to treatment. The purpose of this study was to develop a PRO instrument, the Hypogonadism Impact of Symptoms Questionnaire (HIS-Q) and to assess its content validity. A literature review, expert clinician input, and qualitative concept elicitation with 39 male hypogonadism patients (four focus groups: n = 25; individual interviews: n = 14; mean age 52.3 ± 14.3 years) from the USA were used to develop the draft HIS-Q. Subsequent cognitive interviews (n = 29; mean age 51.5 ± 15.4 years) were used to evaluate content validity. Emergent discussion with participants yielded symptoms within the sexual, physical, energy, sleep, cognition, and mood domains. Low libido and tiredness were most commonly reported. The initial version of the HIS-Q includes 53 items that were consistently understood by the participants, who found the instrument to be relevant to their experiences with hypogonadism and comprehensive in the content coverage of symptoms. The HIS-Q is a comprehensive PRO measure of hypogonadism symptom severity in males. Its design elements, including the response options and recall period, were suitable, and content validity was confirmed.

  13. [Torque resistance of three different types of nickel-titanium rotary instruments].

    PubMed

    Sun, Wei; Hou, Ben-xiang

    2010-10-01

    To compare torsional fracture of three different types of nickel-titanium rotary instruments ProTaper, Hero642 and Mtwo by making a stimulate models in vitro. Through the establishment of model in vitro, compared the different time with 3 kinds of nickel titanium file in cutting-edge bound occurs, and to observe the section of fractured instruments by scanning electron microscope. The resistence to torque was different from three types of nickel titanium instruments. The time to fracture of Mtwo was significantly longer than ProTaper's and Hero642's, but ProTaper's and Hero642's had no significant difference. Three kinds cross-sectional design were different, a lot of toughness nests were seen in broken surface. Most of them were ductile fracture. Time to fracture was influenced by the quality disfigurement. The resistance to torque of Mtwo was better than ProTaper and Hero642. The lifespan was influenced by the design of cross-section. The quality disfigurement of the files reduced the resistance to flexual fatigue.

  14. Developing the draft descriptive system for the child amblyopia treatment questionnaire (CAT-Qol): a mixed methods study.

    PubMed

    Carlton, Jill

    2013-10-22

    Amblyopia is a visual condition that occurs in childhood. Screening programmes exist within the United Kingdom (UK) to detect amblyopia, and once detected treatment is given.Existing patient reported outcome (PRO) measures for amblyopia do not meet current recommendations for the methods adopted during their development, or the way in which the instruments are administered. The overall aim of this study was to produce a self-complete PRO instrument for amblyopia for children aged 4-7 years that uses children's responses in the development phase. The study comprised a number of stages. This paper reports on the refinement of the descriptive system for the draft instrument (the Child Amblyopia Treatment Questionnaire, CAT-QoL) using qualitative and quantitative methods. The study consisted of three components. Children were asked to read, and complete the draft questionnaire as independently as possible. They were then asked about the questionnaire, and its format, in a cognitive debriefing exercise. Observations were made as to the child's ability to read the questionnaire, particular attention was made as to which individual words participants struggled to read. Children were also asked their opinion on the design layout of the questionnaire. Finally, some children were asked to complete a ranking task to help determine the order of the levels of the items as judged by the children. Mid-rank scoring and statistical level of agreement were calculated for the ranking exercise. Thirty-two (n=32) participants completed a draft questionnaire; each of these underwent a cognitive de-briefing interview. Twenty-two (n=22) children completed the ranking exercise. Ten children did not understand the concept of ranking. The results of the qualitative phase (cognitive de-briefing interview) were used to modify the wording of items and layout of the instrument. Results of the ranking exercise were used to inform the order of the response levels for the items. Responses of young children can be used in the development of PRO instruments. They are able to help inform the content, wording, and format of an instrument, ensuring good content and face validity. The results have been used to further refine the CAT-QoL, however further research is required to assess the psychometric properties of the instrument.

  15. Comparative evaluation of rotary ProTaper, Profile, and conventional stepback technique on reduction in Enterococcus faecalis colony-forming units and vertical root fracture resistance of root canals.

    PubMed

    Singla, Mamta; Aggarwal, Vivek; Logani, Ajay; Shah, Naseem

    2010-03-01

    The purpose of this in vitro study was to evaluate the effect of various root canal instrumentation techniques with different instrument tapers on cleaning efficacy and resultant vertical root fracture (VRF) strength of the roots. Fifty human mandibular first premolar roots were enlarged to ISO size 20, inoculated with Enterococcus faecalis [ATCC2912] for 72 hours and divided into 5 groups: group I: prepared with .02 taper hand instruments ISO size 40; group II: Profile .04 taper size 40; group III: Profile .06 taper size 40; group IV: ProTaper size F4; and group V (control group) further divided into: Va: with bacterial inoculation and no mechanical instrumentation; and Group Vb: neither bacterial inoculation nor mechanical instrumentation. Cleaning efficacy was evaluated in terms of reduction of colony forming units (CFUs). The VRF strength was evaluated using D11 spreader as wedge in an Instron testing machine. Root canals instrumented with ProTaper and 6% Profile instruments showed maximum reduction in CFUs, with statistically insignificant difference between them. The VRF resistance decreased in all instrumented groups. The difference of VRF between 2% and 4% taper Profile groups was statistically insignificant (P = .195). One-way analysis of variance showed that canals instrumented with ProTaper F4 showed maximum reduction in VRF resistance compared with control uninstrumented group. Profile 6% taper instruments offer the advantage of maximum debridement without significant reduction in root fracture resistance. Copyright 2010 Mosby, Inc. All rights reserved.

  16. Comparative Analysis of Crack Propagation in Roots with Hand and Rotary Instrumentation of the Root Canal -An Ex-vivo Study.

    PubMed

    Kumari, Manju Raj; Krishnaswamy, Manjunath Mysore

    2016-07-01

    Success of any endodontic treatment depends on strict adherence to 'endodontic triad'. Preparation of root canal system is recognized as being one of the most important stages in root canal treatment. At times, we inevitably end up damaging root dentin which becomes a Gateway for infections like perforation, zipping, dentinal cracks and minute intricate fractures or even vertical root fractures, thereby resulting in failure of treatment. Several factors may be responsible for the formation of dentinal cracks like high concentration of sodium hypochlorite, compaction methods and various canal shaping methods. To compare and evaluate the effects of root canal preparation techniques and instrumentation length on the development of apical root cracks. Seventy extracted premolars with straight roots were mounted on resin blocks with simulated periodontal ligaments, exposing 1-2 mm of the apex followed by sectioning of 1mm of root tip for better visualization under stereomicroscope. The teeth were divided into seven groups of 10 teeth each - a control group and six experimental groups. Subgroup A & B were instrumented with: Stainless Steel hand files (SS) up to Root Canal Length (RCL) & (RCL -1 mm) respectively; sub group C & D were instrumented using ProTaper Universal (PTU) up to RCL and (RCL -1mm) respectively; subgroup E & F were instrumented using ProTaper Next (PTN) up to RCL & (RCL -1 mm) respectively. Stereomicroscopic images of the instrumentation sequence were compared for each tooth. The data was analyzed statistically using descriptive analysis by 'Phi' and 'Cramers' test to find out statistical significance between the groups. The level of significance was set at p< 0.05 using SPSS software. Stainless steel hand file group showed most cracks followed by ProTaper Universal & ProTaper Next though statistically not significant. Samples instrumented up to 1mm short of working length (RCL-1mm) showed lesser number of cracks. All groups showed cracks formation, the stainless steel group being the highest. Working 1mm short of apex reduces the incidence of crack formation.

  17. Comparative Analysis of Protaper and Waveone Systems to Reduce Enterococcus Faecalis from Root Canal System in Primary Molars--An in Vitro Study.

    PubMed

    Pinheiro, Sérgio Luiz; Pessoa, Carolina; da Silva, Josianne Neres; Gonçalves, Rafael Orro; Duarte, Danilo Antonio; da Silveira Bueno, Carlos Eduardo

    2016-01-01

    To assess, in vitro, the ability of the ProTaper(™) and WaveOne(™) systems to reduce Enterococcus faecalis contamination in primary molars. Sixty roots of primary molars were contaminated with E. faecalis. Roots were randomly allocated to one of four groups (n=20): ProTaper(™), WaveOne(™), control A, or control B. The files used were S1 and S2/F1 and F2 (ProTaper(™) system) and 25.08 (WaveOne(™) system). In control group A, the root canal was left uninstrumented, whereas in control group B, the root canal was irrigated with NaCl 0.9%. E. faecalis was sampled from the root canal system before and after instrumentation and the Wilcoxon test and Mann-Whitney U were used. There were no differences in E. faecalis counts between pre-instrumentation counts in the ProTaper™ and WaveOne(™) (p>0.05). The ProTaper(™) system led to an 89.36% reduction in E. faecalis burden, versus 78.10% with the WaveOne(™) system (p>0.05). Instrumentation time was shorter with WaveOne(™) (p<0.0001). The ProTaper(™) and WaveOne™ systems were equally effective in reducing Enterococcus faecalis in primary molars. The WaveOne(™) system was associated with shorter instrumentation time.

  18. Performance of PROMIS Instruments in Patients With Shoulder Instability.

    PubMed

    Anthony, Chris A; Glass, Natalie A; Hancock, Kyle; Bollier, Matt; Wolf, Brian R; Hettrich, Carolyn M

    2017-02-01

    Shoulder instability is a relatively common condition occurring in 2% of the population. PROMIS (Patient-Reported Outcome Measurement Information System) was developed by the National Institutes of Health in an effort to advance patient-reported outcome (PRO) instruments by developing question banks for major health domains. To compare PROMIS instruments to current PRO instruments in patients who would be undergoing operative intervention for recurrent shoulder instability. Cohort study (diagnosis); Level of evidence, 2. A total of 74 patients with a primary diagnosis of shoulder instability who would be undergoing surgery were asked to fill out the American Shoulder and Elbow Surgeons shoulder assessment form (ASES), Marx shoulder activity scale (Marx), Short Form-36 Health Survey Physical Function subscale (SF-36 PF), Western Ontario Shoulder Instability Index (WOSI), PROMIS physical function computer adaptive test (PF CAT), and PROMIS upper extremity item bank (UE). Correlation between PRO instruments was defined as excellent (>0.7), excellent-good (0.61-0.7), good (0.4-0.6), and poor (0.2-0.3). Utilization of the PROMIS UE demonstrated excellent correlation with the SF-36 PF ( r = 0.78, P < .01) and ASES ( r = 0.71, P < .01); there was excellent-good correlation with the EQ-5D ( r = 0.66, P < .01), WOSI ( r = 0.63, P < .01), and PROMIS PF CAT ( r = 0.63, P < .01). Utilization of the PROMIS PF CAT demonstrated excellent correlation with the SF-36 PF ( r = 0.72, P < .01); there was excellent-good correlation with the ASES ( r = 0.67, P < .01) and PROMIS UE ( r = 0.63, P < .01). When utilizing the PROMIS UE, ceiling effects were present in 28.6% of patients aged 18 to 21 years. Patients, on average, answered 4.6 ± 1.8 questions utilizing the PROMIS PF CAT. The PROMIS UE and PROMIS PF CAT demonstrated good to excellent correlation with common shoulder and upper extremity PRO instruments as well as the SF-36 PF in patients with shoulder instability. In patients aged ≤21 years, there were significant ceiling effects utilizing the PROMIS UE. While the PROMIS PF CAT appears appropriate for use in adults of any age, our findings demonstrate that the PROMIS UE has significant ceiling effects in patients with shoulder instability who are ≤21 years old, and we do not recommend use of the PROMIS UE in this population.

  19. [Scanning electron microscopy investigation of canal cleaning after canal preparation with nickel titanium files].

    PubMed

    Brkanić, Tatjana; Ivana, Stojsin; Vukoje, Karolina; Zivković, Slavoljub

    2010-01-01

    Root canal preparation is the most important phase of endodontic procedure and it consists of adequate canal space cleaning and shaping. In recent years, rotary instruments and techniques have gained importance because of the great efficacy, speed and safety of the preparation procedure. The aim of this research was to investigate the influence of different NiTi files on the canal wall cleaning quality, residual dentine debris and smear layer. The research was conducted on extracted human teeth in vitro conditions. Teeth were divided in 7 main groups depending on the kind of instruments used for root canal preparation: ProTaper, GT, ProFile, K-3, FlexMaster, hand ProTaper and hand GT. Root canal preparation was accomplished by crown-down technique. Prepared samples were assessed on scanning electron microscopy JEOL, JSM-6460 LV. The evaluation of dentine debris was done with 500x magnification, and the evaluation of smear layer with 1,000 times magnification. Quantitive assessment of dentine debris and smear layer was done according to the criteria of Hulsmann. The least amount of debris and smear layer has been found in canals shaped with ProFile instruments, and the largest amount in canals shaped with FlexMaster instruments. Canal cleaning efficacy of hand GTand ProTaperfiles has been similar to cleaning efficacy of rotary NiTi files. Statistic analysis has shown a significant difference in amount of dentine debris and smear layer on the canal walls between sample groups. shaped with different instruments. Completely clean canals have not been found in any tested group of instruments. The largest amount of debris and smear layer has been found in the apical third of all canals. The design and the type of endodontic instruments influence the efficacy of the canal cleaning.

  20. Transportation and Centering Ability of Neoniti and ProTaper Instruments; A CBCT Assessment

    PubMed Central

    Madani, Zahrasadat; Soleymani, Ali; Bagheri, Tasnim; Moudi, Ehsan; Bijani, Ali; Rakhshan, Vahid

    2017-01-01

    Introduction: Transportation is an important iatrogenic endodontic error which might cause failure. This study evaluated the canal transportation caused by Neoniti and ProTaper instruments, using cone-beam computed tomography (CBCT) cross sections. Methods and Materials: This in vitro experimental study was performed on 40 mesiobuccal roots of maxillary first molars. The teeth were scanned with CBCT. They were randomly divided into 2 groups (n=20) that were prepared using either Neoniti or ProTaper files. An endodontist prepared the canal according to the manufacturer’s guidelines. Prepared canals were re-scanned. The pre-instrumentation and post-instrumentation CBCT volumes were sectioned at 1 to 9-mm distances from the apex. The extent of canal dentine removal in mesial and distal directions were measured in each cross-section. Canal transportation and instrument centering ability were estimated based on the extents of root wall removal and were compared in both groups. Results: The groups were rather similar in terms of transportation and centering ability (P>0.05). However, canal preparation on mesial and distal walls was statistically significantly less in the Neoniti group, at most cross-sections. Transportation of both groups was not significantly different (P>0.05). Centering ability of both instruments was not significantly different (P>0.05). Conclusion: Neoniti and ProTaper instruments might have proper centering ability and minimum transportations. Both instruments might cause similar extents of transportation and centering abilities. PMID:28179923

  1. Linguistic and content validation of a German-language PRO-CTCAE-based patient-reported outcomes instrument to evaluate the late effect symptom experience after allogeneic hematopoietic stem cell transplantation.

    PubMed

    Kirsch, Monika; Mitchell, Sandra A; Dobbels, Fabienne; Stussi, Georg; Basch, Ethan; Halter, Jorg P; De Geest, Sabina

    2015-02-01

    The aim of this sequential mixed methods study was to develop a PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events)-based measure of the symptom experience of late effects in German speaking long-term survivors of allogeneic stem cell transplantation (SCT), and to examine its content validity. The US National Cancer Institute's PRO-CTAE item library was translated into German and linguistically validated. PRO-CTCAE symptoms prevalent in ≥50% of survivors (n = 15) and recognized in its importance by SCT experts (n = 9) were identified. Additional concepts relevant to the symptom experience and its consequences were elicited. Content validity of the PROVIVO (Patient-Reported Outcomes of long-term survivors after allogeneic SCT) instrument was assessed through an additional round of cognitive debriefing in 15 patients, and item and scale content validity indices by 9 experts. PROVIVO is comprised of a total of 49 items capturing the experience of physical, emotional and cognitive symptoms. To improve the instrument's utility for clinical decision-making, questions soliciting limitations in activities of daily living, frequent infections, and overall well-being were added. Cognitive debriefings demonstrated that items were well understood and relevant to the SCT survivor experience. Scale Content Validity Index (CVI) (0.94) and item CVI (median = 1; range 0.75-1) were very high. Qualitative and quantitative data provide preliminary evidence supporting the content validity of PROVIVO and identify a PRO-CTCAE item bundle for use in SCT survivors. A study to evaluate the measurement properties of PROVIVO and to examine its capacity to improve survivorship care planning is underway. Copyright © 2014 Elsevier Ltd. All rights reserved.

  2. Effect of three different rotary instrumentation systems on postinstrumentation pain: A randomized clinical trial

    PubMed Central

    Subbiya, Arunajatesan; Cherkas, Pavel S.; Vivekanandhan, Paramasivam; Geethapriya, Nagarajan; Malarvizhi, Dhakshinamoorthy; Mitthra, Suresh

    2017-01-01

    Background: Endodontic instrumentation is liable to cause some postinstrumentation pain (PIP). Rotary endodontic instruments differ in their design, metallurgy, surface treatment, etc. Aim: This randomized clinical trial aimed to assess the incidence of PIP after root canal instrumentation with three different rotary endodontic systems which differ in their design, namely, ProTaper, Mtwo, and K3. Materials and Methods: A total of 150 patients between the ages of 25 and 50 were chosen for the study. Teeth with asymptomatic irreversible pulpitis due to carious exposure were selected. The patients received local anesthesia by inferior alveolar nerve block. After preparing the access cavity, root canal instrumentation was done with one of the three instruments (n = 50) and closed dressing was given. PIP was assessed every 12 h for 5 days, and tenderness to percussion was analyzed at the end of 1, 3, and 7 days. Statistical Analysis: Mann–Whitney U-test to determine significant differences at P < 0.01. Results: The PIP and tenderness were less in Mtwo group when compared to ProTaper and K3 groups up to 84 h and 72 h respectively and statistically significant (P < 0.05). There was no statistically significant difference between ProTaper and K3 both in PIP and tenderness. Conclusion: Rotary endodontic instrumentation causes some degree of PIP and tenderness to percussion. Among the instruments used, Mtwo causes less PIP and tenderness when compared to ProTaper and K3, and there was no difference between ProTaper and K3. Clinical Relevance: PIP is highly subjective and may vary among different subjects. The apical (3 mm) taper of ProTaper was 0.08 followed by a smaller taper, whereas, the other two files were of a constant 0.06 taper, which means there could have been a greater apical extrusion and therefore more PIP. Despite, the mean of the age was similar, there could have been a difference in the size of the canal and therefore a difference in apical extrusion and PIP. PMID:29430103

  3. Vertical Root Fracture initiation in curved roots after root canal preparation: A dentinal micro-crack analysis with LED transillumination

    PubMed Central

    Martín-Biedma, Benjamín; Varela-Patiño, Purificación; Ruíz-Piñón, Manuel; Castelo-Baz, Pablo

    2017-01-01

    Background One of the causative factors of root defects is the increased friction produced by rotary instrumentation. A high canal curvature may increase stress, making the tooth more susceptible to dentinal cracks. The purpose of this study was to evaluate dentinal micro-crack formation with the ProTaper NEXT and ProTaper Universal systems using LED transillumination, and to analyze the micro-crack generated at the point of maximum canal curvature. Material and Methods 60 human mandibular premolars with curvatures between 30–49° and radii between 2–4 mm were used. The root canals were instrumented using the Protaper Universal® and Protaper NEXT® systems, with the aid of the Proglider® system. The obtained samples were sectioned transversely before subsequent analysis with LED transillumination at 2 mm and 8 mm from the apex and at the point of maximum canal curvature. Defects were scored: 0 for no defects; and 1 for micro-cracks. Results Root defects were not observed in the control group. The ProTaper NEXT system caused fewer defects (16.7%) than the ProTaper Universal system (40%) (P<0.05). The ProTaper Universal system caused significantly more micro-cracks at the point of maximum canal curvature than the ProTaper NEXT system (P<0.05). Conclusions Rotary instrumentation systems often generate root defects, but the ProTaper NEXT system generated fewer dentinal defects than the ProTaper Universal system. A higher prevalence of defects was found at the point of maximum curvature in the ProTaper Universal group. Key words:Curved root, Micro-crack, point of maximum canal curvature, ProTaper NEXT, ProTaper Universal, Vertical root fracture. PMID:29167712

  4. The effects of different nickel-titanium instruments on dentinal microcrack formations during root canal preparation.

    PubMed

    Ustun, Yakup; Aslan, Tugrul; Sagsen, Burak; Kesim, Bertan

    2015-01-01

    The aim of the present study was to investigate the incidence of dentinal microcracks caused by different preparation techniques. 120 extracted human mandibular incisor teeth were divided into five experimental groups and one control group (n = 20): Group 1: Hand preparation with balanced force technique up to #25 K-file. Group 2: Preparation with only ProTaper F2 instrument in a reciprocating movement. Group 3: Preparation with Reciproc R25 instrument in a reciprocating movement. Group 4: Preparation with ProTaper instruments up to F2 instrument. Group 5: Preparation with ProTaper Next instruments up to X2 instrument. No procedure was applied to control group. The roots were sectioned horizontally at 3, 6 and 9 mm from the apex and examined. Absence or presence of dentinal microcracks was noted. The Chi-square test was performed to compare the appearance of cracked roots between all groups. There were no significant differences among the groups (P > 0.05). In conclusion, except the hand file and control group, all experimental groups showed microcrack formations.

  5. Comparison of the mechanical properties of rotary instruments made of conventional nickel-titanium wire, M-wire, or nickel-titanium alloy in R-phase.

    PubMed

    Lopes, Hélio P; Gambarra-Soares, Thaiane; Elias, Carlos N; Siqueira, José F; Inojosa, Inês F J; Lopes, Weber S P; Vieira, Victor T L

    2013-04-01

    This study compared the mechanical properties of endodontic instruments made of conventional nickel-titanium (NiTi) wire (K(3) and Revo-S SU), M-Wire (ProFile Vortex), or NiTi alloy in R-phase (K(3)XF). The test instruments were subjected to mechanical tests to evaluate resistance to bending (flexibility), cyclic fatigue, and torsional load in clockwise rotation. Data were statistically evaluated by the analysis of variance test and the Student-Newman-Keuls test for multiple comparisons. In the bending resistance test, flexibility decreased in the following order: K(3)XF > Revo-S SU > ProFile Vortex > K(3). The ranking in the fatigue resistance test was the following: K(3)XF > K(3) > ProFile Vortex > Revo-S SU. In the torsional assay, the angular deflection at failure decreased in the following order: K(3)XF > Revo-S SU > K(3) > ProFile Vortex. For the maximum torque values, the ranking was K(3) > K(3)XF > ProFile Vortex > Revo-S SU. The results showed that the K(3)XF instrument, which is made of NiTi alloy in R-phase, had the overall best performance in terms of flexibility, angular deflection at failure, and cyclic fatigue resistance. In addition to the alloy from which the instrument is manufactured, the design and dimensions are important determinants of the mechanical performance of endodontic instruments. Copyright © 2013 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  6. Micro-CT evaluation of several glide path techniques and ProTaper Next shaping outcomes in maxillary first molar curved canals.

    PubMed

    Alovisi, M; Cemenasco, A; Mancini, L; Paolino, D; Scotti, N; Bianchi, C C; Pasqualini, D

    2017-04-01

    To evaluate the ability of ProGlider instruments, PathFiles and K-files to maintain canal anatomy during glide path preparation using X-ray computed micro-tomography (micro-CT). Forty-five extracted maxillary first permanent molars were selected. Mesio-buccal canals were randomly assigned (n = 15) to manual K-file, PathFile or ProGlider groups for glide path preparation. Irrigation was achieved with 5% NaOCl and 10% EDTA. After glide path preparation, each canal was shaped with ProTaper Next X1 and X2 to working length. Specimens were scanned (isotropic voxel size 9.1 μm) for matching volumes and surface areas and post-treatment analyses. Canal volume, surface area, centroid shift, canal geometry variation through ratio of diameter ratios and ratio of cross-sectional areas were assessed in the apical and coronal levels and at the point of maximum canal curvature. One-way factorial anovas were used to evaluate the significance of instrument in the various canal regions. Post-glide path analysis revealed that instrument factor was significant at the apical level for both the ratio of diameter ratios and the ratio of cross-sectional areas (P < 0.001), with an improved maintenance of root canal geometry by ProGlider and PathFile. At the coronal level and point of maximum canal curvature, ProGlider demonstrated a tendency to pre-flare the root canal compared with K-file and PathFile. PathFile and ProGlider demonstrated a significantly lower centroid shift compared with K-file at the apical level (P = 0.023). Post-shaping analysis demonstrated a more centred preparation of ProGlider, compared with PathFile and K-files, with no significant differences for other parameters. Use of ProGlider instruments led to less canal transportation than PathFiles and K-files. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  7. "Dentinal microcracks after root canal preparation" a comparative evaluation with hand, rotary and reciprocating instrumentation.

    PubMed

    Priya, N Tulasi; Chandrasekhar, Veeramachaneni; Anita, S; Tummala, Muralidhar; Raj, T B Phanindhar; Badami, Vijetha; Kumar, Pradeep; Soujanya, E

    2014-12-01

    The purpose of this study was to compare the incidence of dentinal micro cracks after instrumentation with various types of NiTi files in rotary and reciprocating motion. One hundred human extracted mandibular central incisors were taken and divided into 10 groups (n=10 teeth per group). Group 1- No preparation, Group 2 - Hand instrumentation, Groups 3,4 - ProTaper files in rotary and reciprocating motion, Groups 5,6 - ProTaper Next files in rotary and reciprocating motion, Groups 7,8 - Oneshape files in rotary and reciprocating motion, Groups 9,10 - Reciproc files in rotary and reciprocating motion. Specimens were sectioned horizontally at 3,6 and 9 mm from the apex and dentinal micro cracks were observed under a stereomicroscope. There was a statistically significant difference between the groups (p<0.05). There were no significant differences in crack formation between the groups (Protaper Next - Rot, Protaper Next - Rec, Reciproc - Rec); (ProTaper - Rot, ProTaper - Rec, Oneshape - Rot), (Oneshape - Rot, Reciproc - Rot), (One shape Reciproc, Reciproc - Rec); (p >.05). Least cracks were seen in canals instrumented with Pro Taper Next files both in rotary and reciprocating motion. Full sequence rotary systems showed less cracks than single file systems and full sequence rotary systems showed less cracks in reciprocating motion than in rotary motion.

  8. Influence of axial movement on fatigue of PROFILE* NI-TI rotary instruments: an in vitro evaluation

    PubMed Central

    Avoaka, Marie-Chantal; Haïkel, Youssef

    2010-01-01

    The aim of this study was to evaluate the influence of the axial movement and the angle of curve (in degrees) on fatigue of nickel-titanium (Ni-Ti) ProFile’ rotary endodontic instruments. Ni-Ti ProFile’ rotary instruments (Maillefer SA, Ballaigues, Switzerland), 25 mm long in the range of ISO size 15 to 40 with two tapers (0.4 and 0.6) were evaluated. They are divided in two groups: the instruments with axial movement and those without axial movement. The system used to test the fatigue is maintained in mechanical conditions as close as possible to the clinical situation. The axial movement is in the order of 2mm in corono-apical direction with a frequency of 1Hz. The concave radii incorporating a notched V-form for guiding the instruments were: 5; 7,5 and 10 mm. The rotary system is mounted on an electric handpiece and rotated at 350 rpm speed as recommended by the manufacturers. The instruments are rotated until their separation, and the time, in seconds, is recorded. Statístícal evaluation is undertaken using a two-way t-test to identify significant differences between variables in the study (p <0,05). We found significant statistical difference (p<0,05) between Ni-Ti engine drive ProFile’ instruments incorporating an axial movement and the instruments without axial movement with the same radius of curvature, size and taper. The incorporation of the axial movement increases significantly the life-span of the ProFile’ rotary instruments. This should reduce the risk of the instrument separation during the endodontic treatment. PMID:20507289

  9. [Application of hand-use ProTaper instruments in endodontic treatment of molar canals].

    PubMed

    Ma, Sui-qi; Xie, Qian; Zhou, Yin-feng

    2010-07-01

    To evaluate the application of hand-use ProTaper instruments in endodontic treatment of molar canals. A total of 203 permanent molars were randomly divided into the experimental group (99 molars) and control group (104 molars) prepared by hand-use ProTaper instruments and standard stainless steel K-file, respectively. The molars in the two groups were obturated by cold lateral condensation technique. The root canal preparation and obturation were evaluated by radiograph, and the working time of preparation and post-operative emergencies were analyzed. The preparation time in the experimental group was obviously shorter than that in the control group (P<0.01). The rate of satisfactory effect was significantly higher in the experimental group than in the control group (P<0.01), and the rate of post-operative emergencies was significantly lower in the experimental group (P<0.01). The application of hand-use ProTaper instruments may improve the effect of root canal treatment of the molars and shorten the working time and reduce the post-operative emergencies.

  10. The shaping effects of three nickel-titanium rotary instruments in simulated S-shaped canals.

    PubMed

    Yoshimine, Y; Ono, M; Akamine, A

    2005-05-01

    The purpose of this study was to compare the shaping effects of three nickel-titanium rotary instruments, ProTaper, K3, and RaCe, with emphasis on canal transportation. Simulated canals with an S-shaped curvature in clear resin blocks were prepared with a torque-control, low-speed engine. Canals were prepared using the crown-down technique to the size of #30. Canal aberrations were assessed by comparing the pre- and postinstrumentation images under a stereomicroscope. ProTaper instruments caused greater widening of canals compared to K3 or RaCe. Furthermore, ProTaper files showed a tendency to ledge or zip formation at the end-point of preparation. These canal aberrations may be caused by ProTaper finishing files, which appear to be less flexible than other files of the same tip-size, because of their greater taper-size. These results suggest that nickel-titanium file systems including less tapered, more flexible instruments, like K3 and RaCe should be used in the apical preparation of canals with a complicated curvature.

  11. The quality of dying and death measurement instruments: A systematic psychometric review.

    PubMed

    Gutiérrez Sánchez, Daniel; Pérez Cruzado, David; Cuesta-Vargas, Antonio I

    2018-04-19

    To identify instruments that could assess the quality of dying and death and their psychometric properties. To assess the methodological quality of studies on measurement properties. A high quality of death is regarded as a goal at the end of life and, therefore, an assessment of the end of life experience is essential. Many instruments have been developed to evaluate the quality of dying and death. The selection of the most appropriate measure to be used in clinical and research settings is crucial. Psychometric systematic review. We systematically searched ProQuest Medline, SciELO and ProQuest PsycINFO from 1970 - May 2016. Identification and evaluation of instruments that assessed quality of dying and death. Papers were evaluated by two independent reviewers according to the COSMIN checklist with a 4-point scale. A total of 19 studies were included in this review. Seven instruments were found that were specifically designed for assessing quality of dying and death. A retrospective carer proxy report to evaluate this construct was used in most of the papers. The methodological quality of the studies was fair for most of the psychometric characteristics analyzed. Many instruments have been developed to assess the quality of dying and death. The Quality of Dying and Death Questionnaire is the best available measure of the quality of dying and death. It is the only questionnaire identified in this review where all psychometric properties according to the COSMIN checklist have been evaluated. © 2018 John Wiley & Sons Ltd.

  12. Applying mixed methods to pretest the Pressure Ulcer Quality of Life (PU-QOL) instrument.

    PubMed

    Gorecki, C; Lamping, D L; Nixon, J; Brown, J M; Cano, S

    2012-04-01

    Pretesting is key in the development of patient-reported outcome (PRO) instruments. We describe a mixed-methods approach based on interviews and Rasch measurement methods in the pretesting of the Pressure Ulcer Quality of Life (PU-QOL) instrument. We used cognitive interviews to pretest the PU-QOL in 35 patients with pressure ulcers with the view to identifying problematic items, followed by Rasch analysis to examine response options, appropriateness of the item series and biases due to question ordering (item fit). We then compared findings in an interactive and iterative process to identify potential strengths and weaknesses of PU-QOL items, and guide decision-making about further revisions to items and design/layout. Although cognitive interviews largely supported items, they highlighted problems with layout, response options and comprehension. Findings from the Rasch analysis identified problems with response options through reversed thresholds. The use of a mixed-methods approach in pretesting the PU-QOL instrument proved beneficial for identifying problems with scale layout, response options and framing/wording of items. Rasch measurement methods are a useful addition to standard qualitative pretesting for evaluating strengths and weaknesses of early stage PRO instruments.

  13. Assessments of pain, functional impairment, anxiety, and depression in US adults with hemophilia across patient-reported outcome instruments in the Pain, Functional Impairment, and Quality of Life (P-FiQ) study.

    PubMed

    Buckner, Tyler W; Batt, Katharine; Quon, Doris; Witkop, Michelle; Recht, Michael; Kessler, Craig; Baumann, Kimberly; Hernandez, Grace; Wang, Michael; Cooper, David L; Kempton, Christine L

    2018-04-01

    Pain, functional impairment, anxiety, and depression associated with joint disease may affect health-related quality of life (HRQoL) in people with hemophilia. To report detailed patient-reported outcomes (PRO) assessments related to HRQoL in participants in the Pain, Functional Impairment, and Quality of Life (P-FiQ) study. Pain and HRQoL were assessed via PRO instruments in US adult males with hemophilia A or B and a history of joint pain or bleeding. PRO instruments included EQ-5D-5L with visual analog scale, Brief Pain Inventory v2 Short Form, SF-36v2, and Hemophilia Activities List. Instrument domain and item responses were described. Responses were collected from 381 adult males with a median age of 34 years. Pain was observed across instruments and affected daily activities and quality of life. Respondents reported functional impairment that limited the kind of work and activities they participated in, with activities involving the lower extremities being most affected. A high prevalence of mental health disorders was identified across instruments. Pain and HRQoL were evaluated using multiple PRO instruments, which vary in timescales of assessment and levels of detail. More consistent clinical assessments and patient dialog regarding pain and aspects of HRQoL may help drive improved outcomes. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  14. Do NiTi instruments show defects before separation? Defects caused by torsional fatigue in hand and rotary nickel-titanium (NiTi) instruments which lead to failure during clinical use.

    PubMed

    Chakka, N V Murali Krishna; Ratnakar, P; Das, Sanjib; Bagchi, Anandamy; Sudhir, Sudhir; Anumula, Lavanya

    2012-11-01

    Visual and microscopic evaluation of defects caused by torsional fatigue in hand and rotary nickel titanium (NiTi) instruments. Ninety-six NiTi greater taper instruments which were routinely used for root canal treatment only in anterior teeth were selected for the study. The files taken include ProTaper for hand use, ProTaper Rotary files and Endowave rotary files. After every use, the files were observed visually and microscopically (Stereomicroscope at 10×) to evaluate the defects caused by torsional fatigue. Scoring was given according to a new classification formulated which gives an indication of the severity of the defect or damage. Data was statistically analyzed using KruskallWallis and Mann-Whitney U test. Number of files showing defects were more under stereomicroscope than visual examination. But, the difference in the evaluation methods was not statistically significant. The different types of defects observed were bent instrument, straightening/stretching of twist contour and partial reverse twisting. Endowave files showed maximum number of defects followed by ProTaper for hand use and least in ProTaper Rotary. Visible defects due to torsional fatigue do occur in NiTi instruments after clinical use. Both visual and microscopic examinations were efficient in detecting defects caused due to torsional fatigue. This study emphasizes that all files should be observed for any visible defects before and after every instrumentation cycle to minimize the risk of instrument separation and failure of endodontic therapy.

  15. Assessment of apically extruded debris produced by the single-file ProTaper F2 technique under reciprocating movement.

    PubMed

    De-Deus, Gustavo; Brandão, Maria Claudia; Barino, Bianca; Di Giorgi, Karina; Fidel, Rivail Antonio Sergio; Luna, Aderval Severino

    2010-09-01

    This study was designed to quantitatively evaluate the amount of dentin debris extruded from the apical foramen by comparing the conventional sequence of the ProTaper Universal nickel-titanium (NiTi) files with the single-file ProTaper F2 technique. Thirty mesial roots of lower molars were selected, and the use of different instrumentation techniques resulted in 3 groups (n=10 each). In G1, a crown-down hand-file technique was used, and in G2 conventional ProTaper Universal technique was used. In G3, ProTaper F2 file was used in a reciprocating motion. The apical finish preparation was equivalent to ISO size 25. An apparatus was used to evaluate the apically extruded debris. Statistical analysis was performed using 1-way analysis of variance and Tukey multiple comparisons. No significant difference was found in the amount of the debris extruded between the conventional sequence of the ProTaper Universal NiTi files and the single-file ProTaper F2 technique (P>.05). In contrast, the hand instrumentation group extruded significantly more debris than both NiTi groups (P<.05). The present results yielded favorable input for the F2 single-file technique in terms of apically extruded debris, inasmuch as it is the most simple and cost-effective instrumentation approach. Copyright (c) 2010 Mosby, Inc. All rights reserved.

  16. Cleaning capacity promoted by motor-driven or manual instrumentation using ProTaper Universal system: Histological analysis.

    PubMed

    da Frota, Matheus Franco; Filho, Idomeo Bonetti; Berbert, Fábio Luiz Camargo Villela; Sponchiado, Emilio Carlos; Marques, André Augusto Franco; Garcia, Lucas da Fonseca Roberti

    2013-01-01

    The aim of this study was to assess the cleaning capacity of the Protaper system using motor-driven or manual instrumentation. Ten mandibular molars were randomly separated into 2 groups (n = 5) according to the type of instrumentation performed, as follows: Group 1 - instrumentation with rotary nickel-titanium (Ni-Ti) files using ProTaper Universal System (Dentsply/Maillefer); and, Group 2 - instrumentation with Ni-Ti hand files using ProTaper Universal (Dentsply-Maillefer). Afterwards, the teeth were sectioned transversely and submitted to histotechnical processing to obtain histological sections for microscopic evaluation. The images were analyzed by the Corel Photo-Paint X5 program (Corel Corporation) using an integration grid superimposed on the image. Statistical analysis (U-Mann-Whitney - P < 0.05) demonstrated that G1 presented higher cleaning capacity when compared to G2. The rotary technique presented better cleaning results in the apical third of the root canal system when compared to the manual technique.

  17. Assessing Asthma Symptoms in Adolescents and Adults: Qualitative Research Supporting Development of the Asthma Daily Symptom Diary.

    PubMed

    Gater, Adam; Nelsen, Linda; Fleming, Sarah; Lundy, J Jason; Bonner, Nicola; Hall, Rebecca; Marshall, Chris; Staunton, Hannah; Krishnan, Jerry A; Stoloff, Stuart; Schatz, Michael; Haughney, John

    2016-06-01

    Despite the widespread availability of patient-reported asthma questionnaires, instruments developed in accordance with present regulatory expectations are lacking. To address this gap, the Patient-Reported Outcome (PRO) Consortium's Asthma Working Group has developed a patient-reported asthma daily symptom diary (ADSD) for use in clinical research to assess outcomes and support medical product labeling claims in adults and adolescents with asthma. To summarize the qualitative research conducted to inform the initial development of the ADSD and to provide evidence for content validity of the instrument in accordance with the Food and Drug Administration's PRO Guidance. Research informing the initial development and confirming the content validity of the ADSD is summarized. This comprised a review of published qualitative research, semi-structured concept elicitation interviews (n = 55), and cognitive interviews (n = 65) with a diverse and representative sample of adults and adolescents with a clinician-confirmed diagnosis of asthma in the United States to understand the asthma symptom experience and to assess the relevance and understanding of the newly developed ADSD. From the qualitative literature review and concept elicitation interviews, eight core asthma symptoms emerged. These were broadly categorized as breathing symptoms (difficulty breathing, shortness of breath, and wheezing), chest symptoms (chest tightness, chest pain, and pressure/weight on chest), and cough symptoms (cough and the presence of mucus/phlegm). Conceptual saturation was achieved and differences in the experience of participants according to socio-demographic or clinical characteristics were not observed. Subsequent testing of the ADSD confirmed participant relevance and understanding. The ADSD is a new patient-reported asthma symptom diary developed in accordance with the Food and Drug Administration's PRO Guidance. Evidence to date supports the content validity of the instrument. Item performance, reliability, and construct validity will be assessed in future quantitative research. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  18. Efficacy of CM-Wire, M-Wire, and Nickel-Titanium Instruments for Removing Filling Material from Curved Root Canals: A Micro-Computed Tomography Study.

    PubMed

    Rodrigues, Clarissa Teles; Duarte, Marco Antonio Hungaro; de Almeida, Marcela Milanezi; de Andrade, Flaviana Bombarda; Bernardineli, Norberti

    2016-11-01

    The aim of this ex vivo study was to evaluate the removal of filling material after using CM-wire, M-wire, and nickel-titanium instruments in both reciprocating and rotary motions in curved canals. Thirty maxillary lateral incisors were divided into 9 groups according to retreatment procedures: Reciproc R25 followed by Mtwo 40/.04 and ProDesign Logic 50/.01 files; ProDesign R 25/.06 followed by ProDesign Logic 40/.05 and ProDesign Logic 50/.01 files; and Gates-Glidden drills, Hedström files, and K-files up to apical size 30 followed by K-file 40 and K-file 50 up to the working length. Micro-computed tomography scans were performed before and after each reinstrumentation procedure to evaluate root canal filling removal. Statistical analysis was performed with Kruskal-Wallis, Friedman, and Wilcoxon tests (P < .05). No significant differences in filling material removal were found in the 3 groups of teeth. The use of Mtwo and ProDesign Logic 40/.05 rotary files did not enhance filling material removal after the use of reciprocating files. The use of ProDesign Logic 50/.01 files significantly reduced the amount of filling material at the apical levels compared with the use of reciprocating files. Association of reciprocating and rotary files was capable of removing a large amount of filling material in the retreatment of curved canals, irrespective of the type of alloy of the instruments. The use of a ProDesign Logic 50/.01 file for apical preparation significantly reduced the amount of remnant material in the apical portion when compared with reciprocating instruments. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  19. Effectiveness of ProTaper Universal retreatment instruments used with rotary or reciprocating adaptive motion in the removal of root canal filling material.

    PubMed

    Capar, I D; Arslan, H; Ertas, H; Gök, T; Saygılı, G

    2015-01-01

    To compare the effectiveness of ProTaper Universal retreatment instruments with continuous rotation and adaptive motion (AM; a modified reciprocating motion that combines rotational and reciprocating motion) in the removal of filling material. Mesiobuccal root canals in 36 mandibular first molars were instrumented up to size F2 with the ProTaper Universal instrument (Dentsply Maillefer, Ballaigues, Switzerland) and filled using sealer and ProTaper Universal F2 gutta-percha cones. Gutta-percha was then down-packed and the root canal backfilled using the extruder hand-piece of the Elements Obturation System (SybronEndo, Orange, CA, USA). The teeth were assigned to two groups (n = 18), and removal of the root fillings was performed using one of the following techniques: group 1) ProTaper Universal retreatment files used with rotational motion (RM) and group 2) ProTaper Universal retreatment files used with adaptive motion (AM) (600° clockwise/0° counter-clockwise to 370° clockwise/50° counter-clockwise). The teeth were sectioned, and both halves were analysed at 8 × magnification. The percentage of remaining filling material was recorded. The data were analysed statistically using the Student's t-test at a 95% confidence level (P < 0.05). There was no significant difference between the groups with respect to the total time required for retreatment (P = 0.481). The AM technique left significantly less filling material than the RM method (P = 0.013). The use of ProTaper Universal retreatment files with adaptive motion removed more filling materials from root canals than the rotational movement. © 2014 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  20. Evaluation of the efficacy of rotary vs. hand files in root canal preparation of primary teeth in vitro using CBCT.

    PubMed

    Musale, P K; Mujawar, S A V

    2014-04-01

    This in vitro study aimed to evaluate the efficacy of rotary ProFile, ProTaper, Hero Shaper and K-files in shaping ability, cleaning efficacy, preparation time and instrument distortion in primary molars. Sixty extracted primary mandibular second molars were divided into four equal groups: Group I K-file, Group II ProFile, Group III ProTaper file and Group IV Hero Shaper file. The shaping ability was determined by comparing pre- and post-instrumentation CBCT scans and data analysed with SPSS program using the Chi-square test. Cleaning efficacy was evaluated by the degree of India ink removal from the canal walls under stereomicroscopy. Instrumentation times were calculated for each tooth and instrument distortion was visually checked and duly noted. The cleaning efficacy and instrumentation time were determined using ANOVA with Tukey's correction. Instrument distortion was analysed using Chi-square test. The canal taper was significantly more conical for rotary files as compared to K-files with Chi-square test (p < 0.05). Cleaning efficacy of rotary files with average scores (Groups II- 0.68, III- 0.48 and IV- 0.58) was significantly better than K-files (Group I- 0.93) (p < 0.05). Mean instrumentation time with K-file (20.7 min) was significantly higher than rotary files (Groups II 8.9, III 5.6, and IV 8.1 min) (p < 0.05). Instrument distortion was observed in Group I (4.3%), while none of the rotary files were distorted. Rotary files prepared more conical canals in primary teeth than manual instruments. Reduced preparation time with rotary files enhances patient cooperation especially in young children.

  1. Root Canal Transportation and Centering Ability of Nickel-Titanium Rotary Instruments in Mandibular Premolars Assessed Using Cone-Beam Computed Tomography.

    PubMed

    Mamede-Neto, Iussif; Borges, Alvaro Henrique; Guedes, Orlando Aguirre; de Oliveira, Durvalino; Pedro, Fábio Luis Miranda; Estrela, Carlos

    2017-01-01

    The aim of this study was to evaluate, using cone-beam computed tomography (CBCT), transportation and centralization of different nickel-titanium (NiTi) rotary instruments. One hundred and twenty eight mandibular premolars were selected and instrumented using the following brands of NiTi files: WaveOne, WaveOne Gold, Reciproc, ProTaper Next, ProTaper Gold, Mtwo, BioRaCe and RaCe. CBCT imaging was performed before and after root canal preparation to obtain measurements of mesial and distal dentin walls and calculations of root canal transportation and centralization. A normal distribution of data was confirmed by the Kolmogorov-Smirnov and Levene tests, and results were assessed using the Kruskal-Wallis test. Statistical significance was set at 5%. ProTaper Gold produced the lowest canal transportation values, and RaCe, the highest. ProTaper Gold files also showed the highest values for centering ability, whereas BioRaCe showed the lowest. No significant differences were found across the different instruments in terms of canal transportation and centering ability (P > 0.05). Based on the methodology employed, all instruments used for root canal preparation of mandibular premolars performed similarly with regard to canal transportation and centering ability.

  2. Cyclic fatigue resistances of several nickel-titanium glide path rotary and reciprocating instruments at body temperature.

    PubMed

    Yılmaz, K; Uslu, G; Gündoğar, M; Özyürek, T; Grande, N M; Plotino, G

    2018-01-31

    To compare the cyclic fatigue resistance of the One G, ProGlider, HyFlex EDM and R-Pilot glide path NiTi files at body temperature. Twenty One G (size 14, .03 taper), 20 ProGlider (size 16, .02 taper), 20 HyFlex EDM (size 10, .05 taper) and 20 R-Pilot (size 12.5, .04 taper) instruments were operated in rotation at 300 rpm (One G, ProGlider and HyFlex) or in reciprocation (R-Pilot) at 35 °C in artificial canals that were manufactured by reproducing the size and taper of the instrument until fracture occurred. The time to fracture was recorded in seconds using a digital chronometer, and the length of the fractured fragments was registered. Mean data were analysed statistically using the Kruskal-Wallis test and post hoc Tukey tests via SPSS 21.0 software. The statistical significance level was set at 5%. The cyclic fatigue resistance of the R-Pilot files was significantly greater than the other instruments, and the One G was significantly lower (P < 0.05). There was no difference between the HyFlex EDM and the ProGlider (P > 0.05). No significant difference (P > 0.05) was evident in the mean length of the fractured fragments of the various instruments. The cyclic fatigue resistance of the R-Pilot reciprocating glide path file was significantly greater than that of the rotary HyFlex EDM, ProGlider and One G glide path files. © 2018 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  3. Screw-in forces during instrumentation by various file systems.

    PubMed

    Ha, Jung-Hong; Kwak, Sang Won; Kim, Sung-Kyo; Kim, Hyeon-Cheol

    2016-11-01

    The purpose of this study was to compare the maximum screw-in forces generated during the movement of various Nickel-Titanium (NiTi) file systems. Forty simulated canals in resin blocks were randomly divided into 4 groups for the following instruments: Mtwo size 25/0.07 (MTW, VDW GmbH), Reciproc R25 (RPR, VDW GmbH), ProTaper Universal F2 (PTU, Dentsply Maillefer), and ProTaper Next X2 (PTN, Dentsply Maillefer, n = 10). All the artificial canals were prepared to obtain a standardized lumen by using ProTaper Universal F1. Screw-in forces were measured using a custom-made experimental device (AEndoS- k , DMJ system) during instrumentation with each NiTi file system using the designated movement. The rotation speed was set at 350 rpm with an automatic 4 mm pecking motion at a speed of 1 mm/sec. The pecking depth was increased by 1 mm for each pecking motion until the file reach the working length. Forces were recorded during file movement, and the maximum force was extracted from the data. Maximum screw-in forces were analyzed by one-way ANOVA and Tukey's post hoc comparison at a significance level of 95%. Reciproc and ProTaper Universal files generated the highest maximum screw-in forces among all the instruments while M-two and ProTaper Next showed the lowest ( p < 0.05). Geometrical differences rather than shaping motion and alloys may affect the screw-in force during canal instrumentation. To reduce screw-in forces, the use of NiTi files with smaller cross-sectional area for higher flexibility is recommended.

  4. Apical extrusion of debris in four different endodontic instrumentation systems: A meta-analysis.

    PubMed

    Western, J Sylvia; Dicksit, Daniel Devaprakash

    2017-01-01

    All endodontic instrumentation systems tested so far, promote apical extrusion of debris, which is one of the main causes of postoperative pain, flare ups, and delayed healing. Of this meta-analysis was to collect and analyze in vitro studies quantifying apically extruded debris while using Hand ProTaper (manual), ProTaper Universal (rotary), Wave One (reciprocating), and self-adjusting file (SAF; vibratory) endodontic instrumentation systems and to determine methods which produced lesser extrusion of debris apically. An extensive electronic database search was done in PubMed, Scopus, Cochrane, LILACS, and Google Scholar from inception until February 2016 using the key terms "Apical Debris Extrusion, extruded material, and manual/rotary/reciprocating/SAF systems." A systematic search strategy was followed to extract 12 potential articles from a total of 1352 articles. The overall effect size was calculated from the raw mean difference of weight of apically extruded debris. Statistically significant difference was seen in the following comparisons: SAF < Wave One, SAF < Rotary ProTaper. Apical extrusion of debris was invariably present in all the instrumentation systems analyzed. SAF system seemed to be periapical tissue friendly as it caused reduced apical extrusion compared to Rotary ProTaper and Wave One.

  5. Standards for Instrument Migration When Implementing Paper Patient-Reported Outcome Instruments Electronically: Recommendations from a Qualitative Synthesis of Cognitive Interview and Usability Studies.

    PubMed

    Muehlhausen, Willie; Byrom, Bill; Skerritt, Barbara; McCarthy, Marie; McDowell, Bryan; Sohn, Jeremy

    2018-01-01

    To synthesize the findings of cognitive interview and usability studies performed to assess the measurement equivalence of patient-reported outcome (PRO) instruments migrated from paper to electronic formats (ePRO), and make recommendations regarding future migration validation requirements and ePRO design best practice. We synthesized findings from all cognitive interview and usability studies performed by a contract research organization between 2012 and 2015: 53 studies comprising 68 unique instruments and 101 instrument evaluations. We summarized study findings to make recommendations for best practice and future validation requirements. Five studies (9%) identified minor findings during cognitive interview that may possibly affect instrument measurement properties. All findings could be addressed by application of ePRO best practice, such as eliminating scrolling, ensuring appropriate font size, ensuring suitable thickness of visual analogue scale lines, and providing suitable instructions. Similarly, regarding solution usability, 49 of the 53 studies (92%) recommended no changes in display clarity, navigation, operation, and completion without help. Reported usability findings could be eliminated by following good product design such as the size, location, and responsiveness of navigation buttons. With the benefit of accumulating evidence, it is possible to relax the need to routinely conduct cognitive interview and usability studies when implementing minor changes during instrument migration. Application of design best practice and selecting vendor solutions with good user interface and user experience properties that have been assessed in a representative group may enable many instrument migrations to be accepted without formal validation studies by instead conducting a structured expert screen review. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  6. Influence of NiTi alloy on the root canal shaping capabilities of the ProTaper Universal and ProTaper Gold rotary instrument systems.

    PubMed

    Duque, Jussaro Alves; Vivan, Rodrigo Ricci; Cavenago, Bruno Cavalini; Amoroso-Silva, Pablo Andrés; Bernardes, Ricardo Affonso; Vasconcelos, Bruno Carvalho de; Duarte, Marco Antonio Hungaro

    2017-01-01

    This study aimed to evaluate the influence of the NiTi wire in Conventional NiTi (ProTaper Universal PTU) and Controlled Memory NiTi (ProTaper Gold PTG) instrument systems on the quality of root canal preparation. Twelve mandibular molars with separate mesial canals were scanned using a high-definition microcomputed tomography system. The PTU and PTG instruments were used to shape twelve mesial canals each. The canals were scanned after preparation with F2 and F3 instruments of the PTU and PTG systems. The analyzed parameters included the remaining dentin thickness at the apical and cervical levels, root canal volume and untouched canal walls. Data was analyzed for statistical significance by the Friedman and Dunn's tests. For the comparison of data between groups, the Mann-Whitney test was used. In the pre-operative analysis, there were no statistically significant differences between the groups in terms of the area and volume of root canals (P>.05). There was also no statistically significant difference between the systems with respect to root canal volume after use of the F2 and F3 instruments. There was no statistical difference in the dentin thickness at the first apical level between, before and after instrumentation for both systems. At the 3 cervical levels, the PTG maintained centralization of the preparation on the transition between the F2 and F3 instruments, which did not occur with the PTU. Conclusion The Conventional NiTi (PTU) and Controlled Memory NiTi (PTG) instruments displayed comparable capabilities for shaping the straight mesial root canals of mandibular molars, although the PTG was better than the PTU at maintaining the centralization of the shape in the cervical portion.

  7. [Shaping ability of two nickel-titanium rotary systems in simulated S-shaped canals].

    PubMed

    Luo, Hong-xia; Huang, Ding-ming; Zhang, Fu-hua; Tan, Hong; Zhou, Xue-dong

    2008-01-01

    To evaluate the shaping ability of two nickel-titanium rotary systems (ProTaper and Hero642) in simulated S-shaped canals. Thirty simulated S-shaped canals were randomly divided into three groups and prepared by ProTaper, Hero642, ProTaper combined with Hero642 respectively. All the canals were scanned before and after instrumentation, and the amount of material removed in the inner and outer wall and the canal width after instrumentation were measured with a computer image analysis program. There was significant difference in the amount of material removed at the inner side of apical curvature and outer side of apex between ProTaper combined with Hero642 and ProTaper files (P < 0.05) at the same tip size. The inner and outer wall of the canals were evenly prepared by ProTaper combined with Hero642, and the taper of canals were better than those prepared by Hero642. ProTaper combined with Hero 642 had better shaping ability to maintain the original shape and could create good taper canals in the simulated S-shaped canal model.

  8. Comparative analysis of efficacy and cleaning ability of hand and rotary devices for gutta-percha removal in root canal retreatment: an in vitro study.

    PubMed

    Reddy, Narender; Admala, Shilpa Reddy; Dinapadu, Sainath; Pasari, Srikanth; Reddy, Manoranjan P; Rao, M S Rama

    2013-07-01

    To evaluate the efficacy and cleaning ability of Hedstrom files, and ProTaper retreatment instruments in removing gutta-percha from root canals with and without xylene as solvent. Sixty extracted single rooted human teeth were selected and decoronated, straight access established working length determined 1 mm short of canal, chemomechanical preparation done and obturated with guttapercha and AH plus sealer. Samples were stored for 1 week in humidifier divided into four groups of 15 teeth each. • Group I: Hedstrom files without xylene. • Group II: Hedstrom files with xylene. • Group III: ProTaper retreatment instruments without xylene. • Group IV: ProTaper retreatment instruments with xylene. and the following criteria were assessed - Time taken for initial plunge of instrument into guttapercha. - Time taken for complete removal of gutta-percha to reach working length - Ability of H files and ProTaper retreatment files with/ without xylene to remove gutta-percha in coronal, middle and apical 1/3 of canal. The teeth were grooved in labiolingual cross section, observed under a steromicroscope and scored according to gutta-percha debris left in the canal. Results were evaluated using ANOVA test and multiple comparisons done using Scheffe test. The least time to reach working length was found with group IV followed by groups III, II and group I respectively. Also the fastest way to remove maximum gutta-percha was group IV followed by groups III, II, and I respectively with a statistically significant difference among all groups. Apical 1/3 has more amount of remaining gutta-percha debris than middle and coronal 1/3 in all groups. The amount of gutta-percha debris in apical 1/3 was least in group IV followed by groups III, II and I respectively. The better performance of ProTaper rotary instruments has been attributed to their special flute design which tends to pull gutta-percha coronally directing it toward orifice. Also the movements of engine driven instruments produce frictional heat which plasticises gutta-percha and aids in easy removal. Apical third of root canals showed more guttapercha debris compared to coronal and middle 1/3 and has been attributed to the greater anatomic variability and difficulty of instrumentation in the apical area. The existence of deep groves and depressions on dentine walls in this apical 1/3 make them less instrumented areas as it did be difficult to direct the file against the extreme root canal wall. The fastest technique to remove gutta-percha and the shortest time to reach working length was observed with ProTaper retreatment instruments with xylene followed by ProTaper retreatment files without xylene and Hedstrom files without xylene. After instrumentation for removal of gutta-percha, apical third was found to have more debris compared to coronal and middle 1/3 of the root canal.

  9. Comparison of retreatment ability of full-sequence reciprocating instrumentation and 360° rotary instrumentation.

    PubMed

    Capar, Ismail Davut; Gok, Tuba; Orhan, Ezgi

    2015-12-01

    The purpose of the present study was to investigate the amount of root canal filling material after root canal filling removal with 360° rotary instrumentation or reciprocating motion with the same file sequence. Root canals of the 36 mandibular premolars were shaped with ProTaper Universal instruments up to size F2 and filled with corresponding single gutta-percha cone and sealer. The teeth were assigned to two retreatment groups (n = 18): group 1 360° rotational motion and group 2 reciprocating motion of ATR Tecnika motors (1310° clockwise and 578° counterclockwise). Retreatment procedure was performed with ProTaper Universal retreatment files with a sequence of D1-3 and ProTaper Universal F3 instruments. Total time required to remove filling material were recorded. Remaining filling material was examined under stereomicroscope at ×8 magnification. The data were analysed statistically using the Mann-Whitney U test, and testing was performed at 95 % confidence level (p < 0.05). There were no significant differences between the groups (p > 0.05) in terms of remaining filling material. The total time required for retreatment was shorter in 360° rotational motion group compared to reciprocating motion group (p < 0.05). Both continuous rotation and reciprocating motion showed similar effectiveness in terms of root canal filling material removal. Using ProTaper Universal retreatment instruments with reciprocating motion of ATR motor and conventional rotary motion have similar efficacy in root canal filling removal.

  10. The Impact of Three Different Canal Lubricants on Fracture, Deformity and Metal Slivering of ProTaper Rotary Instruments

    PubMed Central

    Shantiaee, Yazdan; Dianat, Omid; Sharifi, Farnoud; Nahvi, Golnaz; Kolahi Ahari, Golbarg

    2014-01-01

    Introduction: The aim of this in vitro study was to evaluate the effect(s) of three canal lubricants i.e. sodium hypochlorite, RC-Prep as the paste form of ethylenediaminetetraacetic acid (EDTA) and aqueous EDTA on the occurrence/incidence of fracture, deformity and metal slivering of ProTaper rotary instruments. Methods: A total of 120 mesial canals (i.e. mesiobuccal and mesiolingual) of first mandibular molars or buccal canals (i.e. mesiobuccal and distobuccal) of first maxillary molars, with curvatures of 10-20 degrees were selected and randomly divided into three groups of forty samples each. These selected canals all had approximate 19-21 mm working length and apical diameter equal to a #15 K-file. In each group, the root canals were prepared using ProTaper rotary instruments with an electric motor using one of the three aforementioned irrigants. Subsequently, samples were compared to each other at different magnifications (16×, 20×, 40× and 57×) for any fracture, deformity or metal slivering, by the Cox regression analysis. Results: The fractures rate of samples in RC-Prep group was significantly higher compared to other groups (P=0.01). No evidence of instrument deformity was detected in any groups. A statistically significant reverse relation between metal slivering and instrument fracture was observed. Conclusions: Application of aqueous EDTA and/or sodium hypochlorite as intracanal lubricants caused less fracture of ProTaper instruments compared to canal lubrication with RC-Prep. PMID:24688582

  11. Laboratory comparison of the mechanical properties of TRUShape with several nickel-titanium rotary instruments.

    PubMed

    Elnaghy, A M; Elsaka, S E

    2017-08-01

    To assess and compare the mechanical properties of TRUShape (TRS) with several nickel-titanium rotary instruments. Cyclic fatigue, torsional resistance, flexibility and surface microhardness of TRS (size 25, 0.06v taper), ProTaper Next X2 (PTN X2, size 25, 0.06 taper), ProTaper Gold (PTG F2; size 25, 0.08 taper) and ProTaper Universal (PTU F2; size 25, 0.08 taper) instruments were evaluated. The topographical structures of the fracture surfaces of instruments were assessed using a scanning electron microscope. The cyclic fatigue resistance, torsional resistance and microhardness data were analysed using one-way analysis of variance (anova) and Tukey's post hoc tests. The fragment length and bending resistance data were analysed statistically with the Kruskal-Wallis H-test and Mann-Whitney U-tests. The statistical significance level was set at P < 0.05. PTN and PTG instruments revealed significantly higher resistance to cyclic fatigue than TRS and PTU instruments (P < 0.001). PTN instruments revealed significantly higher torsional resistance compared with the other instruments (P < 0.001). PTG instrument had significantly higher flexibility than the other tested brands (P < 0.05). However, for microhardness, the PTU had significantly higher surface microhardness values compared with other tested brands (P < 0.05). TRS instruments had lower resistance to cyclic fatigue and lower flexibility compared with PTG and PTN instruments. TRS, PTG and PTU instruments had lower resistance to torsional stress than PTN instruments. TRS and PTG instruments had comparable surface microhardness. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  12. Intellectual Property Protection for Software

    DTIC Science & Technology

    1989-07-01

    regulations. This book is useful for its practical, nical Data. New York: Government Contracts Pro- in-depth coverage of copyright licensing. gram, George ...quence and ordering of input formats could give rise Taylor to copyright liability. Synercom had developed a Taylor Instrument Cos. v. Fawley- Brost Co

  13. Using ProHits to store, annotate and analyze affinity purification - mass spectrometry (AP-MS) data

    PubMed Central

    Liu, Guomin; Zhang, Jianping; Choi, Hyungwon; Lambert, Jean-Philippe; Srikumar, Tharan; Larsen, Brett; Nesvizhskii, Alexey I.; Raught, Brian; Tyers, Mike; Gingras, Anne-Claude

    2012-01-01

    Affinity purification coupled with mass spectrometry (AP-MS) is a robust technique used to identify protein-protein interactions. With recent improvements in sample preparation, and dramatic advances in MS instrumentation speed and sensitivity, this technique is becoming more widely used throughout the scientific community. To meet the needs of research groups both large and small, we have developed software solutions for tracking, scoring and analyzing AP-MS data. Here, we provide details for the installation and utilization of ProHits, a Laboratory Information Management System designed specifically for AP-MS interaction proteomics. This protocol explains: (i) how to install the complete ProHits system, including modules for the management of mass spectrometry files and the analysis of interaction data, and (ii) alternative options for the use of pre-existing search results in simpler versions of ProHits, including a virtual machine implementation of our ProHits Lite software. We also describe how to use the main features of the software to analyze AP-MS data. PMID:22948730

  14. The Computer-based Health Evaluation Software (CHES): a software for electronic patient-reported outcome monitoring.

    PubMed

    Holzner, Bernhard; Giesinger, Johannes M; Pinggera, Jakob; Zugal, Stefan; Schöpf, Felix; Oberguggenberger, Anne S; Gamper, Eva M; Zabernigg, August; Weber, Barbara; Rumpold, Gerhard

    2012-11-09

    Patient-reported Outcomes (PROs) capturing e.g., quality of life, fatigue, depression, medication side-effects or disease symptoms, have become important outcome parameters in medical research and daily clinical practice. Electronic PRO data capture (ePRO) with software packages to administer questionnaires, storing data, and presenting results has facilitated PRO assessment in hospital settings. Compared to conventional paper-pencil versions of PRO instruments, ePRO is more economical with regard to staff resources and time, and allows immediate presentation of results to the medical staff.The objective of our project was to develop software (CHES - Computer-based Health Evaluation System) for ePRO in hospital settings and at home with a special focus on the presentation of individual patient's results. Following the Extreme Programming development approach architecture was not fixed up-front, but was done in close, continuous collaboration with software end users (medical staff, researchers and patients) to meet their specific demands. Developed features include sophisticated, longitudinal charts linking patients' PRO data to clinical characteristics and to PRO scores from reference populations, a web-interface for questionnaire administration, and a tool for convenient creating and editing of questionnaires. By 2012 CHES has been implemented at various institutions in Austria, Germany, Switzerland, and the UK and about 5000 patients participated in ePRO (with around 15000 assessments in total). Data entry is done by the patients themselves via tablet PCs with a study nurse or an intern approaching patients and supervising questionnaire completion. During the last decade several software packages for ePRO have emerged for different purposes. Whereas commercial products are available primarily for ePRO in clinical trials, academic projects have focused on data collection and presentation in daily clinical practice and on extending cancer registries with PRO data. CHES includes several features facilitating the use of PRO data for individualized medical decision making. With its web-interface it allows ePRO also when patients are home. Thus, it provides complete monitoring of patients'physical and psychosocial symptom burden.

  15. The Computer-based Health Evaluation Software (CHES): a software for electronic patient-reported outcome monitoring

    PubMed Central

    2012-01-01

    Background Patient-reported Outcomes (PROs) capturing e.g., quality of life, fatigue, depression, medication side-effects or disease symptoms, have become important outcome parameters in medical research and daily clinical practice. Electronic PRO data capture (ePRO) with software packages to administer questionnaires, storing data, and presenting results has facilitated PRO assessment in hospital settings. Compared to conventional paper-pencil versions of PRO instruments, ePRO is more economical with regard to staff resources and time, and allows immediate presentation of results to the medical staff. The objective of our project was to develop software (CHES – Computer-based Health Evaluation System) for ePRO in hospital settings and at home with a special focus on the presentation of individual patient’s results. Methods Following the Extreme Programming development approach architecture was not fixed up-front, but was done in close, continuous collaboration with software end users (medical staff, researchers and patients) to meet their specific demands. Developed features include sophisticated, longitudinal charts linking patients’ PRO data to clinical characteristics and to PRO scores from reference populations, a web-interface for questionnaire administration, and a tool for convenient creating and editing of questionnaires. Results By 2012 CHES has been implemented at various institutions in Austria, Germany, Switzerland, and the UK and about 5000 patients participated in ePRO (with around 15000 assessments in total). Data entry is done by the patients themselves via tablet PCs with a study nurse or an intern approaching patients and supervising questionnaire completion. Discussion During the last decade several software packages for ePRO have emerged for different purposes. Whereas commercial products are available primarily for ePRO in clinical trials, academic projects have focused on data collection and presentation in daily clinical practice and on extending cancer registries with PRO data. CHES includes several features facilitating the use of PRO data for individualized medical decision making. With its web-interface it allows ePRO also when patients are home. Thus, it provides complete monitoring of patients‘physical and psychosocial symptom burden. PMID:23140270

  16. Cyclic fatigue of ProFile rotary instruments after prolonged clinical use.

    PubMed

    Gambarini, G

    2001-07-01

    The purpose of the present study was to evaluate resistance to cyclic fatigue of new and used ProFile Ni-Ti rotary instruments. Used instruments were operated in 10 clinical cases using passive instrumentation and a crown-down preparation technique. Cyclic fatigue testing of new and used engine-driven instruments was then performed with a specific device which allowed the instruments to rotate freely inside a stainless steel artificial canal, whilst maintaining conditions close to the clinical situation. Instruments were rotated until fracture occurred and time to fracture was visually recorded with a chronometer. A significant reduction of rotation time to breakage (life span) was noted between new and used instruments. In all sizes new instruments were significantly more resistant than used ones (two-sample t-test, P < 0.01). No instrument underwent intracanal failure during clinical use. Prolonged clinical use of Ni-Ti engine-driven instruments significantly reduced their cyclic fatigue resistance. Nevertheless, each rotary instrument was successfully operated in up to 10 clinical cases without any intracanal failure.

  17. Evaluation of apically extruded debris during root canal preparation in primary molar teeth using three different rotary systems and hand files.

    PubMed

    Topçuoğlu, Gamze; Topçuoğlu, Hüseyin Sinan; Akpek, Firdevs

    2016-09-01

    To assess the amount of debris extruded apically during root canal preparation using various nickel titanium instrumentation systems and hand files in primary molar teeth. Sixty extracted primary first mandibular molar human teeth were randomly assigned to four groups (n = 15 teeth for each group). The canals were then instrumented with the following instrument systems: Revo-S, Mtwo, ProTaper Next, and hand files. Apically extruded debris during instrumentation was collected into pre-weighed Eppendorf tubes. The Eppendorf tubes were then stored in an incubator at 70°C for 5 days. The weight of the dry extruded debris was established by subtracting the pre-instrumentation and post-instrumentation weight of the Eppendorf tubes for each group. The data were analyzed using one-way analysis of variance (anova) and Tukey's post hoc tests. ProTaper Next files were associated with less apically extruded debris than the Mtwo, Revo-S, and hand files (P < 0.05). Hand files extruded more debris than Mtwo and Revo-S instruments (P < 0.05), but there was no significant difference found between the Mtwo and Revo-S instruments (P > 0.05). All instruments were associated with apical extrusion of debris. ProTaper Next files caused less debris extrusion compared to the other systems used. © 2015 BSPD, IAPD and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  18. Metallurgical characterization of controlled memory wire nickel-titanium rotary instruments.

    PubMed

    Shen, Ya; Zhou, Hui-Min; Zheng, Yu-Feng; Campbell, Les; Peng, Bin; Haapasalo, Markus

    2011-11-01

    To improve the fracture resistance of nickel-titanium (NiTi) files, manufacturers have introduced new alloys and developed new manufacturing processes for the fabrication of NiTi files. This study aimed to examine the phase transformation behavior and microstructure of NiTi instruments from a novel controlled memory NiTi wire (CM wire). Instruments of EndoSequence (ES), ProFile (PF), ProFile Vortex (Vortex), Twisted Files (TF), Typhoon (TYP), and Typhoon™ CM (TYP CM), all size 25/.04, were examined by differential scanning calorimetry (DSC) and x-ray diffraction (XRD). Microstructures of etched instruments were observed by optical microscopy and scanning electron microscopy with x-ray energy-dispersive spectrometric (EDS) analyses. The DSC analyses showed that each segment of the TYP CM and Vortex instruments had an austenite transformation completion or austenite-finish (A(f)) temperature exceeding 37°C, whereas the NiTi instruments made from conventional superelastic NiTi wire (ES, PF, and TYP) and TF had A(f) temperatures substantially below mouth temperature. The higher A(f) temperature of TYP CM instruments was consistent with a mixture of austenite and martensite structure, which was observed at room temperature with XRD. All NiTi instruments had room temperature martensite microstructures consisting of colonies of lenticular features with substantial twinning. EDS analysis indicated that the precipitates in all NiTi instruments were titanium-rich, with an approximate composition of Ti(2)Ni. The TYP CM and Vortex instruments with heat treatment contribute to increase austenite transformation temperature. The CM instrument has significant changes in the phase transformation behavior, compared with conventional superelastic NiTi instruments. Copyright © 2011 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  19. A comparison of three rotary systems and hand instrumentation technique for the elimination of Enterococcus faecalis from the root canal.

    PubMed

    Gorduysus, Melahat; Nagas, Emre; Torun, Ozgur Yildirim; Gorduysus, Omer

    2011-12-01

    The aim of this study was to compare the in vitro reduction of a bacterial population in a root canal by mechanical instrumentation using three rotary systems and hand instrumentation technique. The root canals contaminated with a suspension of Enterococcus faecalis were instrumented using ProTaper, K3, HeroShaper and K-file hand instrumentation technique. Later the root canals were sampled. After serial dilutions, samples were incubated in culture media for 24 h. Bacterial colonies were counted and the results were given as number of colony-forming units per millilitre. The results showed that all the canal instrumentation systems reduced the number of bacterial cells in the root canals. Statistically, ProTaper instruments were more effective in reducing the number of bacteria than the other rotary files or hand instruments. © 2010 The Authors. Australian Endodontic Journal © 2010 Australian Society of Endodontology.

  20. The PROactive innovative conceptual framework on physical activity.

    PubMed

    Dobbels, Fabienne; de Jong, Corina; Drost, Ellen; Elberse, Janneke; Feridou, Chryssoula; Jacobs, Laura; Rabinovich, Roberto; Frei, Anja; Puhan, Milo A; de Boer, Willem I; van der Molen, Thys; Williams, Kate; Pinnock, Hillary; Troosters, Thierry; Karlsson, Niklas; Kulich, Karoly; Rüdell, Katja

    2014-11-01

    Although physical activity is considered an important therapeutic target in chronic obstructive pulmonary disease (COPD), what "physical activity" means to COPD patients and how their perspective is best measured is poorly understood. We designed a conceptual framework, guiding the development and content validation of two patient reported outcome (PRO) instruments on physical activity (PROactive PRO instruments). 116 patients from four European countries with diverse demographics and COPD phenotypes participated in three consecutive qualitative studies (63% male, age mean±sd 66±9 years, 35% Global Initiative for Chronic Obstructive Lung Disease stage III-IV). 23 interviews and eight focus groups (n = 54) identified the main themes and candidate items of the framework. 39 cognitive debriefings allowed the clarity of the items and instructions to be optimised. Three themes emerged, i.e. impact of COPD on amount of physical activity, symptoms experienced during physical activity, and adaptations made to facilitate physical activity. The themes were similar irrespective of country, demographic or disease characteristics. Iterative rounds of appraisal and refinement of candidate items resulted in 30 items with a daily recall period and 34 items with a 7-day recall period. For the first time, our approach provides comprehensive insight on physical activity from the COPD patients' perspective. The PROactive PRO instruments' content validity represents the pivotal basis for empirically based item reduction and validation. ©ERS 2014.

  1. Apical extrusion of debris and irrigants using two hand and three engine-driven instrumentation techniques.

    PubMed

    Ferraz, C C; Gomes, N V; Gomes, B P; Zaia, A A; Teixeira, F B; Souza-Filho, F J

    2001-07-01

    To evaluate the weight of debris and irrigant volume extruded apically from extracted teeth in vitro after endodontic instrumentation using the balanced force technique, a hybrid hand instrumentation technique, and three engine-driven techniques utilizing nickel-titanium instruments (ProFile .04, Quantec 2000 and Pow-R). Five groups of 20 extracted human teeth with single canals were instrumented using one or other of five techniques: balanced force, hybrid, Quantec 2000, ProFile .04, or Pow-R. Debris extruded from the apical foramen during instrumentation were collected into preweighed 1.5 mL tubes. Following instrumentation, the volume of extruded irrigant fluid was determined by visual comparison to control centrifuge tubes filled with 0.25 mL increments of distilled water. The weight of dry extruded dentine debris was also established. Overall, the engine-driven techniques extruded less debris than the manual ones. However, there was no statistical difference between the balanced force technique and the engine-driven methods. The volume of irrigant extruded through the apex was directly associated with the weight of extruded debris, except within the ProFile group. The hybrid technique was associated with the greatest extrusion of both debris and irrigant. Overall, the engine-driven nickel-titanium systems were associated with less apical extrusion.

  2. Comparative evaluation of apical extrusion of debris and irrigant with three rotary instruments using crown down technique - An in vitro study.

    PubMed

    Jindal, Rahul; Singh, Smita; Gupta, Siddharth; Jindal, Punita

    2012-01-01

    The purpose of this study was to evaluate and compare the apical extrusion of debris and irrigant using various rotary instruments with crown down technique in the instrumentation of root canals. Thirty freshly extracted human permanent straight rooted mandibular premolars with minimum root curvature of 0-10 ° were divided in three groups with 10 teeth in each group. Each group was instrumented using one of the three rotary instrumentation systems: Rotary Hero shapers, Rotary ProTaper and Rotary Mtwo. One ml of sterile water was used as an irrigant after using each instrument. Debris extruded was collected in pre weighed glass vials and the extruded irrigant was measured quantitatively by Myers and Montgomery method and was later evaporated. The weight of the dry extruded debris was calculated by comparing the pre and post instrumentation weight of glass vials for each group. Statistical analysis was done by using by a Kruskal-Wallis One-way ANOVA test. Statistical analysis showed that all the rotary instruments used in this study caused apical extrusion of debris and irrigant. A Statistically significant difference was observed with Rotary ProTaper and Rotary Mtwo groups when compared with Rotary Hero shapers. But no significant difference was observed between Rotary ProTaper and Rotary Mtwo groups. After instrumentation with different rotary instruments, Hero shapers showed a less apical extrusion of debris and irrigant.

  3. Test Review: Gilliam, J. E. (2015), "Attention-Deficit/Hyperactivity Disorder Test" (2nd Ed) [Assessment Instrument]. Austin, TX: Pro-Ed.

    ERIC Educational Resources Information Center

    Perdue, Elizabeth A.

    2016-01-01

    The "Attention-Deficit/Hyperactivity Disorder Test-Second Edition" (ADHDT-2) is published through Pro-Ed in Austin, Texas. It was formally published in 2014, following critical revisions of the ADHDT, the reportedly popular initial version of this test that was published in 1995. The ADHDT-2 purports to act as a screener for individuals…

  4. Efficacy of reciprocating and rotary NiTi instruments for retreatment of curved root canals assessed by micro-CT.

    PubMed

    Rödig, T; Reicherts, P; Konietschke, F; Dullin, C; Hahn, W; Hülsmann, M

    2014-10-01

    To compare the efficacy of reciprocating and rotary NiTi-instruments in removing filling material from curved root canals using micro-computed tomography. Sixty curved root canals were prepared and filled with gutta-percha and sealer. After determination of root canal curvatures and radii in two directions as well as volumes of filling material, the teeth were assigned to three comparable groups (n = 20). Retreatment was performed using Reciproc, ProTaper Universal Retreatment or Hedström files. Percentages of residual filling material and dentine removal were assessed using micro-CT imaging. Working time and procedural errors were recorded. Statistical analysis was performed by variance procedures. No significant differences amongst the three retreatment techniques concerning residual filling material were detected (P > 0.05). Hedström files removed significantly more dentine than ProTaper Universal Retreatment (P < 0.05), but the difference concerning dentine removal between both NiTi systems was not significant (P > 0.05). Reciproc and ProTaper Universal Retreatment were significantly faster than Hedström files (P = 0.0001). No procedural errors such as instrument fracture, blockage, ledging or perforation were detected for Hedström files. Three perforations were recorded for ProTaper Universal Retreatment, and in both NiTi groups, one instrument fracture occured. Remnants of filling material were observed in all samples with no significant differences between the three techniques. Hedström files removed significantly more dentine than ProTaper Universal Retreatment, but no significant differences between both NiTi systems were detected. Procedural errors were observed with ProTaper Universal Retreatment and Reciproc. © 2014 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  5. In vitro comparison of gutta-percha-filled area percentages in root canals instrumented and obturated with different techniques.

    PubMed

    Yilmaz, Ayca; Karagoz-Kucukay, Isil

    2017-01-01

    To evaluate the efficacy of different obturation techniques in root canals instrumented either by hand or rotary instruments with regard to the percentage of gutta- percha-filled area (PGFA). One hundred and sixty extracted mandibular premolars with single, straight root canals were studied. Root canals were prepared to an apical size of 30 by hand with a modified crown-down technique or the ProTaper and HEROShaper systems. Teeth were divided into eight groups (n=20) according to the following instrumentation and obturation techniques: G1: Hand files+lateral condensation (LC), G2: Hand files+Thermafil, G3: ProTaper+LC, G4: ProTaper+single-cone, G5: ProTaper+ProTaper-Obturator, G6: HEROShaper+LC, G7: HEROShaper+single-cone, G8: HEROShaper+HEROfill. Horizontal sections were cut at 1, 3, 5, 7, 9, 11 and 13 mm from the apical foramen. A total of 1120 sections obtained were digitally photographed under a stereomicroscope set at 48X magnification. The cross-sectional area of the canal and the gutta-percha was measured by digital image analysis and the PGFA was calculated for each section. The mean of the PGFA in Thermafil (G2), ProTaper-Obturator (G5) and HEROfill (G8) groups was significantly higher than the other groups. In G3 and G4, PGFA showed no significant difference in the apical segments whereas PGFA was significantly higher at the middle and coronal segments in G3. In G6 and G7, PGFA showed no significant difference in the apical and middle segments whereas PGFA was significantly higher at the coronal segments in G6. The carrier-based gutta-percha obturation systems revealed significantly higher PGFA in comparison to single-cone and lateral condensation techniques.

  6. Evaluation of a new filing system's ability to maintain canal morphology.

    PubMed

    Thompson, Matthew; Sidow, Stephanie J; Lindsey, Kimberly; Chuang, Augustine; McPherson, James C

    2014-06-01

    The manufacturer of the Hyflex CM endodontic files claims the files remain centered within the canal, and if unwound during treatment, they will regain their original shape after sterilization. The purpose of this study was to evaluate and compare the canal centering ability of the Hyflex CM and the ProFile ISO filing systems after repeated uses in simulated canals, followed by autoclaving. Sixty acrylic blocks with a canal curvature of 45° were stained with methylene blue, photographed, and divided into 2 groups, H (Hyflex CM) and P (ProFile ISO). The groups were further subdivided into 3 subgroups: H1, H2, H3; P1, P2, P3 (n = 10). Groups H1 and P1 were instrumented to 40 (.04) with the respective file system. Used files were autoclaved for 26 minutes at 126°C. After sterilization, the files were used to instrument groups H2 and P2. The same sterilization and instrumentation procedure was repeated for groups H3 and P3. Post-instrumentation digital images were taken and superimposed over the pre-instrumentation images. Changes in the location of the center of the canal at predetermined reference points were recorded and compared within subgroups and between filing systems. Statistical differences in intergroup and intragroup transportation measures were analyzed by using the Kruskal-Wallis analysis of variance of ranks with the Bonferroni post hoc test. There was a difference between Hyflex CM and ProFile ISO groups, although it was not statistically significant. Intragroup differences for both Hyflex CM and ProFile ISO groups were not significant (P < .05). The Hyflex CM and ProFile ISO files equally maintained the original canal's morphology after 2 sterilization cycles. Published by Elsevier Inc.

  7. The incidence of root microcracks caused by 3 different single-file systems versus the ProTaper system.

    PubMed

    Liu, Rui; Hou, Ben Xiang; Wesselink, Paul R; Wu, Min-Kai; Shemesh, Hagay

    2013-08-01

    The aim of this study was to compare the incidence of root cracks observed at the apical root surface and/or in the canal wall after canal instrumentation with 3 single-file systems and the ProTaper system (Dentsply Maillefer, Ballaigues, Switzerland). One hundred mandibular incisors were selected. Twenty control teeth were coronally flared with Gates-Glidden drills (Dentsply Maillefer). No further preparation was made. The other 80 teeth were mounted in resin blocks with simulated periodontal ligaments, and the apex was exposed. They were divided into 4 experimental groups (n = 20); the root canals were first coronally flared with Gates-Glidden drills and then instrumented to the full working length with the ProTaper, OneShape (Micro-Mega, Besancon, France), Reciproc (VDW, Munich, Germany), or the Self-Adjusting File (ReDent-Nova, Ra'anana, Israel). The apical root surface and horizontal sections 2, 4, and 6 mm from the apex were observed under a microscope. The presence of cracks was noted. The chi-square test was performed to compare the appearance of cracked roots between the experimental groups. No cracks were found in the control teeth and teeth instrumented with the Self-Adjusting File. Cracks were found in 10 of 20 (50%), 7 of 20 (35%), and 1 of 20 (5%) teeth after canal instrumentation with the ProTaper, OneShape, and Reciproc files, respectively. The difference between the experimental groups was statistically significant (P < .001). Nickel-titanium instruments may cause cracks on the apical root surface or in the canal wall; the Self-Adjusting File and Reciproc files caused less cracks than the ProTaper and OneShape files. Copyright © 2013 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  8. Using Self-Reported Patient Experiences to Understand Patient Burden: Learnings from Digital Patient Communities in Ankylosing Spondylitis.

    PubMed

    Sunkureddi, Prashanth; Gibson, Dawn; Doogan, Stephen; Heid, John; Benosman, Samir; Park, Yujin

    2018-03-01

    Online communities contain a wealth of information containing unsolicited patient experiences that may go beyond what is captured by guided surveys or patient-reported outcome (PRO) instruments used in clinical settings. This study described patient experiences reported online to better understand the day-to-day disease burden of ankylosing spondylitis (AS). Unguided, English-language patient narratives reported between January 2010 and May 2016 were collected from 52 online sources (e.g., general/health social networking sites, patient-physician Q&A sites, AS forums). Using natural language processing combined with manual curation, patient-reported experiences within narratives were evaluated and categorized into social, physical, emotional, cognitive, and role activity (SPEC-R) concepts to assess functional impairment. The same SPEC-R categorization was applied to 5 AS-specific PRO instruments to evaluate their coverage of concepts extracted from patient narratives. A total of 34,780 narratives from 3449 patients with AS were included. Physical aspects of AS (e.g., pain and mobility) were most commonly reported by patients (86.7%), followed by emotional (32.5%), cognitive (23.6%), role activity (8.7%) and social (5.1%). Some frequently discussed subconcepts were effectively captured by ≥ 2 PRO instruments, such as pain (65.3%), asthenia (19.9%), musculoskeletal impairment (19.9%), depression (9.9%), and anger/frustration (5.4%); others [e.g., anxiety (19.1%), mental impairment (3.2%), impulsivity (2.9%)] were not addressed by any of the PRO instruments. These findings highlight the importance of analyzing patient experiences beyond clinical trial settings and physician reports; continuous assessment of existing PRO instruments in collaboration with patients may increase their utility in real-world settings. Novartis Pharmaceuticals Corporation.

  9. Cyclic fatigue resistance of two nickel-titanium rotary instruments in interrupted rotation.

    PubMed

    Pedullà, E; Lizio, A; Scibilia, M; Grande, N M; Plotino, G; Boninelli, S; Rapisarda, E; Lo Giudice, G

    2017-02-01

    To investigate the influence of interrupted rotation on cyclic fatigue of two nickel-titanium rotary instruments. Cyclic fatigue of 300 new ProTaper Next size X1; X2 and Mtwo size 10, .04 taper; size 15, .05 taper; size 20, .06 taper and size 25, .06 taper instruments was tested in continuous or interrupted rotation. Fifty files of the same brand and size were randomly assigned to five groups (n = 10). Group 1 instruments were tested in continuous rotation; groups 2 and 3 in paused rotation for 1 s every 10 or 20 s, respectively; groups 4 and 5 in interrupted rotation for 5 s every 10 or 20 s, respectively. Cyclic fatigue was expressed in time to fracture (TtF) in an artificial canal with 60° angle and 5 mm radius of curvature. The fracture surface was examined with a scanning electron microscope (SEM). Data were evaluated by two-way analysis of variance. Cyclic fatigue of groups 2 and 4 of ProTaper Next X2 and Mtwo size 25, .06 taper was significantly lower than that of group 1 of the same instruments (P < 0.01). ProTaper Next X2 had significantly reduced cyclic fatigue in groups 3 and 5 (P < 0.05). No differences were found by interrupting the rotation for 1 or 5 s in all instruments (P > 0.05). Fatigue of other instruments was not affected by interrupted rotation (P > 0.05). Interrupted rotation reduced cyclic fatigue resistance of ProTaper Next X2 and Mtwo size 25, .06 taper, especially when a higher number of interruptions was performed. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  10. Instrument separation analysis of multi-used ProTaper Universal rotary system during root canal therapy.

    PubMed

    Wu, Jintao; Lei, Gang; Yan, Ming; Yu, Yan; Yu, Jinhua; Zhang, Guangdong

    2011-06-01

    The purpose of this study was to identify the influential factors responsible for clinical instrument separation of reused ProTaper Universal rotary instruments (Dentsply Maillefer, Ballaigues, Switzerland). Six thousand one hundred fifty-four root canals in 2,654 teeth were prepared using ProTaper Universal files in endodontic clinics. Separation incidence was determined based on the number of treated teeth or canals. Data were collected including the size of fractured instrument, the length and location of a broken segment within the root canal, and the curvature of canal. The chi-square test and independent samples t test were used to determine the statistical significance. The overall instrument separation incidences were 2.6% according to the number of teeth and 1.1% according to the canal number, respectively. Separation incidences according to the number of teeth or canals were significantly higher (P < .05) in molars than those in premolars or anterior teeth. Because of its largest diameter, F3 file presented the highest separation incidence according to the number of teeth (1.0%) or canals (0.4%); 47.5% instrument separation of mandibular molars and 61.5% instrument separation of maxillary molars happened in the mesiobuccal canals. Moreover, 91.4% fragments were located in the apical third of root canals, and 54.2% instrument separation occurred in severely curved canals. There was a significant difference (P < .05) in the mean fracture length between shaping (2.42 ± 0.73 mm) and finishing files (3.32 ± 0.73 mm). Separation incidence according to the canal number is more reliable than that according to the number of teeth because of the variable canal number in different teeth. The tooth type, rotary file size, canal location, and anatomy were correlated with the instrument separation of reused ProTaper Universal files. Copyright © 2011 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  11. In Vitro Comparison of Apically Extruded Debris during Root Canal Preparation of Mandibular Premolars with Manual and Rotary Instruments.

    PubMed

    Soi, Sonal; Yadav, Suman; Sharma, Sumeet; Sharma, Mohit

    2015-01-01

    Background and aims. During root canal preparation, debris extruded beyond the apical foramen may result in periapical inflammation and postoperative pain. To date no root canal preparation method has been developed that extrudes no periapical debris. The purpose of this study was to identify a system leading to minimal extrusion of debris from the apical foramen. The study was conducted to comparatively evaluate the amount of apical extrusion of debris during root canal preparation using hand ProTaper and GT rotary and RaCe rotary instruments using crown-down technique. Materials and methods. Ninety freshly extracted human single-rooted mandibular premolars were equally assigned to three groups (n=30). The root canals were instrumented using hand ProTaper, GT rotary and RaCe rotary systems. Debris and irrigant extruded from the apical foramen were collected into vials. The mean weight of the remaining debris was calculated for each group and subjected to statistical analysis. Results. ANOVA was used to compare the mean dry weights of the debris extruded in the three groups, followedby post hoc Tukey tests for multiple comparisons the between groups. Highly significant differences were found in the amount of debris extruded among all the groups (P<0.001). The ProTaper group exhibited the highest mean debris weight (0.8293±0.05433 mg) and the RaCe system exhibited the lowest mean debris weight (0.1280±0.01606 mg). Conclusion. All the systems tested resulted in apical extrusion of debris. However, the hand ProTaper files extruded a significantly higher amount of debris than GT and RaCe systems.

  12. In Vitro Comparison of Apically Extruded Debris during Root Canal Preparation of Mandibular Premolars with Manual and Rotary Instruments

    PubMed Central

    Soi, Sonal; Yadav, Suman; Sharma, Sumeet; Sharma, Mohit

    2015-01-01

    Background and aims. During root canal preparation, debris extruded beyond the apical foramen may result in periapical inflammation and postoperative pain. To date no root canal preparation method has been developed that extrudes no periapical debris. The purpose of this study was to identify a system leading to minimal extrusion of debris from the apical foramen. The study was conducted to comparatively evaluate the amount of apical extrusion of debris during root canal preparation using hand ProTaper and GT rotary and RaCe rotary instruments using crown-down technique. Materials and methods. Ninety freshly extracted human single-rooted mandibular premolars were equally assigned to three groups (n=30). The root canals were instrumented using hand ProTaper, GT rotary and RaCe rotary systems. Debris and irrigant extruded from the apical foramen were collected into vials. The mean weight of the remaining debris was calculated for each group and subjected to statistical analysis. Results. ANOVA was used to compare the mean dry weights of the debris extruded in the three groups, followedby post hoc Tukey tests for multiple comparisons the between groups. Highly significant differences were found in the amount of debris extruded among all the groups (P<0.001). The ProTaper group exhibited the highest mean debris weight (0.8293±0.05433 mg) and the RaCe system exhibited the lowest mean debris weight (0.1280±0.01606 mg). Conclusion. All the systems tested resulted in apical extrusion of debris. However, the hand ProTaper files extruded a significantly higher amount of debris than GT and RaCe systems. PMID:26697144

  13. Apical extrusion of debris in four different endodontic instrumentation systems: A meta-analysis

    PubMed Central

    Western, J. Sylvia; Dicksit, Daniel Devaprakash

    2017-01-01

    Background: All endodontic instrumentation systems tested so far, promote apical extrusion of debris, which is one of the main causes of postoperative pain, flare ups, and delayed healing. Objectives: Of this meta-analysis was to collect and analyze in vitro studies quantifying apically extruded debris while using Hand ProTaper (manual), ProTaper Universal (rotary), Wave One (reciprocating), and self-adjusting file (SAF; vibratory) endodontic instrumentation systems and to determine methods which produced lesser extrusion of debris apically. Methodology: An extensive electronic database search was done in PubMed, Scopus, Cochrane, LILACS, and Google Scholar from inception until February 2016 using the key terms “Apical Debris Extrusion, extruded material, and manual/rotary/reciprocating/SAF systems.” A systematic search strategy was followed to extract 12 potential articles from a total of 1352 articles. The overall effect size was calculated from the raw mean difference of weight of apically extruded debris. Results: Statistically significant difference was seen in the following comparisons: SAF < Wave One, SAF < Rotary ProTaper. Conclusions: Apical extrusion of debris was invariably present in all the instrumentation systems analyzed. SAF system seemed to be periapical tissue friendly as it caused reduced apical extrusion compared to Rotary ProTaper and Wave One. PMID:28761250

  14. Comparative Evaluation of Smear Layer and Debris on the Canal Walls prepared with a Combination of Hand and Rotary ProTaper Technique using Scanning Electron Microscope.

    PubMed

    Kiran, S; Prakash, Sandeep; Siddharth, Pujari R; Saha, Supradip; Geojan, Naiza E; Ramachandran, Mookambika

    2016-07-01

    The effect of smear layer and debris on the success rate of endodontic treatment has not yet been definitely determined. So the present study was aimed to evaluate the amount of smear layer and debris on the canal walls prepared with a combination of hand and rotary ProTaper technique using NaOCl and ethylenediaminetetraacetic acid (EDTA) alternately as root canal irrigants using scanning electron microscope (SEM). Eighty intact freshly extracted human permanent mandibular premolar teeth were collected and randomly divided equally into four groups. In group I canals were prepared with hand K-Flexofiles; group II with rotary ProTaper instruments; group III with rotary ProTaper instruments and final instrumentation was done with hand K-Flexofile; group IV with rotary ProTaper instruments and final instrumentation was done with RC-Prep and irrigated with 1 mL of normal saline. In all groups canals were irrigated using NaOCl and EDTA alternately. After instrumentation, the teeth were prepared for SEM examination using five-score indices for debris and smear layer at coronal, middle, and apical third levels. Statistical analysis was performed using chi-square test (p < 0.05) and Kruskal-Wallis test (p < 0.05). Statistically significant difference was observed between the groups in cleaning the apical third. Groups I and III showed better canal cleanliness compared to group II. The use of EDTA and NaOCl in group III was more effective in removing debris and smear layer compared to EDTA and normal saline in group IV. Regardless of the instrumentation technique employed and the irrigant used, the cleaning ability decreased in the apical third, resulting in higher debris and smear layer scores compared to coronal and middle third levels. None of the instrumentation techniques in the present study could completely eliminate the smear layer and debris from the canal walls. Instrumentation of the canals with hand files after automated rotary preparation could result in cleaner canal walls. Alternate irrigation with NaOCl and EDTA is effective in the removal of debris and smear layer in the coronal and middle level, but the effectiveness in the apical third is less.

  15. Validation of the alcohol use module from a multidimensional prenatal psychosocial risk screening instrument.

    PubMed

    Harrison, Patricia A; Godecker, Amy; Sidebottom, Abbey C

    2012-12-01

    The purpose of the study was to validate the Prenatal Risk Overview (PRO) Alcohol use domain against a structured diagnostic interview. The PRO was developed to screen for 13 psychosocial risk factors associated with poor birth outcomes. After clinic staff administered the PRO to prenatal patients, they asked for consent to administration of selected modules of the structured clinical interview for DSM-IV (SCID) by a research assistant. To assess the criterion validity of the PRO, low and moderate/high risk classifications from the alcohol use domain were cross-tabulated with SCID Alcohol Use Disorder variables. The study sample included 744 women. Based on PRO responses, 48.7% reported alcohol use during the 12 months before they learned they were pregnant; 5.4% reported use post pregnancy awareness. The typical quantity consumed pre-pregnancy was four or more drinks per occasion. Based on the SCID, 7.4% met DSM-IV criteria for either Alcohol Abuse or Dependence. Sensitivity and specificity of the PRO for Alcohol Use Disorders were 83.6 and 80.3%, respectively. Negative predictive value was 98.4% and positive predictive value was 25.3%. The results indicate the PRO effectively identified pregnant women with Alcohol Use Disorders. However, prenatal screening must also detect consumption patterns that do not meet diagnostic thresholds but may endanger fetal development. The PRO also identified women who continued to drink after they knew they were pregnant, as well as those whose previous drinking habits put them at risk for resumption of hazardous use.

  16. Blog and Podcast Watch: Pediatric Emergency Medicine.

    PubMed

    Zaver, Fareen; Hansen, Michael; Leibner, Evan; Little, Andrew; Lin, Michelle

    2016-09-01

    By critically appraising open access, educational blogs and podcasts in emergency medicine (EM) using an objective scoring instrument, this installment of the ALiEM (Academic Life in Emergency Medicine) Blog and Podcast Watch series curated and scored relevant posts in the specific areas of pediatric EM. The Approved Instructional Resources - Professional (AIR-Pro) series is a continuously building curriculum covering a new subject area every two months. For each area, six EM chief residents identify 3-5 advanced clinical questions. Using FOAMsearch.net to search blogs and podcasts, relevant posts are scored by eight reviewers from the AIR-Pro Board, which is comprised of EM faculty and chief residents at various institutions. The scoring instrument contains five measurement outcomes based on 7-point Likert scales: recency, accuracy, educational utility, evidence based, and references. The AIR-Pro label is awarded to posts with a score of ≥26 (out of 35) points. An "Honorable Mention" label is awarded if Board members collectively felt that the posts were valuable and the scores were > 20. We included a total of 41 blog posts and podcasts. Key educational pearls from the 10 high quality AIR-Pro posts and four Honorable Mentions are summarized. The WestJEM ALiEM Blog and Podcast Watch series is based on the AIR and AIR-Pro series, which attempts to identify high quality educational content on open-access blogs and podcasts. Until more objective quality indicators are developed for learners and educators, this series provides an expert-based, crowdsourced approach towards critically appraising educational social media content for EM clinicians.

  17. Blog and Podcast Watch: Pediatric Emergency Medicine

    PubMed Central

    Zaver, Fareen; Hansen, Michael; Leibner, Evan; Little, Andrew; Lin, Michelle

    2016-01-01

    Introduction By critically appraising open access, educational blogs and podcasts in emergency medicine (EM) using an objective scoring instrument, this installment of the ALiEM (Academic Life in Emergency Medicine) Blog and Podcast Watch series curated and scored relevant posts in the specific areas of pediatric EM. Methods The Approved Instructional Resources – Professional (AIR-Pro) series is a continuously building curriculum covering a new subject area every two months. For each area, six EM chief residents identify 3–5 advanced clinical questions. Using FOAMsearch.net to search blogs and podcasts, relevant posts are scored by eight reviewers from the AIR-Pro Board, which is comprised of EM faculty and chief residents at various institutions. The scoring instrument contains five measurement outcomes based on 7-point Likert scales: recency, accuracy, educational utility, evidence based, and references. The AIR-Pro label is awarded to posts with a score of ≥26 (out of 35) points. An “Honorable Mention” label is awarded if Board members collectively felt that the posts were valuable and the scores were > 20. Results We included a total of 41 blog posts and podcasts. Key educational pearls from the 10 high quality AIR-Pro posts and four Honorable Mentions are summarized. Conclusion The WestJEM ALiEM Blog and Podcast Watch series is based on the AIR and AIR-Pro series, which attempts to identify high quality educational content on open-access blogs and podcasts. Until more objective quality indicators are developed for learners and educators, this series provides an expert-based, crowdsourced approach towards critically appraising educational social media content for EM clinicians. PMID:27625713

  18. Vertical Load Induced with Twisted File Adaptive System during Canal Shaping.

    PubMed

    Jamleh, Ahmed; Alfouzan, Khalid

    2016-12-01

    To evaluate the vertical load induced with the Twisted File Adaptive (TFA; SybronEndo, Orange, CA) system during canal shaping of extracted teeth by comparing it with the Twisted File (TF, SybronEndo), ProTaper Next (PTN; Dentsply Maillefer, Ballaigues, Switzerland), and ProTaper Universal (PTU, Dentsply Maillefer) systems. Fifty-two root canals were shaped using the TFA, TF, PTN, or PTU systems (n = 13 for each system). They were shaped gently according to the manufacturers' instructions. During canal shaping, vertical loads were recorded and shown in 2 directions, apically and coronally directed loads. The vertical peak loads of 3 instrumentation stages were used for comparison. The effects of rotary systems on the mean positive and negative peak loads were analyzed statistically using the Kruskal-Wallis and Mann-Whitney tests at a confidence level of 95%. The overall pattern of the instantaneous loads appeared to increase with the use of successive instruments within the system. During canal shaping in all groups, the apically and coronally directed peak loads ranged from 0.84-7.55 N and 2.16-2.79 N, respectively. There were significant differences in both peak loads among the tested systems at each instrumentation stage. TFA had the lowest apically directed peak loads. In terms of coronally directed peak loads, the TFA and TF had a significantly lower amount of loads developed with their instruments than PTN and PTU. The choice of instrument system had an influence on the loads developed during canal shaping. TFA instruments were associated favorably with the lowest values of peak loads followed by TF, PTN, and PTU. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  19. Comparison of dentinal damage induced by different nickel-titanium rotary instruments during canal preparation: An in vitro study.

    PubMed

    Garg, Shiwani; Mahajan, Pardeep; Thaman, Deepa; Monga, Prashant

    2015-01-01

    To compare dentinal damage caused by hand and rotary nickel-titanium instruments using ProTaper, K3 Endo, and Easy RaCe systems after root canal preparation. One hundred and fifty freshly extracted mandibular premolars were randomly divided into five experimental groups of 30 teeth each and biomechanical preparation was done: Group 1 with unprepared teeth; Group 2 were prepared with hand files; Group 3 with ProTaper rotary instruments; Group 4 with K3 rotary; Group 5 with Easy RaCe rotary instruments. Then, roots were cut horizontally at 3, 6, and 9 mm from apex and were viewed under stereomicroscope. The presence of dentinal defects was noted. Groups were analyzed with the Chi-square test. Significant difference was seen between groups. No defects were found in unprepared roots and those prepared with hand files. ProTaper, K3 rotary, and Easy RaCe preparations resulted in dentinal defects in 23.3%, 10%, and 16.7% of teeth, respectively. More defects were shown in coronal and middle sections, and no defect was seen in apical third. The present study revealed that use of rotary instruments could result in an increased chance for dentinal defects as compared to hand instrumentation.

  20. Comparative evaluation of dentinal crack formation after root canal preparation using ProTaper Next, OneShape, and Hyflex EDM

    PubMed Central

    Das, Sanjib; Pradhan, Prasanti Kumari; Lata, S.; Sinha, Sachidananda Prasad

    2018-01-01

    Introduction: The purpose of this study was to compare the incidence of dentinal crack formation after root canal preparation using ProTaper Next, OneShape, and Hyflex electrodischarge machining (HEDM). Materials and Methods: A total of 75 extracted mandibular premolars were selected. The root canals were instrumented using ProTaper Next, OneShape, and HEDM rotary files. All roots were horizontally sectioned at 3, 6, and 9 mm from apex with slow-speed saw under water cooling. The sections were observed under a stereomicroscope at ×25 to determine the absence or presence of crack. Data were analyzed using post hoc test and one-way ANOVA. Results: ProTaper Next and HEDM produced significantly less cracks than OneShape. Conclusion: Within the limitation of this in vitro study, it can be concluded that nickel–titanium instruments may cause cracks on the root surface. ProTaper Next and HEDM tend to produce less number of cracks as compared to OneShape. PMID:29674816

  1. Cause and solution for false upstream boat velocities measured with a StreamPro acoustic doppler current profiler

    USGS Publications Warehouse

    Mueller, David S.; Rehmel, Mike S.; Wagner, Chad R.

    2007-01-01

    In 2003, Teledyne RD Instruments introduced the StreamPro acoustic Doppler current profiler which does not include an internal compass. During stationary moving-bed tests the StreamPro often tends to swim or kite from the end of the tether (the instrument rotates then moves laterally in the direction of the rotation). Because the StreamPro does not have an internal compass, it cannot account for the rotation. This rotation and lateral movement of the StreamPro on the end of the tether generates a false upstream velocity, which cannot be easily distinguished from a moving-bed bias velocity. A field test was completed to demonstrate that this rotation and lateral movement causes a false upstream boat velocity. The vector dot product of the boat velocity and the unit vector of the depth-averaged water velocity is shown to be an effective method to account for the effect of the rotation and lateral movement.

  2. The effect of root canal preparation on the development of dentin cracks.

    PubMed

    Milani, Amin Salem; Froughreyhani, Mohammad; Rahimi, Saeed; Jafarabadi, Mohammad Asghari; Paksefat, Sara

    2012-01-01

    Root fracture is not an instant phenomenon but a result of gradual development of tiny craze lines in tooth structure. Recent studies have shown that canal instrumentation has the potential to cause dentinal cracks. The purpose of this study was to evaluate and compare the formation of dentinal cracks caused by ProTaper rotary system to hand instrumentation. This in vitro study was carried out using 57 mandible incisor teeth. The teeth were decoronated. The roots were then examined to exclude cracked samples. A standard model for PDL simulation was used. The teeth were randomly divided into two experimental and one control group (n=19). The teeth in the experimental groups were prepared using hand or ProTaper Universal rotary instrumentation. The teeth in the control group were left unprepared. The teeth were then sectioned horizontally 3 and 6 mm from the apex, and the number of various dentinal defects was recorded using a dental operating microscope. The differences between groups were analyzed with Fisher's exact test. The hand group demonstrated significantly more defects than the control group (P=0.001). However, there was no significant difference between the rotary compared to the control and hand groups (P>0.05). There was no significant difference between groups with regards to fracture (P>0.05). Other defects including internal, external and surface cracks were more frequent in the hand than in the control or rotary groups (P=0.02), but the difference was not significant between the rotary and control groups (P>0.05). Canal preparation, whether hand or rotary, produces structural defects in dentin. The ProTaper rotary system when used according to the manufacturer's instructions, tends to produce fewer cracks and can be considered a safe preparation technique.

  3. Experimental evaluation of cyclic fatigue resistance of four different nickel-titanium instruments after immersion in sodium hypochlorite and/or sterilization

    PubMed Central

    BULEM, Üreyen Kaya; KECECI, Ayse Diljin; GULDAS, Hilmi Egemen

    2013-01-01

    NiTi instruments have a high risk of separation due to torsional or flexural fatigue (cyclic fatigue). Chemomechanical preparation, cleaning procedures, chemical disinfection and sterilization cause the corrosion of endodontic instruments that may weaken the fracture resistance of the instruments. Objective To assess the effects of NaOCl immersion and autoclave sterilization on the cyclic fatigue resistance of ProFile, FlexMaster, Mtwo and TwistedFiles NiTi instruments (tip size 25, 0.06 taper, n=160). Material and Methods The instruments (n=10 for each subgroup) were dynamically immersed in NaOCl; immersed in NaOCl and sterilized in one autoclave cycle; 5 cycles immersed in NaOCl and sterilized in autoclave and not immersed in NaOCl and not sterilized (control group). Dynamic cyclic fatigue resistance was tested. The number of cycles to failure (NCF) were statistically analyzed (P<0.05). Results Kruskall-Wallis test indicated significant differences among the tested instruments in terms of NCF (P=0.000). The mean NCF of Mtwo (556.75) was higher than that of the Twisted File, Flexmaster and ProFile, 483.1, 376.12, 365.25, respectively. NaOCl immersion and autoclave sterilization have no effect on the NCF values of the tested instruments (P>.05). Conclusions Cyclic fatigue resistance of the tested NiTi instruments cannot be adversely affected by NaOCl immersion and autoclave sterilization. Production process (TwistedFiles) or design (Twisted Files, FlexMaster, Mtwo and ProFile) of the instruments can influence their cyclic fatigue resistance. PMID:24473715

  4. A comparison of three Ni-Ti rotary instruments in apical transportation.

    PubMed

    Javaheri, Homan Hossein; Javaheri, Ghasem Hossein

    2007-03-01

    The purpose of this study was to compare apical transportation and changes in canal curvature of three nickel-titanium (Ni-Ti) rotary instruments: Hero 642, RaCe, and ProTaper. Mesiobuccal canals of 60 maxillary first molars (with angles of curvature between 25 degrees and 35 degrees) were prepared with a torque-control, low-speed engine. Canals were prepared using the crown-down technique to the size of #30. Using a radiographic platform, reproducible preinstrumentation and postinstrumentation radiographs were taken. A computer analysis allowed magnification and superimposition of the images. The central axes of initial and final instruments were radiographically superimposed to measure transportation at 1 mm from WL. Data were analyzed using repeated-measures ANOVA. A statistically significant difference in apical transportation was found in ProTaper group. The results suggest that ProTaper file system be implemented in combination with other less tapered more flexible systems, like RaCe, in preparing curved canals.

  5. Cyclic fatigue of ProTaper instruments.

    PubMed

    Lopes, Hélio Pereira; Moreira, Edson Jorge Lima; Elias, Carlos Nelson; de Almeida, Renata Andriola; Neves, Mônica Schultz

    2007-01-01

    The present work evaluated the influence of the curved segment length of artificial root canals (the arc) and the number of cycles necessary to fracture engine-driven nickel-titanium endodontic instruments. ProTaper F3 25-mm files at 250 rpm were used in two artificial canals. The artificial canals were made of stainless steel with an inner diameter of 1.04 mm, a total length of 20 mm, and arc on the ends with a radius of curvature of 6 mm. The arc length of the first tube measured 9.4 mm, and the straight part measured 10.6 mm. The second tube was 14.1 mm long, and the straight part measured 5.9 mm. We determined the fracture surface distances and the number of cycles necessary to induce fatigue fracture in the ProTaper F3 instruments. The fracture surfaces and the helical shaft of the instruments were investigated using a scanning electron microscope. The results indicated that the required number of cycles to cause a fracture was influenced by the canal arc length, the morphology of the fractured surface presented ductile characteristics, and plastic deformation in the helical shaft of the fractured instruments did not occur.

  6. Step-by-step description of a rotary root canal preparation technique.

    PubMed

    Schrader, C; Ackermann, M; Barbakow, F

    1999-08-01

    CLINICAL TECHNIQUE: Since the introduction of nickel-titanium in endodontics, several canal preparation techniques involving the use of rotary instruments have become popular. Such engine-driven rotary instruments rotate between 150 and 2000 r.p.m. and may be high or low torque orientated. This paper describes one such engine-driven system called the ProFile technique. The instruments are of a different specification to that used for conventional endodontic files and reamers. This paper describes a technique employed by the Division of Endodontology, Zurich Dental School, in a step-by-step procedure using primarily photographs of radiographs. The intention is to give any interested clinician a better idea of the technique using radiographs taken from both the buccolingual (clinical) perspective and the mesiodistal projection. Basically, the technique involves preparing the coronal portion of the root canal using Gates-Glidden burs and the ProFile instruments. Only when any constricting coronal parts of the canals have been removed is the working length established using conventional files. Finally, the apical part of the canal is prepared using only the ProFile instruments. Three clinical cases are also briefly described, in order to illustrate the potential of the technique in cases treated generally by clinicians.

  7. Influence of NiTi alloy on the root canal shaping capabilities of the ProTaper Universal and ProTaper Gold rotary instrument systems

    PubMed Central

    DUQUE, Jussaro Alves; VIVAN, Rodrigo Ricci; CAVENAGO, Bruno Cavalini; AMOROSO-SILVA, Pablo Andrés; BERNARDES, Ricardo Affonso; de VASCONCELOS, Bruno Carvalho; DUARTE, Marco Antonio Hungaro

    2017-01-01

    Abstract Objective This study aimed to evaluate the influence of the NiTi wire in Conventional NiTi (ProTaper Universal PTU) and Controlled Memory NiTi (ProTaper Gold PTG) instrument systems on the quality of root canal preparation. Material and Methods Twelve mandibular molars with separate mesial canals were scanned using a high-definition microcomputed tomography system. The PTU and PTG instruments were used to shape twelve mesial canals each. The canals were scanned after preparation with F2 and F3 instruments of the PTU and PTG systems. The analyzed parameters included the remaining dentin thickness at the apical and cervical levels, root canal volume and untouched canal walls. Data was analyzed for statistical significance by the Friedman and Dunn’s tests. For the comparison of data between groups, the Mann-Whitney test was used. Results In the pre-operative analysis, there were no statistically significant differences between the groups in terms of the area and volume of root canals (P>.05). There was also no statistically significant difference between the systems with respect to root canal volume after use of the F2 and F3 instruments. There was no statistical difference in the dentin thickness at the first apical level between, before and after instrumentation for both systems. At the 3 cervical levels, the PTG maintained centralization of the preparation on the transition between the F2 and F3 instruments, which did not occur with the PTU. Conclusion The Conventional NiTi (PTU) and Controlled Memory NiTi (PTG) instruments displayed comparable capabilities for shaping the straight mesial root canals of mandibular molars, although the PTG was better than the PTU at maintaining the centralization of the shape in the cervical portion. PMID:28198973

  8. In Vitro Comparison of Cyclic Fatigue Resistance of ProTaper Next, HyFlex CM, OneShape, and ProTaper Universal Instruments in a Canal with a Double Curvature.

    PubMed

    Topçuoğlu, Hüseyin Sinan; Topçuoğlu, Gamze; Akti, Ahmet; Düzgün, Salih

    2016-06-01

    The aim of this study was to compare the resistance to cyclic fatigue of ProTaper Next X2 (PTN X2; size 25, 0.06 taper), Hyflex CM (HCM; size 25, 0.06 taper), OneShape (OS; size 25, 0.06 taper), and ProTaper Universal F2 (PTU F2; size 25, 0.08 taper) nickel-titanium files in an artificial root canal with a double (S-shaped) curvature. A total of 160 new PTN X2, OS, HCM, and PTU F2 files were tested in an artificial stainless steel canal with a double curvature. Forty files from each system were rotated until fracture to calculate the number of cycles to failure. The length of each fractured fragment was recorded. Data were analyzed by using one-way analysis of variance and Tukey post hoc tests. The resistance to cyclic fatigue of the PTN X2 and HCM instruments was significantly greater than the OS and PTU F2 instruments in the apical curvature (P < .05). There was no statistical difference in the cyclic fatigue resistance of the PTN X2 and HCM instruments in the apical curvature (P > .05). In addition, there was no statistical difference between the OS and PTU F2 instruments in the apical curvature (P > .05). PTN X2, OS, HCM, and PTU F2 instruments showed similar cyclic fatigue resistance values in the coronal curvature (P > .05). This study showed that PTN X2 and HCM instruments exhibit greater resistance to cyclic fatigue than OS and PTU F2 instruments in the apical curvature of an artificial canal with a double curvature. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  9. Development of a Patient-Reported Outcome Instrument to Evaluate Symptoms of Advanced NSCLC: Qualitative Research and Content Validity of the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)

    PubMed Central

    Atkinson, Thomas M.; DeBusk, Kendra P.A.; Liepa, Astra M.; Scanlon, Michael; Coons, Stephen Joel

    2016-01-01

    PURPOSE To describe the process and results of the preliminary qualitative development of a new symptom-based PRO measure intended to assess treatment benefit in advanced non-small cell lung cancer (NSCLC) clinical trials. METHODS Individual qualitative interviews were conducted with adult NSCLC (Stage I–IV) patients in the US. Experienced interviewers conducted concept elicitation (CE) and cognitive interviews using semi-structured interview guides. The CE interview guide was used to elicit spontaneous reports of symptom experiences along with probing to further explore and confirm concepts. Interview transcripts were coded and analyzed by professional qualitative coders using Atlas.ti software, and were summarized by like-content using an iterative coding framework. Data from the CE interviews were considered alongside existing literature and clinical expert opinion during an item-generation process, leading to development of a preliminary version of the NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ). Three waves of cognitive interviews were conducted to evaluate concept relevance, item interpretability, and structure of the draft items to facilitate further instrument refinement. FINDINGS Fifty-one patients (mean age 64.9 [SD=11.2]; 51.0% female) participated in the CE interviews. A total of 1,897 expressions of NSCLC-related symptoms were identified and coded in interview transcripts, representing approximately 42 distinct symptom concepts. A 9-item initial draft instrument was developed for testing in three waves of cognitive interviews with additional NSCLC patients (n=20), during which both paper and electronic versions of the instrument were evaluated and refined. Participant responses and feedback during cognitive interviews led to the removal of 2 items and substantial modifications to others. IMPLICATIONS The NSCLC-SAQ is a 7-item PRO measure intended for use in advanced NSCLC clinical trials to support medical product labelling. The NSCLC-SAQ uses a 7-day recall period and verbal rating scales. It was developed in accordance with the FDA’s PRO Guidance and scientific best practices, and the resulting qualitative interview data provide evidence of content validity. The NSCLC-SAQ has been prepared in both paper and electronic administration formats and a tablet computer-based version is currently undergoing quantitative testing to confirm its measurement properties and support FDA qualification. PMID:27041408

  10. The PRo3D View Planner - interactive simulation of Mars rover camera views to optimise capturing parameters

    NASA Astrophysics Data System (ADS)

    Traxler, Christoph; Ortner, Thomas; Hesina, Gerd; Barnes, Robert; Gupta, Sanjeev; Paar, Gerhard

    2017-04-01

    High resolution Digital Terrain Models (DTM) and Digital Outcrop Models (DOM) are highly useful for geological analysis and mission planning in planetary rover missions. PRo3D, developed as part of the EU-FP7 PRoViDE project, is a 3D viewer in which orbital DTMs and DOMs derived from rover stereo imagery can be rendered in a virtual environment for exploration and analysis. It allows fluent navigation over planetary surface models and provides a variety of measurement and annotation tools to complete an extensive geological interpretation. A key aspect of the image collection during planetary rover missions is determining the optimal viewing positions of rover instruments from different positions ('wide baseline stereo'). For the collection of high quality panoramas and stereo imagery the visibility of regions of interest from those positions, and the amount of common features shared by each stereo-pair, or image bundle is crucial. The creation of a highly accurate and reliable 3D surface, in the form of an Ordered Point Cloud (OPC), of the planetary surface, with a low rate of error and a minimum of artefacts, is greatly enhanced by using images that share a high amount of features and a sufficient overlap for wide baseline stereo or target selection. To support users in the selection of adequate viewpoints an interactive View Planner was integrated into PRo3D. The users choose from a set of different rovers and their respective instruments. PRo3D supports for instance the PanCam instrument of ESA's ExoMars 2020 rover mission or the Mastcam-Z camera of NASA's Mars2020 mission. The View Planner uses a DTM obtained from orbiter imagery, which can also be complemented with rover-derived DOMs as the mission progresses. The selected rover is placed onto a position on the terrain - interactively or using the current rover pose as known from the mission. The rover's base polygon and its local coordinate axes, and the chosen instrument's up- and forward vectors are visualised. The parameters of the instrument's pan and tilt unit (PTU) can be altered via the user interface, or alternatively calculated by selecting a target point on the visualised DTM. In the 3D view, the visible region of the planetary surface, resulting from these settings and the camera field-of-view is visualised by a highlighted region with a red border, representing the instruments footprint. The camera view is simulated and rendered in a separate window and PTU parameters can be interactively adjusted, allowing viewpoints, directions, and the expected image to be visualised in real-time in order to allow users the fine-tuning of these settings. In this way, ideal viewpoints and PTU settings for various rover models and instruments can efficiently be defined, resulting in an optimum imagery of the regions of interest.

  11. The influence of simulated clinical use on the flexibility of rotary ProTaper Universal, K3 and EndoSequence nickel-titanium instruments.

    PubMed

    Viana, A C D; Pereira, E S J; Bahia, M G A; Buono, V T L

    2013-09-01

    To investigate the influence of cyclic flexural and torsional loading on the flexibility of ProTaper Universal, K3 and EndoSequence nickel-titanium instruments, in view of the hypothesis that these types of loading would decrease the flexibility of the selected NiTi rotary files. The instruments evaluated were S2 and F1 ProTaper Universal, sizes 20 and 25, .06 taper K3, and sizes 20 and 25, .06 taper EndoSequence. Flexibility was determined by 45° bending tests according to ISO 3630-1 specification. Values of the bending moment (MB ) obtained with new instruments were considered as the control group (CG). Bending tests were then conducted in instruments previously fatigued to one-fourth and three-fourths of their average fatigue life (fatigue groups, FG¼ and FG¾), as well as after cyclic torsional loading (torsional group, TG). Fatigue tests were carried out in a bench device that allowed the files to rotate freely inside an artificial canal with an angle of curvature of 45° and a radius of 5 mm. Cyclic torsional loading tests were performed that entailed rotating the instrument from zero angular deflection to 180° and then returning to zero applied torque in 20 cycles. Data were analysed using one-way analysis of variance at a significance level of 5%. Simulated clinical use by means of flexural fatigue tests did not affect the flexibility of the instruments, except for a significant increase in flexibility observed in a few instruments (P < 0.05). In addition, comparative statistical analyses between the values of MB measured in new instruments and after cyclic torsional loading showed no significant differences between them (P > 0.05). The flexibility of rotary ProTaper Universal, K3 and EndoSequence NiTi instruments, measured in bending tests, was not adversely affected by simulated clinical use in curved root canals. © 2013 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  12. Torsional Performance of ProTaper Gold Rotary Instruments during Shaping of Small Root Canals after 2 Different Glide Path Preparations.

    PubMed

    Arias, Ana; de Vasconcelos, Rafaela Andrade; Hernández, Alexis; Peters, Ove A

    2017-03-01

    The purpose of this study was to assess the ex vivo torsional performance of a novel rotary system in small root canals after 2 different glide path preparations. Each independent canal of 8 mesial roots of mandibular molars was randomly assigned to achieve a reproducible glide path with a new set of either PathFile #1 (Dentsply Maillefer, Ballaigues, Switzerland) and #2 or ProGlider (Dentsply Maillefer) after negotiation with a 10 K-file. After glide path preparation, root canals in both groups were shaped with the same sequence of ProTaper Gold (Dentsply Tulsa Dental Specialties, Tulsa, OK) following the directions for use recommended by the manufacturer. A total of 16 new sets of each instrument of the ProTaper Gold (PTG) system were used. The tests were run in a standardized fashion in a torque-testing platform. Peak torque (Ncm) and force (N) were registered during the shaping procedure and compared with Student t tests after normal distribution of data was confirmed. No significant differences were found for any of the instruments in peak torque or force after the 2 different glide path preparations (P > .05). Data presented in this study also serve as a basis for the recommended torque for the use of PTG instruments. Under the conditions of this study, differences in the torsional performance of PTG rotary instruments after 2 different glide path preparations could not be shown. The different geometry of glide path rotary systems seemed to have no effect on peak torque and force induced by PTG rotary instruments when shaping small root canals in extracted teeth. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  13. Comparison of canal transportation and centering ability of rotary protaper, one shape system and wave one system using cone beam computed tomography: An in vitro study

    PubMed Central

    Tambe, Varsha Harshal; Nagmode, Pradnya Sunil; Abraham, Sathish; Patait, Mahendra; Lahoti, Pratik Vinod; Jaju, Neha

    2014-01-01

    Aim: The aim of the present study was to compare the canal transportation and centering ability of Rotary ProTaper, One Shape and Wave One systems using cone beam computed tomography (CBCT) in curved root canals to find better instrumentation technique for maintaining root canal geometry. Materials and Methods: Total 30 freshly extracted premolars having curved root canals with at least 10 degrees of curvature were divided into three groups of 10 teeth each. All teeth were scanned by CBCT to determine the root canal shape before instrumentation. In Group 1, the canals were prepared with Rotary ProTaper files, in Group 2 the canals were prepared with One Shape files and in Group 3 canals were prepared with Wave One files. After preparation, post-instrumentation scan was performed. Pre-instrumentation and post-instrumentation images were obtained at three levels, 3 mm apical, 3 mm coronal and 8 mm apical above the apical foramen were compared using CBCT software. Amount of transportation and centering ability were assessed. The three groups were statistically compared with analysis of variance and Tukey honestly significant. Results: All instruments maintained the original canal curvature with significant differences between the different files. Data suggested that Wave One files presented the best outcomes for both the variables evaluated. Wave One files caused lesser transportation and remained better centered in the canal than One Shape and Rotary ProTaper files. Conclusion: The canal preparation with Wave One files showed lesser transportation and better centering ability than One Shape and ProTaper. PMID:25506145

  14. Quality of Teacher-Child Relationship and Preschoolers' Pro-Social Behaviour in German Kindergartens

    ERIC Educational Resources Information Center

    Glüer, Michael; Gregoriadis, Athanasios

    2017-01-01

    Teacher-child relationships in early childhood are a crucial prerequisite for children's emotional, social and academic development. Therefore, it is important to be able to measure accurately the quality of interactions among them. The Student-Teacher Relationship Scale (STRS) is a widely accepted instrument in measuring the quality of…

  15. Mechanical properties of ProTaper Gold nickel-titanium rotary instruments.

    PubMed

    Elnaghy, A M; Elsaka, S E

    2016-11-01

    To evaluate and compare the resistance to cyclic fatigue and torsional stress, flexibility and surface microhardness of ProTaper Gold (PTG; Dentsply, Tulsa Dental Specialties, Tulsa, OK, USA) system with ProTaper Universal (PTU; Dentsply Maillefer, Ballaigues, Switzerland). PTG and PTU instruments were rotated in simulated canals and the number of cycles to failure was recorded to assess their cyclic fatigue resistance. Torsional strength was measured using a torsiometer after fixing firmly the apical 3 mm of the instrument. A scanning electron microscope was used to characterize the topographic features of the fracture surfaces of the broken instruments. The instruments were tested for bending resistance using cantilever-bending test. Vickers microhardness was measured on the cross section of instruments with 300 g load and 15 s dwell time. Data were analysed statistically using independent t-tests. Statistical significance was set at P < 0.05. PTG instruments had a significantly higher resistance to cyclic fatigue and flexibility than PTU (P < 0.001). The fractured cross-sectional surfaces revealed typical features of cyclic fractures, including crack origins, fatigue zones and overload fast fracture zones. On the other hand, PTU instruments were associated with higher resistance to torsional stress and microhardness than PTG instruments (P < 0.001). After torsional tests, the fractured cross-sectional surfaces revealed skewed dimples near the centre of the fracture surfaces and circular abrasion streaks. The PTG instrument had improved resistance to cyclic fatigue and flexibility compared with PTU. PTU instruments had improved resistance to torsional stress and microhardness compared with PTG. © 2015 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  16. Comparison of canal transportation in simulated curved canals prepared with ProTaper Universal and ProTaper Gold systems

    PubMed Central

    Muniz, Brenda Leite; Pires, Frederico; Belladonna, Felipe Gonçalves; Neves, Aline Almeida; Souza, Erick Miranda; De-Deus, Gustavo

    2016-01-01

    Objectives The purpose of this study was to assess the ability of ProTaper Gold (PTG, Dentsply Maillefer) in maintaining the original profile of root canal anatomy. For that, ProTaper Universal (PTU, Dentsply Maillefer) was used as reference techniques for comparison. Materials and Methods Twenty simulated curved canals manufactured in clear resin blocks were randomly assigned to 2 groups (n = 10) according to the system used for canal instrumentation: PTU and PTG groups, upto F2 files (25/0.08). Color stereomicroscopic images from each block were taken exactly at the same position before and after instrumentation. All image processing and data analysis were performed with an open source program (FIJI). Evaluation of canal transportation was obtained for two independent canal regions: straight and curved levels. Student's t test was used with a cut-off for significance set at α = 5%. Results Instrumentation systems significantly influenced canal transportation (p < 0.0001). A significant interaction between instrumentation system and root canal level (p < 0.0001) was found. PTU and PTG systems produced similar canal transportation at the straight part, while PTG system resulted in lower canal transportation than PTU system at the curved part. Canal transportation was higher at the curved canal portion (p < 0.0001). Conclusions PTG system produced overall less canal transportation in the curved portion when compared to PTU system. PMID:26877984

  17. Determining cutting efficiency of nickel-titanium coronal flaring instruments used in lateral action.

    PubMed

    Peters, O A; Morgental, R D; Schulze, K A; Paqué, F; Kopper, P M P; Vier-Pelisser, F V

    2014-06-01

    To develop a method to evaluate the cutting behaviour of nickel-titanium (NiTi) coronal flaring instruments. BioRaCe BR0 (BR), HyFlex CM 1 (HY), ProFile OS No. 2 (PF) and ProTaper Sx (PT) instruments were used in simulated coronal flaring using a lateral action against bovine dentine blocks, at 250 and 500 rpm. Cutting efficiency was assessed by three methods: first, areas of notches produced by instruments were directly measured under a stereomicroscope. Second, dentine specimens were then analysed by surface profilometry to determine the maximum cutting depth and finally by microcomputed tomography to assess the volume of removed dentine. Data were compared using parametric tests with the significance level set at 0.05. For all three methods, HY and PF were the most and the least cutting-efficient instruments, respectively (P < 0.05). Significant differences were detected between 250 and 500 rpm for HY and PT (area); for BR, HY and PT (depth); and for BR and HY (volume). There were strong positive correlations between the results obtained with those three different methods with r-values ranging from 0.81 to 0.92. Measuring the amount of material removed in a specific time under stereomicroscopy is a simple and rational way to assess the cutting behaviour of NiTi rotary instruments in lateral action. HyFlex, manufactured with thermomechanically treated NiTi wire, was the most efficient instrument, and increased rotational speed was associated with increased cutting efficiency. © 2013 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  18. Apical extrusion of debris in primary molar root canals using mechanical and manual systems.

    PubMed

    Buldur, B; Hascizmeci, C; Aksoy, S; Nur Aydin, M; Guvendi, O N

    2018-03-01

    Apical extrusion of debris in primary root canal treatment has not been well elucidated. The purpose of this study is to compare the amount of apically extruded debris during the preparation of primary molar root canals using ProTaper, ProTaper Next, Self-adjusting File (SAF) and hand files. One hundred sixty extracted primary mandibular molar teeth were assigned to 2 groups: Group 1: Resorbed (n=80) and Group 2: Non-resorbed (n=80) and randomly to four subgroups (n=20 teeth for each subgroup) according to the instruments used, ProTaper, ProTaper Next, SAF, and hand file. The apically extruded debris was collected and dried in preweighed Eppendof tubes. The dry weight was calculated by subtracting the preoperative weight from the postoperative weight. Data were analysed statistically using the ANOVA and the Bonferroni post hoc t-test. The amount of apically extruded debris was significantly less for the non-resorbed group compared to the resorbed group (P<0.05). Regardless of the resorption groups, ProTaper Next and SAF extruded significantly less debris than did the ProTaper and hand files (P<0.05), while no statistically significant difference was found between ProTaper Next and SAF (P>0.05). All instruments caused apically extruded debris in primary teeth.

  19. Clinical Evaluation of Quality of Obturation and Instrumentation Time using Two Modified Rotary File Systems with Manual Instrumentation in Primary Teeth.

    PubMed

    Govindaraju, Lavanya; Jeevanandan, Ganesh; Subramanian, Emg

    2017-09-01

    Pulp therapy in primary teeth has been performed using various instrumentation techniques. However, the conventional instrumentation technique used for root canal preparation in primary teeth is hand instrumentation. Various Nickel-Titanium (Ni-Ti) instruments are available to perform efficient root canal preparation in primary teeth. These Ni-Ti instruments has been designed to aid in better root canal preparation in permanent teeth but are rarely used in primary teeth. It is necessary to assess the feasibility of using these adult rotary files with a modified sequence in primary teeth. To compare the quality of obturation and instrumentation time during root canal preparation using hand files and modified rotary file systems in primary molars. Forty-five primary mandibular molars were randomly assigned to three experimental groups (n=15). Group I was instrumented using k-hand files, Group II with S2 ProTaper universal file and Group III with 0.25 tip 4% taper K3 rotary file. Standardized digital radiographs were taken before and after root canal instrumentation. Root canal preparation time was also recorded. Statistical analysis of the obtained data was done using SPSS Software version 17.0. An intergroup comparison of the instrumentation time and the quality of obturation was done using ANOVA and Chi-square test with the level of significance set at 0.05. No significant differences were noted with regard to the quality of obturation (p=0.791). However, a statistically significant difference was noted in the instrumentation time between the three groups (p<0.05). ProTaper rotary system had significantly lesser instrumentation time when compared to that of K3 rotary system and hand file system. The hand files, S2 ProTaper Universal and K3 0.25 tip 4% taper files systems performed similarly with respect to the quality of obturation. There was a significant difference in instrumentation time with manual instrumentation compared to the modified rotary file systems in primary teeth.

  20. The failures of root canal preparation with hand ProTaper.

    PubMed

    Bătăiosu, Marilena; Diaconu, Oana; Moraru, Iren; Dăguci, C; Tuculină, Mihaela; Dăguci, Luminiţa; Gheorghiţă, Lelia

    2012-07-01

    The failures of root canal preparation are due to some anatomical deviation (canal in "C" or "S") and some technique errors. The technique errors are usually present in canal root cleansing and shaping stage and are the result of endodontic treatment objectives deviation. Our study was made on technique errors while preparing the canal roots with hand ProTaper. Our study was made "in vitro" on 84 extracted teeth (molars, premolars, incisors and canines). The canal root of these teeth were cleansed and shaped with hand ProTaper by crown-down technique and canal irrigation with NaOCl(2,5%). The dental preparation control was made by X-ray. During canal root preparation some failures were observed like: canal root overinstrumentation, zipping and stripping phenomenon, discarded and/or fractured instruments. Hand ProTaper represents a revolutionary progress of endodontic treatment, but a deviation from accepted rules of canal root instrumentation can lead to failures of endodontic treatment.

  1. Evaluation of instrumentation systems in reducing E. faecalis from root canals: TF adaptive and ProTaper next versus single file systems.

    PubMed

    Karataş, Ertuğrul; Gültekin, Esra; Arslan, Hakan; Kirici, Damla Özsu; Alsancak, Meltem; Topçu, Meltem Çolak

    2015-03-01

    To compare the effect of the TF Adaptive, ProTaper Next, OneShape, WaveOne, Reciproc, (SAF) on the reduction of E. faecalis in experimentally infected root canals. 70 human mandibular incisor teeth with straight roots and single root canals were selected for this experiment and the root canals of the selected teeth were infected with E. faecalis. After contamination, all the root canals were randomly divided into 7 groups: control, ProTaper Next, TF Adaptive, SAF, WaveOne, Reciproc, and OneShape. After the irrigation procedures, samples were taken from root canals with paper points and incubated in blood agar plates. The colonies grown on the blood agar were counted and interpreted as colony forming units per milliliter. Analysis of results showed that all instrumentation systems were more effective in reducing the number of bacteria than the control (P<.001). The ProTaper Next, TF Adaptive, WaveOne, Reciproc, and OneShape systems were significantly more effective than the SAF system in reducing E. faecalis within the root canals (P<.001). All instrumentation systems used in this study provided a significant reduction in bacterial populations.

  2. Cone-beam Computed Tomography Evaluation of Root Canal Preparation using Various Rotary Instruments: An in vitro Study.

    PubMed

    Ramanathan, Suhashini; Solete, Pradeep

    2015-11-01

    To evaluate the remaining dentin thickness of teeth after cleaning and shaping the root canal using three rotary instrumentation technique using cone-beam computed tomography (CBCT). This in vitro study is being done with 30 premolar samples with 20' curvature. The study is divided into three groups a CBCT was taken to measure the shortest distance from the root canal outline to the closest adjacent root surface was measured at each level from the cementoenamel junction (CEJ) (1,3, 5 and 7 mm) before and after root canal instrumentation. The purpose of this study was to compare the effects of different instruments used to prepare curved root canals on the remaining cervical dentin thickness and total amount of dentin removed from root canals during instrumentation by using multi-slice CBCT. The remaining dentin thickness is very much necessary for the success rate of root canal treatment. However, this study helps to prove that a conservative preparation with a sound remaining dentin thickness is much more advisable. It was observed that there was a significant difference at 1 and 3 mm (p < 0.05) and at 5 and 7 mm there was no significant difference ( p > 0.05). Mtwo has removed less amount dentin when compared to ProTaper Universal and ProTaper Next system at 1 and 3 mm. Under the conditions of the study, we concluded that ProTaper Universal and ProTaper Next should be used judiciously, as it causes higher thinning of root dentin of the root when compared with Mtwo.

  3. Cleaning effectiveness and shaping ability of rotary ProTaper compared with rotary GT and manual K-Flexofile.

    PubMed

    Liu, Sheng-Bo; Fan, Bin; Cheung, Gary S P; Peng, Bing; Fan, Ming-Wen; Gutmann, James L; Song, Ya-Ling; Fu, Qiang; Bian, Zhuan

    2006-12-01

    To compare the cleaning efficacy and shaping ability of engine-driven ProTaper and GT files, and manual preparation using K-Flexofile instruments in curved root canals of extracted human teeth. 45 canals of maxillary and mandibular molars with curvatures between 25 degrees and 40 degrees were divided into three groups. The groups were balanced with regard to the angle and the radius of canal curvature. Canals in each group were prepared to an apical size of 25 with either the rotary ProTaper or GT system, or manually with K-Flexofile using the modified double-flared technique. Irrigation was done with 2 mL 2.5% NaOCl after each instrument and, as the final rinse, 10 mL 2.5% NaOCl then 10 mL 17% EDTA and finally 5 mL distilled water. The double-exposure radiographic technique was used to examine for the presence of apical transportation. The time required to complete the preparation, as well as any change in working length after preparation were recorded. The roots were then grooved and split longitudinally. The amounts of debris and smear layer were evaluated at the apical, middle and coronal regions under the scanning electron microscope. Data were analyzed either parametrically with the F-test or non-parametrically using the Kruskal-Wallis test, where appropriate. Two GT files but none of the K-Flexofile and ProTaper instruments separated. For debris removal, the ProTaper group achieved a better result than GT (P < 0.05) but not the K-Flexofile group at all three regions (apical, middle and coronal). K-Flexofiles produced significantly less smear layer than ProTaper and GT files only in the middle third of the canal (P < 0.01). Both NiTi rotary instruments maintained the original canal shape better than the K-Flexofiles (P < 0.05) and required significantly less time to complete the preparation.

  4. Cutting efficiency of conventional and martensitic nickel-titanium instruments for coronal flaring.

    PubMed

    Morgental, Renata Dornelles; Vier-Pelisser, Fabiana Vieira; Kopper, Patrícia Maria Poli; de Figueiredo, José Antonio Poli; Peters, Ove A

    2013-12-01

    This study aimed at evaluating the influence of rotational speed and number of uses on the cutting efficiency of 4 nickel-titanium coronal flaring instruments against 2 substrates, bovine dentin and acrylic blocks. BioRaCe BR0, HyFlex CM1, ProFile OS#2, and ProTaper Sx were used in simulated lateral action against both substrates at 250 and 500 rpm up to 5 times, producing 5 notches in each block. Notch areas and lengths were measured under a stereomicroscope, and data were compared by using parametric tests (α = 0.05). Against both substrates, HyFlex CM1 and ProFile OS#2 were the most and the least cutting efficient instruments, respectively (P < .05). Against acrylic, area and length values at 500 rpm were significantly higher than those at 250 rpm for all brands. Against dentin, significant differences were detected between 250 and 500 rpm for HyFlex CM1 and ProTaper Sx (area) and for BioRace BR0, HyFlex CM1, and ProTaper Sx (length). Regarding cutting efficiency loss, area and length for notches 1 and 2 (first notches) and 4 and 5 (last notches) were similar against acrylic. Against dentin, length values for notches 1 and 2 were significantly higher than those for notches 4 and 5 in ProFile OS#2 and ProTaper Sx. A strong correlation was detected between the overall results obtained on acrylic and dentin for area and length (P < .0001), although further analysis showed that data against acrylic were a poor predictor of data against dentin after repeated use. HyFlex CM1 was the most cutting efficient instrument in lateral action. An increase in rotational speed improved the cutting efficiency. Results against acrylic showed a high correlation to data against dentin, but acrylic may not be a proper substrate when the intention is to assess cutting efficiency loss with repeated use. Copyright © 2013 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  5. Applying item response theory and computer adaptive testing: the challenges for health outcomes assessment.

    PubMed

    Fayers, Peter M

    2007-01-01

    We review the papers presented at the NCI/DIA conference, to identify areas of controversy and uncertainty, and to highlight those aspects of item response theory (IRT) and computer adaptive testing (CAT) that require theoretical or empirical research in order to justify their application to patient reported outcomes (PROs). IRT and CAT offer exciting potential for the development of a new generation of PRO instruments. However, most of the research into these techniques has been in non-healthcare settings, notably in education. Educational tests are very different from PRO instruments, and consequently problematic issues arise when adapting IRT and CAT to healthcare research. Clinical scales differ appreciably from educational tests, and symptoms have characteristics distinctly different from examination questions. This affects the transferring of IRT technology. Particular areas of concern when applying IRT to PROs include inadequate software, difficulties in selecting models and communicating results, insufficient testing of local independence and other assumptions, and a need of guidelines for estimating sample size requirements. Similar concerns apply to differential item functioning (DIF), which is an important application of IRT. Multidimensional IRT is likely to be advantageous only for closely related PRO dimensions. Although IRT and CAT provide appreciable potential benefits, there is a need for circumspection. Not all PRO scales are necessarily appropriate targets for this methodology. Traditional psychometric methods, and especially qualitative methods, continue to have an important role alongside IRT. Research should be funded to address the specific concerns that have been identified.

  6. Psychometric Validation of the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT®) Questionnaire: Results of the SYMPHONY Trial.

    PubMed

    Chin, Kelly M; Gomberg-Maitland, Mardi; Channick, Richard N; Cuttica, Michael J; Fischer, Aryeh; Frantz, Robert P; Hunsche, Elke; Kleinman, Leah; McConnell, John W; McLaughlin, Vallerie V; Miller, Chad E; Zamanian, Roham T; Zastrow, Michael S; Badesch, David B

    2018-04-26

    Disease-specific patient-reported outcome (PRO) instruments are important in assessing the impact of disease and treatment. PAH-SYMPACT ® is the first questionnaire for quantifying pulmonary arterial hypertension (PAH) symptoms and impacts developed following the 2009 FDA PRO guidance; previous qualitative research with PAH patients supported its initial content validity. Content finalization and psychometric validation were conducted using data from SYMPHONY, a single-arm, 16-week study with macitentan 10mg in US patients with PAH. Item performance, Rasch, and factor analyses were used to select final item content of the PRO and define its domain structure. Internal consistency, test-retest reliability, known-group and construct validity, sensitivity to change, and influence of oxygen on item performance were evaluated. Data from 278 patients (79% female, mean age 60 years) were analyzed. Following removal of redundant/misfitting items, the final questionnaire has 11 symptom items across 2 domains (cardiopulmonary and cardiovascular symptoms) and 11 impact items across 2 domains (physical and cognitive/emotional impacts). Differential item function analysis confirmed PRO scoring is unaffected by oxygen use. For all 4 domains, internal consistency reliability was high (Cronbach's alpha >0.80) and scores were highly reproducible in stable patients (intra-class correlation coefficient 0.84-0.94). Correlations with CAMPHOR and SF-36 were moderate-to-high ([r]=0.34-0.80). The questionnaire differentiated well between patients with different disease severity levels, and was sensitive to improvements in clinician- and patient-reported disease severity. The PAH-SYMPACT ® is a brief, disease-specific PRO instrument possessing good psychometric properties which can be administered in clinical practice and clinical studies. Copyright © 2018. Published by Elsevier Inc.

  7. Evaluation of apically extruded debris during root canal retreatment with several NiTi systems.

    PubMed

    Dincer, A N; Er, O; Canakci, B C

    2015-12-01

    To compare the amount of debris extruded apically during root canal retreatment using ProTaper, Mtwo and Reciproc instruments with hand H-files. In total, 60 freshly extracted human mandibular incisor teeth were used. All root canals were prepared with a Reciproc R25 file than filled with Gutta-percha and AH Plus sealer using cold lateral condensation before being assigned randomly to four groups (n = 15 each). In group 1, root fillings were removed with the Protaper Universal retreatment system; ProTaper Universal F3 and F4 instruments were used for the final preparation. In group 2, root fillings were removed with the Mtwo retreatment system; Mtwo size 30, .06 taper, size 35, .06 taper and size 40, .06 taper files were used for the final preparation. In group 3, root fillings were removed with Reciproc R25 instruments; Reciproc R40 instruments were used for the final preparation. In group 4, the root fillings were removed with Gates Glidden burs and sizes 35, 30 and 25 H-files; for final preparation, a size 40 H-file was used. Glass vials were used for debris collection. The vials were weighed before and after Gutta-percha removal. Additionally, the times required for the retreatment procedures were recorded. Data were analysed statistically using one-way analysis of variance. The Reciproc system produced significantly smaller amounts of apical extruded debris than the other groups (P < 0.05). There was no significant difference between the Mtwo, H-file and ProTaper groups. The ProTaper and Reciproc groups required significantly less time than the Mtwo and H-file groups (P < 0.001). Use of the reciprocating single file system resulted in the extrusion of significantly less debris compared with the full-sequence rotary NiTi instruments and hand filing. Use of the ProTaper and Reciproc instruments required less time for retreatment procedures than use of the Mtwo or H-file. © 2014 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  8. Comparative evaluation of apically extruded debris during root canal preparation using ProTaper™, Hyflex™ and Waveone™ rotary systems

    PubMed Central

    Surakanti, Jayaprada Reddy; Venkata, Ravi Chandra Polavarapu; Vemisetty, Hari Kumar; Dandolu, Ram Kiran; Jaya, Nagendra Krishna Muppalla; Thota, Shirisha

    2014-01-01

    Background and Aims: Extrusion of any debris during endodontic treatment may potentially cause post-operative complications such as flare-ups. The purpose of this in vitro study was to assess the amount of apically extruded debris during the root canal preparation using rotary and reciprocating nickel-titanium instrumentation systems. Materials and Methods: In this study, 60 human mandibular first premolars were randomly assigned to 3 groups (n = 20 teeth/group). The root canals were instrumented according to the manufacturers’ instructions using the Reciprocating single-file system WaveOne™ (Dentsply Maillefer, Ballaigues, Switzerland) and full-sequence rotary Hyflex CM™ (Coltene Whaledent, Allstetten, Switzerland) and ProTaper™ (Dentsply Maillefer, Ballaigues, Switzerland) instruments. The canals were then irrigated using bidistilled water. The debris that was extruded apically was collected in preweighed eppendorf tubes and assessed with an electronic balance and compared. Statistical Analysis Used: The debris extrusion was compared and statistically analyzed using analysis of variance and the post hoc Student-Newman-Keuls test. Results: The WaveOne™ and ProTaper™ rotary instruments produced significantly more debris compared with Hyflex CM™ rotary instruments (P < 0.05). Conclusions: Under the conditions of this study, all systems that were used resulted in extrusion of apical debris. Full-sequence rotary instrumentation was associated with less debris extrusion compared with the use of reciprocating single-file systems. PMID:24778507

  9. The efficacy of the self-adjusting file and ProTaper for removal of calcium hydroxide from root canals

    PubMed Central

    FARIA, Gisele; KUGA, Milton Carlos; RUY, Alessandra Camila; ARANDA-GARCIA, Arturo Javier; BONETTI-FILHO, Idomeo; GUERREIRO-TANOMARU, Juliane Maria; LEONARDO, Renato Toledo

    2013-01-01

    Objective The goal of this study was to evaluate the efficacy of the Self-Adjusting File (SAF) and ProTaper for removing calcium hydroxide [Ca(OH)2] from root canals. Material and Methods Thirty-six human mandibular incisors were instrumented with the ProTaper system up to instrument F2 and filled with a Ca(OH)2-based dressing. After 7 days, specimens were distributed in two groups (n=15) according to the method of Ca(OH)2 removal. Group I (SAF) was irrigated with 5 mL of NaOCl and SAF was used for 30 seconds under constant irrigation with 5 mL of NaOCl using the Vatea irrigation device, followed by irrigation with 3 mL of EDTA and 5 mL of NaOCl. Group II (ProTaper) was irrigated with 5 mL of NaOCl, the F2 instrument was used for 30 seconds, followed by irrigation with 5 mL of NaOCl, 3 mL of EDTA, and 5 mL of NaOCl. In 3 teeth Ca(OH)2 was not removed (positive control) and in 3 teeth canals were not filled with Ca(OH)2 (negative control). Teeth were sectioned and prepared for the scanning electron microscopy. The amounts of residual Ca(OH)2 were evaluated in the middle and apical thirds using a 5-score system. Results None of the techniques completely removed the Ca(OH)2 dressing. No difference was observed between SAF and ProTaper in removing Ca(OH)2 in the middle (P=0.11) and the apical (P=0.23) thirds. Conclusion The SAF system showed similar efficacy to rotary instrument for removal of Ca(OH)2 from mandibular incisor root canals. PMID:24037074

  10. Evaluating Transportation by Comparing Several uses of Rotary Endodontic Files.

    PubMed

    Elemam, Ranya F; Capelas, J A; Vaz, Mário A P; Viriato, Nuno; Pereira, M L; Azevedo, A; West, John

    2015-12-01

    To evaluate the frequent use of ProTaper Next (PTN; Dentsply Maillefer, Ballaigues, Switzerland) systems on shaping ability of root canal utilizing Solidworks (2014, Dassault Systemes) software. Thirty-six root canals in clear resin blocks (Dentsply-Maillefer) were allocated into six experimental groups (n = 36). Six new sets of PTN instruments (Dentsply Maillefer, Ballaigues, Switzerland) were used six times to shape the resin blocks. A #15 K-file was inserted to the working length (WL), followed by ProGlider (PG) to create a glide path. Sequential use of PTN instrumentation in a crown-down technique was used to reach size (30/07) apically. Macroscopic photos of the blocks were taken before and after instrumentation, layered by Paint Shop Pro 9 from JascSoftware, and then canal transportation was measured using Solidwork 2014. The data were analyzed by SPSS software version 22. Multivariate statistical analysis general linear model (GLM) was also applied. Bonferroni correction test was used in multiple comparisons and the statistical significance was set to 0.05. There was no difference in canal transportation resulted from utilizing PTN files after six multiple uses; in addition, the PTN files showed ability to maintain the original canal anatomy, especially in the apical level, where lowest total mean value of canal center displacement was seen (3 mm level) (0.019 ± 0.017). ProTaper Next files can be used to prepare single and multiple canals in a single furcated tooth. ProTaper Next nickel-titanium (NiTi) file system is a safe instrument that respects the canal shape, allows practitioners to treat difficult cases with good results, and low risk of separation.

  11. Danish translation and linguistic validation of the BODY-Q: a description of the process.

    PubMed

    Poulsen, Lotte; Rose, Michael; Klassen, Anne; Roessler, Kirsten K; Sørensen, Jens Ahm

    2017-01-01

    Patient-reported outcome (PRO) instruments are increasingly being included in research and clinical practice to assess the patient point of view. Bariatric and body contouring surgery has the potential to improve or restore a patient's body image and health-related quality of life (HR-QOL). A new PRO instrument, called the BODY-Q, has recently been developed specifically for this patient group. The aim of the current study was to translate and perform a linguistic validation of the BODY-Q for use in Danish bariatric and body contouring patients. The translation was performed in accordance with the International Society For Pharmacoeconomics and Outcomes Research (ISPOR) and the World Health Organization (WHO) recommendations. Main steps taken included forward and backward translations, an expert panel meeting, and cognitive patient interviews. All translators aimed to conduct a conceptual translation rather than a literal translation and used a simple and clear formulation to create a translation understandable for all patients. The linguistic translation process led to a conceptually equivalent Danish version of the BODY-Q. The comparison between the back translation of the first Danish version and the original English version of the BODY-Q identified 18 items or instructions requiring re-translation. The expert panel helped to identify and resolve inadequate expressions and concepts of the translation. The panel identified 31 items or instructions that needed to be changed, while the cognitive interviews led to seven major revisions. The impact of weight loss methods such as bariatric surgery and body contouring surgery on patients' HR-QOL would benefit from input from the patient perspective. A thorough translation and linguistic validation must be considered an essential step when implementing a PRO instrument to another language and/or culture. A combination of the ISPOR and WHO guidelines contributed to a straightforward and thorough translation methodology well suited for a Danish translation of the BODY-Q. The described method of translation and linguistic validation can be recommended for future translations of PRO instruments in the field of plastic surgery. Level of Evidence: Not ratable.

  12. Geometric analysis of maxillary first premolar prepared by two nickel-titanium rotary instruments.

    PubMed

    Al-Sudani, Dina; Almalki, Majed; Al-Shahrani, Saad; Ahlquist, Michael

    2014-03-01

    The present study was conducted with the aim of evaluating and comparing the shaping ability of two Nickel-titanium rotary instruments, with two disparate design features, on root canal geometry of extracted human maxillary first premolars using microcomputed tomography. Twenty four bifurcated maxillary first premolars were divided into two groups and embedded in a rubber-based impression material. Both groups were submitted to micro-computed tomography before and after canal preparation (buccal and palatal) with either ProFile Vortex or Revo-S rotary instruments. Images were reconstructed and cross-sections corresponding to a distance 1, 2, 3, 4, 5, 6, and 7 mm from the anatomical apex were selected for canal transportation analysis. Volume changes were also measured. The degree and direction of canal transportation were non-significant for both instruments. Statistically significant differences were observed only between levels in the buccal canal in both groups. There was no significant difference between the two rotary systems in regards to the volume of dentin removed. Our findings showed that ProFile Vortex and Revo-S instruments respected the original root canal anatomy and behaved similarly. ProFile Vortex rotary systems produced with innovative process were concluded to shape the upper maxillary premolar by leading minimal canal transportation, similar to Revo-S, rotary systems produced from traditional process.

  13. Comparison of cyclic fatigue and torsional resistance in reciprocating single-file systems and continuous rotary instrumentation systems.

    PubMed

    da Frota, Matheus F; Espir, Camila G; Berbert, Fábio L C V; Marques, André A F; Sponchiado-Junior, Emílio C; Tanomaru-Filho, Mario; Garcia, Lucas F R; Bonetti-Filho, Idomeo

    2014-12-01

    As compared with continuous rotary systems, reciprocating motion is believed to increase the fatigue resistance of NiTi instruments. We compared the cyclic fatigue and torsional resistance of reciprocating single-file systems and continuous rotary instrumentation systems in simulated root canals. Eighty instruments from the ProTaper Universal, WaveOne, MTwo, and Reciproc systems (n = 20) were submitted to dynamic bending testing in stainless-steel simulated curved canals. Axial displacement of the simulated canals was performed with half of the instruments (n = 10), with back-and-forth movements in a range of 1.5 mm. Time until fracture was recorded, and the number of cycles until instrument fracture was calculated. Cyclic fatigue resistance was greater for reciprocating systems than for rotary systems (P < 0.05). Instruments from the Reciproc and WaveOne systems significantly differed only when axial displacement occurred (P < 0.05). Instruments of the ProTaper Universal and MTwo systems did not significantly differ (P > 0.05). Cyclic fatigue and torsional resistance were greater for reciprocating systems than for continuous rotary systems, irrespective of axial displacement.

  14. Smear Layer Evaluation on Root Canal Preparation with Manual and Rotary Techniques using EDTA as an Irrigant: A Scanning Electron Microscopy Study

    PubMed Central

    Manjunatha, M; Annapurna, Kini; Sudhakar, V; Sunil Kumar, VC; Hiremath, Vinay Kumar; Shah, Ankur

    2013-01-01

    Introduction: The aim of any root canal treatment is to achieve a canal free of micro organisms, residual pulp remnants, debris and smear layer for the long term success of the procedure. Manual and automated instrumentation techniques along with proper irrigation regime is used to arrive at the aforementioned goal. Many authors focused on the preparation capabilities of various manual and rotary instruments but very few investigators stressed on the actual cleaning abilities of these instruments. Aims and objectives: This study was undertaken to evaluate the cleaning efficiency of manual K flex files and rotary Pro File systems in the root canals using a scanning electron microscope. Material and Methods:Thirty single rooted mandibular first premolars were divided into two groups and randomized (the manual group-M and the ProFile group-P) with respect to the preparation technique. The Manual group was hand instrumented with stainless steel K- Flexofiles by means of a conventional filing technique. The Pro File group was instrumented according to the manufacturer's instructions using a rotary handpiece. All canals were shaped and cleaned under frequent irrigation with EDTA. Final irrigation was carried out with 3 mL of normal saline solution to neutralize the action of the irrigant. The roots were split, one half of each tooth was selected for further SEM technique analysis and examined under the scanning electron microscope. The canal walls were quantitatively evaluated for the amount of debris and smear layer. The apical, middle and coronal regions of the canal surface, were graded (1-5) for debris and smear layer. A statistical analysis was performed using a Mann-Whitney Rank Sum test. ProFile performed least effective cleaning. Manual K-Flexofiles led to a grooved pattern. Results and Conclusion: A statistically significant difference was observed (p<0.05) between the two instrumentation techniques concerning the amount of debris and smear layer at the apical level. The manually filed canals had less debris and smear layer than those using a rotary technique. It was concluded from this study that none of the instrumentation techniques employed, produced the canal walls which were free of surface debris and smear layer. The manual instrumentation technique was better in cleaning the canals compared to the ProFile rotary Ni-Ti instruments despite the step-back technique used for manual instrumentation. How to cite this article: Manjunatha M, Kini A, Sudhakar V, Sunil K V C, Hiremath V K, Shah A. Smear Layer Evaluation on Root Canal Preparation with Manual and Rotary Techniques using EDTA as an Irrigant: A Scanning Electron Microscopy Study. J Int Oral Health 2013; 5(1):66-78. PMID:24155580

  15. Energy consumption of ProTaper Next X1 after glide path with PathFiles and ProGlider.

    PubMed

    Berutti, Elio; Alovisi, Mario; Pastorelli, Michele Angelo; Chiandussi, Giorgio; Scotti, Nicola; Pasqualini, Damiano

    2014-12-01

    Instrument failure caused by excessive torsional stress can be controlled by creating a manual or mechanical glide path. The ProGlider single-file system (Dentsply Maillefer, Ballaigues, Switzerland) was recently introduced to perform a mechanical glide path. This study was designed to compare the effect of a glide path performed with PathFiles (Dentsply Maillefer) and ProGlider on torque, time, and pecking motion required for ProTaper Next X1 (Dentsply Maillefer) to reach the full working length in simulated root canals. Forty Endo Training Blocks (Dentsply Maillefer) were used. Twenty were prepared with a mechanical glide path using PathFiles 1 and 2 (the PathFile group), and 20 were prepared with a mechanical glide path using a ProGlider single file (the ProGlider group). All samples were shaped with ProTaper Next X1 driven by an endodontic motor connected to a digital wattmeter. The required torque for root canal instrumentation was analyzed by evaluating the electrical power consumption of the endodontic engine. Electric power consumption (mW/h), elapsed time (seconds), and number of pecking motions required to reach the full working length with ProTaper Next X1 were calculated. Differences among groups were analyzed with the parametric Student t test for independent data (P < .05). Elapsed time and electric power consumption were significantly different between groups (P = .0001 for both). ProGlider appears to perform more efficiently than PathFiles in decreasing electric power consumption of ProTaper Next X1 to reach the full working length. This study confirmed the ability of ProGlider to reduce stress in ProTaper Next X1 during shaping through a glide path and preliminary middle and coronal preflaring. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  16. Quantitative evaluation of apically extruded debris during root canal instrumentation with ProTaper Universal, ProTaper Next, WaveOne, and self-adjusting file systems

    PubMed Central

    Ozsu, Damla; Karatas, Ertugrul; Arslan, Hakan; Topcu, Meltem C.

    2014-01-01

    Objectives: The aim of this study was to compare the amount of apically extruded debris during preparation with ProTaper Universal (Dentsply Maillefer, Ballaigues, Switzerland), ProTaper Next (Dentsply Maillefer), a reciprocating single-file (WaveOne; VDW GmbH, Munich, Germany), and a self-adjusting file (SAF; ReDent Nova, Ra’anna, Israel). Materials and Methods: Fifty-six intact mandibular premolar teeth were randomly assigned to four groups. The root canals were prepared according to the manufacturers’ instructions using the ProTaper Universal, ProTaper Next, WaveOne, and SAF. Apically extruded debris was collected in preweighted Eppendorf tubes during instrumentation. The net weight of the apically extruded debris was determined by subtracting the preweights and postweights of the tubes. The data were statistically analyzed using the one-way analysis of variance and the least significant difference tests at a significance level of P < 0.05. Results: A measurable amount of debris was apically extruded in all groups, and the amounts of debris extrusion in the groups were statistically significant (P < 0.001). The ProTaper Next and WaveOne groups resulted in less debris extrusion than the ProTaper Universal group (P < 0.05), and the SAF group resulted in the least debris extrusion. Conclusions: Within the limitations of the present study, it can be concluded that all systems extruded debris beyond the apical foramen. PMID:25512732

  17. Effects of self-adjusting file, Mtwo, and ProTaper on the root canal wall.

    PubMed

    Hin, Ellemieke S; Wu, Min-Kai; Wesselink, Paul R; Shemesh, Hagay

    2013-02-01

    The purpose of this ex vivo study was to observe the incidence of cracks in root dentin after root canal preparation with hand files, self-adjusting file (SAF), ProTaper, and Mtwo. One hundred extracted mandibular premolars with single canals were randomly selected. Two angulated radiographs were taken for each tooth, and the width of the canal was measured at 9 mm from the apex. Five groups of 20 teeth each were comparable in canal width. The control group was left unprepared. Four experimental groups were instrumented with hand files, ProTaper, Mtwo, and SAF. Roots were then sectioned horizontally and observed under a microscope. The presence of dentinal cracks and their location were noted. The difference between the experimental groups was analyzed with a χ(2) test. No cracks were observed in the control group. In the experimental groups, ProTaper, Mtwo, and SAF caused cracks in 35%, 25%, and 10% of teeth, respectively. The hand-file group did not show any dentinal cracks (P < .0001). ProTaper and Mtwo caused more cracks than hand files (P < .05), but SAF did not (P > .05). Instrumentation of root canals with SAF, Mtwo, and ProTaper could cause damage to root canal dentin. SAF has a tendency to cause less dentinal cracks as compared with ProTaper or Mtwo. Copyright © 2013 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  18. Smear layer and debris removal using manual Ni-Ti files compared with rotary Protaper Ni- Ti files - An In-Vitro SEM study.

    PubMed

    Reddy, J M V Raghavendra; Latha, Prasanna; Gowda, Basavana; Manvikar, Varadendra; Vijayalaxmi, D Benal; Ponangi, Kalyana Chakravarthi

    2014-02-01

    Predictable successful endodontic therapy depends on correct diagnosis, effective cleaning, shaping and disinfection of the root canals and adequate obturation. Irrigation serves as a flush to remove debris, tissue solvent and lubricant from the canal irregularities; however these irregularities can restrict the complete debridement of root canal by mechanical instrumentation.Various types of hand and rotary instruments are used for the preparation of the root canal system to obtain debris free canals. The purpose of this study was to evaluate the amount of smear layer and debris removal on canal walls following the using of manual Nickel-Titanium (NiTi) files compared with rotary ProTaperNiTi files using a Scanning Electron Microscope in two individual groups. A comparative study consisting of 50 subjects randomized into two groups - 25 subjects in Group A (manual) and 25 subjects in Group B (rotary) was undertaken to investigate and compare the effects of smear layer and debris between manual and rotary NiTi instruments. Chi square test was used to find the significance of smear layer and debris removal in the coronal, middle and apical between Group A and Group B. Both systems of Rotary ProTaperNiTi and manual NiTi files used in the present study, did not create completely clean root canals. Manual NiTi files produced significantly less smear layer and debris compared to Rotary ProTaperNiTi instruments. Rotary instruments were less time consuming when compared to manual instruments. Instrument separation was not found to be significant with both the groups. Both systems of Rotary ProTaperNiTi and manual NiTi files used did not produce completely clean root canals. Manual NiTi files produced significantly less smear layer and debris compared to Rotary protaper instruments. How to cite the article: Reddy JM, Latha P, Gowda B, Manvikar V, Vijayalaxmi DB, Ponangi KC. Smear layer and debris removal using manual Ni-Ti files compared with rotary Protaper Ni-Ti files - An In-Vitro SEM study. J Int Oral Health 2014;6(1):89-94.

  19. Smear layer and debris removal using manual Ni-Ti files compared with rotary Protaper Ni- Ti files - An In-Vitro SEM study

    PubMed Central

    Reddy, J M V Raghavendra; Latha, Prasanna; Gowda, Basavana; Manvikar, Varadendra; Vijayalaxmi, D Benal; Ponangi, Kalyana Chakravarthi

    2014-01-01

    Background: Predictable successful endodontic therapy depends on correct diagnosis, effective cleaning, shaping and disinfection of the root canals and adequate obturation. Irrigation serves as a flush to remove debris, tissue solvent and lubricant from the canal irregularities; however these irregularities can restrict the complete debridement of root canal by mechanical instrumentation.Various types of hand and rotary instruments are used for the preparation of the root canal system to obtain debris free canals. The purpose of this study was to evaluate the amount of smear layer and debris removal on canal walls following the using of manual Nickel-Titanium (NiTi) files compared with rotary ProTaperNiTi files using a Scanning Electron Microscope in two individual groups. Materials & Methods: A comparative study consisting of 50 subjects randomized into two groups – 25 subjects in Group A (manual) and 25 subjects in Group B (rotary) was undertaken to investigate and compare the effects of smear layer and debris between manual and rotary NiTi instruments. Chi square test was used to find the significance of smear layer and debris removal in the coronal, middle and apical between Group A and Group B. Results: Both systems of Rotary ProTaperNiTi and manual NiTi files used in the present study, did not create completely clean root canals. Manual NiTi files produced significantly less smear layer and debris compared to Rotary ProTaperNiTi instruments. Rotary instruments were less time consuming when compared to manual instruments. Instrument separation was not found to be significant with both the groups. Conclusions: Both systems of Rotary ProTaperNiTi and manual NiTi files used did not produce completely clean root canals. Manual NiTi files produced significantly less smear layer and debris compared to Rotary protaper instruments. How to cite the article: Reddy JM, Latha P, Gowda B, Manvikar V, Vijayalaxmi DB, Ponangi KC. Smear layer and debris removal using manual Ni-Ti files compared with rotary Protaper Ni-Ti files - An In-Vitro SEM study. J Int Oral Health 2014;6(1):89-94. PMID:24653610

  20. CBCT Assessment of Root Dentine Removal by Gates-Glidden Drills and Two Engine-Driven Root Preparation Systems.

    PubMed

    Harandi, Azade; Mohammadpour Maleki, Fatemeh; Moudi, Ehsan; Ehsani, Maryam; Khafri, Soraya

    2017-01-01

    The aim of this study was to compare the dentine removing efficacy of Gates-Glidden drills with hand files, ProTaper and OneShape single-instrument system using cone-beam computed tomography (CBCT). A total of 39 extracted bifurcated maxillary first premolars were divided into 3 groups ( n =13) and were prepared using either Gates-Glidden drills and hand instruments, ProTaper and OneShape systems. Pre- and post-instrumentation CBCT images were obtained. The dentin thickness of canals was measured at furcation, and 1 and 2 mm from the furcation area in buccal, palatal, mesial and distal walls. Data were analyzed using one-way ANOVA test. Tukey's post hoc tests were used for two-by-two comparisons. Gates-Glidden drills with hand files removed significantly more ( P <0.001) dentine than the engine-driven systems in all canal walls (buccal, palatal, mesial and distal). There were no significant differences between OneShape and ProTaper rotary systems ( P >0.05). The total cervical dentine removal during canal instrumentation was significantly less with engine-driven file systems compared to Gates-Glidden drills. There were no significant differences between residual dentine thicknesses left between the various canal walls.

  1. A Comparative Study on the Amount of Extruded Material from the Apical Foramen with NiTi Rotary and Stainless Steel Hand Instruments

    PubMed Central

    Nazari, Shahrzad; MirMotalebi, Farshid

    2006-01-01

    INTRODUCTION: The purpose of the present study was to quantify and compare the amount of extruded debris from apical foramen after instrumentation of the root canal system with hand and rotary instruments. MATERIALS AND METHODS: Root canals of forty five fresh extracted single rooted human teeth with mature apexes and less than 15 degree of root curvature were instrumented in group A with stainless steel K-Type files, in group B with rotary NiTi Flex Master files, and in group C with rotary NiTi ProTaper files and followed weighting the extruded debris by a digital scale to within 0.0001 gram accuracy. RESULTS: In all groups, the mean weight of extruded debris was not more than 5 mg (P=0.0l) and was ranked as: Group A>Group B>Group C. There were statistically significant differences among three groups (p=0.0l). The mean value of extruded debris in the ProTaper and Flex Master groups were 0.652 and 0.788 mg, respectively. CONCLUSION: The study revealed that the amount of extruded debris from the apical foramen was minimal when ProTaper files were used. PMID:24470804

  2. Assessment of apically extruded debris produced by the self-adjusting file system.

    PubMed

    De-Deus, Gustavo André; Nogueira Leal Silva, Emmanuel João; Moreira, Edson Jorge; de Almeida Neves, Aline; Belladonna, Felipe Gonçalves; Tameirão, Michele

    2014-04-01

    This study was designed to quantitatively evaluate the amount of apically extruded debris by the Self-Adjusting-File system (SAF; ReDent-Nova, Ra'anana, Israel). Hand and rotary instruments were used as references for comparison. Sixty mesial roots of mandibular molars were randomly assigned to 3 groups (n = 20). The root canals were instrumented with hand files using a crown-down technique. The ProTaper (Dentsply Maillefer, Ballaigues, Switzerland) and SAF systems were used according to the manufacturers' instructions. Sodium hypochlorite was used as an irrigant, and the apically extruded debris was collected in preweighted glass vials and dried afterward. The mean weight of debris was assessed with a microbalance and statistically analyzed using 1-way analysis of variance and the post hoc Tukey multiple comparison test. Hand file instrumentation produced significantly more debris compared with the ProTaper and SAF systems (P < .05). The ProTaper system produced significantly more debris compared with the SAF system (P < .05). Under the conditions of this study, all systems caused apical debris extrusion. SAF instrumentation was associated with less debris extrusion compared with the use of hand and rotary files. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  3. CT evaluation of canal preparation using rotary and hand NI-TI instruments: An in vitro study

    PubMed Central

    Nagaraja, Shruthi; Sreenivasa Murthy, B V

    2010-01-01

    Background: Controlled, uniformly tapered radicular preparation is a great challenge in endodontics. Improper preparation can lead to procedural errors like transportation of foramen, uneven dentine thickness, stripping of root canal, formation of ledge, zip, and elbow in curved canals. These procedural errors and their sequel can adversely affect the prognosis of treatment. Aim/Objectives: The present in vitro study aims to evaluate canal preparation based on the following factors: canal transportation, remaining dentine thickness and comparing centering ability between hand Ni-Ti K files and ProTaper rotary Ni-Ti instruments using computed tomography (CT). Materials and Methods: For evaluation, 30 mesiobuccal roots of maxillary molars were selected. Of these, 15 roots were distributed into two groups where Group 1 included hand instrumentation with Ni-Ti K-files; and Group 2 comprised ProTaper NiTi rotary system. Pre instrumentation and post instrumentation three-dimensional CT images were obtained from root cross-sections that were 1 mm thick from apex to the canal orifice; scanned images were then superimposed and compared. Result: It was observed that the manual technique using hand Ni-Ti K-file produced lesser canal transportation and maintained greater dentine thickness than the rotary ProTaper technique at middle and coronal third and this difference was statistically significant. No significant difference was seen with regard to canal transportation and remaining root dentine at apical levels. With regard to centering ratio, no significant difference was seen between both the groups at all levels. Conclusion: ProTaper should be used judiciously, especially in curved canals, as it causes higher canal transportation and thinning of root dentine at middle and coronal levels. None of the groups showed optimal centering ability. PMID:20582214

  4. Evaluation of the resistance to cyclic fatigue among ProTaper Next, ProTaper Universal, and Vortex Blue rotary instruments.

    PubMed

    Nguyen, Harrison H; Fong, Hanson; Paranjpe, Avina; Flake, Natasha M; Johnson, James D; Peters, Ove A

    2014-08-01

    The purpose of this study was to compare the fracture resistance to cyclic fatigue of ProTaper Next (PTN; Dentsply Tulsa Dental Specialties, Tulsa, OK), ProTaper Universal (PTU, Dentsply Tulsa Dental Specialties), and Vortex Blue (VB, Dentsply Tulsa Dental Specialties) rotary instruments. Twenty instruments each of PTN X1-X5, PTU S1-F5, and VB 20/04-50/04 were rotated until fracture in a simulated canal of 90° and a 5-mm radius using a custom-made testing platform. The number of cycles to fracture (NCF) was calculated. Weibull analysis was used to predict the maximum number of cycles when 99% of the instrument samples survive. VB 20/04-30/04 had significantly higher NCF than PTU S1-F5 and PTN X1-X5. VB 35/04-45/04 had significantly higher NCF than PTU S2-F5 and PTN X2-X5. PTN X1 had higher NCF than PTU S1-F5. PTN X2 had higher NCF than PTU F2-F5. The Weibull distribution predicted the highest number of cycles at which 99% of instruments survive to be 766 cycles for VB 25/04 and the lowest to be 50 cycles for PTU F2. Under the limitations of this study, VB 20/04-45/04 were more resistant to cyclic fatigue than PTN X2-X5 and PTU S2-F5. PTN X1 and X2 were more resistant to cyclic fatigue than PTU F2-F5. The Weibull distribution appears to be a feasible and potentially clinically relevant model to predict resistance to cyclic fatigue. Copyright © 2014 American Association of Endodontists. All rights reserved.

  5. CT evaluation of canal preparation using rotary and hand NI-TI instruments: An in vitro study.

    PubMed

    Nagaraja, Shruthi; Sreenivasa Murthy, B V

    2010-01-01

    Controlled, uniformly tapered radicular preparation is a great challenge in endodontics. Improper preparation can lead to procedural errors like transportation of foramen, uneven dentine thickness, stripping of root canal, formation of ledge, zip, and elbow in curved canals. These procedural errors and their sequel can adversely affect the prognosis of treatment. The present in vitro study aims to evaluate canal preparation based on the following factors: canal transportation, remaining dentine thickness and comparing centering ability between hand Ni-Ti K files and ProTaper rotary Ni-Ti instruments using computed tomography (CT). For evaluation, 30 mesiobuccal roots of maxillary molars were selected. Of these, 15 roots were distributed into two groups where Group 1 included hand instrumentation with Ni-Ti K-files; and Group 2 comprised ProTaper NiTi rotary system. Pre instrumentation and post instrumentation three-dimensional CT images were obtained from root cross-sections that were 1 mm thick from apex to the canal orifice; scanned images were then superimposed and compared. It was observed that the manual technique using hand Ni-Ti K-file produced lesser canal transportation and maintained greater dentine thickness than the rotary ProTaper technique at middle and coronal third and this difference was statistically significant. No significant difference was seen with regard to canal transportation and remaining root dentine at apical levels. With regard to centering ratio, no significant difference was seen between both the groups at all levels. ProTaper should be used judiciously, especially in curved canals, as it causes higher canal transportation and thinning of root dentine at middle and coronal levels. None of the groups showed optimal centering ability.

  6. Micro-computed Tomographic Analysis of Apical Microcracks before and after Root Canal Preparation by Hand, Rotary, and Reciprocating Instruments at Different Working Lengths.

    PubMed

    de Oliveira, Bruna Paloma; Câmara, Andréa Cruz; Duarte, Daniel Amancio; Heck, Richard John; Antonino, Antonio Celso Dantas; Aguiar, Carlos Menezes

    2017-07-01

    This study aimed to compare apical microcrack formation after root canal shaping by hand, rotary, and reciprocating files at different working lengths using micro-computed tomographic analysis. Sixty mandibular incisors were randomly divided into 6 experimental groups (n = 10) according to the systems and working lengths used for the root canal preparation: ProTaper Universal for Hand Use (Dentsply Maillefer, Ballaigues, Switzerland), HyFlex CM (Coltene-Whaledent, Allstetten, Switzerland), and Reciproc (VDW, Munich, Germany) files working at the apical foramen (AF) and 1 mm short of the AF (AF - 1 mm). The teeth were imaged with micro-computed tomographic scanning at an isotropic resolution of 14 μm before and after root canal preparation, and the cross-sectional images generated were assessed to detect microcracks in the apical portion of the roots. Overall, 17 (28.3%) specimens presented microcracks before instrumentation. Apical microcracks were present in 1 (ProTaper Universal for Hand Use), 3 (Hyflex CM), and 2 (Reciproc) specimens when the instrumentation terminated at the AF. When instrumentation was terminated at AF - 1 mm, apical microcracks were detected in 3 (ProTaper Universal for Hand Use) and 4 (Hyflex CM and Reciproc) specimens. All these microcracks detected after root canal preparation were already present before instrumentation, and no new apical microcrack was visualized. For all groups, the number of slices presenting microcracks after root canal preparation was the same as before canal preparation. Root canal shaping with ProTaper Universal for Hand Use, HyFlex CM, and Reciproc systems, regardless of the working length, did not produce apical microcracks. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  7. Potential relationship between design of nickel-titanium rotary instruments and vertical root fracture.

    PubMed

    Kim, Hyeon-Cheol; Lee, Min-Ho; Yum, Jiwan; Versluis, Antheunis; Lee, Chan-Joo; Kim, Byung-Min

    2010-07-01

    Nickel-titanium (NiTi) rotary files can produce cleanly tapered canal shapes with low tendency of transporting the canal lumen. Because NiTi instruments are generally perceived to have high fracture risk during use, new designs have been marketed to lower fracture risks. However, these design variations may also alter the forces on a root during instrumentation and increase dentinal defects that predispose a root to fracture. This study compared the stress conditions during rotary instrumentation in a curved root for three NiTi file designs. Stresses were calculated using finite element (FE) analysis. FE models of ProFile (Dentsply Maillefer, Ballaigues, Switzerland; U-shaped cross-section and constant 6% tapered shaft), ProTaper Universal (Dentsply; convex triangular cross-section with notch and progressive taper shaft), and LightSpeed LSX (Lightspeed Technology, Inc, San Antonio, TX; noncutting round shaft) were rotated within a curved root canal. The stress and strain conditions resulting from the simulated shaping action were evaluated in the apical root dentin. ProTaper Universal induced the highest von Mises stress concentration in the root dentin and had the highest tensile and compressive principal strain components at the external root surface. The calculated stress values from ProTaper Universal, which had the biggest taper shaft, approached the strength properties of dentin. LightSpeed generated the lowest stresses. The stiffer file designs generated higher stress concentrations in the apical root dentin during shaping of the curved canal, which raises the risk of dentinal defects that may lead to apical root cracking. Thus, stress levels during shaping and fracture susceptibility after shaping vary with instrument design. Copyright 2010 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  8. Hand and nickel-titanium root canal instrumentation performed by dental students: a micro-computed tomographic study.

    PubMed

    Peru, M; Peru, C; Mannocci, F; Sherriff, M; Buchanan, L S; Pitt Ford, T R

    2006-02-01

    The aim of this study was to evaluate root canals instrumented by dental students using the modified double-flared technique, nickel-titanium (NiTi) rotary System GT files and NiTi rotary ProTaper files by micro-computed tomography (MCT). A total of 36 root canals from 18 mesial roots of mandibular molar teeth were prepared; 12 canals were prepared with the modified double-flared technique, using K-flexofiles and Gates-Glidden burs; 12 canals were prepared using System GT and 12 using ProTaper rotary files. Each root was scanned using MCT preoperatively and postoperatively. At the coronal and mid-root sections, System GT and ProTaper files produced significantly less enlarged canal cross-sectional area, volume and perimeter than the modified double-flared technique (P < 0.05). In the mid-root sections there was significantly less thinning of the root structure towards the furcation with System GT and ProTaper (P < 0.05). The rotary techniques were both three times faster than the modified double-flared technique (P < 0.05). Qualitative evaluation of the preparations showed that both ProTaper and System GT were able to prepare root canals with little or no procedural error compared with the modified double-flared technique. Under the conditions of this study, inexperienced dental students were able to prepare curved root canals with rotary files with greater preservation of tooth structure, low risk of procedural errors and much quicker than with hand instruments.

  9. Item response theory, computerized adaptive testing, and PROMIS: assessment of physical function.

    PubMed

    Fries, James F; Witter, James; Rose, Matthias; Cella, David; Khanna, Dinesh; Morgan-DeWitt, Esi

    2014-01-01

    Patient-reported outcome (PRO) questionnaires record health information directly from research participants because observers may not accurately represent the patient perspective. Patient-reported Outcomes Measurement Information System (PROMIS) is a US National Institutes of Health cooperative group charged with bringing PRO to a new level of precision and standardization across diseases by item development and use of item response theory (IRT). With IRT methods, improved items are calibrated on an underlying concept to form an item bank for a "domain" such as physical function (PF). The most informative items can be combined to construct efficient "instruments" such as 10-item or 20-item PF static forms. Each item is calibrated on the basis of the probability that a given person will respond at a given level, and the ability of the item to discriminate people from one another. Tailored forms may cover any desired level of the domain being measured. Computerized adaptive testing (CAT) selects the best items to sharpen the estimate of a person's functional ability, based on prior responses to earlier questions. PROMIS item banks have been improved with experience from several thousand items, and are calibrated on over 21,000 respondents. In areas tested to date, PROMIS PF instruments are superior or equal to Health Assessment Questionnaire and Medical Outcome Study Short Form-36 Survey legacy instruments in clarity, translatability, patient importance, reliability, and sensitivity to change. Precise measures, such as PROMIS, efficiently incorporate patient self-report of health into research, potentially reducing research cost by lowering sample size requirements. The advent of routine IRT applications has the potential to transform PRO measurement.

  10. Canal Transportation and Centering Ability of ProTaper and SafeSider in Preparation of Curved Root Canals: A CBCT Evaluation

    PubMed Central

    Delgoshayi, Negar; Abbasi, Mansoure; Bakhtiar, Hengameh; Sakhdari, Shirin; Ghannad, Setareh; Ellini, Mohammad Reza

    2018-01-01

    Introduction: Maintaining the original central canal path is an important parameter in efficient root canal preparation. Instruments causing minimal changes in original canal path are preferred for this purpose. This study sought to compare canal transportation and centering ability of ProTaper and SafeSider instruments in curved mesiobuccal root canals of mandibular first molars using cone beam computed tomography (CBCT). Methods and Materials : In this experimental study, 30 mesiobuccal root canals of extracted human mandibular first molars with 20° to 40° curvature were randomly divided into two groups (n=15). After mounting in putty, preoperative CBCT scans were obtained of teeth. Root canals in group A were shaped using S1, S2, F1 and F2 of ProTaper system. Root canals in group B were instrumented to size 25 using SafeSider system according to the manufacturers’ instructions. Postoperative CBCT scans were then obtained. The distance between the external root surface and internal canal wall was measured at the mesial and distal at 1, 3 and 7 mm from the apex. The values measured on primary and secondary CBCT scans were compared to assess possible changes in original central canal path and canal transportation. Data were compared using the t-test and repeated measure ANOVA. Results: ProTaper and SafeSider were significantly different in terms of canal transportation and centering ability, and ProTaper was significantly superior to SafeSider in this respect (P<0.001). Conclusion: ProTaper (in contrast to SafeSider) is well capable of maintaining the original central canal path with the least amount of transportation. PMID:29707022

  11. Multi-Center Evaluation of the Automated Immunohematology Instrument, the ORTHO VISION Analyzer.

    PubMed

    Aysola, Agnes; Wheeler, Leslie; Brown, Richard; Denham, Rebecca; Colavecchia, Connie; Pavenski, Katerina; Krok, Elizabeth; Hayes, Chelsea; Klapper, Ellen

    2017-02-01

    ORTHO VISION Analyzer (Vision), is an immunohematology instrument using ID-MT gel card technology with digital image processing. It has a continuous, random sample access with STAT priority processing. The efficiency and ease of operation of Vision was evaluated at 5 medical centers. De-identified patient samples were tested on the ORTHO ProVue Analyzer (ProVue) and repeated on the Vision mimicking the daily workload pattern. Turnaround times (TAT) were collected and compared. Operators rated key features of the analyzer on a scale of 1 to 5. A total of 507 samples were tested on both instruments at the 5 trial sites. The mean TAT (SD) were 31.6 minutes (5.5) with Vision and 35.7 minutes (8.4) with ProVue, which renders a 12% reduction. Type and screens were performed on 381 samples; the mean TAT (SD) was 32.2 minutes (4.5) with Vision and 37.0 minutes (7.4) with ProVue. Antibody identification with eleven panel cells was performed on 134 samples on Vision; TAT (SD) was 43.2 minutes (8.3). The installation, training, configuration, maintenance and validation processes are all streamlined to provide a short implementation time. The average rating of main functions by the operators was 4.1 to 4.8. Opportunities for improvement, such as flexibility with editing QC results, maintenance schedule, and printing options were identified. The capabilities to perform serial dilutions, to accept pediatric tubes, and review results by e-Connectivity are enhancements over the ProVue. Vision provides shorter TAT compared to ProVue. Every site described a positive experience using Vision. © American Society for Clinical Pathology, 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  12. Review of patient-reported outcome instruments measuring health-related quality of life and satisfaction in patients with type 2 diabetes treated with oral therapy.

    PubMed

    Roborel de Climens, Aude; Tunceli, Kaan; Arnould, Benoit; Germain, Nicola; Iglay, Kristy; Norquist, Josephine; Brodovicz, Kimberly G

    2015-04-01

    Treatments and their mode of administration may represent a burden for patients and can therefore impact their health-related quality of life (HRQL) or treatment/health satisfaction. Patients with type 2 diabetes mellitus (T2DM) can be treated with oral hypoglycemic agents (OHAs), injectable medications (such as insulin), or a combination of agents. This review aimed to identify patient-reported outcome (PRO) instruments measuring HRQL and/or satisfaction that could differentiate between oral medications based on medication related attributes such as efficacy, tolerability, weight loss, dosing frequency and pill burden. Medline, Embase, PsycINFO, Cochrane Library and the Patient-Reported Outcome and Quality of Life Questionnaires (PROQOLID) biomedical databases were searched to identify instruments and document their development methodology, content and psychometric properties (i.e. validity, reliability), responsiveness and ability to detect changes between treatments. Nineteen instruments were retained based on their potential to differentiate between OHAs. Ten instruments assessed HRQL, amongst which the Audit of Diabetes Dependent Quality of Life, Diabetes 39, Diabetes Health Profile and Impact of Weight on Quality of Life displayed good psychometric properties in T2DM populations and comprehensive HRQL content. Nine instruments assessed satisfaction. Both the Oral Hypoglycemic Agent Questionnaire (OHAQ) and Diabetes Medication Satisfaction (DiabMedSat) Questionnaire have highly relevant content regarding drug attributes. The OHAQ is specific to oral treatment and the DiabMedSat includes HRQL items. The Diabetes Treatment Satisfaction Questionnaire is a standard instrument that is extensively used and provides conclusive results in studies of patients with T2DM. Very few of the existing PRO instruments are specific to OHAs. Despite satisfaction instruments being recommended to differentiate between OHAs in studies of T2DM based on medication attributes, we find that none of the existing instruments appear to be useful in detecting differences between treatments, therefore limiting their use in clinical and observational research.

  13. Mechanical and Metallurgical Properties of Various Nickel-Titanium Rotary Instruments

    PubMed Central

    Shim, Kyu-Sang; Oh, Soram; Kim, Yu-Chan; Jee, Kwang-Koo

    2017-01-01

    The aim of this study was to investigate the effect of thermomechanical treatment on mechanical and metallurgical properties of nickel-titanium (NiTi) rotary instruments. Eight kinds of NiTi rotary instruments with sizes of ISO #25 were selected: ProFile, K3, and One Shape for the conventional alloy; ProTaper NEXT, Reciproc, and WaveOne for the M-wire alloy; HyFlex CM for the controlled memory- (CM-) wire; and TF for the R-phase alloy. Torsional fracture and cyclic fatigue fracture tests were performed. Products underwent a differential scanning calorimetry (DSC) analysis. The CM-wire and R-phase groups had the lowest elastic modulus, followed by the M-wire group. The maximum torque of the M-wire instrument was comparable to that of a conventional instrument, while those of the CM-wire and R-phase instruments were lower. The angular displacement at failure (ADF) for the CM-wire and R-phase instruments was higher than that of conventional instruments, and ADF of the M-wire instruments was lower. The cyclic fatigue resistance of the thermomechanically treated NiTi instruments was higher. DSC plots revealed that NiTi instruments made with the conventional alloy were primarily composed of austenite at room temperature; stable martensite and R-phase were found in thermomechanically treated instruments. PMID:29318149

  14. Incidence of Dentinal Crack after Root Canal Preparation by ProTaper Universal, Neolix and SafeSider Systems

    PubMed Central

    Harandi, Azadeh; Mirzaeerad, Sina; Mehrabani, Mahgol; Mahmoudi, Elham; Bijani, Ali

    2017-01-01

    Introduction: This study aimed to compare the incidence of dentinal crack formation by instrumentation with ProTaper Universal system (rotary, multi-file system), SafeSider (reciprocation movement, multi-file system) and Neolix (rotary, single-file system). Methods and Materials: In this in vitro study, 60 freshly extracted mandibular first molars were randomly divided into three experimental groups (n=15) and a control group containing unprepared teeth (n=15). Instrumentation in different groups was accomplished using either ProTaper, Neolix or SafeSider systems up to 25/0.08. The teeth were then sectioned at 3, 6 and 9 mm from the apex, and observed under a stereomicroscope for presence of dentinal cracks. Data were analyzed with Chi square test, Fisher’s exact test and Bonferroni correction. Results: Micro cracks were seen in all experimental groups (13.3% in ProTaper, 26.7% in SafeSider and 40% in Neolix). There was a significant difference between Neolix and the control groups in microcrack formation (P=0.042). Micro cracks mainly occurred in the coronal section (9 mm). No microcrack occurred in the control group. Conclusion: Neolix rotary single-file system caused more dentinal cracks compared to the unprepared roots. All the instrumentation systems increased the number of micro cracks compared to unprepared teeth. PMID:29225637

  15. Morphometric analysis of root canal cleaning after rotary instrumentation with or without laser irradiation

    NASA Astrophysics Data System (ADS)

    Marchesan, Melissa A.; Geurisoli, Danilo M. Z.; Brugnera, Aldo, Jr.; Barbin, Eduardo L.; Pecora, Jesus D.

    2002-06-01

    The present study examined root canal cleaning, using the optic microscope, after rotary instrumentation with ProFile.04 with or without laser application with different output energies. Cleaning and shaping can be accomplished manually, with ultra-sonic and sub-sonic devices, with rotary instruments and recently, increasing development in laser radiation has shown promising results for disinfection and smear layer removal. In this study, 30 palatal maxillary molar roots were examined using an optic microscope after rotary instrumentation with ProFile .04 with or without Er:YAG laser application (KaVo KeyLaser II, Germany) with different output energies (2940 nm, 15 Hz, 300 pulses, 500 milli-sec duration, 42 J, 140 mJ showed on the display- input, 61 mJ at fiberoptic tip-output and 140 mJ showed on the display-input and 51 mJ at fiberoptic tip-output). Statistical analysis showed no statistical differences between the tested treatments (ANOVA, p>0.05). ANOVA also showed a statistically significant difference (p<0.01) between the root canal thirds, indicating that the middle third had less debris than the apical third. We conclude that: 1) none of the tested treatments led to totally cleaned root canals; 2) all treatments removed debris similarly, 3) the middle third had less debris than the apical third; 4) variation in output energy did not increase cleaning.

  16. Scanning Electron Microscopic Evaluation of Residual Smear Layer Following Preparation of Curved Root Canals Using Hand Instrumentation or Two Engine-Driven Systems.

    PubMed

    Khademi, Abbasali; Saatchi, Masoud; Shokouhi, Mohammad Mehdi; Baghaei, Badri

    2015-01-01

    In this experimental study, the amount of smear layer (SL) remnants in curved root canals after chemomechanical instrumentation with two engine-driven systems or hand instrumentation was evaluated. Forty-eight mesiobuccal roots of mandibular first molars with curvatures ranging between 25 and 35 degrees (according to Schneider's method) were divided into three groups (n=16) which were prepared by either the ProTaper Universal file series, Reciproc single file system or hand instrumentation. The canals were intermittently irrigated with 5.25% NaOCl and 17% (ethylenediaminetetraacetic acid) EDTA, followed by distilled water as the final rinse. The roots were split longitudinally and the apical third of the specimens were evaluated under 2500× magnification with a scanning electron microscope (SEM). The mean scores of the SL were calculated and analyzed using the non-parametric Kruskal-Wallis and Mann-Whitney U tests. The mean scores of the SL were 2.00±0.73, 1.94±0.68 and 1.44±0.63 µm for the ProTaper Universal, Reciproc and hand instrumentation, respectively. Mean score of SL was significantly less in the hand instrumentation group than the ProTaper (P=0.027) and Reciproc (P=0.035) groups. The difference between the two engine-driven systems, however, was not significant (P=0.803). The amount of smear layer in the apical third of curved root canals prepared with both engine-driven systems was similar and greater than the hand instrumentation technique. Complete cleanliness was not attained.

  17. The failures of root canal preparation with hand ProTaper

    PubMed Central

    Bătăiosu, Marilena; Diaconu, Oana; Moraru, Iren; Dăguci, C.; Ţuculină, Mihaela; Dăguci, Luminiţa; Gheorghiţă, Lelia

    2012-01-01

    The failures of root canal preparation are due to some anatomical deviation (canal in “C” or “S”) and some technique errors. The technique errors are usually present in canal root cleansing and shaping stage and are the result of endodontic treatment objectives deviation. Objectives: Our study was made on technique errors while preparing the canal roots with hand ProTaper. Methodology: Our study was made “in vitro” on 84 extracted teeth (molars, premolars, incisors and canines). The canal root of these teeth were cleansed and shaped with hand ProTaper by crown-down technique and canal irrigation with NaOCl(2,5%). The dental preparation control was made by X-ray. Results: During canal root preparation some failures were observed like: canal root overinstrumentation, zipping and stripping phenomenon, discarded and/or fractured instruments. Conclusions: Hand ProTaper represents a revolutionary progress of endodontic treatment, but a deviation from accepted rules of canal root instrumentation can lead to failures of endodontic treatment. PMID:24778848

  18. Comparison of apical and coronal extrusions using reciprocating and rotary instrumentation systems.

    PubMed

    Lu, Yan; Chen, Min; Qiao, Feng; Wu, Ligeng

    2015-08-07

    The aim of this study was to compare the apical and coronal extrusions by using two reciprocating and two rotary instrumentation systems. Eighty extracted human single-rooted anterior teeth were randomly assigned to four groups. Four different root canal instrumentation systems were used according to the manufacturers instructions, including two reciprocating single-file systems, Reciproc and WaveOne, and two full-sequence rotary BLX and ProTaper instruments. Debris collected from the coronal by the instruments and apical extrusions were quantified respectively. After drying the collections, the mean weight of debris collected from apical and coronal extrusions was assessed using an electronic balance and analyzed using the Kruskal-Wallis H and Mann-Whitney U tests. Statistically significant differences in the apical extrusion were observed among the four groups. Reciproc and WaveOne instruments produced significantly less debris than BLX and ProTaper instruments (P < 0.05). All of the systems produced apical extrusion of debris. However, reciprocating single-file systems produced less apical extrusion than full-sequence rotary systems. No relationship was observed between apical and coronal extrusions.

  19. Clinical Evaluation of Quality of Obturation and Instrumentation Time using Two Modified Rotary File Systems with Manual Instrumentation in Primary Teeth

    PubMed Central

    Govindaraju, Lavanya; Subramanian, EMG

    2017-01-01

    Introduction Pulp therapy in primary teeth has been performed using various instrumentation techniques. However, the conventional instrumentation technique used for root canal preparation in primary teeth is hand instrumentation. Various Nickel-Titanium (Ni-Ti) instruments are available to perform efficient root canal preparation in primary teeth. These Ni-Ti instruments has been designed to aid in better root canal preparation in permanent teeth but are rarely used in primary teeth. It is necessary to assess the feasibility of using these adult rotary files with a modified sequence in primary teeth. Aim To compare the quality of obturation and instrumentation time during root canal preparation using hand files and modified rotary file systems in primary molars. Materials and Methods Forty-five primary mandibular molars were randomly assigned to three experimental groups (n=15). Group I was instrumented using k-hand files, Group II with S2 ProTaper universal file and Group III with 0.25 tip 4% taper K3 rotary file. Standardized digital radiographs were taken before and after root canal instrumentation. Root canal preparation time was also recorded. Statistical analysis of the obtained data was done using SPSS Software version 17.0. An intergroup comparison of the instrumentation time and the quality of obturation was done using ANOVA and Chi-square test with the level of significance set at 0.05. Results No significant differences were noted with regard to the quality of obturation (p=0.791). However, a statistically significant difference was noted in the instrumentation time between the three groups (p<0.05). ProTaper rotary system had significantly lesser instrumentation time when compared to that of K3 rotary system and hand file system. Conclusion The hand files, S2 ProTaper Universal and K3 0.25 tip 4% taper files systems performed similarly with respect to the quality of obturation. There was a significant difference in instrumentation time with manual instrumentation compared to the modified rotary file systems in primary teeth. PMID:29207834

  20. Comparative analysis of torsional and bending behavior through finite-element models of 5 Ni-Ti endodontic instruments.

    PubMed

    Arbab-Chirani, Reza; Chevalier, Valérie; Arbab-Chirani, Shabnam; Calloch, Sylvain

    2011-01-01

    The objectives of this study were to compare numerically the bending and torsional mechanical behavior of 5 endodontic rotary Ni-Ti instruments with equivalent size and various designs for tapers, pitch, and cutting blades.First, the geometries of Hero (20/0.06), HeroShaper (20/0.06), ProFile (20/0.06), Mtwo (20/0.06), and ProTaper F1 were generated by finite element code. Then, the 2 most representative clinical loadings, i.e., bending and torsion, were studied with an ad hoc model for the superelasticity of Ni-Ti. Bending was generated by tip deflection and torsion by a constant twist-angle of the tip. Mechanical behavior of these 5 endodontic rotary Ni-Ti instruments could be evaluated and compared. Protaper F1 presented the greatest level of bending stress and torque. Hero and HeroShaper were more rigid than ProFile and Mtwo. This numerical comparison evaluated the effects of the geometrical parameters on the instrumental mechanical behavior. The 5 endodontic instruments, investigated in the present study, do not have the same bending and torsional mechanical behavior. Each clinician must be aware of these behavior differences so as to use the adequate file according to the clinical situation and to the manufacturer's recommendations. Copyright © 2011 Mosby, Inc. All rights reserved.

  1. Comparison between rotary and manual instrumentation in primary teeth.

    PubMed

    Crespo, S; Cortes, O; Garcia, C; Perez, L

    2008-01-01

    The aim of this study was to compare the efficiency in both, preparation time and root canal shape, when using the Nickel Titanium (Ni-Ti) rotary and K-Files hand instrumentation on root canal preparation of single rooted primary teeth. Sixty single rooted primary teeth were selected and divided into two equal groups: Group (I) 30 teeth instrumented with manual K-files and group (II) 30 teeth instrumented with Ni-Ti rotary files (ProFile 0.04). Instrumentation times were calculated and root canal impressions were taken with light bodied silicone in order to evaluate the shape. The data was analyzed with SPSS program using the t-test and the Chi-square test to compare their means. The preparation time with group (I) K-files was significantly higher than in group (II) rotary files (ProFile 0.04), with a p= .005. The ProFile system showed a significantly more favorable canal taper when compared to the K-files system (P= .002). The use of rotary files in primary teeth has several advantages when compared with manual K files: the efficiency in both, preparation time and root canal shape. 1. A decreased working time, that helps maintain patient cooperation by diminishing the potential for tiredness. 2. The shape of the root canal is more conical, favoring a higher quality of the root canal filling, and increasing clinical success.

  2. Patient-reported outcomes (PRO) focused on adverse events (PRO-AEs) in adjuvant and metastatic breast cancer: clinical and translational implications.

    PubMed

    Stefanovic, Stefan; Wallwiener, Markus; Karic, Uros; Domschke, Christoph; Katic, Luka; Taran, Florin-Andrei; Pesic, Aleksandra; Hartkopf, Andreas; Hadji, Peyman; Teufel, Martin; Schuetz, Florian; Sohn, Christof; Fasching, Peter; Schneeweiss, Andreas; Brucker, Sara

    2017-02-01

    The capture of adequate treatment outcomes and quality of life (QOL) of advanced breast cancer patients in clinical routine represents a great challenge. Patient-reported outcomes (PROs) are data elements directly reported by patients about experiences with care, including symptoms, functional status, or quality of life. There is growing interest in the medical community for the evaluation and implementation of PROs of adverse events (PRO-AEs). Recent interest in PROs in health care has evolved in the context of patient centeredness. Our primary objective was to identify trials that had implemented PRO-AEs in the breast cancer treatment setting, thereby demonstrating its feasibility. We aimed to identify published studies that used patient reports to assess AEs during and after breast cancer treatment, to identify clinician underreported and modifiable AEs that are important to patients, and to analyze the feasibility and usefulness of PRO instrument implementation in everyday oncological practice with special attention given to electronic-based PRO instruments. We conducted a systematic search of PubMed for studies that used PRO instruments to assess AEs of breast cancer treatment in the metastatic and adjuvant settings. Two authors independently reviewed the search results and decided which studies fully met the predefined inclusion criteria. The search yielded 606 publications. The two reviewers found that 9 studies met the inclusion criteria. Three AEs were identified as important to patients but inadequately reported by health care providers, namely hot flushes, vaginal dryness, and weight gain. PROs and PRO-AEs are the consequence of contemporary concepts of patient-centered medicine and the growing feasibility, utility, and implications of collecting data using modern technology. Furthermore, the willingness of patients to utilize innovative applications for their own health has been increasing in parallel to the enhanced impact of the World Wide Web. Especially, the coverage of the metastatic situation promises numerous findings on the structure and quality of health care, enabling implementation of individually tailored interventions. Remote electronic self-reporting (i.e., home reporting) is feasible and is associated with high compliance levels.

  3. [New method and instrument to diagnose crop growth status in greenhouse based on spectroscopy].

    PubMed

    Zhang, Xi-Jie; Li, Min-Zan; Cui, Di; Zhao, Peng; Sun, Jian-Ying; Tang, Ning

    2006-05-01

    Spectral reflectance of cucumber leaves in greenhouse was measured using an ASD FieldSpec Pro VNIR spectrometer with natural illumination. Two sensitive wavelengths, 527 nm and 762 nm, were selected to evaluate the nitrogen content of the cucumber leaves. A model was established and validated using normal difference color index(NDCI) with the correlation coefficient of 0.881. Based on the above efforts, a handheld spectral instrument was developed to diagnose the growth status of the crop in greenhouse using fiber optics. The instrument was mainly composed of four parts: reflected light acquisition system, light intensity measurement unit, signal conditioning unit, and data acquisition system. The sunlight reflected by the crop was transmitted by the fiber, and passed through the light filter to obtain light at the sensitive wavelengths. Finally it was transformed into electronic signal by the photoelectric transistor, and was used to diagnose the growth status of the crop according to the evaluation model. The result showed that the developed instrument was practical.

  4. 'Ecosystem service opportunities': A practice-oriented framework for identifying economic instruments to enhance biodiversity and human livelihoods.

    PubMed

    Rode, Julian; Wittmer, Heidi; Emerton, Lucy; Schröter-Schlaack, Christoph

    2016-09-01

    Economic instruments that promise "win-win" solutions for both biodiversity conservation and human livelihoods have become increasingly popular over recent years. There however remains a gap in terms of practical and policy-relevant guidance about appropriate approaches that take into account the local needs and the specific cultural, legal, and ecological context in which such instruments are being developed and applied. This paper presents a step-by-step framework that helps conservation and development planners and practitioners to identify economic instruments that can promote pro-conservation behaviour in a specific setting. The concept of 'ecosystem service opportunities' builds on, and brings together, general economic principles and an ecosystem services perspective. The framework was designed to also address a number of concerns regarding economic approaches in order to help practitioners recognise the potentials and limits of economic approaches to nature conservation. The framework is illustrated by its application within the realm of a biodiversity conservation project in Thailand.

  5. In vitro resistance to fracture of two nickel-titanium rotary instruments made with different thermal treatments.

    PubMed

    Miccoli, Gabriele; Gaimari, Gianfranco; Seracchiani, Marco; Morese, Antonio; Khrenova, Tatyana; Di Nardo, Dario

    2017-01-01

    Aim of the study was to evaluate effectiveness of different heat treatments in improving Ni-Ti endodontic rotary instruments' resistance to fracture. 24 new NiTi instruments similar in length and shape: 12 M3 instruments, tip size 25 and .06 taper (United Dental, Shanghai, China), and 12 M3 Pro Gold instruments tip size 25 and .06 taper (United Dental, Shanghai, China), were tested in a 60° curved artificial root canal. Each group received a different heat treatment. Cycles to fracture were calculated for each instrument. Differences among groups were evaluated with an analysis of variance test (significance level was set at P<0.05.). Statistical analysis found significant differences (p<0.0213) between groups. The M3 Pro Gold instruments were significantly more resistant to fatigue (mean values = 1012, SD +/- 77) than M3 instruments (mean values = 748, SD +/- 62). No statistically significant differences were found between fragments' lengths (p>0,05). An increased flexibility and the reduction of internal defects produced by heat treatments during or after manufacturing processes, may be responsible for improving resistance to cyclic fatigue and flexural stresses.

  6. PRISM, a Patient-Reported Outcome Instrument, Accurately Measures Symptom Change in Refractory Gastroesophageal Reflux Disease.

    PubMed

    Fuller, Garth; Bolus, Roger; Whitman, Cynthia; Talley, Jennifer; Erder, M Haim; Joseph, Alain; Silberg, Debra G; Spiegel, Brennan

    2017-03-01

    Most patients with gastroesophageal reflux disease (GERD) experience relief following treatment with proton pump inhibitors (PPIs) (Vakil et al. in Am J Gastroenterol 101:1900-1920, 2006; Everhart and Ruhl in Gastroenterology 136:376-386, 2009). As many as 17-44% of patients, however, exhibit only partial response to therapy. Most extant GERD patient-reported outcome (PRO) instruments fail to meet development best practices as described by the FDA (Talley and Wiklund in Qual Life Res 14:21-33, 2005; Van Pinxteren et al. in Cochrane Database Syst Rev 18:CD002095, 2004; El-Serag et al. in Aliment Pharmacol Ther 32:720-737, 2010). To develop and validate a PRO instrument for clinical trials involving patients with GERD who are PPI partial responders. We prepared a systematic literature review, held patient focus groups, convened an expert panel, and conducted cognitive interviews to establish content validity. Eligible participants took PPI therapy for at least 8 weeks, had undergone an upper endoscopy, and scored at least 8 points on the GerdQ [6]. Qualitative data guided development of 26 draft items. Items were reviewed by expert panels and debriefed with patients. The resulting 21-item instrument underwent psychometric evaluation during a Phase IIB trial. During the trial, confirmatory factor analysis (n = 220) resulted in a four-factor model displaying the highest goodness of fit. All domains had a high inter-item correlation (Cronbach's α > 0.8). Test-retest reliability and convergent validity were strong, with highly significant (p < 0.01) correlations between average weekly PRISM scores and severity anchors and significant (p < 0.05) correlations with anchor subscales. Cumulative distribution functions revealed significant differences between responders and non-responders. Analysis in a clinical trial setting demonstrated strong psychometric properties suggesting validity of PRISM. Developed in line with FDA guidance on PROs, PRISM represents an important new outcome measure for patients with GERD with a partial response to PPI therapy.

  7. Validity of instruments to measure physical activity may be questionable due to a lack of conceptual frameworks: a systematic review

    PubMed Central

    2011-01-01

    Background Guidance documents for the development and validation of patient-reported outcomes (PROs) advise the use of conceptual frameworks, which outline the structure of the concept that a PRO aims to measure. It is unknown whether currently available PROs are based on conceptual frameworks. This study, which was limited to a specific case, had the following aims: (i) to identify conceptual frameworks of physical activity in chronic respiratory patients or similar populations (chronic heart disease patients or the elderly) and (ii) to assess whether the development and validation of PROs to measure physical activity in these populations were based on a conceptual framework of physical activity. Methods Two systematic reviews were conducted through searches of the Medline, Embase, PsycINFO, and Cinahl databases prior to January 2010. Results In the first review, only 2 out of 581 references pertaining to physical activity in the defined populations provided a conceptual framework of physical activity in COPD patients. In the second review, out of 103 studies developing PROs to measure physical activity or related constructs, none were based on a conceptual framework of physical activity. Conclusions These findings raise concerns about how the large body of evidence from studies that use physical activity PRO instruments should be evaluated by health care providers, guideline developers, and regulatory agencies. PMID:21967887

  8. Comparison of cyclic fatigue resistance of novel nickel-titanium rotary instruments.

    PubMed

    Capar, Ismail Davut; Ertas, Huseyin; Arslan, Hakan

    2015-04-01

    New files (ProTaper Next/HyFlex/OneShape) are made from novel nickel-titanium (NiTi) alloys/treatments. The purpose of this study was to compare the cyclic fatigue resistance of these new instruments with that of Revo-S instruments. Four groups of 20 NiTi endodontic instruments were tested in steel canals with a 3 mm radius and a 60° angle of curvature. The cyclic fatigue of the following NiTi instruments with a tip size 25 and 0.06 taper that were manufactured with different alloys was tested: ProTaper Next X2 (M-Wire), OneShape (conventional NiTi), Revo-S Shaping Universal (conventional NiTi) and HyFlex 25/0.6 (controlled memory NiTi wire). A one-way anova and post-hoc Tukey's test (α = 0.05) revealed that the HyFlex files had the highest fatigue resistance and the Revo-S had the least fatigue resistance among the groups (P < 0.001). © 2014 Australian Society of Endodontology.

  9. Cyclic fatigue resistance of newly manufactured rotary nickel titanium instruments used in different rotational directions.

    PubMed

    Gambarini, Gianlucca; Gergi, Richard; Grande, Nicola Maria; Osta, Nada; Plotino, Gianluca; Testarelli, Luca

    2013-12-01

    The aim of this study was to investigate whether cyclic fatigue resistance is increased for nickel titanium instruments manufactured with improved heating processes in clockwise or counterclockwise continuous rotation. The instruments compared were produced either using the R-phase heat treatment (K3XF; SybronEndo, Orange, CA, USA) or the M-wire alloy (ProFile Vortex; DENTSPLY Tulsa Dental Specialties, Tulsa, OK, USA). Tests were performed with a specific cyclic fatigue device that evaluated cycles to failure of rotary instruments in curved artificial canals. Results indicated no significant difference in resistance to cyclic fatigue when rotary nickel titanium instruments are used in clockwise or counterclockwise continuous rotation. In both directions of rotation, size 04-25 K3XF showed a significant increase (P < 0.05) in the mean number of cycles to failure when compared with size 04-25 ProFile Vortex. © 2012 The Authors. Australian Endodontic Journal © 2012 Australian Society of Endodontology.

  10. Evaluation of debris extruded apically during the removal of root canal filling material using ProTaper, D-RaCe, and R-Endo rotary nickel-titanium retreatment instruments and hand files.

    PubMed

    Topçuoğlu, Hüseyin Sinan; Aktı, Ahmet; Tuncay, Öznur; Dinçer, Asiye Nur; Düzgün, Salih; Topçuoğlu, Gamze

    2014-12-01

    The aim of this study was to evaluate the amount of debris extruded apically during the removal of root canal filling material using ProTaper (Dentsply Maillefer, Ballaigues, Switzerland), D-RaCe (FKG Dentaire, La Chaux-de-Fonds, Switzerland), and R-Endo (Micro-Mega, Besançon, France) nickel-titanium (NiTi) rotary retreatment instruments and hand files. Sixty extracted single-rooted mandibular premolar teeth were prepared with K-files and filled with gutta-percha and AH Plus sealer (Dentsply DeTrey, Konstanz, Germany). The teeth were then randomly assigned to 4 groups (n = 15 for each group) for retreatment. The removal of canal filling material was performed as follows: hand files, ProTaper, D-RaCe, and R-Endo retreatment instruments. Debris extruded apically during the removal of canal filling material was collected into preweighed Eppendorf tubes. The tubes were then stored in an incubator at 70°C for 5 days. The weight of the dry extruded debris was established by subtracting the preretreatment and postretreatment weight of the Eppendorf tubes for each group. The data obtained were analyzed using 1-way analysis of variance and Tukey post hoc tests. All retreatment techniques caused the apical extrusion of debris. Hand files produced significantly more debris when compared with ProTaper, D-RaCe, and R-Endo rotary systems (P < .05). There was no statistical difference between the ProTaper, D-RaCe, and R-Endo retreatment systems (P > .05). The findings showed that during the removal of root canal filling material, rotary NiTi retreatment instruments used in this study caused less apical extrusion of debris compared with hand files. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  11. Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.

    PubMed

    Calvert, Melanie; Kyte, Derek; Mercieca-Bebber, Rebecca; Slade, Anita; Chan, An-Wen; King, Madeleine T; Hunn, Amanda; Bottomley, Andrew; Regnault, Antoine; Chan, An-Wen; Ells, Carolyn; O'Connor, Daniel; Revicki, Dennis; Patrick, Donald; Altman, Doug; Basch, Ethan; Velikova, Galina; Price, Gary; Draper, Heather; Blazeby, Jane; Scott, Jane; Coast, Joanna; Norquist, Josephine; Brown, Julia; Haywood, Kirstie; Johnson, Laura Lee; Campbell, Lisa; Frank, Lori; von Hildebrand, Maria; Brundage, Michael; Palmer, Michael; Kluetz, Paul; Stephens, Richard; Golub, Robert M; Mitchell, Sandra; Groves, Trish

    2018-02-06

    Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network's methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n = 21) reduced this to 56 items, which were considered by 138 international stakeholder survey participants and 99 Delphi panelists. The final wording of the SPIRIT-PRO Extension was agreed on at a consensus meeting (n = 29 participants) and reviewed by external group of experts during a consultation period. Eleven extensions and 5 elaborations to the SPIRIT 2013 checklist were recommended for inclusion in clinical trial protocols in which PROs are a primary or key secondary outcome. Extension items focused on PRO-specific issues relating to the trial rationale, objectives, eligibility criteria, concepts used to evaluate the intervention, time points for assessment, PRO instrument selection and measurement properties, data collection plan, translation to other languages, proxy completion, strategies to minimize missing data, and whether PRO data will be monitored during the study to inform clinical care. The SPIRIT-PRO guidelines provide recommendations for items that should be addressed and included in clinical trial protocols in which PROs are a primary or key secondary outcome. Improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centered care.

  12. CBCT Assessment of Root Dentine Removal by Gates-Glidden Drills and Two Engine-Driven Root Preparation Systems

    PubMed Central

    Harandi, Azade; Mohammadpour Maleki, Fatemeh; Moudi, Ehsan; Ehsani, Maryam; Khafri, Soraya

    2017-01-01

    Introduction: The aim of this study was to compare the dentine removing efficacy of Gates-Glidden drills with hand files, ProTaper and OneShape single-instrument system using cone-beam computed tomography (CBCT). Methods and Materials: A total of 39 extracted bifurcated maxillary first premolars were divided into 3 groups (n=13) and were prepared using either Gates-Glidden drills and hand instruments, ProTaper and OneShape systems. Pre- and post-instrumentation CBCT images were obtained. The dentin thickness of canals was measured at furcation, and 1 and 2 mm from the furcation area in buccal, palatal, mesial and distal walls. Data were analyzed using one-way ANOVA test. Tukey’s post hoc tests were used for two-by-two comparisons. Results: Gates-Glidden drills with hand files removed significantly more (P<0.001) dentine than the engine-driven systems in all canal walls (buccal, palatal, mesial and distal). There were no significant differences between OneShape and ProTaper rotary systems (P>0.05). Conclusion: The total cervical dentine removal during canal instrumentation was significantly less with engine-driven file systems compared to Gates-Glidden drills. There were no significant differences between residual dentine thicknesses left between the various canal walls. PMID:28179920

  13. Apical extrusion of debris and irrigants using ProTaper hand, M-two rotary and WaveOne single file reciprocating system: An ex vivo study.

    PubMed

    Singh, Abhishek; Arunagiri, Doraiswamy; Pushpa, Shankarappa; Sawhny, Asheesh; Misra, Abhinav; Khetan, Kirti

    2015-01-01

    The purpose of this ex vivo study was to evaluate and compare the weight of debris and volume of irrigant extruded apically from teeth using different preparation techniques. Thirty extracted human mandibular premolars with single canals and similar lengths were instrumented using hand ProTaper F2 (25, 0.08; Dentsply Maillefer, Ballaigues, Switzerland), M-two (25, 0.06; VDW, Munich, Germany) and WaveOne Primary (25, 0.08; Dentsply Maillefer, Ballaigues, Switzerland). Debris and irrigant extruded during instrumentation were collected into preweighed Eppendorf tubes. The volume of the irrigant was measured, and then the tubes were stored in an incubator at 70°C for 2 days. The Eppendorf tubes were weighed to obtain the final weight when the extruded debris was included. Three consecutive weights were obtained for each tube. Data were statistically analyzed by one-way analysis of variance and Student's t-test. There were no statistically significant differences among the groups. The WaveOne reciprocating system showed the maximum amount of apical extrusion of debris and irrigant among all the groups. The least amount of debris and irrigant was observed in ProTaper hand instrument (P > 0.05). All instrumentation techniques were associated with debris and irrigant extrusion.

  14. Heat release, time required, and cleaning ability of MTwo R and ProTaper universal retreatment systems in the removal of filling material.

    PubMed

    Bramante, Clovis Monteiro; Fidelis, Natasha Siqueira; Assumpção, Tatiana Santos; Bernardineli, Norberti; Garcia, Roberto Brandão; Bramante, Alexandre Silva; de Moraes, Ivaldo Gomes

    2010-11-01

    This ex vivo study evaluated the heat release, time required, and cleaning efficacy of MTwo (VDW, Munich, Germany) and ProTaper Universal Retreatment systems (Dentsply/Maillefer, Ballaigues, Switzerland) and hand instrumentation in the removal of filling material. Sixty single-rooted human teeth with a single straight canal were obturated with gutta-percha and zinc oxide and eugenol-based cement and randomly allocated to 3 groups (n = 20). After 30-day storage at 37 °C and 100% humidity, the root fillings were removed using ProTaper UR, MTwo R, or hand files. Heat release, time required, and cleaning efficacy data were analyzed statistically (analysis of variance and the Tukey test, α = 0.05). None of the techniques removed the root fillings completely. Filling material removal with ProTaper UR was faster but caused more heat release. Mtwo R produced less heat release than the other techniques but was the least efficient in removing gutta-percha/sealer. ProTaper UR and MTwo R caused the greatest and lowest temperature increase on root surface, respectively; regardless of the type of instrument, more heat was released in the cervical third. Pro Taper UR needed less time to remove fillings than MTwo R. All techniques left filling debris in the root canals. Copyright © 2010 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  15. ProTaper rotary instrument fracture during root canal preparation: a comparison between rotary and hybrid techniques.

    PubMed

    Farid, Huma; Khan, Farhan Raza; Rahman, Munawar

    2013-03-01

    This study aimed to compare the frequency of ProTaper rotary instrument fracture with rotary (conventional) and hybrid (rotary and hand files) canal preparation techniques. Secondary objectives were to determine whether there was an association of ProTaper file fracture with the canal curvature and to compare the mean time required for canal preparation in the two techniques. An in vitro experiment was conducted on 216 buccal canals of extracted maxillary and mandibular first molars. After creating an access cavity and a glide path for each canal, a periapical radiograph was taken and the canal curvature was measured with Schneider's technique. The canals were then randomly divided into Group A (rotary technique) and Group B (hybrid technique). The length of ProTaper files were measured before and after each canal preparation. Time taken for each canal preparation was recorded. A total of seven ProTaper files fractured in Group A (P=0.014) in canals with a curvature >25 degrees (P<0.001). The mean time taken for preparation of the root canals was 104.04 sec (± 55.7 sec) in Group A versus 122.88 sec (± 41.67 sec) in Group B (P=0.007). In the teeth studied, the hybrid technique of root canal preparation with ProTaper rotary files, although time consuming, was safer in canals having a curvature greater than 25 degrees.

  16. The PROactive innovative conceptual framework on physical activity

    PubMed Central

    Dobbels, Fabienne; de Jong, Corina; Drost, Ellen; Elberse, Janneke; Feridou, Chryssoula; Jacobs, Laura; Rabinovich, Roberto; Frei, Anja; Puhan, Milo A.; de Boer, Willem I.; van der Molen, Thys; Williams, Kate; Pinnock, Hillary; Troosters, Thierry; Karlsson, Niklas; Kulich, Karoly; Rüdell, Katja; Brindicci, Caterina; Higenbottam, Tim; Troosters, Thierry; Dobbels, Fabienne; Decramer, Marc; Tabberer, Margaret; Rabinovich, Roberto A; MacNee, William; Vogiatzis, Ioannis; Polkey, Michael; Hopkinson, Nick; Garcia-Aymerich, Judith; Puhan, Milo; Frei, Anja; van der Molen, Thys; de Jong, Corina; de Boer, Pim; Jarrod, Ian; McBride, Paul; Kamel, Nadia; Rudell, Katja; Wilson, Frederick J.; Ivanoff, Nathalie; Kulich, Karoly; Glendenning, Alistair; Karlsson, Niklas X.; Corriol-Rohou, Solange; Nikai, Enkeleida; Erzen, Damijan

    2014-01-01

    Although physical activity is considered an important therapeutic target in chronic obstructive pulmonary disease (COPD), what “physical activity” means to COPD patients and how their perspective is best measured is poorly understood. We designed a conceptual framework, guiding the development and content validation of two patient reported outcome (PRO) instruments on physical activity (PROactive PRO instruments). 116 patients from four European countries with diverse demographics and COPD phenotypes participated in three consecutive qualitative studies (63% male, age mean±sd 66±9 years, 35% Global Initiative for Chronic Obstructive Lung Disease stage III–IV). 23 interviews and eight focus groups (n = 54) identified the main themes and candidate items of the framework. 39 cognitive debriefings allowed the clarity of the items and instructions to be optimised. Three themes emerged, i.e. impact of COPD on amount of physical activity, symptoms experienced during physical activity, and adaptations made to facilitate physical activity. The themes were similar irrespective of country, demographic or disease characteristics. Iterative rounds of appraisal and refinement of candidate items resulted in 30 items with a daily recall period and 34 items with a 7-day recall period. For the first time, our approach provides comprehensive insight on physical activity from the COPD patients’ perspective. The PROactive PRO instruments’ content validity represents the pivotal basis for empirically based item reduction and validation. PMID:25034563

  17. Apical Extrusion of Intracanal Bacteria following use of Two Engine-driven Instrumentation Techniques: An in vitro Study.

    PubMed

    Mohammed, Niyaz; Noushad, M C; Balan, Biji; Dhanesh, N; Jayasheelan, Nishi; Revankar, Vanita D

    2016-11-01

    The aim of the present study was to compare in vitro the amount of debris extruded apically from extracted teeth, using Twisted files and ProTaper rotary during two different instrumentation systems. Forty-five human single-rooted mandibular premolar teeth were randomly divided into three groups and contaminated with Enterococcus faecalis. The teeth in experimental groups were instrumented until reaching the working length with ProTaper rotary instruments and Twisted files with XSmart and XSmart Dual groups. Debris extruded from the apical foramen was collected into glass vials and the amount of bacteria was calculated. The data obtained were analyzed using Kruskal-Wallis one-way analysis of variance and Mann-Whitney U tests, with p = 0.05 as the level for statistical significance. The XSmart Dual group extruded comparatively lesser bacteria compared to the XSmart group. Lesser amount of bacterial extrusion was seen when Twisted files were used compared to the ProTaper files (p < 0.05). Under the circumstances of this in vitro study, it can be concluded that all instrumentation techniques produced measurable apical extrusion of debris. So, it is upon the practitioner to decide which system best fits their individual needs and their level of skill and experience that will provide the best possible endodontic care for our patients. The newer instrument designs, including noncutting tips, different cross sections, radial lands, and variable tapers, are better for the clinicians to improve working safety, to reduce the working time, and to create a greater flare within the preparations.

  18. [Application and prospect of scale measurement and appraisal in the assessment in TCM therapeutic efficacy evaluation].

    PubMed

    Liu, Feng-Bin

    2007-12-01

    The assessing contents of the health related quality of life (HRQOL) and the patient reported outcomes (PRO) are identical with the inquiry of traditional Chinese medicine (TCM), which are uniformly soft indicators which could be evaluated with the scales for instruments. The assessing method for the soft indicator in the HRQOL and PRO was gradually accepted by TCM practitioners and applied in evaluating the curative effect of TCM. The applying scale in the assessment of curative effect of TCM and the developing scale with the TCM features just started in the TCM field. There was much inadequacy in the scale study, such as no penetrating understanding of the theory and connotation of the scale in the HRQOL and PRO, on scale system for TCM, no direction in selecting scale, not standardizing in the design of the study with scale in the practice. So, it is necessary that the international guideline of developing scale applied for worldwide should be carried out in the study for developing scale. Meanwhile, it must also be under the guidance of TCM theory in the whole course. It will promote the normalization development of applying scale in the assessment of curative effect in the TCM practice.

  19. Langmuir Probe Spacecraft Potential End Item Specification Document

    NASA Technical Reports Server (NTRS)

    Gilchrist, Brian; Curtis, Leslie (Technical Monitor)

    2001-01-01

    This document describes the Langmuir Probe Spacecraft Potential (LPSP) investigation of the plasma environment in the vicinity of the ProSEDS Delta II spacecraft. This investigation will employ a group of three (3) Langmuir Probe Assemblies, LPAs, mounted on the Delta II second stage to measure the electron density and temperature (n(sub e) and T(sub e)), the ion density (n(sub i)), and the spacecraft potential (V(sub s)) relative to the surrounding ionospheric plasma. This document is also intended to define the technical requirements and flight-vehicle installation interfaces for the design, development, assembly, testing, qualification, and operation of the LPSP subsystem for the Propulsive Small Expendable Deployer System (ProSEDS) and its associated Ground Support Equipment (GSE). This document also defines the interfaces between the LPSP instrument and the ProSEDS Delta II spacecraft, as well as the design, fabrication, operation, and other requirements established to meet the mission objectives. The LPSP is the primary measurement instrument designed to characterize the background plasma environment and is a supporting instrument for measuring spacecraft potential of the Delta II vehicle used for the ProSEDS mission. Specifically, the LPSP will use the three LPAs equally spaced around the Delta II body to make measurements of the ambient ionospheric plasma during passive operations to aid in validating existing models of electrodynamic-tether propulsion. These same probes will also be used to measure Delta II spacecraft potential when active operations occur. When the electron emitting plasma contractor is on, dense neutral plasma is emitted. Effective operation of the plasma contactor (PC) will mean a low potential difference between the Delta II second stage and the surrounding plasma and represents one of the voltage parameters needed to fully characterize the electrodynamic-tether closed circuit. Given that the LP already needs to be well away from any near-field disturbances around the Delta II, it is possible to use the same probe with a simple reconfiguration of the electronics to measure potential with respect to the ambient plasma. The LP measurement techniques are outlined in the following text and discussed in detail in the Appendix. The scientific goals of the investigation, the physical and electrical characteristics of the instrument, and the on-orbit measurement requirements are also discussed in this document.

  20. Efficiency of the Self Adjusting File, WaveOne, Reciproc, ProTaper and hand files in root canal debridement.

    PubMed

    Topcu, K Meltem; Karatas, Ertugrul; Ozsu, Damla; Ersoy, Ibrahim

    2014-07-01

    The aim of this study was to compare the canal debridement capabilities of three single file systems, ProTaper, and K-files in oval-shaped canals. Seventy-five extracted human mandibular central incisors with oval-shaped root canals were selected. A radiopaque contrast medium (Metapex; Meta Biomed Co. Ltd., Chungcheongbuk-do, Korea) was introduced into the canal systems and the self-adjusting file (SAF), WaveOne, Reciproc, ProTaper, and K-files were used for the instrumentation of the canals. The percentage of removed contrast medium was calculated using pre- and post-operative radiographs. An overall comparison between the groups revealed that the hand file (HF) and SAF groups presented the lowest percentage of removed contrast medium, whereas the WaveOne group showed the highest percentage (P < 0.001). The ProTaper group removed more contrast medium than the SAF and HF groups (P < 0.05). None of the instruments was able to remove the contrast medium completely. WaveOne performed significantly better than other groups.

  1. Efficiency of the Self Adjusting File, WaveOne, Reciproc, ProTaper and hand files in root canal debridement

    PubMed Central

    Topcu, K. Meltem; Karatas, Ertugrul; Ozsu, Damla; Ersoy, Ibrahim

    2014-01-01

    Objectives: The aim of this study was to compare the canal debridement capabilities of three single file systems, ProTaper, and K-files in oval-shaped canals. Materials and Methods: Seventy-five extracted human mandibular central incisors with oval-shaped root canals were selected. A radiopaque contrast medium (Metapex; Meta Biomed Co. Ltd., Chungcheongbuk-do, Korea) was introduced into the canal systems and the self-adjusting file (SAF), WaveOne, Reciproc, ProTaper, and K-files were used for the instrumentation of the canals. The percentage of removed contrast medium was calculated using pre- and post-operative radiographs. Results: An overall comparison between the groups revealed that the hand file (HF) and SAF groups presented the lowest percentage of removed contrast medium, whereas the WaveOne group showed the highest percentage (P < 0.001). The ProTaper group removed more contrast medium than the SAF and HF groups (P < 0.05). Conclusions: None of the instruments was able to remove the contrast medium completely. WaveOne performed significantly better than other groups. PMID:25202211

  2. Vertical force and torque analysis during mechanical preparation of extracted teeth using hand ProTaper instruments.

    PubMed

    Glavičić, Snježana; Anić, Ivica; Braut, Alen; Miletić, Ivana; Borčić, Josipa

    2011-08-01

    The purpose was to measure and analyse the vertical force and torque developed in the wider and narrower root canals during hand ProTaper instrumentation. Twenty human incisors were divided in two groups. Upper incisors were experimental model for the wide, while the lower incisors for the narrow root canals. Measurements of the force and torque were done by a device constructed for this purpose. Differences between the groups were statistically analysed by Mann-Whitney U-test with the significance level set to P<0.05. Vertical force in the upper incisors ranged 0.25-2.58 N, while in the lower incisors 0.38-6.94 N. Measured torque in the upper incisors ranged 0.53-12.03 Nmm, while in the lower incisor ranged 0.94-10.0 Nmm. Vertical force and torque were higher in the root canals of smaller diameter. The increase in the contact surface results in increase of the vertical force and torque as well in both narrower and wider root canals. © 2010 The Authors. Australian Endodontic Journal © 2010 Australian Society of Endodontology.

  3. Dentine chips produced by nickel-titanium rotary instruments.

    PubMed

    Guppy, D R; Curtis, R V; Ford, T R

    2000-12-01

    This study aimed to compare the cross-sectional shape of two nickel-titanium rotary instruments, namely ProFile and Quantec files, both ISO 25, 0.06 taper, and sought to relate this to the chips produced by cutting dentine. A limited comparison was made with stainless steel engine reamers. First, five files of each type were sectioned transversely at 12 mm, 8 mm and 4 mm from the tip and examined by scanning electron microscopy. The cutting angles were assessed by a direct measurement technique which allowed for the inclination of a cutting edge to the root canal. Second, eight samples of cutting debris were collected from instrumentation by each type of nickel-titanium file and four samples from the engine reamers. The major and minor axis, area and roundness of the dentine chips in each sample were measured using computerized particle analysis. The results demonstrated that all files had a negative cutting angle which varied at the different levels (ProFiles range 69.4 degrees to 58.4 degrees and Quantec range 74.8 degrees to 56.8 degrees). The consistency within files of the same type was good as demonstrated by low standard deviations, except for Quantec files at the 4 mm level where higher standard deviations of 4.1 degrees and 5.5 degrees for the two blades were found. The chip analysis showed significant differences between chips produced by ProFile and Quantec files (P < 0.05). The latter were larger and rounder. The chips from the ProFile and the engine reamer chips were similar in dimension (P > 0.05). No simple relationship existed between file geometry and the dentine chips produced during instrumentation.

  4. A Comparison of Apical Bacterial Extrusion in Manual, ProTaper Rotary, and One Shape Rotary Instrumentation Techniques.

    PubMed

    Mittal, Rakesh; Singla, Meenu G; Garg, Ashima; Dhawan, Anu

    2015-12-01

    Apical extrusion of irrigants and debris is an inherent limitation associated with cleaning and shaping of root canals and has been studied extensively because of its clinical relevance as a cause of flare-ups. Many factors affect the amount of extruded intracanal materials. The purpose of this study was to assess the bacterial extrusion by using manual, multiple-file continuous rotary system (ProTaper) and single-file continuous rotary system (One Shape). Forty-two human mandibular premolars were inoculated with Enterococcus faecalis by using a bacterial extrusion model. The teeth were divided into 3 experimental groups (n = 12) and 1 control group (n = 6). The root canals of experimental groups were instrumented according to the manufacturers' instructions by using manual technique, ProTaper rotary system, or One Shape rotary system. Sterilized saline was used as an irrigant, and bacterial extrusion was quantified as colony-forming units/milliliter. The results obtained were statistically analyzed by using one-way analysis of variance for intergroup comparison and post hoc Tukey test for pair-wise comparison. The level for accepting statistical significance was set at P < .05. All the instrumentation techniques resulted in bacterial extrusion, with manual step-back technique exhibiting significantly more bacterial extrusion than the engine-driven systems. Of the 2 engine-driven systems, ProTaper rotary extruded significantly more bacteria than One Shape rotary system (P < .05). The engine-driven nickel-titanium systems were associated with less apical extrusion. The instrument design may play a role in amount of extrusion. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  5. Development of Hazards Classification Data on Propellants and Explosives

    DTIC Science & Technology

    1978-11-01

    scattering photometer. A near forward, dark field instrument called a Sinclair-Phoenix photometer is common- ly used for measuring a wide range of...hazardä classification pro- cedure for in-process materials, and 5) Experimental evaluation of selected small-scale tests for application in the hazards...responsible for the experimental por- tion of this work. In addition to the authors, other IITRI personnel who contributed to this program were R

  6. Development of a frequent heartburn index.

    PubMed

    Stull, Donald E; van Hanswijck de Jonge, Patricia; Houghton, Katherine; Kocun, Christopher; Sandor, David W

    2011-09-01

    The aim of this study is to develop and validate a brief instrument for the measurement of overall psychosocial impact of frequent heartburn (heartburn experienced 2+ times weekly) in the general U.S. population, yielding a single, composite score. Item reduction and psychometric analyses of an existing Frequent Heartburn (FHB) Survey, a 52-item, 13-domain, patient-reported outcomes (PRO) survey assessing the impact of frequent heartburn on psychosocial quality of life. Item reduction resulted in 9 items from the original FHB Survey measuring all domains. All retained items in this full Frequent Heartburn Index (FHBI-Full) had moderate to strong factor loadings on the underlying factor (range: 0.66-0.85) and acceptable overall model fit (CFI = 0.93, SRMR = 0.04). Coefficient alpha was 0.92. A shorter FHBI (FHBI-Brief) was created that excludes the two employment-related items. The FHBI-Brief had a coefficient alpha of 0.90. Both FHBI versions have good psychometric properties and capture a full range of psychosocial effects of frequent heartburn. Normed national scores for the FHBI are available against which an individual can compare their own FHBI score. The FHBI-Full and FHBI-Brief show promise as PRO instruments that may help individuals and clinicians better understand the effect of frequent heartburn on psychosocial functioning.

  7. Evidence for Reduced Fatigue Resistance of Contemporary Rotary Instruments Exposed to Body Temperature.

    PubMed

    de Vasconcelos, Rafaela Andrade; Murphy, Sarah; Carvalho, Claudio Antonio Talge; Govindjee, Rajiv G; Govindjee, Sanjay; Peters, Ove A

    2016-05-01

    The purpose of this study was to evaluate the effect of 2 different temperatures (20°C and 37°C) on the cyclic fatigue life of rotary instruments and correlate the results with martensitic transformation temperatures. Contemporary nickel-titanium rotary instruments (n = 20 each and tip size #25, including Hyflex CM [Coltene, Cuyahoga Falls, OH], TRUShape [Dentsply Tulsa Dental Specialties, Tulsa, OK], Vortex Blue [Dentsply Tulsa Dental Specialties], and ProTaper Universal [Dentsply Tulsa Dental Specialties]) were tested for cyclic fatigue at room temperature (20°C ± 1°C) and at body temperature (37°C ± 1°C). Instruments were rotated until fracture occurred in a simulated canal with an angle curvature of about 60° and a radius curvature of 3 mm; the center of the curvature was 4.5 mm from the instrument tip. The number of cycles to fracture was measured. Phase transformation temperatures for 2 instruments of each brand were analyzed by differential scanning calorimetry. Data were analyzed using the t test and 1-way analysis of variance with the significance level set at 0.05. For the tested size and at 20°C, Hyflex CM showed the highest resistance to fracture; no significant difference was found between TRUShape and Vortex Blue, whereas ProTaper Universal showed the lowest resistance to fracture. At 37°C, resistance to fatigue fracture was significantly reduced, up to 85%, for the tested instruments (P < .001); at that temperature, Hyflex CM and Vortex Blue had similar and higher fatigue resistance compared with TRUShape and ProTaper Universal. Under the conditions of this study, using a novel testing design, immersion in water at simulated body temperature was associated with a marked decrease in the fatigue life of all rotary instruments tested. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  8. A comparative evaluation of efficacy of protaper universal rotary retreatment system for gutta-percha removal with or without a solvent.

    PubMed

    Kumar, M Sita Ram; Sajjan, Girija S; Satish, Kalyan; Varma, K Madhu

    2012-09-01

    The aim was to evaluate and compare the efficacy of ProTaper Universal rotary retreatment system with or without solvent and stainless steel hand files for endodontic filling removal from root canals and also to compare retreatment time for each system. Thirty extracted mandibular premolars with single straight canals were endodontically treated. Teeth were divided into three major groups, having 10 specimens each. Removal of obturating material in group 1 by stainless steel hand files with RC Solve, group 2 by ProTaper Universal retreatment instruments and group 3 by ProTaper Universal retreatment instruments along with RC solve was done. Retreatment was considered complete for all groups when no filling material was observed on the instruments. The retreatment time was recorded for each tooth. All specimens were grooved longitudinally in a buccolingual direction. The split halves were examined under a stereomicroscope and images were captured and analyzed. The remaining filling debris area ratios were considered for statistical analysis. With ANOVA test, statistical analysis showed that there was statistically no significant difference regarding the amount of filling remnants between the groups (P < 0.05). Differences between the means of groups are statistically significant regarding the retreatment time. Irrespective of the technique used, all the specimens had some remnants on the root canal wall. ProTaper Universal retreatment system files alone proved to be faster than the other experimental groups.

  9. Dynamic Torsional and Cyclic Fracture Behavior of ProFile Rotary Instruments at Continuous or Reciprocating Rotation as Visualized with High-speed Digital Video Imaging.

    PubMed

    Tokita, Daisuke; Ebihara, Arata; Miyara, Kana; Okiji, Takashi

    2017-08-01

    This study examined the dynamic fracture behavior of nickel-titanium rotary instruments in torsional or cyclic loading at continuous or reciprocating rotation by means of high-speed digital video imaging. The ProFile instruments (size 30, 0.06 taper; Dentsply Maillefer, Ballaigues, Switzerland) were categorized into 4 groups (n = 7 in each group) as follows: torsional/continuous (TC), torsional/reciprocating (TR), cyclic/continuous (CC), and cyclic/reciprocating (CR). Torsional loading was performed by rotating the instruments by holding the tip with a vise. For cyclic loading, a custom-made device with a 38° curvature was used. Dynamic fracture behavior was observed with a high-speed camera. The time to fracture was recorded, and the fractured surface was examined with scanning electron microscopy. The TC group initially exhibited necking of the file followed by the development of an initial crack line. The TR group demonstrated opening and closing of a crack according to its rotation in the cutting and noncutting directions, respectively. The CC group separated without any detectable signs of deformation. In the CR group, initial crack formation was recognized in 5 of 7 samples. The reciprocating rotation exhibited a longer time to fracture in both torsional and cyclic fatigue testing (P < .05). The scanning electron microscopic images showed a severely deformed surface in the TR group. The dynamic fracture behavior of NiTi rotary instruments, as visualized with high-speed digital video imaging, varied between the different modes of rotation and different fatigue testing. Reciprocating rotation induced a slower crack propagation and conferred higher fatigue resistance than continuous rotation in both torsional and cyclic loads. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  10. Cleaning Effectiveness of a Reciprocating Single-file and a Conventional Rotary Instrumentation System.

    PubMed

    de Carvalho, Fredson Marcio Acris; Gonçalves, Leonardo Cantanhede de Oliveira; Marques, André Augusto Franco; Alves, Vanessa; Bueno, Carlos Eduardo da Silveira; De Martin, Alexandre Sigrist

    2016-01-01

    To compare cleaning effectiveness by histological analysis of a reciprocating single-file system with ProTaper rotary instruments during the preparation of curved root canals in extracted teeth. A total of 40 root canals with curvatures ranging between 20 - 40 degrees were divided into two groups of 20 canals. Canals were prepared to the following apical sizes: Reciproc size 25 (n=20); ProTaper: F2 (n=20). The normal distribution of data was tested by the Kolmogorov-Smirnov test and the values obtained for the test (Mann-Whitney U test, P < .05) were statistically analyzed using the GraphPad InStat for the Mac OS software (GraphPad Software, La Jolla, CA, USA). There were no significant differences in remaining debris (P > .05) between the two groups. The application of reciprocating motion during instrumentation did not result in increased debris when compared with continuous rotation motion, even in the apical part of curved canals. Both instruments resulted in debris in the canal lumen, irrespective of the movement kinematics applied.

  11. Influence of rotational speed, torque and operator's proficiency on ProFile failures.

    PubMed

    Yared, G M; Bou Dagher, F E; Machtou, P

    2001-01-01

    The purpose of this study was to evaluate the influence of rotational speed, torque, and operator experience with a specific Ni-Ti rotary instrumentation technique on the incidence of locking, deformation and separation of instruments. ProFile Ni-Ti rotary instruments (PRI) sizes 40-15 with a 6% taper were used in a crown-down technique. In one group of canals (n = 300) speeds of 150, 250 and 350 rpm (subgroups 1, 2 and 3) were used. Each one of the subgroups included 100 canals. In a second group (n = 300) torque was set at 20, 30 and 55 Ncm (subgroups 4, 5 and 6). In the third group (n = 300) three operators with varying experience (subgroups 7, 8 and 9) were also compared. Each subgroup included the use of 10 sets of PRI and 100 canals of extracted human molars. Each set of PRI was used in up to 10 canals and then sterilized before each case. NaOCl 2.5% was used as an irrigant. The number of locked, deformed, and separated instruments for the different groups, and within each part of the study was analysed statistically for significance with chi-squared tests. In group 1 only one instrument was deformed in the 150-rpm group and no instruments separated or locked. In the 250-rpm group instrument separation did not occur, however, a high incidence of locking, deformation and separation was noted in the 350-rpm group. In general, instrument sizes 30-15 locked, deformed and separated. Chi-squared statistics showed a significant difference between the 150 and 350 rpm groups but no difference between the 150 and 250 rpm groups with regard to instrument separation. Overall, there was a trend toward a higher incidence of instrument deformation and separation in smaller instruments. Locking and separation occurred during the final passage of the instruments, in the last (tenth) canal in each subgroup. In the second group, neither separation nor deformation and locking occurred during the use of the ProFile instruments, at 150 rpm, and at the different torque values. In the third group, chi-squared analysis demonstrated that significantly more instruments separated with the least experienced operator. Instrument locking, deformation, and separation did not occur with the most experienced operator. Preclinical training in the use of the PRI technique with crown-down at 150 rpm were crucial in avoiding instrument separation and reducing the incidence of instrument locking and deformation.

  12. A promising method for identifying cross-cultural differences in patient perspective: the use of Internet-based focus groups for content validation of new Patient Reported Outcome assessments

    PubMed Central

    Atkinson, Mark J; Lohs, Jan; Kuhagen, Ilka; Kaufman, Julie; Bhaidani, Shamsu

    2006-01-01

    Objectives This proof of concept (POC) study was designed to evaluate the use of an Internet-based bulletin board technology to aid parallel cross-cultural development of thematic content for a new set of patient-reported outcome measures (PROs). Methods The POC study, conducted in Germany and the United States, utilized Internet Focus Groups (IFGs) to assure the validity of new PRO items across the two cultures – all items were designed to assess the impact of excess facial oil on individuals' lives. The on-line IFG activities were modeled after traditional face-to-face focus groups and organized by a common 'Topic' Guide designed with input from thought leaders in dermatology and health outcomes research. The two sets of IFGs were professionally moderated in the native language of each country. IFG moderators coded the thematic content of transcripts, and a frequency analysis of code endorsement was used to identify areas of content similarity and difference between the two countries. Based on this information, draft PRO items were designed and a majority (80%) of the original participants returned to rate the relative importance of the newly designed questions. Findings The use of parallel cross-cultural content analysis of IFG transcripts permitted identification of the major content themes in each country as well as exploration of the possible reasons for any observed differences between the countries. Results from coded frequency counts and transcript reviews informed the design and wording of the test questions for the future PRO instrument(s). Subsequent ratings of item importance also deepened our understanding of potential areas of cross-cultural difference, differences that would be explored over the course of future validation studies involving these PROs. Conclusion The use of IFGs for cross-cultural content development received positive reviews from participants and was found to be both cost and time effective. The novel thematic coding methodology provided an empirical platform on which to develop culturally sensitive questionnaire content using the natural language of participants. Overall, the IFG responses and thematic analyses provided a thorough evaluation of similarities and differences in cross-cultural themes, which in turn acted as a sound base for the development of new PRO questionnaires. PMID:16995935

  13. A promising method for identifying cross-cultural differences in patient perspective: the use of Internet-based focus groups for content validation of new patient reported outcome assessments.

    PubMed

    Atkinson, Mark J; Lohs, Jan; Kuhagen, Ilka; Kaufman, Julie; Bhaidani, Shamsu

    2006-09-22

    This proof of concept (POC) study was designed to evaluate the use of an Internet-based bulletin board technology to aid parallel cross-cultural development of thematic content for a new set of patient-reported outcome measures (PROs). The POC study, conducted in Germany and the United States, utilized Internet Focus Groups (IFGs) to assure the validity of new PRO items across the two cultures--all items were designed to assess the impact of excess facial oil on individuals' lives. The on-line IFG activities were modeled after traditional face-to-face focus groups and organized by a common 'Topic' Guide designed with input from thought leaders in dermatology and health outcomes research. The two sets of IFGs were professionally moderated in the native language of each country. IFG moderators coded the thematic content of transcripts, and a frequency analysis of code endorsement was used to identify areas of content similarity and difference between the two countries. Based on this information, draft PRO items were designed and a majority (80%) of the original participants returned to rate the relative importance of the newly designed questions. The use of parallel cross-cultural content analysis of IFG transcripts permitted identification of the major content themes in each country as well as exploration of the possible reasons for any observed differences between the countries. Results from coded frequency counts and transcript reviews informed the design and wording of the test questions for the future PRO instrument(s). Subsequent ratings of item importance also deepened our understanding of potential areas of cross-cultural difference, differences that would be explored over the course of future validation studies involving these PROs. The use of IFGs for cross-cultural content development received positive reviews from participants and was found to be both cost and time effective. The novel thematic coding methodology provided an empirical platform on which to develop culturally sensitive questionnaire content using the natural language of participants. Overall, the IFG responses and thematic analyses provided a thorough evaluation of similarities and differences in cross-cultural themes, which in turn acted as a sound base for the development of new PRO questionnaires.

  14. ALiEM Blog and Podcast Watch: Toxicology.

    PubMed

    Zaver, Fareen; Craddick, Michael; Sanford, Audrey; Sefa, Nana; Hughes, George; Lin, Michelle

    2017-10-01

    The WestJEM Blog and Podcast Watch presents high-quality open-access educational blogs and podcasts in emergency medicine based on the ongoing Academic Life in Emergency Medicine (ALiEM) Approved Instructional Resources (AIR) and AIR-Professional (Pro) series. Both series critically appraise open-access educational blogs and podcasts in EM using an objective scoring instrument. This installment of the blog and podcast watch series curated and scored relevant posts in the specific topic of toxicology emergencies from the AIR-Pro Series. The AIR-Pro Series is a continuously building curriculum covering a new subject area every two months. For each area, eight EM chief residents identify 3-5 advanced clinical questions. Using FOAMsearch.net and FOAMSearcher to search blogs and podcasts, relevant posts are scored by eight reviewers from the AIR-Pro editorial board, which is comprised of EM faculty and chief residents at various institutions across North America. The scoring instrument contains five measurement outcomes based on seven-point Likert scales: recency, accuracy, educational utility, evidence based, and references. The AIR-Pro label is awarded to posts with a score of ≥28 (out of 35) points. An "honorable mention" label is awarded if board members collectively felt that the blogs were valuable and the scores were > 25. A total of 31 blog posts and podcasts were included. Key educational pearls from the six high-quality AIR-Pro posts and four honorable mentions are summarized. The WestJEM ALiEM Blog and Podcast Watch series is based on the AIR and AIR-Pro Series, which attempts to identify high-quality educational content on open-access blogs and podcasts. This series provides an expert-based, crowdsourced approach towards critically appraising educational social media content for EM clinicians. This installment focuses on toxicology emergencies.

  15. ALiEM Blog and Podcast Watch: Toxicology

    PubMed Central

    Zaver, Fareen; Craddick, Michael; Sanford, Audrey; Sefa, Nana; Hughes, George; Lin, Michelle

    2017-01-01

    Introduction The WestJEM Blog and Podcast Watch presents high-quality open-access educational blogs and podcasts in emergency medicine based on the ongoing Academic Life in Emergency Medicine (ALiEM) Approved Instructional Resources (AIR) and AIR-Professional (Pro) series. Both series critically appraise open-access educational blogs and podcasts in EM using an objective scoring instrument. This installment of the blog and podcast watch series curated and scored relevant posts in the specific topic of toxicology emergencies from the AIR-Pro Series. Methods The AIR-Pro Series is a continuously building curriculum covering a new subject area every two months. For each area, eight EM chief residents identify 3–5 advanced clinical questions. Using FOAMsearch.net and FOAMSearcher to search blogs and podcasts, relevant posts are scored by eight reviewers from the AIR-Pro editorial board, which is comprised of EM faculty and chief residents at various institutions across North America. The scoring instrument contains five measurement outcomes based on seven-point Likert scales: recency, accuracy, educational utility, evidence based, and references. The AIR-Pro label is awarded to posts with a score of ≥28 (out of 35) points. An “honorable mention” label is awarded if board members collectively felt that the blogs were valuable and the scores were > 25. Results A total of 31 blog posts and podcasts were included. Key educational pearls from the six high-quality AIR-Pro posts and four honorable mentions are summarized. Conclusion The WestJEM ALiEM Blog and Podcast Watch series is based on the AIR and AIR-Pro Series, which attempts to identify high-quality educational content on open-access blogs and podcasts. This series provides an expert-based, crowdsourced approach towards critically appraising educational social media content for EM clinicians. This installment focuses on toxicology emergencies. PMID:29085545

  16. The development of a clinical outcomes survey research application: Assessment Center.

    PubMed

    Gershon, Richard; Rothrock, Nan E; Hanrahan, Rachel T; Jansky, Liz J; Harniss, Mark; Riley, William

    2010-06-01

    The National Institutes of Health sponsored Patient-Reported Outcome Measurement Information System (PROMIS) aimed to create item banks and computerized adaptive tests (CATs) across multiple domains for individuals with a range of chronic diseases. Web-based software was created to enable a researcher to create study-specific Websites that could administer PROMIS CATs and other instruments to research participants or clinical samples. This paper outlines the process used to develop a user-friendly, free, Web-based resource (Assessment Center) for storage, retrieval, organization, sharing, and administration of patient-reported outcomes (PRO) instruments. Joint Application Design (JAD) sessions were conducted with representatives from numerous institutions in order to supply a general wish list of features. Use Cases were then written to ensure that end user expectations matched programmer specifications. Program development included daily programmer "scrum" sessions, weekly Usability Acceptability Testing (UAT) and continuous Quality Assurance (QA) activities pre- and post-release. Assessment Center includes features that promote instrument development including item histories, data management, and storage of statistical analysis results. This case study of software development highlights the collection and incorporation of user input throughout the development process. Potential future applications of Assessment Center in clinical research are discussed.

  17. Convergent Validity with the BERS-2 Teacher Rating Scale and the Achenbach Teacher's Report Form: A Replication and Extension

    ERIC Educational Resources Information Center

    Benner, Gregory J.; Beaudoin, Kathleen; Mooney, Paul; Uhing, Brad M.; Pierce, Corey D.

    2008-01-01

    In the present study, we sought to extend instrument validation research for a strength-based emotional and behavior rating scale, the "Teacher Rating Scale of the Behavior and Emotional Rating Scale-Second Edition" (BERS-2; Epstein, M. H. (2004). "Behavioral and emotional rating scale" (2nd ed.). Austin, TX: PRO-ED) through…

  18. Influence of Operator's Experience on the Shaping Ability of Protaper Universal and Waveone Systems: A Comparative Study on Simulated Root Canals.

    PubMed

    Troiano, Giuseppe; Dioguardi, Mario; Cocco, Armando; Giannatempo, Giovanni; Laino, Luigi; Ciavarella, Domenico; Berutti, Elio; Lo Muzio, Lorenzo

    2016-01-01

    To assess the influence of operator experience on: shaping and centering ability, mean preparation time and presence of canal aberrations of ProTaper Universal and WaveOne systems on simulated root canals. Sixty S-shaped canals in resin blocks were assigned to four groups (n=15 for each group). Group1 (Experienced operator, ProTaper), Group2 (Experienced operator, WaveOne), Group3 (Inexperienced operator, ProTaper), Group4 (Inexperienced operator, WaveOne). Photographic method was used to record pre- and post-instrumentations images. After superimposition, it has been evaluated presence of canal aberrations and differences in shaping and centering ability between groups. WaveOne system produced a lower amount of canal aberrations both in the hand of expert than inexpert operators. However, a WaveOne instrument breakage occurred in the hands of an inexperienced operator. No differences have been found in the evaluation of shaping ability with both systematics. Operator's experience doesn't influence the shaping ability of ProTaper and WaveOne systems. Experience factor could influence the centering ability in the use of both the systematics. However, WaveOne Primary reduce the mean preparation time and the presence of canal aberrations.

  19. Comparative evaluation of apically extruded debris with V-Taper, ProTaper Next, and the Self-adjusting File systems.

    PubMed

    Vyavahare, Nishant K; Raghavendra, Srinidhi Surya; Desai, Niranjan N

    2016-01-01

    Complete cleaning of the root canal is the goal for ensuring success in endodontics. Removal of debris plays an important role in achieving this goal. In spite of advancements in instrument design, apical extrusion of debris remains a source of inflammation in the periradicular region. To comparatively evaluate the amount of apically extruded debris with V-Taper, ProTaper Next, and the self-adjusting File (SAF) system. Sixty-four extracted human mandibular teeth with straight root canals were taken. Access openings were done and working length determined. The samples were randomly divided into three groups: Group I - V-Taper files (n = 20), Group II - ProTaper Next (n = 20), Group III - SAF (n = 20). Biomechanical preparation was completed and the debris collected in vials to be quantitatively determined. The data obtained was statistically analyzed using ANOVA and post hoc Tukey's test. All the specimens showed apical debris extrusion. SAF showed significantly less debris extrusion compared to V-Taper and ProTaper Next (P < 0.001). Among Groups I and II, ProTaper Next showed lesser debris extrusion as compared to V-Taper, but it was not significant (P = 0.124). The SAF showed least amount of apical debris extrusion when compared to newer rotary endodontic instruments. This indicates that the incidence of inter-treatment flare-ups due to debris extrusion would be less with the SAF.

  20. Cyclic fatigue of endodontic nickel titanium rotary instruments: static and dynamic tests.

    PubMed

    Li, Uei-Ming; Lee, Bor-Shiunn; Shih, Chin-Tsai; Lan, Wan-Hong; Lin, Chun-Pin

    2002-06-01

    Endodontic instruments upon rotation are subjected to both tensile and compressive stress in curved canals. This stress is localized at the point of curvature. The purpose of this study was to evaluate the cyclic fatigue of 0.04 ProFile nickel titanium rotary instruments operating at different rotational speeds and varied distances of pecking motion in metal blocks that simulated curved canals. A total of 150 ProFile instruments were made to rotate freely in sloped metal blocks at speeds of 200, 300, or 400 rpm by a contra-angle handpiece mounted on an Instron machine. The electric motor and Instron machine were activated until the instruments were broken in two different modes, static and dynamic pecking-motion. The fractured surfaces of separated instruments were examined under a scanning electron microscope. All data obtained were analyzed by a stepwise multiple regression method using a 95% confidence interval. The results demonstrated that the time to failure significantly decreased as the angles of curvature or the rotational speeds increased. However, as pecking distances increased, the time to failure increased. This is because a longer pecking distance gives the instrument a longer time interval before it once again passes through the highest stress area. Microscopic evaluation indicated that ductile fracture was the major cyclic failure mode. To prevent breakage of a NiTi rotary instrument, appropriate rotational speeds and continuous pecking motion in the root canals are recommended.

  1. WEAR PROMOTED IN THE APICAL THIRD OF SIMULATED CANALS AFTER INSTRUMENTATION WITH PROTAPER UNIVERSAL SYSTEM

    PubMed Central

    da Silva, Kathrein Tapia; Grazziotin-Soares, Renata; Limongi, Orlando; Irala, Luis Eduardo Duarte; Salles, Alexandre Azevedo

    2009-01-01

    Objective: This study evaluated the wear in the apical third of simulate canals after preparation with ProTaper Universal Rotary System. Material and Methods: 24 sets of instruments were used in 24 simulated canals in transparent epoxy resin blocks with degree of curvature of either 20°or 40°. The canals were photographed preoperatively and after preparation of the apical stop with ProTaper F3, F4 and F5 instruments. The initial and final images were exported to Adobe Photoshop® software and superimposed to detect the root canal wall differences (in mm) between them, in two points located 1 (A) and 5 (B) mm from the point where the working length was established. Data were subjected to analysis of variance to verify the existence of interaction among the factors: canal curvature, instrument size and curve location. Significant level was set at 5%. Results: Regardless of the location and the canal curvature, F4 and F5 instruments produced the greatest wear (p<0.05). Conclusions: There was a deviation from the original pathway towards the outside of the root curvature in both analyzed points. All instruments produced canal transportation, but the F4 and F5 instruments produced more than the other instruments, and should thus be used with care in curved canals. PMID:19936533

  2. Analysis of mechanical preparations in extracted teeth using ProTaper rotary instruments: value of the safety quotient.

    PubMed

    Blum, J Y; Machtou, P; Ruddle, C; Micallef, J P

    2003-09-01

    The purpose of this study was to apply the Endographe to analyze the vertical forces and torque developed during mechanical preparations in extracted teeth. The data collected in this study may be used to calculate the safety quotient (SQ) as proposed by J.T. McSpadden. The SQ formula is defined as the torque required to break a file at D3 divided by the mean working torque required to cut dentin. The Endographe is a unique force-analyzer device equipped to measure, record, and generate graphs of the vertical forces and torque exerted during root canal preparation. All preparations were performed by endodontists in roots with narrow, more restrictive canals, larger, more open canals, or in roots sectioned in two halves. All canals, including the sectioned canals, were prepared with ProTaper files in accordance with the manufacturer's guidelines for use. For narrow canals, the mean values of the generated vertical forces (g) and torque (g.cm) varied from 80 (+/- 20) g (SX) to 232 (+/- 60) g (F2) and from 80 (+/- 24) g x cm (F1) to 150 (+/- 45) g x cm (S2), respectively. For large canals, the mean values of the generated vertical forces (g) and torque (g x cm) varied from 80 (+/- 20) g (SX) to 340 (+/- 20) g (F1) and from 31 (+/- 9) g x cm (S2) to 96 (+/- 35) g x cm (SX), respectively. The SQ varied from 0.93 to 7.95 for narrow canals and from 1.58 to 14.50 for large canals. The SQ is intended to provide values that can be analyzed to predict whether a rotary file will have a tendency to break or will work safely during clinical use. However, if the formula is going to provide useful information, it must index the "rotation to failure torque" with the "mean working torque" at a specific location along the cutting blades of a file. Additionally, this mathematical formula does not account for factors such as the concentration of forces, the way the instruments are used, or the wear of the instruments. A precise protocol for canal preparation should emphasize using small flexible stainless steel hand files to create or verify that within any portion of a root canal there is sufficient space for rotary instruments to follow. When there is a confirmed smooth, reproducible glide path, then a "secured" space exists to safely guide the more flexible terminal extent of a rotary NiTi file. Endogrammes provide an innovative approach to the analysis of mechanical preparations and suggest that the ProTaper shaping files are best used with lateral forces to decrease the coronal screwing effect. The ProTaper finishing files should be used with slow penetration and be introduced only into canals that have a confirmed smooth and reproducible glide path. When any part of the overall length of a canal has been secured, then the number of instruments, the time spent utilizing each instrument, and the overall time progressing through a sequence of instruments to shape this region of the canal is reduced.

  3. Quantitative evaluation of apical extrusion of intracanal bacteria using rotary ProTaper, K3XF, twisted and hand K-file system: An ex vivo study.

    PubMed

    Ghogre, Priyanka; Chourasia, Hemant Ramesh; Agarwal, Manish; Singh, M P; Gurav, Sandeep; Ghogre, Rahul

    2015-01-01

    The aim of this study was to evaluate the number of intracanal bacteria extruded apically during root canal preparation using rotary ProTaper, K3XF, twisted, and hand K-file system. Seventy extracted single-rooted human mandibular premolar teeth were used. Access cavities were prepared and the teeth were mounted in glass vials. Root canals were then contaminated with a pure culture of Enterococcus faecalis (ATCC 29212) and incubated at 37°C for 24 h. The contaminated roots were divided into four experimental groups of 15 teeth each and one control group of 10 teeth. Group 1: ProTaper; Group 2: K3XF; Group 3: Twisted file; Group 4: Hand K-file; Group 5: Control group. Bacteria extruded from the apical foramen during instrumentation were collected into vials. The microbiological samples were incubated in culture media for 24 h. Colonies of bacteria were counted and the results were given as number of colony-forming units (CFU)/ml. The obtained data were analyzed using the Kruskal-Wallis one-way analysis of variance and Mann-Whitney U-tests. There was a significant difference between the rotary and hand instrumentation system related to the apically extruded intracanal bacteria. Both the rotary and hand instrumentation systems extruded intracanal bacteria through the apical foramen. K3XF file system showed least bacterial extrusion amongst all instrumentation groups.

  4. Ex vivo evaluation of various instrumentation techniques and irrigants in reducing E. faecalis within root canals.

    PubMed

    Basmaci, F; Oztan, M D; Kiyan, M

    2013-09-01

    To evaluate ex vivo the effectiveness of single-file instrumentation techniques compared with serial Ni-Ti rotary instrumentation with several irrigation regimens in reducing E. faecalis within root canals. A total of 81 extracted human mandibular premolar teeth with a single root canal were infected with E. faecalis before and after canal preparation. Samples were divided randomly into 9 groups, as follows: group 1-A: sterile phosphate-buffered saline + Self-adjusting file, group 1-B: 5% sodium hypochlorite + 15% EDTA + Self-adjusting file, group 1-C: 5% sodium hypochlorite + 7% maleic acid + Self-adjusting file, group 2-A: sterile phosphate-buffered saline + Reciproc (R25), group 2-B: 5% sodium hypochlorite + 15% EDTA + Reciproc (R25), group 2-C: 5% sodium hypochlorite + 7% maleic acid + Reciproc (R25), group 3-A: sterile phosphate-buffered saline + ProTaper, group 3-B: 5% sodium hypochlorite + 15% EDTA + ProTaper, group 3-C: 5% sodium hypochlorite + 7% maleic acid + ProTaper. anova was used to analyse statistically the differences in terms of reduction in colony counts between the groups, and Dunn's post hoc test was used for multiple comparisons. All techniques and irrigation regimens significantly reduced the number of bacterial cells in the root canal (P < 0.001). Comparisons amongst the groups revealed significant differences between group 1A (sterile phosphate-buffered saline + Self-adjusting file)/group 1B (5% sodium hypochlorite + 15% EDTA + Self-adjusting file) (P = 0.031), group 1A (sterile phosphate-buffered saline + Self-adjusting file)/group 2C (5% sodium hypochlorite + 7% maleic acid + Reciproc) (P = 0.003), group 2A (sterile phosphate-buffered saline + Reciproc)/group 3B (5% sodium hypochlorite + 15% EDTA + ProTaper) (P = 0.036), group 3B (5% sodium hypochlorite + 15% EDTA + ProTaper)/group 1A (sterile phosphate-buffered saline + Self-adjusting file) (P < 0.001), and group 3C (5% sodium hypochlorite + 7% maleic acid + ProTaper)/group 1A (sterile phosphate-buffered saline + Self-adjusting file) (P = 0.033). No significant differences in terms of reduction in microbial counts were observed between single-file techniques (SAF and Reciproc) and serial Ni-Ti instrumentation technique (ProTaper) in combination with irrigants. © 2013 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  5. Informative value of Patient Reported Outcomes (PRO) in Health Technology Assessment (HTA)

    PubMed Central

    Brettschneider, Christian; Lühmann, Dagmar; Raspe, Heiner

    2011-01-01

    Background “Patient-Reported Outcome” (PRO) is used as an umbrella term for different concepts for measuring subjectively perceived health status e. g. as treatment effects. Their common characteristic is, that the appraisal of the health status is reported by the patient himself. In order to describe the informative value of PRO in Health Technology Assessment (HTA) first an overview of concepts, classifications and methods of measurement is given. The overview is complemented by an empirical analysis of clinical trials and HTA-reports on rheumatoid arthritis and breast cancer in order to report on type, frequency and consequences of PRO used in these documents. Methods For both issues systematic reviews of the literature have been performed. The search for methodological literature covers the publication period from 1990 to 2009, the search for clinical trials of rheumatoid arthritis and breast cancer covers the period 2005 to 2009. Both searches were performed in the medical databases of the German Institute of Medical Documentation and Information (DIMDI). The search for HTA-reports and methodological papers of HTA-agencies was performed in the CRD-Databases (CRD = Centre for Reviews and Dissemination) and by handsearching the websites of INAHTA member agencies (INAHTA = International Network of Agencies for Health Technology Assessment). For all issues specific inclusion and exclusion criteria were defined. The methodological quality of randomized controlled trials (RCT) was assessed by a modified version of the Cochrane Risk of Bias Tool. For the methodological part information extraction from the literature is structured by the report’s chapters, for the empirical part data extraction sheets were constructed. All information is summarized in a qualitative manner. Results Concerning the methodological issues the literature search retrieved 158 documents (87 documents related to definition or classification, 125 documents related to operationalisation of PRO). For the empirical analyses 225 RCT (rheumatoid arthritis: 77; breast cancer: 148) and 40 HTA-reports and method papers were found. The analysis of the methodological literature confirms the role of PRO as an umbrella term for a variety of different concepts. The newest classification system facilitates the description of PRO measures by construct, target population and the method of measurement. Steps of operationalisation involve defining a conceptual framework, instrument development, exploration of measurement properties or, possibly, the modification of existing instruments. Seven out of 59 RCT analysing the effects of antibody therapy for rheumatoid arthritis define PRO as the primary endpoint, 38 trials utilize composite measures (ACR, DAS) and ten trials report clinical or radiological parameters as the primary endpoint. Six out of 123 chemotherapy trials for breast cancer define PRO as the primary endpoint, while 98 trials report clinical endpoints (survival, tumour response, progression) in their primary analyses. Discrepancies in the number of trials result from inaccurate specifications of endpoints in the publications. This distribution is reflected in the HTA-reports: while almost all reports on rheumatoid arthritis refer to PRO, this is only the case in about half of the reports on breast cancer. Conclusions As definition and classification of PRO are concerned, coherent concepts are found in the literature. Their operationalisation and implementation must be guided by scientific principles. The type and frequency of PRO used in clinical trials largely depend on the disease analysed. The HTA-community seems to pursue the utilization of PRO proactively – in case of missing data the need for further research is stated. PMID:21468289

  6. Informative value of Patient Reported Outcomes (PRO) in Health Technology Assessment (HTA).

    PubMed

    Brettschneider, Christian; Lühmann, Dagmar; Raspe, Heiner

    2011-02-02

    "Patient-Reported Outcome" (PRO) is used as an umbrella term for different concepts for measuring subjectively perceived health status e. g. as treatment effects. Their common characteristic is, that the appraisal of the health status is reported by the patient himself. In order to describe the informative value of PRO in Health Technology Assessment (HTA) first an overview of concepts, classifications and methods of measurement is given. The overview is complemented by an empirical analysis of clinical trials and HTA-reports on rheumatoid arthritis and breast cancer in order to report on type, frequency and consequences of PRO used in these documents. For both issues systematic reviews of the literature have been performed. The search for methodological literature covers the publication period from 1990 to 2009, the search for clinical trials of rheumatoid arthritis and breast cancer covers the period 2005 to 2009. Both searches were performed in the medical databases of the German Institute of Medical Documentation and Information (DIMDI). The search for HTA-reports and methodological papers of HTA-agencies was performed in the CRD-Databases (CRD = Centre for Reviews and Dissemination) and by handsearching the websites of INAHTA member agencies (INAHTA = International Network of Agencies for Health Technology Assessment). For all issues specific inclusion and exclusion criteria were defined. The methodological quality of randomized controlled trials (RCT) was assessed by a modified version of the Cochrane Risk of Bias Tool. For the methodological part information extraction from the literature is structured by the report's chapters, for the empirical part data extraction sheets were constructed. All information is summarized in a qualitative manner. Concerning the methodological issues the literature search retrieved 158 documents (87 documents related to definition or classification, 125 documents related to operationalisation of PRO). For the empirical analyses 225 RCT (rheumatoid arthritis: 77; breast cancer: 148) and 40 HTA-reports and method papers were found. The analysis of the methodological literature confirms the role of PRO as an umbrella term for a variety of different concepts. The newest classification system facilitates the description of PRO measures by construct, target population and the method of measurement. Steps of operationalisation involve defining a conceptual framework, instrument development, exploration of measurement properties or, possibly, the modification of existing instruments. Seven out of 59 RCT analysing the effects of antibody therapy for rheumatoid arthritis define PRO as the primary endpoint, 38 trials utilize composite measures (ACR, DAS) and ten trials report clinical or radiological parameters as the primary endpoint. Six out of 123 chemotherapy trials for breast cancer define PRO as the primary endpoint, while 98 trials report clinical endpoints (survival, tumour response, progression) in their primary analyses. Discrepancies in the number of trials result from inaccurate specifications of endpoints in the publications. This distribution is reflected in the HTA-reports: while almost all reports on rheumatoid arthritis refer to PRO, this is only the case in about half of the reports on breast cancer. As definition and classification of PRO are concerned, coherent concepts are found in the literature. Their operationalisation and implementation must be guided by scientific principles. The type and frequency of PRO used in clinical trials largely depend on the disease analysed. The HTA-community seems to pursue the utilization of PRO proactively - in case of missing data the need for further research is stated.

  7. Torsional resistance of XP-endo Shaper at body temperature compared with several nickel-titanium rotary instruments.

    PubMed

    Elnaghy, A M; Elsaka, S E

    2018-05-01

    To compare the torsional resistance of XP-endo Shaper (XPS; size 30, .01 taper, FKG Dentaire, La Chaux-de-Fonds, Switzerland) instruments at body temperature with TRUShape (TRS; size 30, .06 taper, Dentsply Tulsa Dental Specialties, Tulsa, OK, USA), ProFile Vortex (PV; size 30, .04 taper, Dentsply Tulsa Dental Specialties) and FlexMaster (FM; size 30, .04 taper, VDW GmbH, Munich, Germany) nickel-titanium rotary instruments. A metal block with a square-shaped mould (5 mm × 5 mm × 5 mm) was positioned inside a glass container. Five millimetres of the tip of each instrument was held inside the metal block by filling the mould with a resin composite. The instruments were tested for torsional resistance in saline solution at 37 °C. Data were analysed using one-way analysis of variance (anova) and Tukey post hoc tests. The significance level was set at P < 0.05. FM had the greatest torsional resistance amongst the instruments tested (P < 0.001). There was no significant difference between FM and PV instruments (P = 0.211). The ranking for torsional resistance values was: FM > PV > TRS > XPS. FlexMaster and ProFile Vortex instruments were more resistant to torsional stress compared with TRUShape and XP-endo Shaper instruments. The manufacturing process used to produce XP-endo Shaper instruments did not enhance their resistance to torsional stress as compared with the other instruments. © 2017 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  8. Comparison of the remaining dentin thickness in the root after hand and four rotary instrumentation techniques: an in vitro study.

    PubMed

    Rao, M S Rama; Shameem, Abdul; Nair, Rashmi; Ghanta, Sureshbabu; Thankachan, Rekha P; Issac, Johnson K

    2013-07-01

    The aim of the present study was to compare the remaining dental thickness (RDT) in the mesiobuccal root of mandibular first molars at 3 and 7 mm from the anatomic apex after instrumentation with ProTaper, light speed LSX, K3 and M2 and to compare with that of K-files. In this study, 60 extracted, untreated human mandibular first molars with fully formed apices, with curvature less than 35° and no root resorption were used. Prepared specimens were cut horizontally at 3 and 7 mm short of anatomic apex. The least dentin thickness from canal to external root surface was observed under 3× magnification and recorded using Clemax measuring tool and the sections were reassembled. Group I-instrumentation with ProTaper, group II-instrumentation with K3, group III-instrumentation with Light Speed LSX, group IV-instrumentation with M2 and group V- instrumentation with K-files and RDT was measured. Results showed that group V removed lesser amount of dentin compared to all other groups while all the three instrumentation techniques removed almost equal amount of dentin apically. Cleaning and shaping of the root canal space involves the elimination of pathogenic contents as well as attaining a uniform specific shape. However, the RDT following the use of various intraradicular procedures is an important factor to be considered as an iatrogenic cause that may result in root fracture. To avoid this, newer rotary instruments are being introduced.

  9. Influence of rotational speed on the cyclic fatigue of rotary nickel-titanium endodontic instruments.

    PubMed

    Lopes, Hélio P; Ferreira, Alessandra A P; Elias, Carlos N; Moreira, Edson J L; de Oliveira, Júlio C Machado; Siqueira, José F

    2009-07-01

    During the preparation of curved canals, rotary nickel-titanium (NiTi) instruments are subjected to cyclic fatigue, which can lead to instrument fracture. Although several factors may influence the cyclic fatigue resistance of instruments, the role of the rotational speed remains uncertain. This study was intended to evaluate the effects of rotational speed on the number of cycles to fracture of rotary NiTi instruments. ProTaper Universal instruments F3 and F4 (Maillefer SA, Ballaigues, Switzerland) were used in an artificial curved canal under rotational speeds of 300 rpm or 600 rpm. The artificial canal was made of stainless steel, with an inner diameter of 1.5 mm, total length of 20 mm, and arc at the end with a curvature radius of 6 mm. The arc length was 9.4 mm and 10.6 mm on the straight part. The number of cycles required to fracture was recorded. Fractured surfaces and the helical shafts of the fractured instruments were analyzed by scanning electron microscopy. The results showed approximately a 30% reduction in the observed number of cycles to fracture as rotational speed was increased from 300 to 600 RPM (p < 0.05). The morphology of the fractured surface was always of ductile type, and no plastic deformation was observed on the helical shaft of fractured instruments. The present findings for both F3 and F4 ProTaper instruments revealed that the increase in rotational speed significantly reduced the number of cycles to fracture.

  10. Cleaning and shaping curved root canals: Mtwo vs ProTaper instruments, a lab comparison.

    PubMed

    Kuzekanani, Maryam; Walsh, Laurence J; Yousefi, Mohammad Ali

    2009-01-01

    The purpose of this study was to compare root canal preparation in curved canals in molar teeth with the rotary NiTi Mtwo and ProTaper systems in terms of canal shape and smear layer. Mesiobuccal canals of 60 molar teeth with angles of curvature between 25 and 35 degrees were prepared with a torque controlled low speed engine; 30 canals for each system. Each individual instrument was used to prepare four root canals and the time required for preparation was recorded. Standardized radiographs were taken before and following instrumentation and used to determine changes in canal curvature. There was no significant difference in preparation time between the two systems. No instruments separated during use. The Mtwo system gave a statistically smaller change in canal curvature and thus was better for maintaining the original shape of the root canal, with less transportation (P less than 0.05). The greatest difference was seen for maxillary molar teeth. When prepared root canals were examined by SEM there was no difference between the two systems at the coronal, middle or apical thirds. Overall, the results of this study suggest that Mtwo instruments are preferable for situations where canals are curved, particularly for maxillary molars.

  11. Postoperative endodontic pain of three different instrumentation techniques in asymptomatic necrotic mandibular molars with periapical lesion: a prospective, randomized, double-blind clinical trial.

    PubMed

    Shokraneh, Ali; Ajami, Majid; Farhadi, Nastaran; Hosseini, Mohsen; Rohani, Bita

    2017-01-01

    The purpose of this prospective, randomized, double-blind study was to compare postoperative pain of root canal treatment in patients with asymptomatic mandibular molar teeth with necrotic pulp and periapical lesion using three different instrumentation techniques: hand, multi-file rotary (ProTaper Universal), and reciprocating single-file (Wave-One) instrumentation techniques. Ninety-six patients who fulfilled specific inclusion criteria were assigned to three groups according to the root canal instrumentation technique used: Hand (G1), ProTaper Universal (G2), and Wave-One (G3). One-visit root canal treatment was carried out, and the severity of the postoperative pain was assessed by the Heft-Parker visual analogue scale 6, 12, 18, 24, 48, and 72 h after treatment. Data were analyzed by Kruskal-Wallis, χ 2 , Cochrane Q, one-way ANOVA, and Spearman's correlation analyses (α = 0.05). The patients in group 3 reported significantly lower postoperative pain levels at 6, 12, and 18 h compared with the patients in the two other groups (P < .05). In addition, the patients in group 2 reported significantly lower postoperative pain levels at 6 and 12 h compared with the patients in group 1 (P < .05). There were no significant differences in postoperative pain between the three groups at other time intervals (P > .05). The analgesic consumption was significantly higher in group 1 (P < .05), but no difference was seen between the two other groups (P > .05). Postoperative pain was significantly lower in patients undergoing root canal instrumentation with the Wave-One file compared with the ProTaper Universal and hand files.

  12. Comparison of air-driven vs electric torque control motors on canal centering ability by ProTaper NiTi rotary instruments.

    PubMed

    Zarei, Mina; Javidi, Maryam; Erfanian, Mahdi; Lomee, Mahdi; Afkhami, Farzaneh

    2013-01-01

    Cleaning and shaping is one of the most important phases in root canal therapy. Various rotary NiTi systems minimize accidents and facilitate the shaping process. Todays NiTi files are used with air-driven and electric handpieces. This study compared the canal centering after instrumentation using the ProTaper system using Endo IT, electric torque-control motor, and NSK air-driven handpiece. This ex vivo randomized controlled trial study involved 26 mesial mandibular root canals with 10 to 35° curvature. The roots were randomly divided into 2 groups of 13 canals each. The roots were mounted in an endodontic cube with acrylic resin, sectioned horizontally at 2, 6 and 10 mm from the apex and then reassembled. The canals were instrumented according to the manufacturer's instructions using ProTaper rotary files and electric torque-control motors (group 1) or air-driven handpieces (group 2). Photographs of the cross-sections included shots before and after instrumentation, and image analysis was performed using Photoshop software. The centering ability and canal transportation was also evaluated. Repeated measurement and independent t-test provided statistical analysis of canal transportation. The comparison of the rate of transportation toward internal or external walls between the two groups was not statistically significant (p = 0.62). Comparison of the rate of transportation of sections within one group was not significant (p = 0.28). Use of rotary NiTi file with either electric torquecontrol motor or air-driven handpiece had no effect on canal centering. NiTi rotary instruments can be used with air-driven motors without any considerable changes in root canal anatomy, however it needs the clinician to be expert.

  13. Effect of Instrument Design and Access Outlines on the Removal of Root Canal Obturation Materials in Oval-shaped Canals.

    PubMed

    Niemi, Tuomas K; Marchesan, Melissa A; Lloyd, Adam; Seltzer, Robert J

    2016-10-01

    The aim of this study was to compare the effectiveness of TRUShape (TS) instruments with ProFile Vortex Blue (VB) instruments for the removal of obturation materials during retreatment of single-canal mandibular premolars performed through 2 access outlines. Initial root canal treatment was completed through a contracted endodontic cavity (CEC) design. Canals were instrumented to an F2 ProTaper instrument, obturated with warm lateral condensation of gutta-percha with AH Plus sealer, and allowed to set for 30 days at 37°C and 100% humidity. For retreatment, specimens were divided into 2 groups (n = 24) on the basis of access outline, CEC or traditional endodontic cavity (TEC). Retreatment was initiated by using ProTaper Retreatment instruments (D1-D3). Specimens were then stratified, further divided (n = 12), and reinstrumented up to TS 40 .06v or 40 .06 VB. Irrigation was performed by using 8.25% NaOCl and QMix 2in1. Retreatment time was recorded. Teeth were sectioned and photographed, and the percentage of remaining obturation materials was measured. Data were analyzed with Kruskal-Wallis analysis of variance for two-factor tests (α < 0.05). The interaction between access design and instrument type showed that the combination of CEC-VB presented significantly higher amounts of remaining obturation materials on the canal surface when compared with TEC-VB, CEC-TS, and TEC-TS (P ≤ .05). None of these other combinations were different from each other (P > .05). Significantly more time was required for retreatment with CEC-TS (27.68 ± 1.4 minutes) than the other groups (P < .05). Neither retreatment protocol was able to completely eliminate all obturation materials from the root canal surface of mandibular premolars. However, in the presence of a CEC access design, using TS instruments removed more obturating material in single-rooted, oval-shaped canals. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  14. Comparison of Apical Extrusion of Debris by Using Single-File, Full-Sequence Rotary and Reciprocating Systems

    PubMed Central

    Ehsani, Maryam; Harandi, Azadeh; Tavanafar, Saeid; Raoof, Maryam; Galledar, Saeedeh

    2016-01-01

    Objectives: During root canal preparation, apical extrusion of debris can cause inflammation, flare-ups, and delayed healing. Therefore, instrumentation techniques that cause the least extrusion of debris are desirable. This study aimed to compare apical extrusion of debris by five single-file, full-sequence rotary and reciprocating systems. Materials and Methods: One hundred twenty human mandibular premolars with similar root lengths, apical diameters, and canal curvatures were selected and randomly assigned to six groups (n=20): Reciproc R25 (25, 0.08), WaveOne Primary (25, 0.08), OneShape (25, 0.06), F360 (25, 0.04), Neoniti A1 (25, 0.08), and ProTaper Universal. Instrumentation of the root canals was performed in accordance with the manufacturers’ instructions. Each tooth's debris was collected in a pre-weighed vial. After drying the debris in an incubator, the mass was measured three times consecutively; the mean was then calculated. The preparation time by each system was also measured. For data analysis, one-way ANOVA and Games-Howell post hoc test were used. Results: The mean masses (±standard deviation) of the apical debris were as follows: 2.071±1.38mg (ProTaper Universal), 1.702±1.306mg (Neoniti A1), 1.295±0.839mg (OneShape), 1.109±0.676mg (WaveOne), 0.976±0.478mg (Reciproc) and 0.797±0.531mg (F360). Compared to ProTaper Universal, F360 generated significantly less debris (P=0.02). The ProTaper system required the longest preparation time (mean=88.6 seconds); the Reciproc (P=0.008), OneShape (P=0.006), and F360 (P=0.001) required significantly less time (P<0.05). Conclusions: All instruments caused extrusion of debris through the apex. The F360 produced significantly less debris than did the ProTaper Universal. PMID:28243300

  15. Comparison of Apical Extrusion of Debris by Using Single-File, Full-Sequence Rotary and Reciprocating Systems.

    PubMed

    Ehsani, Maryam; Farhang, Robab; Harandi, Azadeh; Tavanafar, Saeid; Raoof, Maryam; Galledar, Saeedeh

    2016-11-01

    During root canal preparation, apical extrusion of debris can cause inflammation, flare-ups, and delayed healing. Therefore, instrumentation techniques that cause the least extrusion of debris are desirable. This study aimed to compare apical extrusion of debris by five single-file, full-sequence rotary and reciprocating systems. One hundred twenty human mandibular premolars with similar root lengths, apical diameters, and canal curvatures were selected and randomly assigned to six groups (n=20): Reciproc R25 (25, 0.08), WaveOne Primary (25, 0.08), OneShape (25, 0.06), F360 (25, 0.04), Neoniti A1 (25, 0.08), and ProTaper Universal. Instrumentation of the root canals was performed in accordance with the manufacturers' instructions. Each tooth's debris was collected in a pre-weighed vial. After drying the debris in an incubator, the mass was measured three times consecutively; the mean was then calculated. The preparation time by each system was also measured. For data analysis, one-way ANOVA and Games-Howell post hoc test were used. The mean masses (±standard deviation) of the apical debris were as follows: 2.071±1.38mg (ProTaper Universal), 1.702±1.306mg (Neoniti A1), 1.295±0.839mg (OneShape), 1.109±0.676mg (WaveOne), 0.976±0.478mg (Reciproc) and 0.797±0.531mg (F360). Compared to ProTaper Universal, F360 generated significantly less debris (P=0.02). The ProTaper system required the longest preparation time (mean=88.6 seconds); the Reciproc (P=0.008), OneShape (P=0.006), and F360 (P=0.001) required significantly less time (P<0.05). All instruments caused extrusion of debris through the apex. The F360 produced significantly less debris than did the ProTaper Universal.

  16. Beyond the Basics of Clinical Outcomes Assessment: Selecting Appropriate Patient-Rated Outcomes Instruments for Patient Care

    ERIC Educational Resources Information Center

    Valier, Alison R.; Lam, Kenneth C.

    2015-01-01

    The fifth edition of the "Athletic Training Education Competencies" emphasizes the concepts of clinical outcomes assessment. In athletic training, clinical outcomes assessment, especially as it relates to patient-rated outcomes (PRO) instruments, is new, which produces uncertainty with regard to how to integrate PROs into athletic…

  17. Cleaning Effectiveness of a Reciprocating Single-file and a Conventional Rotary Instrumentation System

    PubMed Central

    de Carvalho, Fredson Marcio Acris; Gonçalves, Leonardo Cantanhede de Oliveira; Marques, André Augusto Franco; Alves, Vanessa; Bueno, Carlos Eduardo da Silveira; De Martin, Alexandre Sigrist

    2016-01-01

    Objective: To compare cleaning effectiveness by histological analysis of a reciprocating single-file system with ProTaper rotary instruments during the preparation of curved root canals in extracted teeth. Methods: A total of 40 root canals with curvatures ranging between 20 - 40 degrees were divided into two groups of 20 canals. Canals were prepared to the following apical sizes: Reciproc size 25 (n=20); ProTaper: F2 (n=20). The normal distribution of data was tested by the Kolmogorov-Smirnov test and the values obtained for the test (Mann-Whitney U test, P < .05) were statistically analyzed using the GraphPad InStat for the Mac OS software (GraphPad Software, La Jolla, CA, USA). Results: There were no significant differences in remaining debris (P > .05) between the two groups. Conclusion: The application of reciprocating motion during instrumentation did not result in increased debris when compared with continuous rotation motion, even in the apical part of curved canals. Both instruments resulted in debris in the canal lumen, irrespective of the movement kinematics applied. PMID:28217185

  18. Cyclic fatigue of nickel-titanium rotary instruments in a double (S-shaped) simulated curvature.

    PubMed

    Al-Sudani, Dina; Grande, Nicola M; Plotino, Gianluca; Pompa, Giorgio; Di Carlo, Stefano; Testarelli, Luca; Gambarini, Gianluca

    2012-07-01

    The goal of the present study was to test the fatigue resistance of nickel-titanium rotary files in a double curvature (S-shaped) artificial root canal and to compare those results with single curvature artificial root canals. Two nickel-titanium endodontic instruments consisting of identical instrument sizes (constant .06 taper and 0.25 tip diameter) were tested, ProFile instruments and Vortex instruments. Both instruments were tested for fatigue inside an artificial canal with a double curvature and inside a curved artificial canal with a single curvature. Ten instruments for each group were tested to fracture in continuous rotary motion at 300 rpm. Number of cycles to failure (NCF) was calculated to the nearest whole number, and the length of the fractured fragment was measured in millimeters. Data were statistically analyzed with a level of significance set at 95% confidence level. The NCF value was always statistically lower in the double curved artificial canal when compared with the single curve (P < .05) in both the apical and coronal curvatures. Statistically significant differences (P < .05) were noted between instruments of the same size of different brand only in the single curve; ProFile registered a mean of 633.5 ± 75.1 NCF, whereas Vortex registered a mean of 548 ± 48.9 NCF. Regardless of the differences between the instruments used in the present study, the results suggest that the more complex is the root canal, the more adverse are the effects on the cyclic fatigue resistance of the instruments. Copyright © 2012 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  19. Performance of PROMIS Physical Function Compared with KOOS, SF-36, Eq5d And Marx Activity Scale in Patients Who Undergo ACL Reconstruction

    PubMed Central

    Scott, Elizabeth; Glass, Natalie; Wolf, Brian R.; Hettrich, Carolyn M.; Bollier, Matthew

    2018-01-01

    Objectives: Anterior cruciate ligament reconstruction is a commonly performed orthopaedic procedure. PROMIS (Patient-Reported Outcome Measurement Information System) was developed by the National Institutes of Health in an effort to advance patient-reported outcome (PRO) instruments by developing question banks for major health domains. Our goal was to compare the responsiveness and construct validity of the PROMIS physical function (PF) computer adaptive test (CAT) with current PRO instruments utilized in patients who undergo anterior cruciate ligament reconstruction. Methods: A total of 174 patients ages 14-53 scheduled to undergo anterior cruciate ligament reconstruction were asked to complete PROMIS PF-CAT, Short Form-36 Health Survey (SF36-PF and -GH), Marx activity rating scale (Marx), Knee Injury and Osteoarthritis Score (KOOS-ADL, -Sport, -QOL), and the EuroQol five dimensions questionnaire (EQ5D) at their preoperative visit. These surveys were repeated at six weeks and six months after surgery. Correlations between PRO instruments was defined as excellent (>0.7), excellent-good (0.61-0.7), good (0.4-0.6), and poor (0.2-0.3) using Spearman Correlation Coefficients. The effect size (Cohen d) and standardized response mean (SRM) were used to describe the responsiveness of each PRO at the 6 week and 6 month follow-up visits and were defined as small (0.2), medium (0.5) and large (0.8). Ceiling and floor effects were defined as present if ≥15% of participants scored the highest or lowest score on a PRO, respectively. Subgroup analyses were performed comparing change in PRO scores at follow-up between participants with and without additional arthroscopic procedures (meniscal debridement and/or repair, microfracture, or OATS vs ACL reconstruction only) using linear mixed models. Results: There were excellent and excellent-good correlations between the PROMIS PF-CAT and physical function PROs including the SF36-PF (r=0.75-0.80, p<.01), KOOS-ADL (r=0.62-0.70, p<.01) and KOOS-Sport (r=0.32-0.69, p<0.01) at most time points, respectively. There was also excellent-good correlation with the EQ5D (r=0.60-0.71, p<.01) and good correlation with the KOOS-QOL (r=0.52-0.58, p<0.01). As expected, there was no (p>0.05) to poor correlation with Marx activity (r=0.24, p<0.01) and the SF36-GH (r=0.32-0.34, p<0.01). No ceiling or floor effects were noted for the PROMIS PF-CAT; there was a ceiling effect noted for KOOS-ADL at the 6 month visit (38.1%). Effect size estimates for physical function PROs increased from small to large changes from the 6 week to 6 month visits and were largest in the PROMIS PF-CAT (1.34) followed by KOOS-ADL (1.19) and SF36-PF (1.06). Patients answered on average 4 questions utilizing the PROMIS. Baseline subgroup analyses showed no significant differences in physical function PRO scores, and at follow-up, both groups showed significant improvement in physical function PRO scores that was not statistically different. Conclusion: Our results support the construct validity of the PROMIS PF-CAT in patients who undergo ACL reconstruction. Responsiveness to change was highest by 6 months postop and greater for the PROMIS PF-CAT than for other measures of physical function with no ceiling or floor effects and a low time-burden. Taken together, these findings suggest that the PROMIS PF-CAT is a beneficial alternative to measuring and tracking changes in physical function in adults undergoing ACL reconstruction.

  20. Comparative evaluation of apically extruded debris with V-Taper, ProTaper Next, and the Self-adjusting File systems

    PubMed Central

    Vyavahare, Nishant K.; Raghavendra, Srinidhi Surya; Desai, Niranjan N.

    2016-01-01

    Background: Complete cleaning of the root canal is the goal for ensuring success in endodontics. Removal of debris plays an important role in achieving this goal. In spite of advancements in instrument design, apical extrusion of debris remains a source of inflammation in the periradicular region. Aim: To comparatively evaluate the amount of apically extruded debris with V-Taper, ProTaper Next, and the self-adjusting File (SAF) system. Materials and Methods: Sixty-four extracted human mandibular teeth with straight root canals were taken. Access openings were done and working length determined. The samples were randomly divided into three groups: Group I - V-Taper files (n = 20), Group II - ProTaper Next (n = 20), Group III - SAF (n = 20). Biomechanical preparation was completed and the debris collected in vials to be quantitatively determined. The data obtained was statistically analyzed using ANOVA and post hoc Tukey's test. Results: All the specimens showed apical debris extrusion. SAF showed significantly less debris extrusion compared to V-Taper and ProTaper Next (P < 0.001). Among Groups I and II, ProTaper Next showed lesser debris extrusion as compared to V-Taper, but it was not significant (P = 0.124). Conclusion: The SAF showed least amount of apical debris extrusion when compared to newer rotary endodontic instruments. This indicates that the incidence of inter-treatment flare-ups due to debris extrusion would be less with the SAF. PMID:27217636

  1. ‘Trial Exegesis’: Methods for Synthesizing Clinical and Patient Reported Outcome (PRO) Data in Trials to Inform Clinical Practice. A Systematic Review

    PubMed Central

    Macefield, Rhiannon C.; Blencowe, Natalie S.; Brookes, Sara T.; Blazeby, Jane M.

    2016-01-01

    Purpose The CONSORT extension for patient reported outcomes (PROs) aims to improve reporting, but guidance on the optimal integration with clinical data is lacking. This study examines in detail the reporting of PROs and clinical data from randomized controlled trials (RCTs) in gastro-intestinal cancer to inform design and reporting of combined PRO and clinical data from trials to improve the ‘take home’ message for clinicians to use in practice. Materials and Methods The case study was undertaken in gastro-intestinal cancer trials. Well-conducted RCTs reporting PROs with validated instruments were identified and categorized into those combining PRO and clinical data in a single paper, or those separating data into linked primary and supplemental papers. Qualitative methods were developed to examine reporting of the critical interpretation of the trial results (trial exegesis) in the papers in relation of the PRO and clinical outcomes and applied to each publication category. Results were used to inform recommendations for practice. Results From 1917 screened abstracts, 49 high quality RCTs were identified reported in 36 combined and 15 linked primary and supplemental papers. In-depth analysis of manuscript text identified three categories for understanding trial exegesis: where authors reported a “detailed”, “general”, or absent PRO rationale and integrated interpretation of clinical and PRO results. A total of 11 (30%) and 6 (16%) combined papers reported “detailed” PRO rationale and integrated interpretation of results although only 2 (14%) and 1 (7%) primary papers achieved the same standard respectively. Supplemental papers provide better information with 11 (73%) and 3 (20%) achieving “detailed” rationale and integrated interpretation of results. Supplemental papers, however, were published a median of 20 months after the primary RCT data in lower impact factor journals (median 16.8 versus 5.2). Conclusion It is recommended that single papers, with detailed PRO rationale and integrated PRO and clinical data are published to optimize trial exegesis. Further work to examine whether this improves the use of PRO data to inform practice is needed. PMID:27571514

  2. Bending properties of a new nickel-titanium alloy with a lower percent by weight of nickel.

    PubMed

    Testarelli, Luca; Plotino, Gianluca; Al-Sudani, Dina; Vincenzi, Valentina; Giansiracusa, Alessio; Grande, Nicola M; Gambarini, Gianluca

    2011-09-01

    The aim of the present study was to evaluate the bending properties of Hyflex instruments, which exhibit a lower percent in weight of nickel (52 Ni %wt) and compare them with other commercially available nickel-titanium (NiTi) rotary instruments. Ten instruments with tip size 25, 0.06 taper of each of the following NiTi rotary instrumentation techniques were selected for the study: Hyflex, EndoSequence, ProFile, Hero, and Flexmasters. All instruments from each group were tested for stiffness by comparing their bending moment when they attained a 45-degree bend. Experimental procedures strictly followed testing methodology described in ISO 3630-1. All data were recorded and subjected to statistical evaluation by using analysis of variance test. Statistical significance was set at P < .05). Statistical analysis of the data revealed that Hyflex files were found to be the most flexible instruments, with a significant difference (P < .05) in comparison with the other instruments. Among the other files, a significant difference has been reported for EndoSequence instruments compared with ProFile, Hero, and FlexMaster (P < .05), whereas no significant differences have been reported among those 3 files (P > .05). Results of the present study have illustrated an increased flexibility of the new NiTi alloy over conventional NiTi alloy, and they highlight the potential of the new manufacturing process. Copyright © 2011 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  3. Patient-Centered Research to Support the Development of the Symptoms of Major Depressive Disorder Scale (SMDDS): Initial Qualitative Research.

    PubMed

    McCarrier, Kelly P; Deal, Linda S; Abraham, Lucy; Blum, Steven I; Bush, Elizabeth Nicole; Martin, Mona L; Thase, Michael E; Coons, Stephen Joel

    2016-04-01

    Content valid, patient-reported outcome (PRO) measures of major depressive disorder (MDD) symptoms are needed to assess MDD treatment benefit. While a range of questionnaires are currently available to evaluate aspects of depression from the patient's perspective, their comprehensiveness and qualitative development histories are unclear. The objective of this study was to describe the process and results of the preliminary qualitative development of a new symptom-based PRO measure intended to assess treatment benefit in MDD clinical trials. Qualitative interviews were conducted with adult MDD patients in the USA who recently experienced a major depressive episode. Experienced interviewers conducted concept elicitation (CE) and cognitive interviews using semi-structured interview guides. The CE interview guide was used to elicit spontaneous reports of symptom experiences along with probing to further explore and confirm concepts. The cognitive interview guide was developed to evaluate concept relevance, understandability, and structure of the draft items, and to facilitate further instrument refinement. Forty patients participated in the CE interviews. A total of 3022 symptom codes, representing 84 different concepts were derived from the transcripts. Data from the CE interviews were considered alongside existing literature and clinical expert opinion during an item-generation process, leading to development of a preliminary version of the Symptoms of Major Depressive Disorder Scale (SMDDS). Fifteen patients participated in three waves of cognitive interviews, during which the SMDDS was further refined. The SMDDS is a 35-item PRO measure intended for use as an endpoint in MDD clinical trials to support medical product labeling. The SMDDS uses a 7-day recall period and verbal rating scales. It was developed in accordance with the US Food and Drug Administration (FDA)'s PRO Guidance and best practices. Qualitative interviews have provided evidence for content validity. Future quantitative studies will confirm the SMDDS's measurement properties and support FDA qualification.

  4. The Brief Pain Inventory and its "pain at its worst in the last 24 hours" item: clinical trial endpoint considerations.

    PubMed

    Atkinson, Thomas M; Mendoza, Tito R; Sit, Laura; Passik, Steven; Scher, Howard I; Cleeland, Charles; Basch, Ethan

    2010-03-01

    In 2006, the United States Food and Drug Administration (FDA) released a draft Guidance for Industry on the use of patient-reported outcomes (PRO) Measures in Medical Product Development to Support Labeling Claims. This draft guidance outlines psychometric aspects that should be considered when designing a PRO measure, including conceptual framework, content validity, construct validity, reliability, and the ability to detect clinically meaningful score changes. When finalized, it may provide a blueprint for evaluations of PRO measures that can be considered by sponsors and investigators involved in PRO research and drug registration trials. In this review we examine the short form of the Brief Pain Inventory (BPI) and particularly the "pain at its worst in the last 24 hours" item in the context of the FDA draft guidance, to assess its utility in clinical trials that include pain as a PRO endpoint. After a systematic evaluation of the psychometric aspects of the BPI, we conclude that the BPI and its "pain at its worst in the last 24 hours" item generically satisfy most key recommendations outlined in the draft guidance for assessing a pain-reduction treatment effect. Nonetheless, when the BPI is being considered for assessment of pain endpoints in a registration trial, sponsors and investigators should consult with the appropriate FDA division early during research design to discuss whether there is sufficient precedent to use the instrument in the population of interest or whether additional evaluations of measurement properties are advisable.

  5. The development of a clinical outcomes survey research application: Assessment CenterSM

    PubMed Central

    Rothrock, Nan E.; Hanrahan, Rachel T.; Jansky, Liz J.; Harniss, Mark; Riley, William

    2013-01-01

    Introduction The National Institutes of Health sponsored Patient-Reported Outcome Measurement Information System (PROMIS) aimed to create item banks and computerized adaptive tests (CATs) across multiple domains for individuals with a range of chronic diseases. Purpose Web-based software was created to enable a researcher to create study-specific Websites that could administer PROMIS CATs and other instruments to research participants or clinical samples. This paper outlines the process used to develop a user-friendly, free, Web-based resource (Assessment CenterSM) for storage, retrieval, organization, sharing, and administration of patient-reported outcomes (PRO) instruments. Methods Joint Application Design (JAD) sessions were conducted with representatives from numerous institutions in order to supply a general wish list of features. Use Cases were then written to ensure that end user expectations matched programmer specifications. Program development included daily programmer “scrum” sessions, weekly Usability Acceptability Testing (UAT) and continuous Quality Assurance (QA) activities pre- and post-release. Results Assessment Center includes features that promote instrument development including item histories, data management, and storage of statistical analysis results. Conclusions This case study of software development highlights the collection and incorporation of user input throughout the development process. Potential future applications of Assessment Center in clinical research are discussed. PMID:20306332

  6. Patient-Reported Outcome and Observer-Reported Outcome Assessment in Rare Disease Clinical Trials: An ISPOR COA Emerging Good Practices Task Force Report.

    PubMed

    Benjamin, Katy; Vernon, Margaret K; Patrick, Donald L; Perfetto, Eleanor; Nestler-Parr, Sandra; Burke, Laurie

    Rare diseases (RDs) affect a small number of people within a population. About 5000 to 8000 distinct RDs have been identified, with an estimated 6% to 8% of people worldwide suffering from an RD. Approximately 75% of RDs affect children. Frequently, these conditions are heterogeneous; many are progressive. Regulatory incentives have increased orphan drug designations and approvals. To develop emerging good practices for RD outcomes research addressing the challenges inherent in identifying, selecting, developing, adapting, and implementing patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments for use in RD clinical trials. This report outlines the challenges and potential solutions in determining clinical outcomes for RD trials. It follows the US Food and Drug Administration Roadmap to Patient-Focused Outcome Measurement in Clinical Trials. The Roadmap consists of three columns: 1) Understanding the Disease or Condition, 2) Conceptualizing Treatment Benefit, and 3) Selecting/Developing the Outcome Measure. Challenges in column 1 include factors such as incomplete natural history data and heterogeneity of disease presentation and patient experience. Solutions include using several information sources, for example, clinical experts and patient advocacy groups, to construct the condition's natural history and understand treatment patterns. Challenges in column 2 include understanding and measuring treatment benefit from the patient's perspective, especially given challenges in defining the context of use such as variations in age or disease severity/progression. Solutions include focusing on common symptoms across patient subgroups, identifying short-term outcomes, and using multiple types of COA instruments to measure the same constructs. Challenges in column 3 center around the small patient population and heterogeneity of the condition or study sample. Few disease-specific instruments for RDs exist. Strategies include adapting existing instruments developed for a similar condition or that contain symptoms of importance to the RD patient population, or using a generic instrument validated for the context of use. This report provides state-of-the-art solutions to patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments challenges in clinical trials of patients with RDs. These recommended solutions are both pragmatic and creative and posed with clear recognition of the global regulatory context used in RD clinical development programs. Copyright © 2017. Published by Elsevier Inc.

  7. Effect of Bacterial Endotoxin and Interleukin-2 on Human Leu-11(+) NK cells: Ultrastructural and Functional Correlations

    DTIC Science & Technology

    1988-01-01

    REPORT DOCUMENTATION PAGE 17 RPORT SICIJRITY (LASWIC,.dION 1 b . RESTRiCIivE MARIN~ AGS Unclassif ied IS. SiCuRItv CLAISJICArION AUTMORITY 3...comparison with T cell detella pertussis endotoxin. subsets. Anat. Rec., 217:274. Mol. Inmuncl., 21:389. 25.Kang, Y. H., M. Carl, and L. 20.Herberman, R. B ... b . OFFICE SYMBOL 9. PRO(.UREMENT INSTRUMENT IDENTIfICATION NUMBER ORGANIZATION Naval Medical of appikawble Research and Development Command 64

  8. Identifying content for the glaucoma-specific item bank to measure quality-of-life parameters.

    PubMed

    Khadka, Jyoti; McAlinden, Colm; Craig, Jamie E; Fenwick, Eva K; Lamoureux, Ecosse L; Pesudovs, Konrad

    2015-01-01

    Patient-reported outcomes (PROs) have become essential clinical trial end points. However, a comprehensive, multidimensional, patient-relevant, and precise glaucoma-specific PRO instrument is not available. Therefore, the purpose of this study was to identify content for a new, glaucoma-specific, quality-of-life (QOL) item bank. Content identification was undertaken in 5 phases: (1) identification of extant items in glaucoma-specific instruments and the qualitative literature; (2) focus groups and interviews with glaucoma patients; (3) item classification and selection; (4) expert review and revision of items; and (5) cognitive interviews with patients. A total of 737 unique items (extant items from PRO instruments, 247; qualitative articles, 14 items; focus groups and semistructured interviews, 476 items) were identified. These items were classified into 10 QOL domains. Four criteria (item redundancy, item inconsistent with domain definition, item content too narrow to have wider applicability, and item clarity) were used to remove and refine the items. After the cognitive interviews, the final minimally representative item set had a total of 342 unique items belonging to 10 domains: activity limitation (88), mobility (20), visual symptoms (19), ocular surface symptoms (22), general symptoms (15), convenience (39), health concerns (45), emotional well-being (49), social issues (23), and economic issues (22). The systematic content identification process identified 10 QOL domains, which were important to patients with glaucoma. The majority of the items were identified from the patient-specific focus groups and semistructured interviews suggesting that the existing PRO instruments do not adequately address QOL issues relevant to individuals with glaucoma.

  9. Incidence of apical root cracks and apical dentinal detachments after canal preparation with hand and rotary files at different instrumentation lengths.

    PubMed

    Liu, Rui; Kaiwar, Anjali; Shemesh, Hagay; Wesselink, Paul R; Hou, Benxiang; Wu, Min-Kai

    2013-01-01

    The aim of this study was to compare the incidence of apical root cracks and dentinal detachments after canal preparation with hand and rotary files at different instrumentation lengths. Two hundred forty mandibular incisors were mounted in resin blocks with simulated periodontal ligaments, and the apex was exposed. The root canals were instrumented with rotary and hand files, namely K3, ProTaper, and nickel-titanium Flex K files to the major apical foramen (AF), short AF, or beyond AF. Digital images of the apical surface of every tooth were taken during the apical enlargement at each file change. Development of dentinal defects was determined by comparing these images with the baseline image. Multinomial logistic regression test was performed to identify influencing factors. Apical crack developed in 1 of 80 teeth (1.3%) with hand files and 31 of 160 teeth (19.4%) with rotary files. Apical dentinal detachment developed in 2 of 80 teeth (2.5%) with hand files and 35 of 160 teeth (21.9%) with rotary files. Instrumentation with rotary files terminated 2 mm short of AF and did not cause any cracks. Significantly less cracks and detachments occurred when instrumentation with rotary files was terminated short of AF, as compared with that terminated at or beyond AF (P < .05). The AF deviated from the anatomic apex in 128 of 240 teeth (53%). Significantly more apical dentinal detachments appeared in teeth with a deviated AF (P = .033). Rotary instruments caused more dentinal defects than hand instruments; instrumentation short of AF reduced the risk of dentinal defects. Copyright © 2013 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  10. [Comparison of effectiveness and safety between Twisted File technique and ProTaper Universal rotary full sequence based on micro-computed tomography].

    PubMed

    Chen, Xiao-bo; Chen, Chen; Liang, Yu-hong

    2016-02-18

    To evaluate the efficacy and security of two type of rotary nickel titanium system (Twisted File and ProTaper Universal) for root canal preparation based on micro-computed tomography(micro-CT). Twenty extracted molars (including 62 canals) were divided into two experimental groups and were respectively instrumented using Twisted File rotary nickel titanium system (TF) and ProTaper Universal rotary nickel titanium system (PU) to #25/0.08 following recommended protocol. Time for root canal instrumentation (accumulation of time for every single file) was recorded. The 0-3 mm root surface from apex was observed under an optical stereomicroscope at 25 × magnification. The presence of crack line was noted. The root canals were scanned with micro-CT before and after root canal preparation. Three-dimensional shape images of canals were reconstructed, calculated and evaluated. The amount of canal central transportation of the two groups was calculated and compared. The shorter preparation time [(0.53 ± 0.14) min] was observed in TF group, while the preparation time of PU group was (2.06 ± 0.39) min (P<0.05). In mid-root level, TF group shaping resulted in less canal center transportation than PU group [(0.070 ± 0.056) mm vs. (0.097 ± 0.084) mm, P<0.05]. No instrument separation was observed in both the groups. Cracks were not found in both the groups either based in micro-CT images or observation under an optical stereomicroscope at 25 × magnification. Compared with ProTaper Universal, Twisted File took less time in root canal preparation and exhibited better shaping ability, and less canal transportation.

  11. Development of a canopy Solar-induced chlorophyll fluorescence measurement instrument

    NASA Astrophysics Data System (ADS)

    Sun, G.; Wang, X.; Niu, Zh; Chen, F.

    2014-02-01

    A portable solar-induced chlorophyll fluorescence detecting instrument based on Fraunhofer line principle was designed and tested. The instrument has a valid survey area of 1.3 × 1.3 meter when the height was fixed to 1.3 meter. The instrument uses sunlight as its light source. The instrument is quipped with two sets of special photoelectrical detectors with the centre wavelength at 760 nm and 771 nm respectively and bandwidth less than 1nm. Both sets of detectors are composed of an upper detector which are used for detecting incidence sunlight and a bottom detector which are used for detecting reflex light from the canopy of crop. This instrument includes photoelectric detector module, signal process module, A/D convert module, the data storage and upload module and human-machine interface module. The microprocessor calculates solar-induced fluorescence value based on the A/D values get from detectors. And the value can be displayed on the instrument's LCD, stored in the flash memory of instrument and can also be uploaded to PC through the PC's serial interface. The prototype was tested in the crop field and the results demonstrate that the instrument can measure the solar-induced chlorophyll value exactly with the correlation coefficients was 0.9 compared to the values got from Analytical Spectral Devices FieldSpec Pro spectrometer. This instrument can diagnose the plant growth status by the acquired spectral response.

  12. French translation and cross-cultural adaptation of The Myotonic Dystrophy Health Index.

    PubMed

    Gagnon, Cynthia; Tremblay, Marjolaine; CôTé, Isabelle; Heatwole, Chad

    2018-04-01

    Validation studies of disease-specific instruments for myotonic dystrophy type-1 (DM1) are required prior to their global use in clinical trials involving different cultures and countries. Here we translate and culturally adapt the Myotonic Dystrophy Health Index (MDHI), a disease-specific patient-reported outcome (PRO) measure, for a French DM1 population. Using the International Society for Pharmacoeconomics and Outcomes Research Task Force method for translation and adaptation of PRO questionnaires, we created a French translation of the MDHI. We subsequently tested this instrument in a cohort of French-speaking patients with DM1. The MDHI was forward and back translated and modified by consensus to create the most compatible translation. Cognitive interviews were conducted with 5 patients with DM1 to ensure the usability and understanding of the translation. The French version of the MDHI is an optimal translation of the original instrument that is acceptable to native patients and ready for clinical trial use. Muscle Nerve 57: 686-689, 2018. © 2017 Wiley Periodicals, Inc.

  13. A Novel Method to Evaluate the Community Built Environment Using Photographs – Environmental Profile of a Community Health (EPOCH) Photo Neighbourhood Evaluation Tool

    PubMed Central

    Chow, Clara K.; Corsi, Daniel J.; Lock, Karen; Madhavan, Manisha; Mackie, Pam; Li, Wei; Yi, Sun; Wang, Yang; Swaminathan, Sumathi; Lopez-Jaramillo, Patricio; Gomez-Arbelaez, Diego; Avezum, Álvaro; Lear, Scott A.; Dagenais, Gilles; Teo, Koon; McKee, Martin; Yusuf, Salim

    2014-01-01

    Background Previous research has shown that environments with features that encourage walking are associated with increased physical activity. Existing methods to assess the built environment using geographical information systems (GIS) data, direct audit or large surveys of the residents face constraints, such as data availability and comparability, when used to study communities in countries in diverse parts of the world. The aim of this study was to develop a method to evaluate features of the built environment of communities using a standard set of photos. In this report we describe the method of photo collection, photo analysis instrument development and inter-rater reliability of the instrument. Methods/Principal Findings A minimum of 5 photos were taken per community in 86 communities in 5 countries according to a standard set of instructions from a designated central point of each community by researchers at each site. A standard pro forma derived from reviewing existing instruments to assess the built environment was developed and used to score the characteristics of each community. Photo sets from each community were assessed independently by three observers in the central research office according to the pro forma and the inter-rater reliability was compared by intra-class correlation (ICC). Overall 87% (53 of 60) items had an ICC of ≥0.70, 7% (4 of 60) had an ICC between 0.60 and 0.70 and 5% (3 of 60) items had an ICC ≤0.50. Conclusions/Significance Analysis of photos using a standardized protocol as described in this study offers a means to obtain reliable and reproducible information on the built environment in communities in very diverse locations around the world. The collection of the photographic data required minimal training and the analysis demonstrated high reliability for the majority of items of interest. PMID:25369366

  14. Effect of Zingiber officinale and propolis on microorganisms and endotoxins in root canals

    PubMed Central

    MAEKAWA, Lilian Eiko; VALERA, Marcia Carneiro; de OLIVEIRA, Luciane Dias; CARVALHO, Cláudio Antonio Talge; CAMARGO, Carlos Henrique Ribeiro; JORGE, Antonio Olavo Cardoso

    2013-01-01

    The purpose of this study was to evaluate the effectiveness of glycolic propolis (PRO) and ginger (GIN) extracts, calcium hydroxide (CH), chlorhexidine (CLX) gel and their combinations as ICMs (ICMs) against Candida albicans, Enterococcus faecalis, Escherichia coli and endotoxins in root canals. Material and Methods: After 28 days of contamination with microorganisms, the canals were instrumented and then divided according to the ICM: CH+saline; CLX, CH+CLX, PRO, PRO+CH; GIN; GIN+CH; saline. The antimicrobial activity and quantification of endotoxins by the chromogenic test of Limulus amebocyte lysate were evaluated after contamination and instrumentation at 14 days of ICM application and 7 days after ICM removal. Results and Conclusion: After analysis of results and application of the Kruskal-Wallis and Dunn statistical tests at 5% significance level, it was concluded that all ICMs were able to eliminate the microorganisms in the root canals and reduce their amount of endotoxins; however, CH was more effective in neutralizing endotoxins and less effective against C. albicans and E. faecalis, requiring the use of medication combinations to obtain higher success. PMID:23559108

  15. Effect of autoclaving on the surfaces of TiN -coated and conventional nickel-titanium rotary instruments.

    PubMed

    Spagnuolo, G; Ametrano, G; D'Antò, V; Rengo, C; Simeone, M; Riccitiello, F; Amato, M

    2012-12-01

    To evaluate the effects of repeated autoclave sterilization cycles on surface topography of conventional nickel-titanium ( NiTi ) and titanium nitride ( TiN )-coated rotary instruments. A total of 60 NiTi rotary instruments, 30 ProTaper (Dentsply Maillefer) and 30 TiN -coated AlphaKite (Komet/Gebr. Brasseler), were analysed. Instruments were evaluated in the as-received condition and after 1, 5 and 10 sterilization cycles. After sterilization, the samples were observed using scanning electron microscope (SEM), and surface chemical analysis was performed on each instrument with energy dispersive X-ray spectroscopy (EDS). Moreover, the samples were analysed by atomic force microscopy (AFM), and roughness average (Ra) and the root mean square value (RMS) of the scanned surface profiles were recorded. Data were analysed by means of anova followed by Tukey's test. Scanning electron microscope observations revealed the presence of pitting and deep milling marks in all instruments. EDS analysis confirmed that both types of instruments were composed mainly of nickel and titanium, whilst AlphaKite had additional nitride. After multiple autoclave sterilization cycles, SEM examinations revealed an increase in surface alterations, and EDS values indicated changes in chemical surface composition in all instruments. Ra and RMS values of ProTaper significantly increased after 5 (P = 0.006) and 10 cycles (P = 0.002) with respect to the as-received instruments, whilst AlphaKite showed significant differences compared with the controls after 10 cycles (P = 0.03). Multiple autoclave sterilization cycles modified the surface topography and chemical composition of conventional and TiN -coated NiTi rotary instruments. © 2012 International Endodontic Journal.

  16. Foramen Changes following Over Instrumentation of Curved Canals with Three Engine-Driven Instruments: An In Vitro Study

    PubMed Central

    Yammine, Salwa; Jabbour, Edgard; Nahas, Paul; Majzoub, Zeina

    2017-01-01

    Introduction: The present in vitro study aimed to evaluate and compare the changes in shape and surface area of the major foramen following shaping of curved canals with three new generation NiTi engine-driven instruments naming ProTaper Next, BT RaCe and WaveOne Gold- with 3 different levels of protrusion beyond the major apical foramen. Methods and Materials: A total of 45 extracted human molars with at least one curved canal were distributed in 3 comparable groups of 15 that were instrumented using either ProTaper Next (PTN), BT RaCe (BTR) or WaveOne Gold (WOG). The canals were instrumented to the major foramen and then over instrumented with the final file 0.5 mm, 1 mm and 1.5 mm beyond the foramen. Standardized pre- and post-instrumentation photographs of the foramen were obtained for all groups using a stereomicroscope. Foramen shape and surface area were evaluated using the AmScope software for measurements and compared between groups and levels of instrumentation applying binary conditional logistic regression and repeated measures ANOVA. The level of significance was set at 0.05. Results: Foramen shape tended to gradually change from circular to oval as the level of instrumentation increased in all groups. The original foramen shape in WOG group remained better than other groups. Foramen surface areas increased in all groups with Group BTR demonstrating significantly greater values than the other 2 groups. Conclusion: Over instrumentation resulted in apical enlargement and ovalization in all 3 groups but with different patterns. These differences can be attributed to the final file size, design characteristics and kinematics of the 3 systems. PMID:29225641

  17. Ex vivo study on root canal instrumentation of two rotary nickel-titanium systems in comparison to stainless steel hand instruments.

    PubMed

    Vaudt, J; Bitter, K; Neumann, K; Kielbassa, A M

    2009-01-01

    To investigate instrumentation time, working safety and the shaping ability of two rotary nickel-titanium (NiTi) systems (Alpha System and ProTaper Universal) in comparison to stainless steel hand instruments. A total of 45 mesial root canals of extracted human mandibular molars were selected. On the basis of the degree of curvature the matched teeth were allocated randomly into three groups of 15 teeth each. In group 1 root canals were prepared to size 30 using a standardized manual preparation technique; in group 2 and 3 rotary NiTi instruments were used following the manufacturers' instructions. Instrumentation time and procedural errors were recorded. With the aid of pre- and postoperative radiographs, apical straightening of the canal curvature was determined. Photographs of the coronal, middle and apical cross-sections of the pre- and postoperative canals were taken, and superimposed using a standard software. Based on these composite images the portion of uninstrumented canal walls was evaluated. Active instrumentation time of the Alpha System was significantly reduced compared with ProTaper Universal and hand instrumentation (P < 0.05; anova). No instrument fractures occurred in any of the groups. The Alpha System revealed significantly less apical straightening compared with the other instruments (P < 0.05; Mann-Whitney U test). In the apical cross-sections Alpha System resulted in significantly less uninstrumented canal walls compared with stainless steel files (P < 0.05; chi-squared test). Despite the demonstrated differences between the systems, an apical straightening effect could not be prevented; areas of uninstrumented root canal wall were left in all regions using the various systems.

  18. Foramen Changes following Over Instrumentation of Curved Canals with Three Engine-Driven Instruments: An In Vitro Study.

    PubMed

    Yammine, Salwa; Jabbour, Edgard; Nahas, Paul; Majzoub, Zeina

    2017-01-01

    The present in vitro study aimed to evaluate and compare the changes in shape and surface area of the major foramen following shaping of curved canals with three new generation NiTi engine-driven instruments naming ProTaper Next, BT RaCe and WaveOne Gold- with 3 different levels of protrusion beyond the major apical foramen. A total of 45 extracted human molars with at least one curved canal were distributed in 3 comparable groups of 15 that were instrumented using either ProTaper Next (PTN), BT RaCe (BTR) or WaveOne Gold (WOG). The canals were instrumented to the major foramen and then over instrumented with the final file 0.5 mm, 1 mm and 1.5 mm beyond the foramen. Standardized pre- and post-instrumentation photographs of the foramen were obtained for all groups using a stereomicroscope. Foramen shape and surface area were evaluated using the AmScope software for measurements and compared between groups and levels of instrumentation applying binary conditional logistic regression and repeated measures ANOVA. The level of significance was set at 0.05. Foramen shape tended to gradually change from circular to oval as the level of instrumentation increased in all groups. The original foramen shape in WOG group remained better than other groups. Foramen surface areas increased in all groups with Group BTR demonstrating significantly greater values than the other 2 groups. Over instrumentation resulted in apical enlargement and ovalization in all 3 groups but with different patterns. These differences can be attributed to the final file size, design characteristics and kinematics of the 3 systems.

  19. Assessment Using AutoCAD Software of the Preparation of Dentin Walls in Root Canals Produced by 4 Different Endodontic Instrument Systems

    PubMed Central

    Cabanillas, Cristina; Monterde, Manuel; Pallarés, Antonio; Aranda, Susana; Montes, Raquel

    2015-01-01

    Objectives. To compare the effectiveness of four instrument systems for preparing oval root canals: manual instrumentation (Step-Back technique), ProTaper Universal, ProTaper Next, and Wave One. Material and Methods. For the purpose of this assessment, 60 teeth extracted for orthodontic or periodontal reasons, specifically canines and premolars with full coronal and root anatomy, were used and 15 samples were assigned to each group. The section of the canals was compared before and after instrumenting and the section of untouched canal wall was measured using AutoCAD software. The data was analysed by means of Shapiro-Wilk, ANOVA, and Kruskal-Wallis tests. Results. In the apical third, 100% of the canals were prepared with all the systems. In the middle third, a p value of 0.5989 in the Kruskal-Wallis test was obtained, which indicates no significant difference between the groups. At the coronal third level, the results obtained revealed that Wave One had a significantly lower mean average than the rest (p < 0.05). Conclusions. There are no differences between the various root canal instrument systems in the apical and middle thirds. At the coronal third level, Wave One system showed performance significantly worse than the rest, among which there were no differences. PMID:26664361

  20. Assessment Using AutoCAD Software of the Preparation of Dentin Walls in Root Canals Produced by 4 Different Endodontic Instrument Systems.

    PubMed

    Cabanillas, Cristina; Monterde, Manuel; Pallarés, Antonio; Aranda, Susana; Montes, Raquel

    2015-01-01

    Objectives. To compare the effectiveness of four instrument systems for preparing oval root canals: manual instrumentation (Step-Back technique), ProTaper Universal, ProTaper Next, and Wave One. Material and Methods. For the purpose of this assessment, 60 teeth extracted for orthodontic or periodontal reasons, specifically canines and premolars with full coronal and root anatomy, were used and 15 samples were assigned to each group. The section of the canals was compared before and after instrumenting and the section of untouched canal wall was measured using AutoCAD software. The data was analysed by means of Shapiro-Wilk, ANOVA, and Kruskal-Wallis tests. Results. In the apical third, 100% of the canals were prepared with all the systems. In the middle third, a p value of 0.5989 in the Kruskal-Wallis test was obtained, which indicates no significant difference between the groups. At the coronal third level, the results obtained revealed that Wave One had a significantly lower mean average than the rest (p < 0.05). Conclusions. There are no differences between the various root canal instrument systems in the apical and middle thirds. At the coronal third level, Wave One system showed performance significantly worse than the rest, among which there were no differences.

  1. A comparative evaluation of two rotary Ni-Ti instruments in the removal of gutta-percha during retreatment.

    PubMed

    Preetam, C S; Chandrashekhar, M; Gunaranjan, T; Kumar, S Kishore; Miskeen Sahib, S A; Kumar, M Senthil

    2016-08-01

    The purpose of this study is to achieve an effective method to remove root canal filling material from the root canal system. The study, thus, aims to evaluate the efficacy of the cleaning ability of two different rotary Ni-Ti systems; ProTaper Retreatment files and RaCe System compared to hand instrumentation with Hedstrom files for the removal of gutta-percha during retreatment. Thirty mandibular premolars with one single straight canal were decoronated and instrumented with ProTaper files and filled with thermoplastic gutta-percha. After 30 days, the samples were divided into three groups and gutta-percha was removed with the test instruments. The postoperative radiographs were evaluated with known criteria by dividing the root into cervical third, middle third, and apical third. The results were tabulated and Statistical Package for Social Sciences Software (IBM Corporation) was used for analysis. The mean deviation of the results were first calculated and then t-test and analysis of variance test (two-tailed P value) were evaluated for establishing significant differences. The rotary instruments were effective in removing the gutta-percha from the canals. Therefore, significant difference was observed between the efficacies of the two rotary systems used. The rotary instruments showed effective gutta-percha removal in the cervical and middle one third. (P > 0.05). However, apical debridement was effective with Hedstrom files. The study concluded the use of both rotary and hand instrumentation for effective removal of gutta-percha for retreatment.

  2. Presence of Metallic Microfragments on Dentinal Walls and Instrument Defects following Root Canal Preparation.

    PubMed

    Solda, Caroline; Langaro, Marina C; Machado, Alessandra N; Vanni, José R; de A Decurcio, Daniel; Silva, Julio A; Estrela, Carlos; Barletta, Fernando B

    2017-04-01

    To determine the presence of metallic microfragments and their elemental composition in the dentinal walls of root canals following preparation using different endodontic instruments and to assess the active cutting edges of instruments with regard to structural defects. A total of 108 molar teeth were selected and prepared using different endodontic instruments. Teeth were randomly divided into nine groups of 12 teeth each, according to the instruments employed: Manual systems -K-FlexoFile, K-File, and Hedstroem; rotary systems - ProTaper Next, Mtwo, BioRaCe; and reciprocating systems - Reciproc, Unicone, and WaveOne. Both root canals and instruments were assessed using scanning electron microscopy, and the elemental composition of metallic microfragments was determined using energy-dispersive X-ray spectroscopy. Metallic microfragments were found in the groups prepared with both manual and reciprocating instruments, with no statistically significant differences between groups, thirds, or presence of metallic microfragments (p ≥ 0.05). Moreover, all groups presented structural defects in both new and used instruments; however, rotary instruments (ProTaper Next, Mtwo 702, BioRaCe) were the ones with the lowest number of defects, at statistically significant differences in comparison with other instruments (p < 0.05). The presence of metallic microfragments on dentinal walls following root canal preparation was associated with manual and reciprocating instrumentation. Furthermore, rotary instruments were the ones with the lowest number of defects. Considering the outcomes measured in this study, rotary instruments performed better than the other two groups, as they were associated with the lowest number of metallic microfragments and structural defects. During root canal preparation, operative procedures may induce changes to the root canal shape, as well as the release of metallic fragments resulting from the action of instruments on dentinal walls. Therefore, it is important to determine, among the different techniques used for this purpose, which ones are least susceptible to this occurrence.

  3. Influence of torque control motors and the operator's proficiency on ProTaper failures.

    PubMed

    Yared, Ghassan; Bou Dagher, Fadia; Kulkarni, Kiran

    2003-08-01

    The purpose of this study was to evaluate the influence of 2 electric torque control motors and operator experience with a specific nickel-titanium rotary instrumentation technique on the incidence of deformation and separation of instruments. ProTaper (PT) nickel-titanium rotary instruments were used at 300 rpm. In the first part of the study, electric high torque control (group 1) and low torque control (group 2) motors were compared. In the second part of the study, 3 operators with varying experience (groups 3, 4, and 5) were also compared. Twenty sets of PT instruments and 100 canals of extracted human molars were used in each group. Each set of PT instruments was used in up to 5 canals and sterilized before each case. For irrigation, 2.5% NaOCl was used. The number of deformed and separated instruments among the groups (within each part of the study) was statistically analyzed for significance with pair-wise comparisons by using the Fisher exact test (alpha =.05). In part 1, instrument deformation and separation did not occur in groups 1 and 2. In part 2, 25 and 12 instruments were deformed and separated, respectively, with the least experienced operator. Instrument deformation and separation did not occur with the most experienced operator. The Fisher exact test revealed a significant difference between groups 3 and 4 with respect to instrument deformation (P =.0296). In addition, the Fisher exact test revealed that the incidence of instrument deformation was statistically different between groups 3 and 5 (P <.0001) and groups 4 and 5 (P =.0018). The incidence of instrument separation was significantly higher in group 5 than in groups 3 and 4 (P =.001). Preclinical training in the use of the PT technique at 300 rpm is crucial to prevent instrument separation and reduce the incidence of instrument deformation. The use of an electric high torque control motor is safe with the experienced operator.

  4. Micro-CT evaluation of the effectiveness of the combined use of rotary and hand instrumentation in removal of Resilon.

    PubMed

    Asheibi, Fatma; Qualtrough, Alison J E; Mellor, Anthony; Withers, Philip J; Lowe, Tristan

    2014-01-01

    This study compares the effectiveness of ProTaper rotary files with ProTaper retreatment and K-files in the removal of Resilon or gutta percha (GP) from canals filled either by cold lateral condensation or thermal obturation using micro-CT. Ninety-six teeth were prepared using ProTaper files and allocated into four groups (n=24): Group-1 was filled with GP/AH-Plus and Group-2 with Resilon/RealSeal using cold lateral condensation. Group-3 was filled with GP/AH-Plus and Group-4 with Resilon/RealSeal using System B and Obtura II. The roots were scanned by micro-CT. Each group was divided into two subgroups (n=12): A, retreated using ProTaper files and B, using ProTaper retreatment and K-files. The roots were scanned to calculate the volume of the remaining material. With thermal obturation, roots filled with Resilon had significantly more remaining material than GP. Obturation using thermal technique resulted in significantly less remaining material than cold condensation except Resilon retreated using ProTaper retreatment and K-files.

  5. To evaluate and compare the efficacy, cleaning ability of hand and two rotary systems in root canal retreatment.

    PubMed

    Shivanand, Sunita; Patil, Chetan R; Thangala, Venugopal; Kumar, Pabbati Ravi; Sachdeva, Jyoti; Krishna, Akash

    2013-05-01

    To evaluate and compare the efficacy, cleaning ability of hand and two rotary systems in root canal retreatment. Sixty extracted premolars were retreated with following systems: Group -ProTaper Universal retreatment files, Group 2-ProFile system, Group 3-H-file. Specimens were split longitudinally and amount of remaining gutta-percha on the canal walls was assessed using direct visual scoring with the aid of stereomicroscope. Results were statistically analyzed using ANOVA test. Completely clean root canal walls were not achieved with any of the techniques investigated. However, all three systems proved to be effective for gutta-percha removal. Significant difference was found between ProTaper universal retreatment file and H-file, and also between ProFile and H-file. Under the conditions of the present study, ProTaper Universal retreatment files left significantly less guttapercha and sealer than ProFile and H-file. Rotary systems in combination with gutta-percha solvents can perform superiorly as compared to the time tested traditional hand instrumentation in root canal retreatment.

  6. Comparison of debris extruded apically and working time used by ProTaper Universal rotary and ProTaper retreatment system during gutta-percha removal

    PubMed Central

    UEZU, Mary Kinue Nakamune; BRITTO, Maria Leticia Borges; NABESHIMA, Cleber K.; PALLOTTA, Raul Capp

    2010-01-01

    Objective The aim of this study was to evaluate the in vitro action of ProTaper retreatment files and ProTaper Universal in the retreatment of mandibular premolars. Material and methods The amount of debris extruded apically was measured and the time to reach the working length and to complete the removal of gutta-percha was observed. Thirty teeth had their canals prepared using ProTaper Universal files and were obturated by the single cone technique. The teeth were then stored at 37ºC in a humid environment for 7 days. During the use of the rotary instruments for root canal filling removal, the apical portions of the teeth were attached to the open end of a resin tube to collect the apically extruded debris. Results ProTaper Universal files were significantly faster (p=0.0011) than the ProTaper retreatment files to perform gutta-percha removal, but no significant difference was found between the files regarding the time to reach the working length or the amount of apical extrusion. Conclusions ProTaper Universal rotary had better results for endodontic retreatment, and both techniques promote similar apical extrusion of debris. PMID:21308282

  7. Development of the pediatric daily ulcerative colitis signs and symptoms scale (DUCS): qualitative research findings.

    PubMed

    Flood, Emuella; Silberg, Debra G; Romero, Beverly; Beusterien, Kathleen; Erder, M Haim; Cuffari, Carmen

    2017-09-25

    The purpose of this study is to develop patient-reported (PRO) and observer-reported (ObsRO) outcome measures of ulcerative colitis (UC) signs/symptoms in children aged 5-17 with mild/moderate UC. The daily ulcerative colitis signs and symptoms scale (DUCS) was developed in two phases. Phase I involved concept elicitation interviews with patients and healthcare providers, review of website posts and item generation. Phase II involved cognitive debriefing and assessment of usability and feasibility of the eDiaries. Participants were recruited from five US clinical sites, a research recruitment agency, and internet advertising. Thematic and content analysis was performed to identify concepts from Phase I. The Phase II cognitive debriefing interviews were analyzed iteratively to identify problems with clarity and relevance of eDiary content. The US Food and Drug Administration (FDA) also reviewed and provided feedback on the eDiaries. Phase I included 32 participants (22 remission; 10 active disease). Phase II included 38 participants (22 remission; 16 active disease). A core set of seven signs and symptoms emerged that were reported by at least 30% of the patients interviewed: abdominal pain, blood in stool, frequent stools, diarrhea, stool urgency, nighttime stools, and tiredness. Participant input influenced changes such as refinement of item wording, revision of graphics, and selection of response scales. Revisions suggested by FDA included simplifying the response scale and adding questions to capture symptoms during sleeping hours. The findings of instrument development suggest that the DUCS PRO and ObsRO eDiaries are content-valid instruments for capturing the daily signs and symptoms of pediatric patients with mild to moderate UC in a clinical trial setting.

  8. Qualitative development of a patient-reported outcome symptom measure in diarrhea-predominant irritable bowel syndrome.

    PubMed

    Marquis, P; Lasch, K E; Delgado-Herrera, L; Kothari, S; Lembo, A; Lademacher, C; Spears, G; Nishida, A; Tesler, Waldman L; Piault, E; Rosa, K; Zeiher, B

    2014-06-26

    Despite a documented clinical need, no patient reported outcome (PRO) symptom measure meeting current regulatory requirements for clinically relevant end points is available for the evaluation of treatment benefit in diarrhea-predominant IBS (IBS-D). Patients (N=113) with IBS-D participated in five study phases: (1) eight concept elicitation focus groups (N=34), from which a 17-item IBS-D Daily Symptom Diary and four-item IBS-D Symptom Event Log (Diary and Event Log) were developed; (2) one-on-one cognitive interviews (N=11) to assess the instrument's comprehensiveness, understandability, appropriateness, and readability; (3) four data triangulation focus groups (N=32) to confirm the concepts elicited; (4) two hybrid (concept elicitation and cognitive interview) focus groups (N=16); and (5) two iterative sets of one-on-one cognitive interviews (N=20) to further clarify the symptoms of IBS-D and debrief a revised seven-item Diary and four-item Event Log. Of thirty-six concepts initially identified, 22 were excluded because they were not saturated, not clinically relevant, not critical symptoms of IBS-D, considered upper GI symptoms, or too broad or vaguely defined. The remaining concepts were diarrhea, immediate need (urgency), bloating/pressure, frequency of bowel movements, cramps, abdominal/stomach pain, gas, completely emptied bowels/incomplete evacuation, accidents, bubbling in intestines (bowel sounds), rectal burning, stool consistency, rectal spasm, and pain while wiping. The final instrument included a daily diary with separate items for abdominal and stomach pain and an event log with four items completed after each bowel movement as follows: (1) a record of the bowel movement/event and an assessment of (2) severity of immediacy of need/bowel urgency, (3) incomplete evacuation, and (4) stool consistency (evaluated using the newly developed Astellas Stool Form Scale). Based on rounds of interviews and clinical input, items considered secondary or nonspecific to IBS-D (rectal burning, bubbling in intestines, spasms, and pain while wiping) were excluded. The IBS-D Symptom Diary and Event Log represent a rigorously developed PRO instrument for the measurement of the IBS-D symptom experience from the perspective of the patient. Its content validity has been supported, and future work should evaluate the instrument's psychometric properties.

  9. Oncology patient-reported claims: maximising the chance for success.

    PubMed

    Kitchen, H; Rofail, D; Caron, M; Emery, M-P

    2011-01-01

    To review Patient Reported Outcome (PRO) labelling claims achieved in oncology in Europe and in the United States and consider the benefits, and challenges faced. PROLabels database was searched to identify oncology products with PRO labelling approved in Europe since 1995 or in the United States since 1998. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) websites and guidance documents were reviewed. PUBMED was searched for articles on PRO claims in oncology. Among all oncology products approved, 22 were identified with PRO claims; 10 in the United States, 7 in Europe, and 5 in both. The language used in the labelling was limited to benefit (e.g. "…resulted in symptom benefits by significantly prolonging time to deterioration in cough, dyspnoea, and pain, versus placebo") and equivalence (e.g. "no statistical differences were observed between treatment groups for global QoL"). Seven products used a validated HRQoL tool; two used symptom tools; two used both; seven used single-item symptom measures (one was unknown). The following emerged as likely reasons for success: ensuring systematic PRO data collection; clear rationale for pre-specified endpoints; adequately powered trials to detect differences and clinically significant changes; adjusting for multiplicity; developing an a priori statistical analysis plan including primary and subgroup analyses, dealing with missing data, pooling multiple-site data; establishing clinical versus statistical significance; interpreting failure to detect change. End-stage patient drop-out rates and cessation of trials due to exceptional therapeutic benefit pose significant challenges to demonstrating treatment PRO improvement. PRO labelling claims demonstrate treatment impact and the trade-off between efficacy and side effects ultimately facilitating product differentiation. Reliable and valid instruments specific to the desired language, claim, and target population are required. Practical considerations include rationale for study endpoints, transparency in assumptions, and attention to subtle variations in data.

  10. Oncology patient-reported claims: maximising the chance for success

    PubMed Central

    Kitchen, H; Rofail, D; Caron, M; Emery, M-P

    2011-01-01

    Objectives/purpose: To review Patient Reported Outcome (PRO) labelling claims achieved in oncology in Europe and in the United States and consider the benefits, and challenges faced. Methods: PROLabels database was searched to identify oncology products with PRO labelling approved in Europe since 1995 or in the United States since 1998. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) websites and guidance documents were reviewed. PUBMED was searched for articles on PRO claims in oncology. Results: Among all oncology products approved, 22 were identified with PRO claims; 10 in the United States, 7 in Europe, and 5 in both. The language used in the labelling was limited to benefit (e.g. “…resulted in symptom benefits by significantly prolonging time to deterioration in cough, dyspnoea, and pain, versus placebo”) and equivalence (e.g. “no statistical differences were observed between treatment groups for global QoL”). Seven products used a validated HRQoL tool; two used symptom tools; two used both; seven used single-item symptom measures (one was unknown). The following emerged as likely reasons for success: ensuring systematic PRO data collection; clear rationale for pre-specified endpoints; adequately powered trials to detect differences and clinically significant changes; adjusting for multiplicity; developing an a priori statistical analysis plan including primary and subgroup analyses, dealing with missing data, pooling multiple-site data; establishing clinical versus statistical significance; interpreting failure to detect change. End-stage patient drop-out rates and cessation of trials due to exceptional therapeutic benefit pose significant challenges to demonstrating treatment PRO improvement. Conclusions: PRO labelling claims demonstrate treatment impact and the trade-off between efficacy and side effects ultimately facilitating product differentiation. Reliable and valid instruments specific to the desired language, claim, and target population are required. Practical considerations include rationale for study endpoints, transparency in assumptions, and attention to subtle variations in data. PMID:22276055

  11. Systematic review of the psychometric properties and theoretical grounding of instruments evaluating self-care in people with type 2 diabetes mellitus.

    PubMed

    Caro-Bautista, Jorge; Martín-Santos, Francisco Javier; Morales-Asencio, Jose Miguel

    2014-06-01

    To determine the psychometric properties and theoretical grounding of instruments that evaluate self-care behaviour or barriers in people with type 2 diabetes. There are many instruments designed to evaluate self-care behaviour or barriers in this population, but knowledge about their psychometric validation processes is lacking. Systematic review. We conducted a search for psychometric or validation studies published between January 1990-December 2012. We carried out searches in Pubmed, CINAHL, PsycINFO, ProQuolid, BibliPRO and Google SCHOLAR to identify instruments that evaluated self-care behaviours or barriers to diabetes self-care. We conducted a systematic review with the following inclusion criteria: Psychometric or clinimetric validation studies that included patients with type 2 diabetes (exclusively or partially) and which analysed self-care behaviour or barriers to self-care and proxies like self-efficacy or empowerment, from a multidimensional approach. Language: Spanish or English. Two authors independently assessed the quality of the studies and extracted data using Terwee's proposed criteria: psychometrics properties, dimensionality, theoretical ground and population used for validation through each included instrument. Sixteen instruments achieved the inclusion criteria for the review. We detected important methodological flaws in many of the selected instruments. Only the Self-management Profile for Type 2 Diabetes and Problem Areas in Diabetes Scale met half of Terwee's quality criteria. There are no instruments for identifying self-care behaviours or barriers elaborated with a strong validation process. Further research should be carried out to provide patients, clinicians and researchers with valid and reliable instruments that are methodologically solid and theoretically grounded. © 2013 John Wiley & Sons Ltd.

  12. Blue treatment enhances cyclic fatigue resistance of vortex nickel-titanium rotary files.

    PubMed

    Plotino, Gianluca; Grande, Nicola M; Cotti, Elisabetta; Testarelli, Luca; Gambarini, Gianluca

    2014-09-01

    The aim of the present study was to evaluate the difference in cyclic fatigue resistance between Vortex Blue (Dentsply Tulsa Dental, Tulsa, OK) and Profile Vortex nickel-titanium (Dentsply Tulsa Dental) rotary instruments. Two groups of nickel-titanium endodontic instruments, ProFile Vortex and Vortex Blue, consisting of identical instruments in tip size and taper (15/.04, 20/.06, 25/.04, 25/.06, 30/.06, 35/.06, and 40/.04) were tested. Ten instruments from each system and size were tested for cyclic fatigue resistance, resulting in a total of 140 new instruments. All instruments were rotated in a simulated root canal with a 60° angle of curvature and a 5-mm radius of curvature of a specific cyclic fatigue testing device until fracture occurred. The number of cycles to failure and the length of the fractured tip were recorded for each instrument in each group. The mean values and standard deviation were calculated, and data were subjected to 1-way analysis of variance and a Bonferroni t test. Significance was set at the 95% confidence level. When comparing the same size of the 2 different instruments, a statistically significant difference (P < .05) was noted between all sizes of Vortex Blue and Profile Vortex instruments except for tip size 15 and .04 taper (P = 1.000). No statistically significant difference (P > .05) was noted among all groups tested in terms of fragment length. Vortex Blue showed a significant increase in cyclic fatigue resistance when compared with the same sizes of ProFile Vortex. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  13. Centering Ability of ProTaper Next and WaveOne Classic in J-Shape Simulated Root Canals

    PubMed Central

    Dioguardi, Mario; Cocco, Armando; Giuliani, Michele; Fabiani, Cristiano; D'Alessandro, Alfonso; Ciavarella, Domenico

    2016-01-01

    Introduction. The aim of this study was to evaluate and compare the shaping and centering ability of ProTaper Next (PTN; Dentsply Maillefer, Ballaigues, Switzerland) and WaveOne Classic systems (Dentsply Maillefer) in simulated root canals. Methods. Forty J-shaped canals in resin blocks were assigned to two groups (n = 20 for each group). Photographic method was used to record pre- and postinstrumentation images. After superimposition, centering and shaping ability were recorded at 9 different levels from the apex using the software Autocad 2013 (Autodesk Inc., San Rafael, USA). Results. Shaping procedures with ProTaper Next resulted in a lower amount of resin removed at each reference point level. In addition, the pattern of centering ability improved after the use of ProTaper Next in 8 of 9 measurement points. Conclusions. Within the limitations of this study, shaping procedures with ProTaper Next instruments demonstrated a lower amount of resin removed and a better centering ability than WaveOne Classic system. PMID:28054031

  14. Centering Ability of ProTaper Next and WaveOne Classic in J-Shape Simulated Root Canals.

    PubMed

    Troiano, Giuseppe; Dioguardi, Mario; Cocco, Armando; Giuliani, Michele; Fabiani, Cristiano; D'Alessandro, Alfonso; Ciavarella, Domenico; Lo Muzio, Lorenzo

    Introduction . The aim of this study was to evaluate and compare the shaping and centering ability of ProTaper Next (PTN; Dentsply Maillefer, Ballaigues, Switzerland) and WaveOne Classic systems (Dentsply Maillefer) in simulated root canals. Methods . Forty J-shaped canals in resin blocks were assigned to two groups ( n = 20 for each group). Photographic method was used to record pre- and postinstrumentation images. After superimposition, centering and shaping ability were recorded at 9 different levels from the apex using the software Autocad 2013 (Autodesk Inc., San Rafael, USA). Results . Shaping procedures with ProTaper Next resulted in a lower amount of resin removed at each reference point level. In addition, the pattern of centering ability improved after the use of ProTaper Next in 8 of 9 measurement points. Conclusions . Within the limitations of this study, shaping procedures with ProTaper Next instruments demonstrated a lower amount of resin removed and a better centering ability than WaveOne Classic system.

  15. Concept Elicitation Within Patient-Powered Research Networks: A Feasibility Study in Chronic Lymphocytic Leukemia.

    PubMed

    McCarrier, Kelly P; Bull, Scott; Fleming, Sarah; Simacek, Kristina; Wicks, Paul; Cella, David; Pierson, Renee

    2016-01-01

    To explore the feasibility of using social media-based patient networks to gather qualitative data on patient-reported outcome (PRO) concepts relevant to chronic lymphocytic leukemia (CLL). Between August and November 2013, US-residing members of the PatientsLikeMe online CLL patient community completed open-ended web-based surveys designed to elicit descriptions of CLL symptoms, impacts, and treatment-related perceptions. Qualitative telephone follow-up interviews were conducted with a subsample of respondents. Survey responses and interview transcripts were coded for qualitative analysis using Atlas.ti. Fifty survey responses were included in the analyses. Participants were age 60.5 ± 6.9 years, 54% female, and 96% white. When surveyed, 20% were receiving current treatment, 16% were in remission, and 64% were treatment-naïve. Among respondents, 369 descriptions of CLL symptoms were coded. Fatigue-related symptoms were expressed most frequently, with 54% reporting "fatigue," "tiredness," or both in their responses. These concepts were followed by night sweats (38%), swollen lymph nodes (32%), and frequent infections (28%). Among impacts of CLL, worry and fear (66% of respondents), depressed feelings (52%), and work limitations (50%) were noted most frequently. Survey results identified constitutional symptoms of CLL included in existing PRO instruments and the literature. Although the findings suggest that qualitative data obtained through social media applications can be potentially useful in supporting concept identification for newly developed PRO instruments, they also indicate that online approaches alone may not be sufficient to achieve efficient and exhaustive concept elicitation. Further research is needed to identify whether the results can support content validity in the same way as established qualitative research methods. Copyright © 2016. Published by Elsevier Inc.

  16. Key issues affecting quality of life and patient-reported outcomes in prostate cancer: an analysis conducted in 2128 patients with initial psychometric assessment of the prostate cancer symptom scale (PCSS).

    PubMed

    Msaouel, Pavlos; Gralla, Richard J; Jones, Randy A; Hollen, Patricia J

    2017-09-01

    Evidence-based quality of life (QL) questionnaires require the identification of issues of importance to patients. The primary aim of this study was to inform providers on patient-expressed issues while enhancing the content validity of instruments assessing QL and patient-reported outcomes (PROs) in prostate cancer. The study provided additional psychometric properties for the new PRO and QL instrument, the Prostate Cancer Symptom Scale (PCSS). An anonymous web-based survey of 2128 patients with prostate cancer was conducted with patients rating 18 QL items on a five-point scale. Most respondents (74%) were aged 55-74 years, had early stage disease at diagnosis (81%) and were diagnosed within 2 years of the survey (81%). The top five-rated issues were: overall QL, ability to perform normal activities, maintaining independence, ability to sleep and not being a burden. These items were ranked as either 'very important' or 'important' by at least 88% of patients. None of the most highly ranked issues were symptoms. Instead, the highest ranked items were global issues reflecting the impact of symptoms on patients. In addition to the enhanced content validity findings, good reliability results and initial support for construct validity are reported for the PCSS. This is the largest survey providing patient-expressed background for content validity for QL and PRO measures. The findings of this study should aid development of newer practical questionnaires, such as the PCSS, which can be adapted to electronic platforms enhancing rapid and accurate PRO and QL evaluation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  17. The Effects of Torsional Preloading on the Torsional Resistance of Nickel-titanium Instruments.

    PubMed

    Oh, Seung-Hei; Ha, Jung-Hong; Kwak, Sang Won; Ahn, Shin Wook; Lee, WooCheol; Kim, Hyeon-Cheol

    2017-01-01

    This study evaluated the effect of torsional preloading on the torsional resistance of nickel-titanium (NiTi) endodontic instruments. WaveOne Primary (Dentsply Maillefer, Ballaigues, Switzerland) and ProTaper Universal F2 (Dentsply Maillefer) files were used. The ultimate torsional strength until fracture was determined for each instrument. In the phase 1 experiment, the ProTaper and WaveOne files were loaded to have a maximum load from 2.0 up to 2.7 or 2.8 Ncm, respectively. In the phase 2 experiment, the number of repetitions of preloading for each file was increased from 50 to 200, whereas the preloading torque was fixed at 2.4 Ncm. Using torsionally preloaded specimens from phase 1 and 2, the torsional resistances were calculated to determine the ultimate strength, distortion angle, and toughness. The results were analyzed using 1-way analysis of variance and Duncan post hoc comparison. The fracture surfaces and longitudinal aspect of 5 specimens per group were examined under a scanning electron microscope. All preloaded groups showed significantly higher ultimate strength than the unpreloaded groups (P < .05). There was no significant difference among all groups for distortion angle and toughness. Although WaveOne had no significant difference between the repetition groups for ultimate strength, fracture angle, and toughness, ProTaper had a higher distortion angle and toughness in the 50-repetition group compared with the other repetition groups (P < .05). Scanning electron microscopic examinations of the fractured surface showed typical features of torsional fracture. Torsional preloading within the ultimate values could enhance the torsional strength of NiTi instruments. The total energy until fracture was maintained constantly, regardless of the alloy type. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  18. The effectiveness of manual and mechanical instrumentation for the retreatment of three different root canal filling materials.

    PubMed

    Somma, Francesco; Cammarota, Giuseppe; Plotino, Gianluca; Grande, Nicola M; Pameijer, Cornelis H

    2008-04-01

    The aim of this study was to compare the effectiveness of the Mtwo R (Sweden & Martina, Padova, Italy), ProTaper retreatment files (Dentsply-Maillefer, Ballaigues, Switzerland), and a Hedström manual technique in the removal of three different filling materials (gutta-percha, Resilon [Resilon Research LLC, Madison, CT], and EndoRez [Ultradent Products Inc, South Jordan, UT]) during retreatment. Ninety single-rooted straight premolars were instrumented and randomly divided into 9 groups of 10 teeth each (n = 10) with regards to filling material and instrument used. For all roots, the following data were recorded: procedural errors, time of retreatment, apically extruded material, canal wall cleanliness through optical stereomicroscopy (OSM), and scanning electron microscopy (SEM). A linear regression analysis and three logistic regression analyses were performed to assess the level of significance set at p = 0.05. The results indicated that the overall regression models were statistically significant. The Mtwo R, ProTaper retreatment files, and Resilon filling material had a positive impact in reducing the time for retreatment. Both ProTaper retreatment files and Mtwo R showed a greater extrusion of debris. For both OSM and SEM logistic regression models, the root canal apical third had the greatest impact on the score values. EndoRez filling material resulted in cleaner root canal walls using OSM analysis, whereas Resilon filling material and both engine-driven NiTi rotary techniques resulted in less clean root canal walls according to SEM analysis. In conclusion, all instruments left remnants of filling material and debris on the root canal walls irrespective of the root filling material used. Both the engine-driven NiTi rotary systems proved to be safe and fast devices for the removal of endodontic filling material.

  19. Incidence of microcracks in maxillary first premolars after instrumentation with three different mechanized file systems: a comparative ex vivo study.

    PubMed

    Kfir, A; Elkes, D; Pawar, A; Weissman, A; Tsesis, I

    2017-01-01

    The objective of this study is to determine the potential for microcracks in the radicular dentin of first maxillary premolars using three different mechanized endodontic instrumentation systems. Eighty extracted maxillary first premolars with two root canals and no externally visible microcracks were selected. Root canal instrumentation was performed with either the ProTaper file system, the WaveOne primary file, or the self-adjusting file (SAF). Teeth with intact roots served as controls. The roots were cut into segments and examined with an intensive, small-diameter light source that was applied diagonally to the entire periphery of the root slice under ×20 magnification; the presence of microcracks and fractures was recorded. Pearson's chi-square method was used for statistical analysis, and significance was set at p < 0.05. Microcracks were present in 30 and 20 % of roots treated with the ProTaper and WaveOne systems, respectively, while no microcracks were present in the roots treated with the SAF (p = 0.008 and p = 0.035, respectively). Intact teeth presented with cracks in 5 % of the roots. The intensive, small-diameter light source revealed microcracks that could not be detected when using the microscope's light alone. Within the limitations of this study, it could be concluded that mechanized root canal instrumentation with the ProTaper and WaveOne systems in maxillary first premolars causes microcracks in the radicular dentin, while the use of the SAF file causes no such microcracks. Rotary and reciprocating files with large tapers may cause microcracks in the radicular dentin of maxillary first premolars. Less aggressive methods should be considered for these teeth.

  20. The Deflection Plate Analyzer: A Technique for Space Plasma Measurements Under Highly Disturbed Conditions

    NASA Technical Reports Server (NTRS)

    Wright, Kenneth H., Jr.; Dutton, Ken; Martinez, Nelson; Smith, Dennis; Stone, Nobie H.

    2004-01-01

    A technique has been developed to measure the characteristics of space plasmas under highly disturbed conditions; e.g., non-Maxwellian plasmas with strong drifting populations and plasmas contaminated by spacecraft outgassing. The present method is an extension of the capabilities of the Differential Ion Flux Probe (DIFP) to include a mass measurement that does not include either high voltage or contamination sensitive devices such as channeltron electron multipliers or microchannel plates. This reduces the complexity and expense of instrument fabrication, testing, and integration of flight hardware as compared to classical mass analyzers. The new instrument design is called the Deflection Plate Analyzer (DPA) and can deconvolve multiple ion streams and analyze each stream for ion flux intensity (density), velocity (including direction of motion), mass, and temperature (or energy distribution). The basic functionality of the DPA is discussed. The performance characteristics of a flight instrument as built for an electrodynamic tether mission, the Propulsive Small Expendable Deployer System (ProSEDS), and the instrument s role in measuring key experimental conditions are also discussed.

  1. The Deflection Plate Analyzer: A Technique for Space Plasma Measurements Under Highly Disturbed Conditions

    NASA Technical Reports Server (NTRS)

    Wright, Kenneth H., Jr.; Dutton, Ken; Martinez, Nelson; Smith, Dennis; Stone, Nobie H.

    2003-01-01

    A technique has been developed to measure the characteristics of space plasmas under highly disturbed conditions; e.g., non-Maxwellian plasmas with strong drifting populations and plasmas contaminated by spacecraft outgassing. The present method is an extension of the capabilities of the Differential Ion Flux Probe (DIFP) to include a mass measurement that does not include either high voltage or contamination sensitive devices such as channeltron electron multipliers or microchannel plates. This reduces the complexity and expense of instrument fabrication, testing, and integration of flight hardware as compared to classical mass analyzers. The new instrument design is called the Deflection Plate Analyzer (DPA) and can deconvolve multiple ion streams and analyze each stream for ion flux intensity (density), velocity (including direction of motion), mass, and temperature (or energy distribution). The basic functionality of the DPA is discussed. The performance characteristics of a flight instrument as built for an electrodynamic tether mission, the Propulsive Small Expendable Deployer System (ProSEDS), and the instrument s role in measuring key experimental conditions are also discussed.

  2. A comparative evaluation of two rotary Ni-Ti instruments in the removal of gutta-percha during retreatment

    PubMed Central

    Preetam, C. S.; Chandrashekhar, M.; Gunaranjan, T.; Kumar, S. Kishore; Miskeen Sahib, S. A.; Kumar, M. Senthil

    2016-01-01

    Aim: The purpose of this study is to achieve an effective method to remove root canal filling material from the root canal system. The study, thus, aims to evaluate the efficacy of the cleaning ability of two different rotary Ni-Ti systems; ProTaper Retreatment files and RaCe System compared to hand instrumentation with Hedstrom files for the removal of gutta-percha during retreatment. Materials and Methods: Thirty mandibular premolars with one single straight canal were decoronated and instrumented with ProTaper files and filled with thermoplastic gutta-percha. After 30 days, the samples were divided into three groups and gutta-percha was removed with the test instruments. The postoperative radiographs were evaluated with known criteria by dividing the root into cervical third, middle third, and apical third. The results were tabulated and Statistical Package for Social Sciences Software (IBM Corporation) was used for analysis. Results: The mean deviation of the results were first calculated and then t-test and analysis of variance test (two-tailed P value) were evaluated for establishing significant differences. The rotary instruments were effective in removing the gutta-percha from the canals. Therefore, significant difference was observed between the efficacies of the two rotary systems used. The rotary instruments showed effective gutta-percha removal in the cervical and middle one third. (P > 0.05). However, apical debridement was effective with Hedstrom files. Conclusion: The study concluded the use of both rotary and hand instrumentation for effective removal of gutta-percha for retreatment. PMID:27652245

  3. Extrusion of Debris from Primary Molar Root Canals following Instrumentation with Traditional and New File Systems.

    PubMed

    Thakur, Bhagyashree; Pawar, Ajinkya M; Kfir, Anda; Neelakantan, Prasanna

    2017-11-01

    To assess the amount of debris extruded apically during instrumentation of distal canals of extracted primary molars by three instrument systems [ProTaper Universal (PTU), ProTaper NEXT (PTN), and self-adjusting file (SAF)] compared with conventional stainless steel hand K-files (HF, control). Primary mandibular molars (n = 120) with a single distal canal were selected and randomly divided into four groups (n = 30) for root canal instrumentation using group I, HF (to size 0.30/0.02 taper), group II, PTU (to size F3), group III, PTN (to size X3), and group IV, SAF. Debris extruded during instrumentation was collected in preweighed Eppendorf tubes, stored in an incubator at 70°C for 5 days and then weighed. Statistical analysis was performed by one-way analysis of variance (ANOVA), followed by Turkey's post hoc test (p = 0.05). All the groups resulted in extrusion of debris. There was statistically significant difference (p < 0.001) in the debris extrusion between the three groups: HF (0.00133 ± 0.00012), PTU (0.00109 ± 0.00005), PTN (0.00052 ± 0.00008), and SAF (0.00026 ± 0.00004). Instrumentation with SAF resulted in the least debris extrusion when used for shaping root canals of primary molar teeth. Debris extrusion in primary teeth poses an adverse effect on the stem cells and may also alter the permanent dental germ. Debris extrusion is rarely reported for primary teeth and it is important for the clinician to know which endodontic instrumentation leads to less extrusion of debris.

  4. Genetic evidence of a causal effect of insulin resistance on branched-chain amino acid levels.

    PubMed

    Mahendran, Yuvaraj; Jonsson, Anna; Have, Christian T; Allin, Kristine H; Witte, Daniel R; Jørgensen, Marit E; Grarup, Niels; Pedersen, Oluf; Kilpeläinen, Tuomas O; Hansen, Torben

    2017-05-01

    Fasting plasma levels of branched-chain amino acids (BCAAs) are associated with insulin resistance, but it remains unclear whether there is a causal relation between the two. We aimed to disentangle the causal relations by performing a Mendelian randomisation study using genetic variants associated with circulating BCAA levels and insulin resistance as instrumental variables. We measured circulating BCAA levels in blood plasma by NMR spectroscopy in 1,321 individuals from the ADDITION-PRO cohort. We complemented our analyses by using previously published genome-wide association study (GWAS) results from the Meta-Analyses of Glucose and Insulin-related traits Consortium (MAGIC) (n = 46,186) and from a GWAS of serum BCAA levels (n = 24,925). We used a genetic risk score (GRS), calculated using ten established fasting serum insulin associated variants, as an instrumental variable for insulin resistance. A GRS of three variants increasing circulating BCAA levels was used as an instrumental variable for circulating BCAA levels. Fasting plasma BCAA levels were associated with higher HOMA-IR in ADDITION-PRO (β 0.137 [95% CI 0.08, 0.19] p = 6 × 10 -7 ). However, the GRS for circulating BCAA levels was not associated with fasting insulin levels or HOMA-IR in ADDITION-PRO (β -0.011 [95% CI -0.053, 0.032] p = 0.6 and β -0.011 [95% CI -0.054, 0.031] p = 0.6, respectively) or in GWAS results for HOMA-IR from MAGIC (β for valine-increasing GRS -0.012 [95% CI -0.069, 0.045] p = 0.7). By contrast, the insulin-resistance-increasing GRS was significantly associated with increased BCAA levels in ADDITION-PRO (β 0.027 [95% CI 0.005, 0.048] p = 0.01) and in GWAS results for serum BCAA levels (β 1.22 [95% CI 0.71, 1.73] p = 4 × 10 -6 , β 0.96 [95% CI 0.45, 1.47] p = 3 × 10 -4 , and β 0.67 [95% CI 0.16, 1.18] p = 0.01 for isoleucine, leucine and valine levels, respectively) and instrumental variable analyses in ADDITION-PRO indicated that HOMA-IR is causally related to higher circulating fasting BCAA levels (β 0.73 [95% CI 0.26, 1.19] p = 0.002). Our results suggest that higher BCAA levels do not have a causal effect on insulin resistance while increased insulin resistance drives higher circulating fasting BCAA levels.

  5. Use of a capillary electrophoresis instrument with laser-induced fluorescence detection for DNA quantitation. Comparison of YO-PRO-1 and PicoGreen assays.

    PubMed

    Guillo, Christelle; Ferrance, Jerome P; Landers, James P

    2006-04-28

    Highly selective and sensitive assays are required for detection and quantitation of the small masses of DNA typically encountered in clinical and forensic settings. High detection sensitivity is achieved using fluorescent labeling dyes and detection techniques such as spectrofluorometers, microplate readers and cytometers. This work describes the use of a laser-induced fluorescence (LIF) detector in conjunction with a commercial capillary electrophoresis instrument for DNA quantitation. PicoGreen and YO-PRO-1, two fluorescent DNA labeling dyes, were used to assess the potential of the system for routine DNA analysis. Linearity, reproducibility, sensitivity, limits of detection and quantitation, and sample stability were examined for the two assays. The LIF detector response was found to be linear (R2 > 0.999) and reproducible (RSD < 9%) in both cases. The PicoGreen assay displayed lower limits of detection and quantitation (20 pg and 60 pg, respectively) than the YO-PRO-1 assay (60 pg and 260 pg, respectively). Although a small variation in fluorescence was observed for the DNA/dye complexes over time, quantitation was not significantly affected and the solutions were found to be relatively stable for 80 min. The advantages of the technique include a 4- to 40-fold reduction in the volume of sample required compared to traditional assays, a 2- to 20-fold reduction in the volume of reagents consumed, fast and automated analysis, and low cost (no specific instrumentation required).

  6. Validation of the German patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™).

    PubMed

    Hagelstein, V; Ortland, I; Wilmer, A; Mitchell, S A; Jaehde, U

    2016-12-01

    Integrating the patient's perspective has become an increasingly important component of adverse event reporting. The National Cancer Institute has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™). This instrument has been translated into German and linguistically validated; however, its quantitative measurement properties have not been evaluated. A German language survey that included 31 PRO-CTCAE items, as well as the EORTC QLQ-C30 and the Oral Mucositis Daily Questionnaire (OMDQ), was distributed at 10 cancer treatment settings in Germany and Austria. Item quality was assessed by analysis of acceptability and comprehensibility. Reliability was evaluated by using Cronbach's' alpha and validity by principal components analysis (PCA), multitrait-multimethod matrix (MTMM) and known groups validity techniques. Of 660 surveys distributed to the study centres, 271 were returned (return rate 41%), and data from 262 were available for analysis. Participants' median age was 59.7 years, and 69.5% of the patients were female. Analysis of item quality supported the comprehensibility of the 31 PRO-CTCAE items. Reliability was very good; Cronbach's' alpha correlation coefficients were >0.9 for almost all item clusters. Construct validity of the PRO-CTCAE core item set was shown by identifying 10 conceptually meaningful item clusters via PCA. Moreover, construct validity was confirmed by the MTMM: monotrait-heteromethod comparison showed 100% high correlation, whereas heterotrait-monomethod comparison indicated 0% high correlation. Known groups validity was supported; PRO-CTCAE scores were significantly lower for those with impaired versus preserved health-related quality of life. A set of 31 items drawn from the German PRO-CTCAE item library demonstrated favourable measurement properties. These findings add to the body of evidence that PRO-CTCAE provides a rigorous method to capture patient self-reports of symptomatic toxicity for use in cancer clinical trials. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  7. Root canal preparation of mandibular molars with 3 nickel-titanium rotary instruments: a micro-computed tomographic study.

    PubMed

    Zhao, Dan; Shen, Ya; Peng, Bin; Haapasalo, Markus

    2014-11-01

    The aim of this study was to describe the canal shaping properties of ProTaper Next (PTN; Dentsply Maillefer, Ballaigues, Switzerland), ProTaper Universal (PTU; Dentsply Tulsa Dental Specialties, Johnson City, TN), and WaveOne (Dentsply Maillefer) nickel-titanium instruments in mandibular first molars by using micro-computed tomographic (micro-CT) scanning. A total of 36 maxillary first molars with 2 separate mesial canals and 1 distal canal were selected and scanned preoperatively and postoperatively by using micro-CT scanning with a voxel size of 30 μm. Canals were prepared with PTU, PTN, and WaveOne systems under hypochlorite irrigation. The volume of the untreated canal; the volume of dentin removed after preparation; the amount of the uninstrumented area; and the transportation to the coronal, middle, and apical thirds of canals were measured. The preparation time and instrument failure were also recorded. Instrumentation of canals increased their volume and surface area. The distal canals had a significantly higher proportion of unprepared surfaces than mesial canals (P < .05). The PTN system produced less transportation than the WaveOne and PTU systems in the apical third of the mesial canals (P < .05). There was no significant difference on apical transportation in distal canals among the 3 instrument systems. Instrumentation with WaveOne was significantly faster than with the other 2 instruments (P < .05). The PTN, PTU, and WaveOne instruments shaped root canals in mandibular first molars in vitro without significant shaping errors. The curved canals prepared using PTN had less apical transportation than the canals prepared using WaveOne and PTU. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  8. Behavior of nickel-titanium instruments manufactured with different thermal treatments.

    PubMed

    Pereira, Érika Sales Joviano; Viana, Ana Cecília Diniz; Buono, Vicente Tadeu Lopes; Peters, Ove A; Bahia, Maria Guiomar de Azevedo

    2015-01-01

    The purpose of this study was to investigate if nickel-titanium instruments with similar designs manufactured by different thermal treatments would exhibit significantly different in vitro behavior. Thirty-six instruments each of ProTaper Universal (PTU F1; Dentsply Maillefer, Ballaigues, Switzerland), ProFile Vortex (PV; Dentsply Tulsa Dental Specialties, Tulsa, OK), Vortex Blue (VB, Dentsply Tulsa Dental Specialties), and TYPHOON Infinite Flex NiTi (TYP; Clinician's Choice Dental Products, New Milford, CT) (all size 25/.06) were evaluated. Bending resistance, torsion at failure, and dynamic torsional tests were performed with the instruments (n = 12). Analysis of variance and Tukey post hoc tests were applied. Flexibility was significantly higher for TYP compared with the other 3 groups (P < .0001). With respect to the maximum torque at failure, PV group showed the highest resistance to twisting (torsional strength) among the analyzed instruments followed by VB, TYP, and PTU. The TYP group exhibited greater angular deflection at failure compared with the other groups (P < .0001). The mean dynamic torque scores during simulated canal preparation were highest for TYP (3.01 ± 0.71 Ncm) and lowest for PV (1.62 ± 0.79 Ncm). However, no significant differences were observed comparing groups PTU with TYP and VB and VB with PV (P > .05). The highest mean forces were recorded with PTU (7.02 ± 2.36 N) and the lowest with TYP (1.22 ± 0.40 N). TYP instruments were significantly more flexible than the other instruments tested. The PV group had the highest torsional strength and TYP, despite being the most flexible, showed similar torsional moments to the other instruments, whereas its angular deflection was the highest among the groups. Copyright © 2015 American Association of Endodontists. All rights reserved.

  9. Wizard CD Plus and ProTaper Universal: analysis of apical transportation using new software

    PubMed Central

    GIANNASTASIO, Daiana; da ROSA, Ricardo Abreu; PERES, Bernardo Urbanetto; BARRETO, Mirela Sangoi; DOTTO, Gustavo Nogara; KUGA, Milton Carlos; PEREIRA, Jefferson Ricardo; SÓ, Marcus Vinícius Reis

    2013-01-01

    Objective This study has two aims: 1) to evaluate the apical transportation of the Wizard CD Plus and ProTaper Universal after preparation of simulated root canals; 2) to compare, with Adobe Photoshop, the ability of a new software (Regeemy) in superposing and subtracting images. Material and Methods Twenty five simulated root canals in acrylic-resin blocks (with 20º curvature) underwent cone beam computed tomography before and after preparation with the rotary systems (70 kVp, 4 mA, 10 s and with the 8×8 cm FoV selection). Canals were prepared up to F2 (ProTaper) and 24.04 (Wizard CD Plus) instruments and the working length was established to 15 mm. The tomographic images were imported into iCAT Vision software and CorelDraw for standardization. The superposition of pre- and post-instrumentation images from both systems was performed using Regeemy and Adobe Photoshop. The apical transportation was measured in millimetres using Image J. Five acrylic resin blocks were used to validate the superposition achieved by the software. Student's t-test for independent samples was used to evaluate the apical transportation achieved by the rotary systems using each software individually. Student's t-test for paired samples was used to compare the ability of each software in superposing and subtracting images from one rotary system per time. Results The values obtained with Regeemy and Adobe Photoshop were similar to rotary systems (P>0.05). ProTaper Universal and Wizard CD Plus promoted similar apical transportation regardless of the software used for image's superposition and subtraction (P>0.05). Conclusion Wizard CD Plus and ProTaper Universal promoted little apical transportation. Regeemy consists in a feasible software to superpose and subtract images and appears to be an alternative to Adobe Photoshop. PMID:24212994

  10. In Vitro Comparison of Gutta-Percha Removal with H-File and ProTaper with or without Chloroform

    PubMed Central

    Khalilak, Zohreh; Vatanpour, Mehdi; Dadresanfar, Bahareh; Moshkelgosha, Pouneh; Nourbakhsh, HamidReza

    2013-01-01

    Introduction Removal of root filling materials is one of the key steps in success of root canal retreatment. The purpose of this study was to evaluate the efficacy of H-File and ProTaper with or without chloroform in the removal of gutta-percha during retreatment of mandibular premolars. Materials and Methods Sixty mandibular premolars with one canal, and curvatures less than 30 degrees were used in this experimental study. They were instrumented with K-files and laterally obturated with condensed gutta-percha using AH26 as the sealer and were stored in 100% humidity at 37°C for 2 weeks. The teeth were randomly divided into four groups of 15 teeth each. Removal of gutta-percha was performed with H-File and ProTaper. All techniques were used with or without chloroform. The teeth were split longitudinally and the area of remaining gutta-percha/sealer on the root canal wall was explored under stereomicroscope. Retreatment time duration was also recorded for each sample. Data were analyzed statistically by Two-way ANOVA, t-test and Tukey’s. Results In all groups, no significant difference was found in remaining gutta-percha and sealer with or without using chloroform, but chloroform shortened the time of retreatment. ProTaper left significantly less remaining filling materials than H-File (P<0.05). Retreatment time was significantly different between the studied groups (P<0.001). Conclusion ProTaper Ni-Ti instruments proved to be more efficient and time-saving devices for removal of gutta-percha compared to H-File in canals with no or slight curvature. PMID:23413203

  11. Wizard CD Plus and ProTaper Universal: analysis of apical transportation using new software.

    PubMed

    Giannastasio, Daiana; Rosa, Ricardo Abreu da; Peres, Bernardo Urbanetto; Barreto, Mirela Sangoi; Dotto, Gustavo Nogara; Kuga, Milton Carlos; Pereira, Jefferson Ricardo; Só, Marcus Vinícius Reis

    2013-01-01

    This study has two aims: 1) to evaluate the apical transportation of the Wizard CD Plus and ProTaper Universal after preparation of simulated root canals; 2) to compare, with Adobe Photoshop, the ability of a new software (Regeemy) in superposing and subtracting images. Twenty five simulated root canals in acrylic-resin blocks (with 20º curvature) underwent cone beam computed tomography before and after preparation with the rotary systems (70 kVp, 4 mA, 10 s and with the 8×8 cm FoV selection). Canals were prepared up to F2 (ProTaper) and 24.04 (Wizard CD Plus) instruments and the working length was established to 15 mm. The tomographic images were imported into iCAT Vision software and CorelDraw for standardization. The superposition of pre- and post-instrumentation images from both systems was performed using Regeemy and Adobe Photoshop. The apical transportation was measured in millimetres using Image J. Five acrylic resin blocks were used to validate the superposition achieved by the software. Student's t-test for independent samples was used to evaluate the apical transportation achieved by the rotary systems using each software individually. Student's t-test for paired samples was used to compare the ability of each software in superposing and subtracting images from one rotary system per time. The values obtained with Regeemy and Adobe Photoshop were similar to rotary systems (P>0.05). ProTaper Universal and Wizard CD Plus promoted similar apical transportation regardless of the software used for image's superposition and subtraction (P>0.05). Wizard CD Plus and ProTaper Universal promoted little apical transportation. Regeemy consists in a feasible software to superpose and subtract images and appears to be an alternative to Adobe Photoshop.

  12. Influence of operator experience on canal preparation time when using the rotary Ni-Ti ProFile system in simulated curved canals.

    PubMed

    Mesgouez, C; Rilliard, F; Matossian, L; Nassiri, K; Mandel, E

    2003-03-01

    The aim of this study was to determine the influence of operator experience on the time needed for canal preparation when using a rotary nickel-titanium (Ni-Ti) system. A total of 100 simulated curved canals in resin blocks were used. Four operators prepared a total of 25 canals each. The operators included practitioners with prior experience of the preparation technique, and practitioners with no experience. The working length for each instrument was precisely predetermined. All canals were instrumented with rotary Ni-Ti ProFile Variable Taper Series 29 engine-driven instruments using a high-torque handpiece (Maillefer, Ballaigues, Switzerland). The time taken to prepare each canal was recorded. Significant differences between the operators were analysed using the Student's t-test and the Kruskall-Wallis and Dunn nonparametric tests. Comparison of canal preparation times demonstrated a statistically significant difference between the four operators (P < 0.001). In the inexperienced group, a significant linear regression between canal number and preparation time occurred. Time required for canal preparation was inversely related to operator experience.

  13. Working plan for the use of patient-reported outcome measures in adults with brain tumours: a Response Assessment in Neuro-Oncology (RANO) initiative.

    PubMed

    Dirven, Linda; Armstrong, Terri S; Blakeley, Jaishri O; Brown, Paul D; Grant, Robin; Jalali, Rakesh; Leeper, Heather; Mendoza, Tito; Nayak, Lakshmi; Reijneveld, Jaap C; Le Rhun, Emilie; Walbert, Tobias; Weller, Michael; Wen, Patrick Y; Taphoorn, Martin J B

    2018-03-01

    The Response Assessment in Neuro-Oncology-Patient-Reported Outcome (RANO-PRO) working group is an international multidisciplinary collaboration that provides guidance on the use of patient-reported outcome (PRO) measures in clinical trials and practice for adult patients with brain tumours. Findings from both PROs and traditional outcome measures, such as survival, and clinical or radiological response, are essential to inform the research community, policy makers, physicians, and patients in the treatment decision-making process. Previous initiatives in oncology have focused on guidelines concerning the collection, analysis, interpretation, and reporting of PRO data. However, we recommend the application of appropriate PRO instruments, with respect to its content and measurement properties (ie, research question, content validity, and other measurement properties), in brain tumour research. PROs should be well defined and reliable to generate high-quality evidence, and our recommendations on the use of specific PRO measures could help to improve the quality of PRO evidence derived from neuro-oncological studies, and might add a new dimension in how the value of therapeutics is assessed in patients with brain tumours. In this Policy Review, we present the RANO-PRO working plan for the use of PROs in adults with brain tumours. Copyright © 2018 Elsevier Ltd. All rights reserved.

  14. Validity of the prenatal risk overview for detecting drug use disorders in pregnancy.

    PubMed

    Harrison, Patricia A; Godecker, Amy; Sidebottom, Abbey

    2012-11-01

    To validate the Prenatal Risk Overview (PRO) drug use questions against a structured diagnostic interview among pregnant women. Prenatal care patients were administered the PRO at intake and then asked to consent to a research diagnostic interview. Of 1,367 women asked to participate, 1,274 consented and 745 completed the study. Three drug use items comprised one of 13 PRO psychosocial risk domains. The Structured Clinical Interview for DSM-IV (SCID) was used as the validation instrument. To assess criterion validity, the Moderate/High and High Risk classifications were cross-tabulated with SCID Drug Use Disorder diagnoses. In response to the PRO, almost one third of participants (29.4%) reported drug use during the 12 months pre-pregnancy awareness and 11.0% reported use post-pregnancy awareness; 7.0% met SCID diagnostic criteria for Drug Abuse, Drug Dependence, or both, primarily for marijuana use. Drug Use Disorder sensitivity and specificity rates for the PRO Moderate/High Risk classifications were 88.5% and 74.3%, respectively, and for High Risk only, 78.8% and 87.3%. The PRO yielded substantial self-reporting of drug use before and after pregnancy awareness with high sensitivity and specificity for detecting Drug Use Disorders. PRO results can inform decisions about appropriate clinical responses. © 2012 Wiley Periodicals, Inc.

  15. [The influence of autoclave sterilization on surface characteristics and cyclic fatigue resistance of 3 nickel-titanium rotary instruments].

    PubMed

    Li, Xiang-fen; Zheng, Ping; Xu, Li; Su, Qin

    2015-12-01

    To investigate the effects of autoclave sterilization on surface characteristics and cyclic fatigue resistance of 3 types of nickel-titanium rotary instruments (K3, Mtwo, ProTaper). Three brands of NiTi rotary endodontic instruments of the same size (tip diameter 0.25 mm and constant 0.06 taper) were selected: K3, Mtwo and Protaper (F2). 24 instruments for each brand were used to evaluate the effects of autoclave sterilization on inner character in the as-received condition and after subjection to 0, 1, 5, and 10 sterilization cycles (6 for each group). Time to fracture (TtF) from the start of the test to the moment of file breakage and the length of the fractured fragment were recorded. Means and standard deviations of TtF and fragment length were calculated. The data was analyzed with SPSS13.0 software package. Another 12 NiTi rotary instruments for each brand were used, 6 subjected to 10 autoclave sterilization cycles and the other as control. Scanning electron microscope was used to observe the changes in surface topography and inner character. For cyclic fatigue resistance, when sterilization was not performed, K3 showed the highest value of TtF means and ProTaper the lowest. The differences between each brand were statistically significant (P<0.05).When disinfection was performed, K3 brand showed greater fatigue resistance in comparison with the control when autoclave sterilization cycled 5 times and 10 times. The difference between 10 cycles of sterilization and the control was statistically significant (P<0.05); ProTaper brand showed significantly greater fatigue resistance in all the disinfected groups compared with the control (P<0.05) and 5 cycles of sterilization led to the greatest increment; The fatigue resistance of Mtwo brands increased with sterilization cycles and the difference between 5/10 cycles and the control were statistically significant (P<0.05). For surface characteristics, under scanning electron microscope, surface and inner imperfections in all instruments were intensified greatly after 10 cycles of sterilization. Cycle fatigue resistance is different among instruments of different brands. Autoclave sterilization may increase fatigue resistance of the 3 brands. Autoclave sterilization may increase the surface roughness and inner defects in cross section.

  16. Development of an instrument to measure patient perception of the quality of nursing care and related hospital services at the national hospital of sri lanka.

    PubMed

    Senarat, Upul; Gunawardena, Nalika S

    2011-06-01

    This study aimed to develop and validate an instrument to measure patient perception of quality of nursing care and related hospital services in a tertiary care setting. We compiled an instrument with 72 items that patients may perceive as quality of nursing care and related hospital services, following an extensive literature search, discussions with patients and care pro-I viders and a brainstorming session with an expert panel. A cross-sectional study was conducted at the National Hospital of Sri Lanka. A sample (n = 120) of patients stayed in general surgical or medical units responded to the interviewer administered instrument upon discharge. Item analysis and principal component factor analysis were performed to assess validity, and internal consistency was calculated to measure reliability. Of the 72 items, 18 had greater than 20% of responses as 'not relevant'. A further 11 items were eliminated since item-total correlations were less than .2. Factor analysis was performed on remaining 43 items which resulted in 36 items classifying into eight factors accounting for 71% of the variation. Factor loadings in the final solution after Varimax rotation were interpersonal aspects (.68-.85), efficiency (.62-.79), competency (.66-.68), comfort (.60-.84), physical environment (.65-.82), cleanliness (.81-.85), personalized information (.76-.83), and general instructions (.61-.78). The instrument had high Internal consistency (Cronbach's alpha = .91). We developed a comprehensive, reliable and valid, 36-item instrument that may be used to measure patient perception of quality of nursing care in tertiary care settings. Copyright © 2011 Korean Society of Nursing Science. Published by Elsevier B.V. All rights reserved.

  17. Development and psychometric validation of the Nausea/Vomiting Symptom Assessment patient-reported outcome (PRO) instrument for adults with secondary hyperparathyroidism.

    PubMed

    McHorney, Colleen A; Bensink, Mark E; Burke, Laurie B; Belozeroff, Vasily; Gwaltney, Chad

    2017-01-01

    We developed the Nausea/Vomiting Symptom Assessment (NVSA © ) patient-reported outcome (PRO) instrument to capture patients' experience with nausea and vomiting while on calcimimetic therapy to treat secondary hyperparathyroidism (SHPT) related to end-stage kidney disease. This report summarizes the content validity and psychometric validation of the NVSA © . The two NVSA © items were drafted by two health outcomes researchers, one medical development lead, and one regulatory lead: it yields three scores: the number of days of vomiting or nausea per week, the number of vomiting episodes per week, and the mean severity of nausea. An eight-week prospective observational study was conducted at ten dialysis centers in the U.S. with 91 subjects. Criterion measures included in the study were the Functional Living Index-Emesis, Kidney Disease Quality of Life Instrument, EQ-5D-5 L, Static Patient Global Assessment, and Patient Global Rating of Change. Analyses included assessment of score distributions, convergent and known-groups validity, test-retest reliability, ability to detect change, and thresholds for meaningful change. Qualitative interviews verified that the NVSA © captures relevant aspects of nausea and vomiting. Patients understood the NVSA © instructions, items, and response scales. Correlations between the NVSA © and related and unrelated measures indicated strong convergent and discriminant validity, respectively. Mean differences between externally-defined vomiting/nausea groups supported known-groups validity. The scores were stable in subjects who reported no change on the Patient Global Rating of Change indicating sufficient test-retest reliability. The no-change group had mean differences and effect sizes close to zero; mean differences were mostly positive for a worsening group and mostly negative for the improvement group with predominantly medium or large effect sizes. Preliminary thresholds for meaningful worsening were 0.90 days for number of days of vomiting or nausea per week, 1.20 for number of episodes of vomiting per week, and 0.40 for mean severity of nausea. The NVSA © instrument demonstrated content validity, convergent and known-groups validity, test-retest reliability, and the ability to detect change. Preliminary thresholds for minimally important change should be further refined with additional interventional research. The NVSA © may be used to support study endpoints in clinical trials comparing the nausea/vomiting profile of novel SHPT therapies.

  18. Assessment of postoperative pain after reciprocating or rotary NiTi instrumentation of root canals: a randomized, controlled clinical trial.

    PubMed

    Relvas, João Bosko Formigas; Bastos, Mariana Mena Barreto; Marques, André Augusto Franco; Garrido, Angela Delfina Bitencourt; Sponchiado, Emílio Carlos

    2016-11-01

    The aim of this study was to assess postoperative pain in a prospective randomized clinical trial comparing two groups, using the Reciproc® system in one group and the ProTaper® rotary system in the other. The study included 78 male patients, aged 18-64 years (mean age of 26 years), with asymptomatic pulp necrosis in mandibular molar teeth (n = 78). The single-session endodontic treatment was performed by a single operator specialized in Endodontics. Mechanical preparation of the root canals was performed using the ProTaper® and Reciproc® instrumentation techniques. Postoperative pain was recorded using a verbal rating scale (VRS) and verbal description with well-defined categories at the three following time intervals: 24 h, 72 h, and 7 days after the endodontic procedure. The assessment of postoperative pain was recorded as no pain, mild pain, moderate pain, and severe pain or flare-up. Data were analyzed using the nonparametric Mann-Whitney test with the aid of the STATA® software. The incidence of postoperative pain in the ProTaper group (PT) 24 h after the endodontic procedure was 17.9 and 5.1 % after 72 h. In the Reciproc group (RP), the incidence after 24 h was 15.3 and 2.5 % after 72 h. No patients presented severe pain at the time intervals assessed. No significant difference (p > 0.05) in postoperative pain was found between the ProTaper® and Reciproc® instrumentation technique during endodontic treatment in this study. According to our findings and the results of the clinical trial, the occurrence of postoperative pain was low and similar between the reciprocating and rotary techniques during the time intervals assessed. These results are different from basic laboratory studies that affirm that the reciprocating techniques tend to promote more postoperative pain since extrusion of debris is greater.

  19. Effectiveness of ProTaper, D-RaCe, and Mtwo retreatment files with and without supplementary instruments in the removal of root canal filling material.

    PubMed

    Marques da Silva, B; Baratto-Filho, F; Leonardi, D P; Henrique Borges, A; Volpato, L; Branco Barletta, F

    2012-10-01

    To assess the efficacy of different retreatment rotary files in removing gutta-percha and endodontic sealer from canals. Ninety straight single-rooted premolars were prepared up to a size 30 and filled with gutta-percha and sealer and then randomly assigned to six retreatment groups (n = 15). Groups I, III, and V were retreated using rotary systems ProTaper Universal Retreatment (PTUR), D-RaCe, and Mtwo Retreatment, respectively. Groups II, IV, and VI were retreated using the additional instruments F4, size 40, .04 taper RaCe, and size 40, .04 taper Mtwo, respectively. The roots were split vertically, and images of the halves were obtained using a high-resolution scanner and evaluated with AutoCAD software to calculate the percentage of residual material. Data were analyzed with Kruskal-Wallis and Student-Newman-Keuls tests using a 5% significance cutoff (P < 0.05). There were no statistically significant differences (P > 0.05) between groups when additional instruments were used. The percentage of residual material was lowest in the PTUR group and was statistically significant only when compared to the D-RaCe system (P = 0.0038). All root canals had residual filling material after retreatment even when additional instruments were used. © 2012 International Endodontic Journal.

  20. Channelling urban modernity to sustainable pro-poor tourism development in Indonesia

    NASA Astrophysics Data System (ADS)

    Prasetyanti, R.

    2017-06-01

    Sustainable urban planning and development requires not only a fast-growing economic growth and modernity, but also social equity and environmental sustainability. Meanwhile, the global goals of sustainable development have fascinatingly set a promising urban development future by enhancing ecology based pro-poor policy program. Apparently, pro-poor development agenda has led to the notion of pro-poor tourism as part of urban development strategies on poverty alleviation. This research presents Jakarta Hidden Tour and Kampung Warna-warni as certain cases of pro-poor tourism in Indonesia. By the emergence of criticism on “pro-growth” paradigm, the critical analysis of this research focuses on the scenario of sustainable pro-poor tourism through eco-cultural based Kampung-Tour development. In accordance, debates and dilemma have been continuously arising as pros and cons regarding the ethical issues of poverty alleviation based Kampung-Tour development. Nevertheless, this paper tries to redefine Slum Kampung as potential; the writer wildly offers a concept of poverty alleviation by reinventing pro-poor tourism strategy; revitalizing slum site to eco-cultural based pro-poor tourism development as an embodiment of a sustainable urban development. By holding system thinking analysis as research method, sustainable pro-poor tourism highlights the urgency community based tourism and eco-tourism so that poverty alleviation based tourism can be tangibly perceived by the poor. In this sense, good local governance and public private partnership must be enhanced, it is due to, like any other development projects; sustainable pro-poor tourism needs a strong political commitment to alleviate urban poverty, as well as to pursue a better future of sustainable nation.

  1. A comparison of mesial molar root canal preparations using two engine-driven instruments and the balanced-force technique.

    PubMed

    Imura, N; Kato, A S; Novo, N F; Hata, G; Uemura, M; Toda, T

    2001-10-01

    The purpose of this study was to compare the effects of two engine-driven, nickel-titanium instrument systems with hand files in the final shape of slight and moderately curved canals. A total of 72 mesial roots of extracted human mandibular molars were divided into three groups: ProFile .04 taper, Pow-R rotary systems, and Flex-R hand-filing technique. The roots were mounted and cross-sectioned at two different horizontal levels using a modified Bramante technique. Pre- and postinstrumented cross-sectional roots were imaged, recorded, and computer analyzed. Results showed that, at the middle third, in almost all groups, there was a tendency of cutting more toward the mesial side with only one exception: Pow-R cut more to the distal side (danger zone) (p < 0.02). At the apical third, Flex-R (p < 0.03) and ProFile (0.001) transported to the mesial side (danger zone) when the curvature increased. When the three techniques were compared analyzing each side and considering the two groups of curvature, at the middle third in the moderately curved-canal group, Flex-R cut statistically more than Pow-R toward the lingual side. The other comparisons showed no statistically significant difference. When the techniques were compared in relation with the degree of curvature, in the apical third, ProFile .04 cut statistically more toward the mesial side in the moderately curved canal group than in the slightly curved canal group. The other comparisons showed no statistically significant difference. Canal preparation time was shorter with hand instrumentation (p < .05) in a few instances.

  2. Standards for Clinical Trials in Male and Female Sexual Dysfunction: II. Patient-Reported Outcome Measures.

    PubMed

    Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio

    2016-12-01

    The second article in this series, Standards for Clinical Trials in Male and Female Sexual Dysfunction, focuses on measurement of patient-reported outcomes (PROs). Together with the design of appropriate phase I to phase IV clinical trials, the development, validation, choice, and implementation of valid PRO measurements-the focus of the present article-form the foundation of research on treatments for male and female sexual dysfunctions. PRO measurements are assessments of any aspect of a patient's health status that come directly from the patient (ie, without the interpretation of the patient's responses by a physician or anyone else). PROs are essential for assessing male and female sexual dysfunction and treatment response, including symptom frequency and severity, personal distress, satisfaction, and other measurements of sexual and general health-related quality of life. Although there are some relatively objective measurements of sexual dysfunction (ie, intravaginal ejaculatory latency time, frequency of sexual activity, etc), these measurements do not comprehensively assess the occurrence and extent of sexual dysfunction or treatment on the patient's symptoms, functioning, and well-being. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient's perspective. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

  3. Overview of Classical Test Theory and Item Response Theory for Quantitative Assessment of Items in Developing Patient-Reported Outcome Measures

    PubMed Central

    Cappelleri, Joseph C.; Lundy, J. Jason; Hays, Ron D.

    2014-01-01

    Introduction The U.S. Food and Drug Administration’s patient-reported outcome (PRO) guidance document defines content validity as “the extent to which the instrument measures the concept of interest” (FDA, 2009, p. 12). “Construct validity is now generally viewed as a unifying form of validity for psychological measurements, subsuming both content and criterion validity” (Strauss & Smith, 2009, p. 7). Hence both qualitative and quantitative information are essential in evaluating the validity of measures. Methods We review classical test theory and item response theory approaches to evaluating PRO measures including frequency of responses to each category of the items in a multi-item scale, the distribution of scale scores, floor and ceiling effects, the relationship between item response options and the total score, and the extent to which hypothesized “difficulty” (severity) order of items is represented by observed responses. Conclusion Classical test theory and item response theory can be useful in providing a quantitative assessment of items and scales during the content validity phase of patient-reported outcome measures. Depending on the particular type of measure and the specific circumstances, either one or both approaches should be considered to help maximize the content validity of PRO measures. PMID:24811753

  4. AGARD Flight Test Instrumentation Series. Volume 18. Microprocessor Applications in Airborne Flight Test Instrumentation

    DTIC Science & Technology

    1987-02-01

    flowcharting . 3. ProEram Codin in HLL. This stage consists of transcribing the previously designed program into R an t at can be translated into the machine...specified conditios 7. Documentation. Program documentation is necessary for user information, for maintenance, and for future applications. Flowcharts ...particular CP U. Asynchronous. Operating without reference to an overall timing source. BASIC. Beginners ’ All-purpose Symbolic Instruction Code; a widely

  5. Resistance to fracture of teeth instrumented using novel EndoStar E5 rotary versus ProTaper NEXT and WaveOne file systems

    PubMed Central

    Pawar, Ajinkya M.; Pawar, Mansing G.; Thakur, Bhagyashree; Banga, Kulwinder Singh; Luke, Alexander Maniangat

    2018-01-01

    Aim: The current study compared the fracture resistance of samples instrumented by two rotary files and a reciprocating file, obturated with gutta-percha and AH Plus. Materials and Methods: A total of 60 freshly extracted mandibular premolar teeth with single roots and single canals were acquired and decoronated at or below the cementoenamel junction. The samples were randomly divided into four groups (n = 15). Group 1 control (noninstrumented/obturated), and for Groups 2–4 root canal instrumentation was done by EndoStar E5 (EE5), ProTaper NEXT (PTN), and WaveOne, respectively. Following instrumentation, the samples were obturated using gutta-percha cones and AH Plus sealer using lateral compaction. A week later, vertical load was applied to the specimen's canal in each group until fracture. The loads required for fracture were recorded and statistically analyzed. Results: The mean loads required to fracture (Newton; N) for the four groups were; 388.54 (±29.93), 310.35 (±26.05), 328.40 (±20.67), and 278.54 (±34.16). The loads exhibited highly significant difference (P < 0.0001; analysis variance). The following Tukey's post hoc test confirmed, both samples in Groups 2 and 3 required similar loads for fracture (P > 0.05) and significantly higher than Group 4 (P < 0.01). Conclusion: The samples instrumented by EE5 and PTN exhibit similar fracture resistance. PMID:29628648

  6. Endodontic shaping performance using nickel-titanium hand and motor ProTaper systems by novice dental students.

    PubMed

    Tu, Ming-Gene; Chen, San-Yue; Huang, Heng-Li; Tsai, Chi-Cheng

    2008-05-01

    Preparing a continuous tapering conical shape and maintaining the original shape of a canal are obligatory in root canal preparation. The purpose of this study was to compare the shaping performance in simulated curved canal resin blocks of the same novice dental students using hand-prepared and engine-driven nickel-titanium (NiTi) rotary ProTaper instruments in an endodontic laboratory class. Twenty-three fourth-year dental students attending China Medical University Dental School prepared 46 simulated curved canals in resin blocks with two types of NiTi rotary systems: hand and motor ProTaper files. Composite images were prepared for estimation. Material removed, canal width and canal deviation were measured at five levels in the apical 4 mm of the simulated curved canals using AutoCAD 2004 software. Data were analyzed using Wilcoxon's rank-sum test. The hand ProTaper group cut significantly wider than the motor rotary ProTaper group in the outer wall, except for the apical 0 mm point. The total canal width was cut significantly larger in the hand group than in the motor group. There was no significant difference between the two groups in centering canal shape, except at the 3 mm level. These findings show that the novice students prepared the simulated curved canal that deviated more outwardly from apical 1 mm to 4 mm using the hand ProTaper. The ability to maintain the original curvature was better in the motor rotary ProTaper group than in the hand ProTaper group. Undergraduate students, if following the preparation sequence carefully, could successfully perform canal shaping by motor ProTaper files and achieve better root canal geometry than by using hand ProTaper files within the same teaching and practicing sessions.

  7. Field evaluation of shallow-water acoustic doppler current profiler discharge measurements

    USGS Publications Warehouse

    Rehmel, M.S.

    2007-01-01

    In 2004, the U.S. Geological Survey (USGS) Office of Surface Water staff and USGS Water Science employees began testing the StreamPro, an acoustic Doppler current profiler (ADCP) for shallow-water discharge measurements. Teledyne RD Instruments introduced the StreamPro in December of 2003. The StreamPro is designed to make a "moving boat" discharge measurement in streams with depths between 0.15 and 2 m. If the StreamPro works reliably in these conditions, it will allow for use of ADCPs in a greater number of streams than previously possible. Evaluation sites were chosen to test the StreamPro over a range of conditions. Simultaneous discharge measurements with mechanical and other acoustic meters, along with stable rating curves at established USGS streamflow-gaging stations, were used for comparisons. The StreamPro measurements ranged in mean velocity from 0.076 to 1.04 m/s and in discharge from 0.083 m 3/s to 43.4 m 3/s. Tests indicate that discharges measured with the StreamPro compare favorably to the discharges measured with the other meters when the mean channel velocity is greater than 0.25 m/s. When the mean channel velocity is less than 0.25 m/s, the StreamPro discharge measurements for individual transects have greater variability than those StreamPro measurements where the mean channel velocity is greater than 0.25 m/s. Despite this greater variation in individual transects, there is no indication that the StreamPro measured discharges (the mean discharge for all transects) are biased, provided that enough transects are used to determine the mean discharge. ?? 2007 ASCE.

  8. Associations between a patient reported outcome (PRO) measure of sarcopenia and falls, functional status, and physical performance in older patients with cancer

    PubMed Central

    Gewandter, Jennifer S.; Dale, William; Magnuson, Allison; Pandya, Chintan; Heckler, Charles E.; Lemelman, Tatyana; Roussel, Breton; Ifthikhar, Rafa; Dolan, James; Noyes, Katia; Mohile, Supriya G.

    2015-01-01

    Objective In older patients with cancer, we aimed to investigate associations between a patient-reported outcome measure for sarcopenia (SarcoPRO) and the Short Physical Performance Battery (SPPB), self-reported falls, and limitations in instrumental activities of daily living (IADLs). Materials and Methods Assessments were conducted as part of the initial evaluation of older, often frail, patients with cancer seen in the Specialized Oncology Care and Research in the Elderly (SOCARE) clinic. Univariate associations were evaluated using Spearman’s correlation and Wilcoxon sign ranked tests. Logistic regressions were used to identify associations of clinical factors and SarcoPRO scores or SPPB scores with falls and IADL limitations. Results In total, 174 older patients with cancer were evaluated. A moderate correlation was found between the SarcoPRO and the SPPB (ρ = 0.62). After adjusting for multiple clinical factors, neither the SarcoPRO nor the SPPB were associated with falls. In contrast, both higher SarcoPRO (i.e., worse) and lower SPPB (i.e., worse) scores were associated with limitations in IADLs (Odds ratio for one unit change in predictor: SarcoPRO: 1.06, p<0.0001; SPPB: 0.71, p = 0.003, respectively). Models using the SarcoPRO and SPPB explained similar amounts of variability in association with IADL limitations (AUC: 0.88 vs 0.87, respectively). Conclusions The SarcoPRO was moderately associated with the SPPB, an objective measure of physical performance, and was associated with limitations in IADLs. Thus, older patients with cancer who present with IADL limitations should be screened for sarcopenia. The SarcoPRO shows promise as a measure for screening as well as outcome assessment for research on sarcopenia. PMID:26365897

  9. Apical extrusion of debris and irrigants using hand and three rotary instrumentation systems − An in vitro study.

    PubMed

    Madhusudhana, Koppolu; Mathew, Vinod Babu; Reddy, Nelaturi Madhusudhan

    2010-10-01

    Sterilization of the root canal is a prime aim of successful endodontics. The cleaning and shaping of the canal is directed as achieving this goal. The extrusion of apical debris has a deleterious effect on the prognosis of root canal treatment. Several instrument designs and instrumentation techniques have been developed to prevent this. Forty caries free single rooted human mandibular premolar teeth were divided in four groups of ten teeth each. Teeth in each group were instrumented until the working length with rotary ProTaper, K3, Mtwo systems, and hand K-type stainless steel files. Debris and irrigant extruded from the apical foramen were collected into vials and the amounts were quantitatively determined. The data obtained were analyzed using Kruskal-Wallis one-way analysis of variance and Mann-Whitney U tests. The results show that all instrumentation techniques produced significant amount of extruded debris and irrigant. The engine-driven nickel-titanium systems showed less apical extrusion of debris and irrigant than manual technique. No statistically significant difference was found between the groups at [P > 0.05]. Maximum apical debris and irrigant extrusion was seen with K-file group and least in the Mtwo group. The use of rotary files and techniques to perform instrumentation does show less extrusion of the debris and irrigant from the apex. This can contribute to more successful endodontic therapy.

  10. ProMIS augmented reality training of laparoscopic procedures face validity.

    PubMed

    Botden, Sanne M B I; Buzink, Sonja N; Schijven, Marlies P; Jakimowicz, Jack J

    2008-01-01

    Conventional video trainers lack the ability to assess the trainee objectively, but offer modalities that are often missing in virtual reality simulation, such as realistic haptic feedback. The ProMIS augmented reality laparoscopic simulator retains the benefit of a traditional box trainer, by using original laparoscopic instruments and tactile tasks, but additionally generates objective measures of performance. Fifty-five participants performed a "basic skills" and "suturing and knot-tying" task on ProMIS, after which they filled out a questionnaire regarding realism, haptics, and didactic value of the simulator, on a 5-point-Likert scale. The participants were allotted to 2 experience groups: "experienced" (>50 procedures and >5 sutures; N = 27), and "moderately experienced" (<50 procedures and <5 sutures; N = 28). General consensus among all participants, particularly the experienced, was that ProMIS is a useful tool for training (mean: 4.67, SD: 0.48). It was considered very realistic (mean: 4.44, SD: 0.66), with good haptics (mean: 4.10, SD: 0.97) and didactic value (mean 4.10, SD: 0.65). This study established the face validity of the ProMIS augmented reality simulator for "basic skills" and "suturing and knot-tying" tasks. ProMIS was considered a good tool for training in laparoscopic skills for surgical residents and surgeons.

  11. A comparative evaluation of gutta percha removal and extrusion of apical debris by rotary and hand files.

    PubMed

    Chandrasekar; Ebenezar, A V Rajesh; Kumar, Mohan; Sivakumar, A

    2014-11-01

    The aim of this study was to evaluate the efficacy of Protaper retreatment files in comparison with RaCe, K3 and H-files for removal of gutta-percha and apically extruded debris using volumetric analysis. Forty extracted single rooted maxillary incisor teeth with straight canals and mature apices were selected for the study. After access cavity preparation, apical patency was confirmed with a size 10 K-file extending 1mm beyond the point at which it was first visible at the apical end. Working lengths were determined with the use of size 15 K-file. The canals were prepared in a step-back technique and the master apical file was size 30 for all teeth. 3% sodium hypochlorite was used as an irrigant after each instrumentation. Before final rinse, size 20 K-file was passed 1mm beyond the apex to remove any dentinal shaving plugs and maintain the apical patency. Then the canals were dried with paper points. The root canal was filled using standard gutta-percha points and zinc oxide eugenol sealer under lateral condensation technique. The teeth were then randomly divided into four groups of ten teeth each based on the instrument used for gutta percha removal. All the rotary instruments used in this study were rotated at 300rpm. The instruments used were: Group 1 - RaCe Files, Group 2 - ProTaper retreatment Files, Group 3 - K3 Files and Group 4 - H Files. The volume of the obturating material was calculated before and after removal using volumetric analysis with spiral CT. The removal efficacy with each instrument was calculated and statistically analysed. The results of the study show that the ProTaper retreatment files (Group 2) (97.4%) showed the highest efficiency in the removal of obturating material, which was followed by RaCe (95.74%), K3 (92.86%) and H files (90.14%) with the efficiency in the decreasing order. Similarly the mean apical extrusion in H files (0.000 ± 0.002) was significantly lower than all the rotary instruments. However, the difference among the rotary files were not statistically significant (p>0.05). ProTaper retreatment files show significant difference over other groups in removal of obturating material and can be the system of choice in endodontic retreatment procedures.

  12. Effect of Cycling Skills on Bicycle Safety and Comfort Associated with Bicycle Infrastructure and Environment

    DOT National Transportation Integrated Search

    2017-08-31

    This study seeks to improve the methodology for determining the relationship between cycling dynamic performance and roadway environment characteristics across different bicyclists' skill levels. To achieve the goal of this study, an Instrumented Pro...

  13. What should we call instruments commonly known as payments for environmental services? A review of the literature and a proposal.

    PubMed

    Shelley, Barry G

    2011-02-01

    Researchers, policy makers, and practitioners have used various terms to describe instruments that reward the stewardship of ecosystem services that benefit "external" actors. Payments for environmental services, or PES, has been the predominant name. However, critics have challenged both the payments and environmental components of this nomenclature, most commonly proposing markets, compensation, or rewards as alternatives for the former, and ecosystem for the latter. Additional questions arise regarding what to call the agents directly involved in the transaction: sellers and buyers, or stewards and beneficiaries? For some, concerns about this terminology have emerged from so-called "pro-poor PES" debates that ask if actors could and should incorporate poverty alleviation goals into PES instruments. This review of the modulating use of terms and the arguments about which best fit theory and experience points to the key policy and ethical issues at stake as PES programs face critical and timely questions about the direction they will head. The author contends that the choices of terms will influence that direction and proposes a new alternative-rewards for ecosystem service stewardship (RESS)-that better encompasses pro-poor options. © 2011 New York Academy of Sciences.

  14. The self-adjusting file instrumentation results in less debris extrusion apically when compared to WaveOne and ProTaper NEXT

    PubMed Central

    Pawar, Ajinkya M.; Pawar, Mansing G.; Metzger, Zvi; Kokate, Sharad R.

    2015-01-01

    Aim: The present ex vivo study aimed to evaluate the debris extrusion after instrumenting the root canals by three different files systems. Materials and Methods: Sixty extracted human mandibular premolars with single canals were selected and randomly divided into three groups (n = 20) for instrumentation with three different files. Group 1: WaveOne (primary) single reciprocating file (WO; Dentsply Maillefer, Ballaigues, Switzerland) (25/08), Group 2: Self-adjusting file (SAF; ReDent-Nova, Ra’anana, Israel) (1.5 mm), and Group 3: ProTaper NEXT X1 and X2 (PTN; Dentsply Tulsa Dental, Tulsa, OK) (25/06). Debris extruding by instrumentation were collected into pre-weighed Eppendorf tubes. These tubes were then stored in an incubator at 70°C for 5 days. The tubes were then weighed to obtain the final weight, with the extruded debris. Statistical analysis for the debris extruded apically was performed using one-way analysis of variance and post hoc Tukey's test. Results: The statistical analysis showed a significant difference between all the three groups tested (P < 0.01). The following post hoc Tukey's test confirmed that Group 2 (SAF) exhibited significantly least (P < 0.01) debris extrusion between the three groups tested. Conclusions: The SAF resulted in significantly less extrusion of debris when compared to reciprocating WO and rotary PTN. PMID:25829683

  15. Micro-computed Tomography versus the Cross-sectioning Method to Evaluate Dentin Defects Induced by Different Mechanized Instrumentation Techniques.

    PubMed

    Stringheta, Carolina Pessoa; Pelegrine, Rina Andréa; Kato, Augusto Shoji; Freire, Laila Gonzales; Iglecias, Elaine Faga; Gavini, Giulio; Bueno, Carlos Eduardo da Silveira

    2017-12-01

    The objective of this study was to compare the methods of micro-computed tomography (micro-CT) and cross-sectioning followed by stereomicroscopy in assessing dentinal defects after instrumentation with different mechanized systems. Forty mesial roots of mandibular molars were scanned and divided into 4 groups (n = 10): Group R, Reciproc; Group PTN, ProTaper Next; Group WOG, WaveOne Gold; Group PDL, ProDesign Logic. After instrumentation, the roots were once again submitted to a micro-CT scan, and then sectioned at 3, 6, and 9 mm from the apex, and assessed for the presence of complete and incomplete dentinal defects under a stereomicroscope. The nonparametric Kruskal-Wallis, Friedman, and Wilcoxon tests were used in the statistical analysis. The study used a significance level of 5%. The total number of defects observed by cross-sectioning followed by stereomicroscopy was significantly higher than that observed by micro-CT, in all of the experimental groups (P ≤ .05). All of the defects identified in the postoperative period were already present in the corresponding preoperative period. There was no significant difference among the instrumentation systems as to the median numbers of defects, for either cross-sectioning followed by stereomicroscopy or micro-CT, at all the root levels (P > .05). In the micro-CT analysis, no significant difference was found between the median numbers of pre- and postinstrumentation defects, regardless of the instrumentation system (P > .05). None of the evaluated instrumentation systems led to the formation of new dentin defects. All of the defects identified in the stereomicroscopic analysis were already present before instrumentation, or were absent at both time points in the micro-CT analysis, indicating that the formation of new defects resulted from the sectioning procedure performed before stereomicroscopy and not from instrumentation. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  16. A Survey on Nickel Titanium Rotary Instruments and their Usage Techniques by Endodontists in India.

    PubMed

    Patil, Thimmanagowda N; Saraf, Prahlad A; Penukonda, Raghavendra; Vanaki, Sneha S; Kamatagi, Laxmikant

    2017-05-01

    The preference and usage of nickel titanium rotary instruments varies from individual to individual based on their technique, experience with the rotary systems and the clinical situation. Very limited information is available to explain the adoption of changing concepts with respect to nickel titanium rotary instruments pertaining to the endodontists in India. The aim of this study was to conduct a questionnaire survey to acquire the knowledge concerning different NiTi rotary instruments and their usage techniques by endodontists in India. A Survey questionnaire was designed which consisted of 32 questions regarding designation, demographics, experience with rotary instruments, usage of different file systems, usage techniques, frequency of reuse, occurrence of file fracture, reasons and their management was distributed by hand in the national postgraduate convention and also disseminated via electronic medium to 400 and 600 endodontists respectively. Information was collected from each individual to gain insight into the experiences and beliefs of endodontists concerning the new endodontic technology of rotary NiTi instrumentation based on their clinical experience with the rotary systems. The questions were designed to ascertain the problems, patterns of use and to identify areas of perceived or potential concern regarding the rotary instruments and the data acquired was statistically evaluated using Fisher's-exact test and the Chi-Square test. Overall 63.8% (638) endodontists responded. ProTaper was one of the most commonly used file system followed by M two and ProTaper Next. There was a significant co relation between the years of experience and the file re use frequency, preparation technique, file separation, management of file separation. A large number of Endodontists prefer to reuse the rotary NiTi instruments. As there was an increase in the experience, the incidence of file separation reduced with increasing number of re use frequency and with experience, the management of separated file was better.

  17. A Survey on Nickel Titanium Rotary Instruments and their Usage Techniques by Endodontists in India

    PubMed Central

    Saraf, Prahlad A; Penukonda, Raghavendra; Vanaki, Sneha S; Kamatagi, Laxmikant

    2017-01-01

    Introduction The preference and usage of nickel titanium rotary instruments varies from individual to individual based on their technique, experience with the rotary systems and the clinical situation. Very limited information is available to explain the adoption of changing concepts with respect to nickel titanium rotary instruments pertaining to the endodontists in India. Aim The aim of this study was to conduct a questionnaire survey to acquire the knowledge concerning different NiTi rotary instruments and their usage techniques by endodontists in India. Materials and Methods A Survey questionnaire was designed which consisted of 32 questions regarding designation, demographics, experience with rotary instruments, usage of different file systems, usage techniques, frequency of reuse, occurrence of file fracture, reasons and their management was distributed by hand in the national postgraduate convention and also disseminated via electronic medium to 400 and 600 endodontists respectively. Information was collected from each individual to gain insight into the experiences and beliefs of endodontists concerning the new endodontic technology of rotary NiTi instrumentation based on their clinical experience with the rotary systems. The questions were designed to ascertain the problems, patterns of use and to identify areas of perceived or potential concern regarding the rotary instruments and the data acquired was statistically evaluated using Fisher’s-exact test and the Chi-Square test. Results Overall 63.8% (638) endodontists responded. ProTaper was one of the most commonly used file system followed by M two and ProTaper Next. There was a significant co relation between the years of experience and the file re use frequency, preparation technique, file separation, management of file separation. Conclusion A large number of Endodontists prefer to reuse the rotary NiTi instruments. As there was an increase in the experience, the incidence of file separation reduced with increasing number of re use frequency and with experience, the management of separated file was better. PMID:28658903

  18. Comparison of the cyclic fatigue resistance of 5 different rotary pathfinding instruments made of conventional nickel-titanium wire, M-wire, and controlled memory wire.

    PubMed

    Capar, Ismail Davut; Kaval, Mehmet Emin; Ertas, Hüseyin; Sen, Bilge Hakan

    2015-04-01

    This study compared the cyclic fatigue resistance of current nickel-titanium rotary path-finding instruments. Five types of nickel-titanium rotary pathfinding instruments were used in steel canals with a 90° curvature and a curvature radius of 3 mm (n = 10) and 5 mm (n = 10). The cyclic fatigue of the following instruments was tested at 4 mm from the tip: PathFile (#16 and a .02 taper; Dentsply Maillefer, Ballaigues, Switzerland), G-File (#12 and a .03 taper; Micro-Mega, Besançon Cedex, France), Scout Race (#15 and a .02 taper; FKG Dentaire, La Chaux-de-Fonds, Switzerland), HyFlex GPF (#15 and a .02 taper; Coltene-Whaledent, Allstetten, Switzerland), and ProGlider (#16 with a mean taper of .04125 and a .02 at the first 4 mm from the tip, Dentsply Maillefer). The length of the fractured parts was measured, and the number of cycles to fracture (NCF) was calculated. The data were statistically analyzed using Kruskal-Wallis and Mann-Whitney tests (α = .05). After Bonferroni correction, the new P value was set as .005. The difference in the cyclic fatigue of all the files at both curvatures was statistically significant (P values from .0035 to less than .0001). The ranking of the instruments from the highest to the lowest NCF was as follows: HyFlex GPF, G files, ProGlider, PathFile, and Scout Race. The length of the fractured part of the instruments was similar in all the groups (P > .05). All the tested instruments had a lower NCF at a curvature radius of 3 mm when compared with a curvature radius of 5 mm (P < .0001). Within the limitations of this study, the cyclic fatigue resistance of the HyFlex GPF instrument was the highest, and the curvature radius had a significant effect on the fatigue resistance. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  19. Quantitative assessment of apical debris extrusion and intracanal debris in the apical third, using hand instrumentation and three rotary instrumentation systems.

    PubMed

    H K, Sowmya; T S, Subhash; Goel, Beena Rani; T N, Nandini; Bhandi, Shilpa H

    2014-02-01

    Decreased apical extrusion of debris and apical one third debris have strong implications for decreased incidence of postoperative inflammation and pain. Thus, the aim of this study was to assess quantitatively the apical extrusion of debris and intracanal debris in the apical third during root canal instrumentation using hand and three different types of rotary instruments. Sixty freshly extracted single rooted human teeth were randomly divided into four groups. Canal preparation was done using step-back with hand instrumentation, crown-down technique with respect to ProTaper and K3, and hybrid technique with LightSpeed LSX. Irrigation was done with NaOCl, EDTA, and normal saline and for final irrigation, EndoVac system was used. The apically extruded debris was collected on the pre-weighed Millipore plastic filter disk and weighed using microbalance. The teeth were submitted to the histological processing. Sections from the apical third were analyzed by a trinocular research microscope that was coupled to a computer where the images were captured and analyzed using image proplus V4.1.0.0 software. The mean weight of extruded debris for each group and intracanal debris in the root canal was statistically analyzed by a Kruskal-Wallis one-way analysis of variance and Mann-Whitney U test. The result showed that, hand instrumentation using K files showed the highest amount of debris extrusion apically when compared to ProTaper, K3 and LightSpeed LSX. The result also showed that there was no statistically significant difference between the groups in relation to presence of intracanal debris in the apical one third. Based on the results, all instrumentation techniques produced debris extrusion. The engine driven Ni-Ti systems extruded significantly less apical debris than hand instrumentation. There was no statistically significant difference between the groups in relation to presence of intracanal debris in the apical one third.

  20. A comparison of the relative efficacies of four hand and rotary instrumentation techniques during endodontic retreatment.

    PubMed

    Imura, N; Kato, A S; Hata, G I; Uemura, M; Toda, T; Weine, F

    2000-07-01

    The purpose of this study was to quantify the amount of remaining gutta-percha/scaler on the walls of root canals when two engine-driven instruments (Quantec and ProFile) and two hand instruments (K-file and Hedström file) were used to remove these materials. The amount of apically extruded debris and the time required for treatment were also recorded. One hundred extracted mandibular premolars were prepared using a modified step-back, flare technique and obturated with the lateral condensation technique. After repreparation with the test instruments, the specimens were cut transversally at the cervical, middle and apical thirds with steel discs and the three sections were split longitudinally. The amount of residual debris on the canal walls in each section was examined using a stereomicroscope. In all groups the cervical and middle thirds showed no debris. In the apical third, obturating material was observed in some specimens. No statistically significant difference was found between the two groups for incidence of debris, although the Hedström group showed a greater number of samples with remaining gutta-percha/sealer. When analysing dirty specimens only, there was a statistically significant difference between the four groups (P < 0.01) with the Hedström group having significantly less length of canal wall with remaining obturation material than the Quantec group. There was no significant difference amongst the groups for weight of extruded debris. However, there was a significant difference amongst the groups for mean treatment time with the Hedström file group requiring significantly less time than the Quantec group (P < 0.001); no significant differences were found between the other groups. Six instruments fractured in the Quantec group, four in the ProFile group, two in the Hedström group and two in the K-type group. The results showed that overall, all instruments may leave filling material inside the root canal. During retreatment there is a risk of instrument breakage, especially rotary instruments.

  1. Quantitative Assessment of Apical Debris Extrusion and Intracanal Debris in the Apical Third, Using Hand Instrumentation and Three Rotary Instrumentation Systems

    PubMed Central

    H.K., Sowmya; T.S., Subhash; Goel, Beena Rani; T.N., Nandini; Bhandi, Shilpa H.

    2014-01-01

    Introduction: Decreased apical extrusion of debris and apical one third debris have strong implications for decreased incidence of postoperative inflammation and pain. Thus, the aim of this study was to assess quantitatively the apical extrusion of debris and intracanal debris in the apical third during root canal instrumentation using hand and three different types of rotary instruments. Methodology: Sixty freshly extracted single rooted human teeth were randomly divided into four groups. Canal preparation was done using step-back with hand instrumentation, crown-down technique with respect to ProTaper and K3, and hybrid technique with LightSpeed LSX. Irrigation was done with NaOCl, EDTA, and normal saline and for final irrigation, EndoVac system was used. The apically extruded debris was collected on the pre-weighed Millipore plastic filter disk and weighed using microbalance. The teeth were submitted to the histological processing. Sections from the apical third were analyzed by a trinocular research microscope that was coupled to a computer where the images were captured and analyzed using image proplus V4.1.0.0 software. The mean weight of extruded debris for each group and intracanal debris in the root canal was statistically analyzed by a Kruskal-Wallis one-way analysis of variance and Mann-Whitney U test. Results: The result showed that, hand instrumentation using K files showed the highest amount of debris extrusion apically when compared to ProTaper, K3 and LightSpeed LSX. The result also showed that there was no statistically significant difference between the groups in relation to presence of intracanal debris in the apical one third. Conclusion: Based on the results, all instrumentation techniques produced debris extrusion. The engine driven Ni-Ti systems extruded significantly less apical debris than hand instrumentation. There was no statistically significant difference between the groups in relation to presence of intracanal debris in the apical one third. PMID:24701536

  2. ULTIMATE: a deployable multiple integral field unit for Subaru

    NASA Astrophysics Data System (ADS)

    Ellis, S. C.; Zhelem, Ross; Brown, David; Staszak, Nicholas F.; Lidman, Chris; Nataf, David M.; Casey, Andrew R.; Xavier, Pascal; Sheinis, Andrew; Gillingham, Peter; Tims, Julia; Lawrence, Jon; Bryant, Julia; Sharp, Rob

    2016-08-01

    ULTIMATE is an instrument concept under development at the AAO, for the Subaru Telescope, which will have the unique combination of ground layer adaptive optics feeding multiple deployable integral field units. This will allow ULTIMATE to probe unexplored parameter space, enabling science cases such as the evolution of galaxies at z 0:5 to 1.5, and the dark matter content of the inner part of our Galaxy. ULTIMATE will use Starbugs to position between 7 and 13 IFUs over a 14 × 8 arcmin field-of-view, pro- vided by a new wide-field corrector. All Starbugs can be positioned simultaneously, to an accuracy of better than 5 milli-arcsec within the typical slew-time of the telescope, allowing for very efficient re-configuration between observations. The IFUs will feed either the near-infrared nuMOIRCS or the visible/ near-infrared PFS spectrographs, or both. Future possible upgrades include the possibility of purpose built spectrographs and incorporating OH suppression using fibre Bragg gratings. We describe the science case and resulting design requirements, the baseline instrument concept, and the expected performance of the instrument.

  3. Lateral and axial cutting efficiency of instruments manufactured with conventional nickel-titanium and novel gold metallurgy.

    PubMed

    Vasconcelos, R A; Arias, A; Peters, O A

    2018-05-01

    To isolate the effect of metallurgy in lateral and axial cutting efficacy against plastic and bovine dentine substrates by comparing two rotary systems with identical design but manufactured with either conventional nickel-titanium or heat-treated gold alloy. A total of 258 ProTaper Universal (PTU) and ProTaper Gold (PTG) Shaping instruments were used. Bending behaviour was assessed to determine the appropriate displacement associated with a 2 N force in lateral cutting. Ten instruments of each type were used in lateral action for 60 s against bovine dentine or plastic substrates four consecutive times producing four notches in each specimen. Ten further instruments of each type were used in on axial action in four standardized simulated root canals fabricated from 4-mm thick plastic or dentine discs. Both tests were performed at 300 rpm in a computer-controlled testing platform. Notch area and torsional load were compared with Student's t-tests. Repeated measures ANOVA was used to compare cutting efficiency across the four different time-points. Pearson correlation coefficients between substrates were also determined. For lateral action, all three PTG instruments cut significantly more effectively (P < 0.05) than PTU on the plastic substrate. S1 and S2 PTG cut significantly more after 120 and 180 s (P < 0.05) on bovine dentine substrate. For axial action, S1 and S2 PTG were significantly more efficient in cutting at 180 s on plastic and 120 s on bovine dentine (P < 0.05). Instruments made from heat-treated nickel-titanium gold alloy had equal or greater cutting efficiency when compared to those made from conventional nickel-titanium. © 2017 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  4. Effect of alloy type on the life-time of torsion-preloaded nickel-titanium endodontic instruments.

    PubMed

    Ha, Jung-Hong; Kim, Sung Kyo; Cheung, Gary Shun-Pan; Jeong, Seong Hwa; Bae, Yong Chul; Kim, Hyeon-Cheol

    2015-01-01

    This study was aimed to evaluate the effect of torsional preloads on the cyclic fatigue life of nickel-titanium (NiTi) instruments with different history of heat treatments by manufacturers. WaveOne (Primary) made of M-wire, K3XF (#30/0.06) of R-phase, and ProTaper (F2) of conventional NiTi alloy was used. Each file was preloaded at four conditions (nil, 25, 50, and 75% of their mean ultimate torsional strength) before fatigue testing. The torsional preloads 10-, 30-, or 50-times were applied by securing 5 mm of the file tip, rotating it until the preset torque was attained before returning to the origin. Then, the number of cycles to failure (NCF) was evaluated by rotational bending in a simulated canal. Data were analyzed using multiple linear regression analysis and two-way ANOVA. Fractured instruments were examined under scanning electron microscope (SEM). SEM showed that most WaveOne after 75% preloading, regardless of repetitions, showed some longitudinal cracks parallel to the long axis of the file, which were rare for K3XF. Regression analysis revealed that the brand of instrument was the most critical factor. At up to 75% preloading, ProTaper and K3XF did not show any significant decline in NCF. For 30-repetition groups of WaveOne, the 50 and 25% torsion preloaded groups showed a significantly higher NCF than the 0 and 75% groups. Within the limitations of this study, the alloy type of NiTi instrument have a significant effect on the phenomenon that a certain amount of torsional preload may improve the cyclic fatigue resistance of NiTi rotary instruments. © Wiley Periodicals, Inc.

  5. Development of a Symptom-Focused Patient-Reported Outcome Measure for Functional Dyspepsia: The Functional Dyspepsia Symptom Diary (FDSD)

    PubMed Central

    Taylor, Fiona; Higgins, Sophie; Carson, Robyn T; Eremenco, Sonya; Foley, Catherine; Lacy, Brian E; Parkman, Henry P; Reasner, David S; Shields, Alan L; Tack, Jan; Talley, Nicholas J

    2018-01-01

    Objectives: The Functional Dyspepsia Symptom Diary (FDSD) was developed to address the lack of symptom-focused, patient-reported outcome (PRO) measures designed for use in functional dyspepsia (FD) patients and meeting Food and Drug Administration recommendations for PRO instrument development. Methods: Concept elicitation interviews were conducted with FD participants to identify symptoms important and relevant to FD patients. A preliminary version of the FDSD was constructed, then completed by FD participants on an electronic device in cognitive interviews to evaluate the readability, comprehensibility, relevance, and comprehensiveness of the FDSD, and to preliminarily evaluate its measurement properties. Results: During concept elicitation interviews, 45 participants spontaneously reported 19 symptom concepts. Of those, seven symptoms were selected for assessment by the eight-item FDSD. Cognitive interviews with 57 participants confirmed that participants were able to comprehend and provide meaningful responses to the FDSD, and that the handheld electronic FDSD format was suitable for use in the target population. Scores of the FDSD were well-distributed among response options, item discrimination indices suggested that the FDSD items differentiate among patients with varying degrees of FD severity, and inter-item correlations suggested that no items of the FDSD were capturing redundant information. Internal consistency estimates (0.87) and construct-related validity estimates using known-groups methods were within acceptable ranges. Conclusions: The FDSD is a content-valid PRO measure, with preliminary psychometric evidence providing support for the FDSD’s items and total score. Further psychometric evaluations are recommended to more fully test the FDSD’s score performance and other measurement properties in the target patient population. PMID:28925989

  6. A comparative evaluation of the increase in root canal surface area and canal transportation in curved root canals by three rotary systems: A cone-beam computed tomographic study

    PubMed Central

    Prasanthi, Nalam NVD; Rambabu, Tanikonda; Sajjan, Girija S; Varma, K Madhu; Satish, R Kalyan; Padmaja, M

    2016-01-01

    Aim: The aim of this study was to measure the increase in root canal surface area and canal transportation after biomechanical preparation at 1, 3, and 5 mm short of the apex with three different rotary systems in both continuous rotary and reciprocating rotary motions. Materials and Methods: Sixty freshly extracted human mandibular molars with mesial root canal curvatures between 20° and 30° were included in the study. Teeth were randomly distributed into three groups (n = 20). Biomechanical preparations were done in all the mesial canals. In Group 1, instrumentation was done with ProTaper universal rotary files, Group 2, with K3XF rotary files, and Group 3, with LSX rotary files. Each group was further subdivided into subgroups A and B (n = 10) where instrumentation was done by continuous rotary and reciprocating rotary techniques, respectively. Increase in root canal surface area and canal transportation was measured using the preoperative and postoperative cone-beam computed tomography scans. Statistical Analysis: The data were analyzed by one-way ANOVA followed by Tukey pairwise multiple comparison tests. Results: Increase in root canal surface area was significantly more (P < 0.05) in ProTaper and K3XF groups when compared to LSX group. Canal transportation was significantly more (P < 0.05) in ProTaper group when compared to K3XF and LSX groups. There was no significant difference (P > 0.05) in increase of root canal surface area and canal transportation between continuous rotary and reciprocating rotary techniques for ProTaper Universal, K3XF and LSX groups. Conclusion: LSX rotary system showed minimal increase of root canal surface area and minimal canal transportation when compared to ProTaper and K3XF rotary systems. PMID:27656062

  7. NT-proBNP concentrations in mountain marathoners.

    PubMed

    Banfi, Giuseppe; Lippi, Giuseppe; Susta, Daniele; Barassi, Alessandra; D'Eril, Gianvico Melzi; Dogliotti, Giada; Corsi, Massimiliano M

    2010-05-01

    The 76 amino acid N-terminal proB-type natriuretic peptide (NT-proBNP) is proposed for evaluating and monitoring heart pathologies characterized by myocardial wall stress. Strenuous exercise might generate transitory ischemia, myocardial stress, and diastolic left ventricular dysfunction, possibly inducing an increase of some biochemical parameter concentrations. An alert has been claimed owing to biochemical and instrumental signs of heart dysfunction in recreational athletes during marathon races. We studied the behaviour of NT-proBNP in 15 mountain marathoners before and after a race. The concentrations of the parameter were lower than that observed in controls at rest and were similar to that observed in professional soccer and rugby players. The concentrations significantly increased after the race. NT-proBNP is low at rest in professional athletes, and the increase after physical exercise is physiological. The marathoners, even when performing races in a high-altitude environment, show NT-proBNP concentrations similar to those of athletes from other sports disciplines, characterized by low levels of effort and by a mix of aerobic and anaerobic metabolism. The increase of NT-proBNP is linked to strenuous physical exercise and to heavy heart effort, testified also by an increase of troponin I. However, the role of the NT-proBNP could be important to screen recreational and professional marathoners to avoid possible heart problems and sudden cardiac death in subjects with occult heart disease. The results of the present study are relevant to the design and evaluation of training programs for improving strength and function of professional marathoners.

  8. The novel ER membrane protein PRO41 is essential for sexual development in the filamentous fungus Sordaria macrospora.

    PubMed

    Nowrousian, Minou; Frank, Sandra; Koers, Sandra; Strauch, Peter; Weitner, Thomas; Ringelberg, Carol; Dunlap, Jay C; Loros, Jennifer J; Kück, Ulrich

    2007-05-01

    The filamentous fungus Sordaria macrospora develops complex fruiting bodies (perithecia) to propagate its sexual spores. Here, we present an analysis of the sterile mutant pro41 that is unable to produce mature fruiting bodies. The mutant carries a deletion of 4 kb and is complemented by the pro41 open reading frame that is contained within the region deleted in the mutant. In silico analyses predict PRO41 to be an endoplasmic reticulum (ER) membrane protein, and a PRO41-EGFP fusion protein colocalizes with ER-targeted DsRED. Furthermore, Western blot analysis shows that the PRO41-EGFP fusion protein is present in the membrane fraction. A fusion of the predicted N-terminal signal sequence of PRO41 with EGFP is secreted out of the cell, indicating that the signal sequence is functional. pro41 transcript levels are upregulated during sexual development. This increase in transcript levels was not observed in the sterile mutant pro1 that lacks a transcription factor gene. Moreover, microarray analysis of gene expression in the mutants pro1, pro41 and the pro1/41 double mutant showed that pro41 is partly epistatic to pro1. Taken together, these data show that PRO41 is a novel ER membrane protein essential for fruiting body formation in filamentous fungi.

  9. The novel ER membrane protein PRO41 is essential for sexual development in the filamentous fungus Sordaria macrospora

    PubMed Central

    Nowrousian, Minou; Frank, Sandra; Koers, Sandra; Strauch, Peter; Weitner, Thomas; Ringelberg, Carol; Dunlap, Jay C.; Loros, Jennifer J.; Kück, Ulrich

    2013-01-01

    Summary The filamentous fungus Sordaria macrospora develops complex fruiting bodies (perithecia) to propagate its sexual spores. Here, we present an analysis of the sterile mutant pro41 that is unable to produce mature fruiting bodies. The mutant carries a deletion of 4 kb and is complemented by the pro41 open reading frame that is contained within the region deleted in the mutant. In silico analyses predict PRO41 to be an endoplasmic reticulum (ER) membrane protein, and a PRO41–EGFP fusion protein colocalizes with ER-targeted DsRED. Furthermore, Western blot analysis shows that the PRO41–EGFP fusion protein is present in the membrane fraction. A fusion of the predicted N-terminal signal sequence of PRO41 with EGFP is secreted out of the cell, indicating that the signal sequence is functional. pro41 transcript levels are upregulated during sexual development. This increase in transcript levels was not observed in the sterile mutant pro1 that lacks a transcription factor gene. Moreover, microarray analysis of gene expression in the mutants pro1, pro41 and the pro1/41 double mutant showed that pro41 is partly epistatic to pro1. Taken together, these data show that PRO41 is a novel ER membrane protein essential for fruiting body formation in filamentous fungi. PMID:17501918

  10. Evaluating patient-reported outcome measurement comparability between paper and alternate versions, using the lung function questionnaire as an example.

    PubMed

    Dalal, Anand A; Nelson, Lauren; Gilligan, Theresa; McLeod, Lori; Lewis, Sandy; DeMuro-Mercon, Carla

    2011-01-01

    The goal of this study was to provide recommended steps to assess measurement comparability using a crossover study design and to demonstrate these steps using a short patient-reported outcome (PRO) instrument as an example. The example PRO instrument was administered via paper, Web, interactive voice response system, and interview; a randomized crossover design was used to gather data across the multiple administration types. Participants completed the PRO instrument, demographic and health questions, and a short preference questionnaire. Evaluation included comparisons of the item-level responses and agreement, comparison of mean scale scores, score classifications, and questions designed to collect usability and administration preference. Here the authors provide a four-step evaluation guide to evaluate measurement comparability and illustrate these steps using a case-finding tool. In the example, item-level kappa statistics between the paper and the alternate versions ranged from good to excellent, intraclass correlation coefficient for mean scores were above 0.70, and the rate of disagreement ranged from 2% to 14%. In addition, although participants had an administration preference, they reported few difficulties with the versions they were assigned. The steps described in this article provide a guide for evaluating whether to combine scores across administration versions to simplify analyses and interpretation under a crossover design. The guide recommends the investigation of item-level responses, summary scores, and participant usability/preference when comparing versions, with each step providing unique information to support comprehensive evaluation and informed decisions regarding whether to combine data. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  11. Effect of ProTaper Gold, Self-Adjusting File, and XP-endo Shaper Instruments on Dentinal Microcrack Formation: A Micro-computed Tomographic Study.

    PubMed

    Bayram, H Melike; Bayram, Emre; Ocak, Mert; Uygun, Ahmet Demirhan; Celik, Hakan Hamdi

    2017-07-01

    The aim of the present study was to evaluate the frequency of dentinal microcracks observed after root canal preparation with ProTaper Universal (PTU; Dentsply Tulsa Dental Specialties, Tulsa, OK), ProTaper Gold (PTG; Dentsply Tulsa Dental Specialties), Self-Adjusting File (SAF; ReDent Nova, Ra'anana, Israel), and XP-endo Shaper (XP; FKG Dentaire, La Chaux-de-Fonds, Switzerland) instruments using micro-computed tomographic (CT) analysis. Forty extracted human mandibular premolars having single-canal and straight root were randomly assigned to 4 experimental groups (n = 10) according to the different nickel-titanium systems used for root canal preparation: PTU, PTG, SAF, and XP. In the SAF and XP groups, the canals were first prepared with a K-file until #25 at the working length, and then the SAF or XP files were used. The specimens were scanned using high-resolution micro-computed tomographic imaging before and after root canal preparation. Afterward, preoperative and postoperative cross-sectional images of the teeth were screened to identify the presence of dentinal defects. For each group, the number of microcracks was determined as a percentage rate. The McNemar test was used to determine significant differences before and after instrumentation. The level of significance was set at P ≤ .05. The PTU system significantly increased the percentage rate of microcracks compared with preoperative specimens (P < .05). No new dentinal microcracks were observed in the PTG, SAF, or XP groups. Root canal preparations with the PTG, SAF, and XP systems did not induce the formation of new dentinal microcracks on straight root canals of mandibular premolars. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  12. An Evaluation of Apical Cracks in Teeth Undergoing Orthograde Root Canal Instrumentation.

    PubMed

    Rose, Elizabeth; Svec, Timothy

    2015-12-01

    Dentinal damage and cracks induced by orthograde preparation methods have been reported in studies using extracted teeth. The purpose of this in situ investigation was to evaluate dentinal cracks in nonextracted teeth after final instrumentation. The null hypothesis is that orthograde root canal instrumentation will have no effect on crack initiation in teeth retained in the natural periodontium. Mandibular first and second premolars of pig jaws were selected. Forty single-rooted canals were divided into 5 groups (n = 8): (1) WaveOne (Dentsply Tulsa Dental Specialties, Tulsa, OK) 25/08; (2) ProTaper rotary S1, S2, F2 (25/08) (Dentsply Tulsa Dental Specialties); (3) crown-down GT hand files 20/12, 20/10, 20/08 (Dentsply Tulsa Dental Specialties); (4) positive control (purposefully cracked); and (5) negative control (uninstrumented teeth). After instrumentation, superficial soft tissue was removed, and bone was carefully peeled away with surgical burs to the level of the root apices. Roots were resected 1 mm coronal to the working length, stained with caries indicator dye, and transilluminated; images were captured and viewed at 30× magnification to determine the presence or absence of dentinal cracks. WaveOne, ProTaper rotary, and GT hand files produced no cracks. All positive controls had cracks; all negative controls had no cracks. Within the limits of this investigation, the presence of natural periodontal structures may prevent cracking or dentinal damage in teeth receiving orthograde root canal instrumentation. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  13. Fatigue resistance of engine-driven rotary nickel-titanium endodontic instruments.

    PubMed

    Chaves Craveiro de Melo, Marta; Guiomar de Azevedo Bahia, Maria; Lopes Buono, Vicente Tadeu

    2002-11-01

    A comparative study of the fatigue resistance of engine-driven nickel-titanium endodontic instruments was performed, aiming to access the influence of the cutting flute design and of the size of the files that reach the working length in curved canal shaping. Geometrical conditions similar to those found in practice were used. Series 29 #5 ProFile, together with #6 and #8 Quantec instruments, were tested in artificial canals with a 45-degree angle of curvature and 5-mm radius of curvature. It was observed that the size of the instrument, which determines the maximum strain amplitude during cyclic deformation, is the most important factor controlling fatigue resistance. The effect of heat sterilization on the fatigue resistance of the instruments was also examined. The results obtained indicate that the application of five sterilization procedures in dry heat increases the average number of cycles to failure of unused instruments by approximately 70%.

  14. The comparison of the effect of endodontic irrigation on cell adherence to root canal dentin.

    PubMed

    Ring, Karla C; Murray, Peter E; Namerow, Kenneth N; Kuttler, Sergio; Garcia-Godoy, Franklin

    2008-12-01

    The purpose of this study was to compare the effect of 10 different endodontic irrigation and chelating treatments on dental pulp stem cell (DPSC) attachment to root canal surfaces. Thirty-eight extracted human nondiseased single-canal teeth were cleaned and shaped using ProTaper and ProFile rotary instrumentation (Tulsa Dentsply, Tulsa, OK). The irrigation treatments investigated were 6% sodium hypochlorite, 2% chlorhexidine gluconate, Aquatine Endodontic Cleanser, and Morinda citrifolia juice. The irrigation treatments were used in conjunction with EDTA or MTAD. The instrumented teeth were immediately placed in cell culture with confluent DPSCs for 1 week. The number of attached DPSCs appeared to be correlated with the cytotoxicity of the root canal irrigating solution (analysis of variance, p < 0.0001). The presence or absence of the smear layer had little influence on DPSC activity (chi-square, p > 0.05). The results suggest that biocompatible irrigants are needed to promote DPSC attachment to root canal dentin, which is essential to accomplish some regenerative endodontic therapies.

  15. Clinical comparison of the effectiveness of single-file reciprocating systems and rotary systems for removal of endotoxins and cultivable bacteria from primarily infected root canals.

    PubMed

    Martinho, Frederico C; Gomes, Ana P M; Fernandes, Aletéia M M; Ferreira, Nádia S; Endo, Marcos S; Freitas, Lilian F; Camões, Izabel C G

    2014-05-01

    This clinical study was conducted to compare the effectiveness of single-file reciprocating systems and rotary systems in removing endotoxins and cultivable bacteria from primarily infected root canals. Forty-eight primarily infected root canals were selected and randomly divided into 4 groups: WaveOne (Dentsply Maillefer, Ballaigues, Switzerland) (n = 12); Reciproc (VDW, Munich, Germany) (n = 12), ProTaper (Dentsply Maillefer) (n = 12), and Mtwo (VDW) (n = 12). Samples were collected before and after chemomechanical preparation. The irrigation was performed by using 2.5% sodium hypochlorite. A chromogenic limulus amebocyte lysate assay test was used to quantify endotoxins. Culture techniques were used to determine bacterial colony-forming unit counts. In the baseline samples (ie, samples collected before chemomechanical preparation), endotoxins and cultivable bacteria were recovered from 100% of the root canal samples. No differences were found in the median percentage values of endotoxin reduction achieved with reciprocating systems (ie, WaveOne [95.15%] and Reciproc [96.21%]) and with rotary systems (ie, ProTaper [97.98%] and Mtwo [96.34%]) (P < .05). Both single-file reciprocating systems (ie, WaveOne [99.45%] and Reciproc [99.93%]) and rotary systems (ProTaper [99.85%] and Mtwo [99.41%]) were effective in reducing the cultivable bacteria (all P < .05). Moreover, the culture analysis revealed no differences in bacterial load reduction (P > .05). Both single-file reciprocating systems (ie, WaveOne and Reciproc instruments) and rotary systems (ie, ProTaper and Mtwo instruments) showed similar effectiveness in reducing endotoxins and cultivable bacteria from primarily infected root canals, but they were not able to eliminate them from all root canals analyzed. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  16. Interpreting change from patient reported outcome (PRO) endpoints: patient global ratings of concept versus patient global ratings of change, a case study among osteoporosis patients.

    PubMed

    Nixon, Annabel; Doll, Helen; Kerr, Cicely; Burge, Russel; Naegeli, April N

    2016-02-19

    Regulatory guidance recommends anchor-based methods for interpretation of treatment effects measured by PRO endpoints. Methodological pros and cons of patient global ratings of change vs. patient global ratings of concept have been discussed but empirical evidence in support of either approach is lacking. This study evaluated the performance of patient global ratings of change and patient global ratings of concept for interpreting patient stability and patient improvement. Patient global ratings of change and patient global ratings of concept were included in a psychometric validation study of an osteoporosis-targeted PRO instrument (the OPAQ-PF) to assess its ability to detect change and to derive responder definitions. 144 female osteoporosis patients with (n = 37) or without (n = 107) a recent (within 6 weeks) fragility fracture completed the OPAQ-PF and global items at baseline, 2 weeks (no recent fracture), and 12 weeks (recent fracture) post-baseline. Results differed between the two methods. Recent fracture patients reported more improvement while patients without recent fracture reported more stability on ratings of change than ratings of concept. However, correlations with OPAQ-PF score change were stronger for ratings of concept than ratings of change (both groups). Effect sizes for OPAQ-PF score change increased consistently with level of change in ratings of concept but inconsistently with ratings of change, with the mean AUC for prediction of a one-point change being 0.72 vs. 0.56. This study provides initial empirical support for methodological and regulatory recommendations to use patient global ratings of concept rather than ratings of change when interpreting change captured by PRO instruments in studies evaluating treatment effects. These findings warrant being confirmed in a purpose-designed larger scale analysis.

  17. The Effect of Canal Preparation with Four Different Rotary Systems on Formation of Dentinal Cracks: An In Vitro Evaluation.

    PubMed

    Khoshbin, Elham; Donyavi, Zakiyeh; Abbasi Atibeh, Erfan; Roshanaei, Ghodratollah; Amani, Faranak

    2018-01-01

    Endodontic rotary systems may result in dentinal cracks. They may propagate to vertical root fracture that compromises the outcome of endodontic treatment. This study aimed to compare Neolix and Reciproc (single-file systems), Mtwo and ProTaper (conventional rotary systems) in terms of dentinal crack formation in root canal walls. This in vitro study was conducted on 110 extracted human single-rooted teeth. The teeth were randomly divided into four experimental groups ( n =25) for root canal preparation with Neolix, Reciproc, Mtwo and ProTaper systems and two control groups ( n =5). The first control group underwent root canal instrumentation with hand files while the second control group received no preparation and was only irrigated. After instrumentation, root canals were horizontally sectioned at 3, 6 and 9 mm from the apex and inspected under a stereomicroscope under 12× magnification for detection of cracks. The data were analyzed using Chi-square, GEE test and Bonferroni tests ( P <0.05). No crack was found in the control groups. All rotary systems caused dentinal cracks. ProTaper, Reciproc, Mtwo and Neolix caused cracks in 92%, 80%, 68% and 48% of samples. ProTaper caused significantly more cracks than Neolix and Mtwo ( P <0.05). No significant differences were noted between other groups ( P >0.05). All rotary systems cause dentinal cracks and it is significantly different in apical, middle and coronal third of the root. Neolix appears to be a suitable alternative to other rotary systems since use of this single-file system saves time and cost and minimizes trauma to dentinal walls.

  18. Root canal volume change and transportation by Vortex Blue, ProTaper Next, and ProTaper Universal in curved root canals

    PubMed Central

    2018-01-01

    Objectives The aim of this study was to compare root canal volume change and canal transportation by Vortex Blue (VB; Dentsply Tulsa Dental Specialties), ProTaper Next (PTN; Dentsply Maillefer), and ProTaper Universal (PTU; Dentsply Maillefer) nickel-titanium rotary files in curved root canals. Materials and Methods Thirty canals with 20°–45° of curvature from extracted human molars were used. Root canal instrumentation was performed with VB, PTN, and PTU files up to #30.06, X3, and F3, respectively. Changes in root canal volume before and after the instrumentation, and the amount and direction of canal transportation at 1, 3, and 5 mm from the root apex were measured by using micro-computed tomography. Data of canal volume change were statistically analyzed using one-way analysis of variance and Tukey test, while data of amount and direction of transportation were analyzed using Kruskal-Wallis and Mann-Whitney U test. Results There were no significant differences among 3 groups in terms of canal volume change (p > 0.05). For the amount of transportation, PTN showed significantly less transportation than PTU at 3 mm level (p = 0.005). VB files showed no significant difference in canal transportation at all 3 levels with either PTN or PTU files. Also, VB files showed unique inward transportation tendency in the apical area. Conclusions Other than PTN produced less amount of transportation than PTU at 3 mm level, all 3 file systems showed similar level of canal volume change and transportation, and VB file system could prepare the curved canals without significant shaping errors. PMID:29487834

  19. The Effect of Canal Preparation with Four Different Rotary Systems on Formation of Dentinal Cracks: An In Vitro Evaluation

    PubMed Central

    Khoshbin, Elham; Donyavi, Zakiyeh; Abbasi Atibeh, Erfan; Roshanaei, Ghodratollah; Amani, Faranak

    2018-01-01

    Introduction: Endodontic rotary systems may result in dentinal cracks. They may propagate to vertical root fracture that compromises the outcome of endodontic treatment. This study aimed to compare Neolix and Reciproc (single-file systems), Mtwo and ProTaper (conventional rotary systems) in terms of dentinal crack formation in root canal walls. Methods and Materials: This in vitro study was conducted on 110 extracted human single-rooted teeth. The teeth were randomly divided into four experimental groups (n=25) for root canal preparation with Neolix, Reciproc, Mtwo and ProTaper systems and two control groups (n=5). The first control group underwent root canal instrumentation with hand files while the second control group received no preparation and was only irrigated. After instrumentation, root canals were horizontally sectioned at 3, 6 and 9 mm from the apex and inspected under a stereomicroscope under 12× magnification for detection of cracks. The data were analyzed using Chi-square, GEE test and Bonferroni tests (P<0.05). Results: No crack was found in the control groups. All rotary systems caused dentinal cracks. ProTaper, Reciproc, Mtwo and Neolix caused cracks in 92%, 80%, 68% and 48% of samples. ProTaper caused significantly more cracks than Neolix and Mtwo (P<0.05). No significant differences were noted between other groups (P>0.05). Conclusion: All rotary systems cause dentinal cracks and it is significantly different in apical, middle and coronal third of the root. Neolix appears to be a suitable alternative to other rotary systems since use of this single-file system saves time and cost and minimizes trauma to dentinal walls. PMID:29707009

  20. Apical extrusion of debris and irrigants using hand and three rotary instrumentation systems– An in vitro study

    PubMed Central

    Madhusudhana, Koppolu; Mathew, Vinod Babu; Reddy, Nelaturi Madhusudhan

    2010-01-01

    Introduction: Sterilization of the root canal is a prime aim of successful endodontics. The cleaning and shaping of the canal is directed as achieving this goal. The extrusion of apical debris has a deleterious effect on the prognosis of root canal treatment. Several instrument designs and instrumentation techniques have been developed to prevent this. Materials and Methods: Forty caries free single rooted human mandibular premolar teeth were divided in four groups of ten teeth each. Teeth in each group were instrumented until the working length with rotary ProTaper, K3, Mtwo systems, and hand K-type stainless steel files. Debris and irrigant extruded from the apical foramen were collected into vials and the amounts were quantitatively determined. The data obtained were analyzed using Kruskal-Wallis one-way analysis of variance and Mann-Whitney U tests. Results: The results show that all instrumentation techniques produced significant amount of extruded debris and irrigant. The engine-driven nickel-titanium systems showed less apical extrusion of debris and irrigant than manual technique. No statistically significant difference was found between the groups at [P > 0.05]. Maximum apical debris and irrigant extrusion was seen with K-file group and least in the Mtwo group. Conclusions: The use of rotary files and techniques to perform instrumentation does show less extrusion of the debris and irrigant from the apex. This can contribute to more successful endodontic therapy. PMID:22114427

  1. Optical Alignment of the Chromospheric Lyman-Alpha SpectroPolarimeter using Sophisticated Methods to Minimize Activities under Vacuum

    NASA Technical Reports Server (NTRS)

    Giono, G.; Katsukawa, Y.; Ishikawa, R.; Narukage, N.; Kano, R.; Kubo, M.; Ishikawa, S.; Bando, T.; Hara, H.; Suematsu, Y.; hide

    2016-01-01

    The Chromospheric Lyman-Alpha Spectro-Polarimeter (CLASP) is a sounding-rocket instrument developed at the National Astronomical Observatory of Japan (NAOJ) as a part of an international collaboration. The in- strument main scientific goal is to achieve polarization measurement of the Lyman-alpha line at 121.56 nm emitted from the solar upper-chromosphere and transition region with an unprecedented 0.1% accuracy. For this purpose, the optics are composed of a Cassegrain telescope coated with a "cold mirror" coating optimized for UV reflection and a dual-channel spectrograph allowing for simultaneous observation of the two orthogonal states of polarization. Although the polarization sensitivity is the most important aspect of the instrument, the spatial and spectral resolutions of the instrument are also crucial to observe the chromospheric features and resolve the Ly- pro les. A precise alignment of the optics is required to ensure the resolutions, but experiments under vacuum conditions are needed since Ly-alpha is absorbed by air, making the alignment experiments difficult. To bypass this issue, we developed methods to align the telescope and the spectrograph separately in visible light. We will explain these methods and present the results for the optical alignment of the CLASP telescope and spectrograph. We will then discuss the combined performances of both parts to derive the expected resolutions of the instrument, and compare them with the flight observations performed on September 3rd 2015.

  2. Brain natriuretic peptide and insulin resistance in older adults.

    PubMed

    Kim, F; Biggs, M L; Kizer, J R; Brutsaert, E F; de Filippi, C; Newman, A B; Kronmal, R A; Tracy, R P; Gottdiener, J S; Djoussé, L; de Boer, I H; Psaty, B M; Siscovick, D S; Mukamal, K J

    2017-02-01

    Higher levels of brain natriuretic peptide (BNP) have been associated with a decreased risk of diabetes in adults, but whether BNP is related to insulin resistance in older adults has not been established. N-terminal of the pro hormone brain natriuretic peptide (NT-pro BNP) was measured among Cardiovascular Health Study participants at the 1989-1990, 1992-1993 and 1996-1997 examinations. We calculated measures of insulin resistance [homeostatic model assessment of insulin resistance (HOMA-IR), quantitative insulin sensitivity check index (QUICKI), Gutt index, Matsuda index] from fasting and 2-h concentrations of glucose and insulin among 3318 individuals with at least one measure of NT-proBNP and free of heart failure, coronary heart disease and chronic kidney disease, and not taking diabetes medication. We used generalized estimating equations to assess the cross-sectional association of NT-proBNP with measures of insulin resistance. Instrumental variable analysis with an allele score derived from nine genetic variants (single nucleotide polymorphisms) within or near the NPPA and NPPB loci was used to estimate an un-confounded association of NT-proBNP levels on insulin resistance. Lower NT-proBNP levels were associated with higher insulin resistance even after adjustment for BMI, waist circumference and other risk factors (P < 0.001 for all four indices). Although the genetic score was strongly related to measured NT-proBNP levels amongst European Americans (F statistic = 71.08), we observed no association of genetically determined NT-proBNP with insulin resistance (P = 0.38; P = 0.01 for comparison with the association of measured levels of NT-proBNP). In older adults, lower NT-proBNP is associated with higher insulin resistance, even after adjustment for traditional risk factors. Because related genetic variants were not associated with insulin resistance, the causal nature of this association will require future study. © 2016 Diabetes UK.

  3. An In vitro Comparison of Apically Extruded Debris Using Reciproc, ProTaper Universal, Neolix and Hyflex in Curved Canals.

    PubMed

    Labbaf, Hossein; Nazari Moghadam, Kiumars; Shahab, Shahriar; Mohammadi Bassir, Mahshid; Fahimi, Mohammad Amin

    2017-01-01

    As a consequence of root canal preparation, dentinal chips, irrigants and pulp remnants are extruded into preradicular space. This phenomenon may lead to post endodontic flare-ups. The purpose of this study was to compare the amount of extruded debris with four endodontic NiTi engine-driven systems. Sixty mesiobuccal roots of maxillary molars with 15-30˚ curvature were divided randomly into four groups ( n =15). Each group was instrumented up to apical size of 25 using Reciproc, ProTaper Universal, Neolix and Hyflex. Bidistilled water was used as irrigant and extruded debris was collected in pre-weighted Eppendorf tubes. Tubes were stored in incubator for drying the debris. Extruded debris were weighted in electronic microbalance with accuracy of 0.0001 g. The raw data was analyzed with one way analysis of variance (ANOVA) and Tukey's HSD post hoc test. Level of significance was set at 0.05. The debris extrusion with Reciproc files was significantly higher than the other groups ( P <0.05). Hyflex significantly extruded less debris than other files ( P <0.05). There was no significant difference between ProTaper Universal and Neolix regarding the amount of extruded debris ( P =0.98). All systems extruded debris during the instrumentation. Reciproc system significantly extruded more debris. Caution should be taken when interpreting the results of this study and applying it to the real clinical situation.

  4. Canal shaping with WaveOne Primary reciprocating files and ProTaper system: a comparative study.

    PubMed

    Berutti, Elio; Chiandussi, Giorgio; Paolino, Davide Salvatore; Scotti, Nicola; Cantatore, Giuseppe; Castellucci, Arnaldo; Pasqualini, Damiano

    2012-04-01

    This study compared the canal curvature and axis modification after instrumentation with WaveOne Primary reciprocating files (Dentsply Maillefer, Ballaigues, Switzerland) and nickel-titanium (NiTi) rotary ProTaper (Dentsply Maillefer). Thirty ISO 15, 0.02 taper, Endo Training Blocks (Dentsply Maillefer) were used. In all specimens, the glide path was achieved with PathFile 1, 2, and 3 (Dentsply Maillefer) at the working length (WL). Specimens were then assigned to 1 of 2 groups for shaping: specimens in group 1 were shaped with ProTaper S1-S2-F1-F2 at the WL and specimens in group 2 were shaped with WaveOne Primary reciprocating files at the WL. Pre- and postinstrumentation digital images were superimposed and processed with Matlab r2010b (The MathWorks Inc, Natick, MA) software to analyze the curvature-radius ratio (CRr) and the relative axis error (rAe), representing canal curvature modification. Data were analyzed with one-way balanced analyses of variance at 2 levels (P < .05). The instrument factor was extremely significant for both the CRr parameter (F(1) = 9.59, P = .004) and the rAe parameter (F(1) = 13.55, P = .001). Canal modifications are reduced when the new WaveOne NiTi single-file system is used. Copyright © 2012 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  5. Comparison of the amount of apical debris extrusion associated with different retreatment systems and supplementary file application during retreatment process.

    PubMed

    Çiçek, Ersan; Koçak, Mustafa Murat; Koçak, Sibel; Sağlam, Baran Can

    2016-01-01

    The type of instrument affects the amount of debris extruded. The aim of this study was to compare the effect of retreatment systems and supplementary file application on the amount of apical debris extrusion. Forty-eight extracted mandibular premolars with a single canal and similar length were selected. The root canals were prepared with the ProTaper Universal system with a torque-controlled engine. The root canals were dried and were obturated using Gutta-percha and sealer. The specimens were randomly divided into four equal groups according to the retreatment procedures (Group 1, Mtwo retreatment files; Group 2, Mtwo retreatment files + Mtwo rotary file #30 supplementary file; Group 3, ProTaper Universal retreatment (PTUR) files; and Group 4, PTUR files + ProTaper F3 supplementary file). The extruded debris during instrumentation were collected into preweighed Eppendorf tubes. The amount of apically extruded debris was calculated by subtracting the initial weight of the tube from the final weight. Three consecutive weights were obtained for each tube. No statistically significant difference was found in the amount of apically extruded debris between Groups 1 and 3 (P = 0.590). A significant difference was observed between Groups 1 and 2 (P < 0.05), and between Groups 3 and 4 (P < 0.05). The use of supplementary file significantly increased the amount of apically extruded debris.

  6. Canal Transportation, Unprepared Areas, and Dentin Removal after Preparation with BT-RaCe and ProTaper Next Systems.

    PubMed

    Brasil, Sabrina C; Marceliano-Alves, Marília F; Marques, Márcia L; Grillo, João P; Lacerda, Mariane F L S; Alves, Flávio R F; Siqueira, José F; Provenzano, José C

    2017-10-01

    This study compared the shaping ability of ProTaper Next (Dentsply Sirona, Tulsa, OK) and BT-RaCe (FKG Dentaire, La Chaux-de-Fonds, Switzerland) instrument systems in the mesial canals of mandibular molars using micro-computed tomographic (micro-CT) imaging. A total of 17 type IV mesial roots of extracted first mandibular molars were scanned using micro-CT imaging before and after root canal preparation with the 2 instrument systems. Both systems were used in the same root but alternating the mesial canals from root to root. The following parameters were analyzed: root canal volume, surface area, unprepared surface areas, transportation, canal/root width ratio, and preparation time. There were no statistically significant differences between the 2 systems for all evaluated parameters (P > .05). The unprepared surface areas for the full canal length and the apical 5-mm segment were 33% and 14% for BT-RaCe and 31% and 14% for ProTaper Next, respectively. After preparation, all root canals had a diameter that was not larger than 35% of the root diameter at the coronal and middle segments. The 2 systems showed no differences in any of the evaluated shaping parameters. None of the tested systems put the roots at risk of fracture because of excessive dentin removal. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  7. Effect of retained fractured instruments on tooth resistance to vertical fracture with or without attempt at removal.

    PubMed

    Madarati, A A; Qualtrough, A J E; Watts, D C

    2010-11-01

    To investigate the effect of retained fractured endodontic instruments on root strength and to evaluate the effectiveness of several root filling materials in reinforcing roots that had undergone unsuccessful attempt at removal of fractured instruments. Seventy five mandibular premolar roots were divided into five groups. In group A (control), canals were prepared to a size F5-ProTaper instrument and filled with gutta-percha and TubliSeal sealer fragments. In the experimental groups (B, C, D and E), 4 mm of F5-ProTaper instruments were fractured in the apical one-third of the canal and then treated as follows: in group B, the fragments were left in situ without attempt at removal, and canals were filled with gutta-percha and TubliSeal sealer (GP No Removal). In groups C, D and E, an attempt at removal of the fragment was simulated by preparing a staging platform coronal to the fragment using modified Gates Glidden burs (No 2-5). Canals in group C were filled with gutta-percha and TubliSeal sealer (GP Removal), group D filled with Resilon (Resilon Removal) and group E with mineral trioxide aggregate (MTA Removal). Roots then underwent vertical fracture. Data were analysed using the one-way anova at P<0.05. Roots in the GP Removal group had significantly lower values for mean force for fracture (404.9 N). There was no significant difference between the control group and GP No Removal (765.2 and 707.8, respectively). Resilon Removal and MTA Removal groups (577.3 and 566.6 N) were not significantly different from the GP No Removal group. Leaving fractured instruments in the apical one-third of the canal does not appear to affect the resistance of the root to vertical fracture; Resilon and MTA appear to compensate for root dentine loss that occurred as a consequence of attempts at retrieval of fractured instruments when used as canal filling materials. © 2010 International Endodontic Journal.

  8. THE DETERMINATION OF TOTAL ORGANIC HALIDE IN WATER: A COMPARATIVE STUDY OF TWO INSTRUMENTS

    EPA Science Inventory

    Total organic halide (TOX) analyzers are commonly used to measure the amount of dissolved halogenated organic byproducts in disinfected waters. ecause of the lack of information on the identity of disinfection byproducts, rigorous testing of the dissolved organic halide (DOX) pro...

  9. Trilingual Education and Mongolian Ethnicity

    ERIC Educational Resources Information Center

    Bilik, Naran; Erdene, Has

    2016-01-01

    Anxieties about Chinese-Mongolian-English trilingual program in Inner Mongolia reflect three linguistic ideologies, that is, the instrumental and the essentialist among Mongolian elites and the assimilationist among Han elites. Mongolian ethnicity is on trial in front of an upsurge of Chinese nationalism. Both pro and con trilingual education…

  10. Effect of ultrasound streaming on the disinfection of flattened root canals prepared by rotary and reciprocating systems

    PubMed Central

    de Vasconcelos, Layla Reginna Silva Munhoz; Midena, Raquel Zanin; Minotti, Paloma Gagliardi; Pereira, Thais Cristina; Duarte, Marco Antonio Hungaro; de Andrade, Flaviana Bombarda

    2017-01-01

    Abstract New technical and scientific developments have been advocated to promote the success of the endodontic treatment. In addition to rotary and reciprocating systems, irrigating solution agitation has been suggested and passive ultrasonic irrigation (PUI) is the most used. Objective: To evaluate, in vitro, the effect of ultrasound streaming (US) in the disinfection of flattened root canal systems prepared by the ProTaper, BioRaCe and Reciproc systems, utilizing the microbiological culture. Methodology: Extracted human mandibular incisors (n=84) were used. Suspensions of Enterococcus faecalis (ATCC 29212) were standardized and inserted along with the teeth immersed in brain-heart infusion (BHI) broth. The contamination was made following a protocol during 5 days. The teeth were randomly divided into six groups: G1, ProTaper Universal; G2, ProTaper Universal with US; G3, BioRaCe; G4, BioRaCe with US; G5, Reciproc; and G6, Reciproc with US. Irrigation was performed with saline solution. After biomechanical preparation, microbiological samples were performed with sterilized paper points, which were diluted and spread on BHI agar; after 48 h, the colony forming units (CFU/mL) were counted for each sample. Results: Groups using ultrasonic agitation presented a greater antibacterial effect than the other ones, even using saline solution as irrigant. The ProTaper Universal system showed the best antibacterial activity of the tested systems (median of 0 CFU/mL with and without surfactant or ultrasonic activation [PUI]). Even with PUI, Reciproc (median of 2.5 CFU/mL with PUI and 5 without it) could not reduce as many colonies as ProTaper Universal without US. The BioRaCe system had greater bacterial reduction when using US (median of 0 CFU/mL with PUI and 30 without it). Conclusions: US promoted greater reduction in the number of bacteria in the flattened root canals prepared with nickel-titanium mechanized systems. Regarding the instruments used, the ProTaper Universal system was the most effective in reducing the bacterial number. PMID:29069144

  11. Measurement and control of bias in patient reported outcomes using multidimensional item response theory.

    PubMed

    Dowling, N Maritza; Bolt, Daniel M; Deng, Sien; Li, Chenxi

    2016-05-26

    Patient-reported outcome (PRO) measures play a key role in the advancement of patient-centered care research. The accuracy of inferences, relevance of predictions, and the true nature of the associations made with PRO data depend on the validity of these measures. Errors inherent to self-report measures can seriously bias the estimation of constructs assessed by the scale. A well-documented disadvantage of self-report measures is their sensitivity to response style (RS) effects such as the respondent's tendency to select the extremes of a rating scale. Although the biasing effect of extreme responding on constructs measured by self-reported tools has been widely acknowledged and studied across disciplines, little attention has been given to the development and systematic application of methodologies to assess and control for this effect in PRO measures. We review the methodological approaches that have been proposed to study extreme RS effects (ERS). We applied a multidimensional item response theory model to simultaneously estimate and correct for the impact of ERS on trait estimation in a PRO instrument. Model estimates were used to study the biasing effects of ERS on sum scores for individuals with the same amount of the targeted trait but different levels of ERS. We evaluated the effect of joint estimation of multiple scales and ERS on trait estimates and demonstrated the biasing effects of ERS on these trait estimates when used as explanatory variables. A four-dimensional model accounting for ERS bias provided a better fit to the response data. Increasing levels of ERS showed bias in total scores as a function of trait estimates. The effect of ERS was greater when the pattern of extreme responding was the same across multiple scales modeled jointly. The estimated item category intercepts provided evidence of content independent category selection. Uncorrected trait estimates used as explanatory variables in prediction models showed downward bias. A comprehensive evaluation of the psychometric quality and soundness of PRO assessment measures should incorporate the study of ERS as a potential nuisance dimension affecting the accuracy and validity of scores and the impact of PRO data in clinical research and decision making.

  12. Effect of ultrasound streaming on the disinfection of flattened root canals prepared by rotary and reciprocating systems.

    PubMed

    Vasconcelos, Layla Reginna Silva Munhoz de; Midena, Raquel Zanin; Minotti, Paloma Gagliardi; Pereira, Thais Cristina; Duarte, Marco Antonio Hungaro; Andrade, Flaviana Bombarda de

    2017-01-01

    New technical and scientific developments have been advocated to promote the success of the endodontic treatment. In addition to rotary and reciprocating systems, irrigating solution agitation has been suggested and passive ultrasonic irrigation (PUI) is the most used. To evaluate, in vitro, the effect of ultrasound streaming (US) in the disinfection of flattened root canal systems prepared by the ProTaper, BioRaCe and Reciproc systems, utilizing the microbiological culture. Extracted human mandibular incisors (n=84) were used. Suspensions of Enterococcus faecalis (ATCC 29212) were standardized and inserted along with the teeth immersed in brain-heart infusion (BHI) broth. The contamination was made following a protocol during 5 days. The teeth were randomly divided into six groups: G1, ProTaper Universal; G2, ProTaper Universal with US; G3, BioRaCe; G4, BioRaCe with US; G5, Reciproc; and G6, Reciproc with US. Irrigation was performed with saline solution. After biomechanical preparation, microbiological samples were performed with sterilized paper points, which were diluted and spread on BHI agar; after 48 h, the colony forming units (CFU/mL) were counted for each sample. Groups using ultrasonic agitation presented a greater antibacterial effect than the other ones, even using saline solution as irrigant. The ProTaper Universal system showed the best antibacterial activity of the tested systems (median of 0 CFU/mL with and without surfactant or ultrasonic activation [PUI]). Even with PUI, Reciproc (median of 2.5 CFU/mL with PUI and 5 without it) could not reduce as many colonies as ProTaper Universal without US. The BioRaCe system had greater bacterial reduction when using US (median of 0 CFU/mL with PUI and 30 without it). US promoted greater reduction in the number of bacteria in the flattened root canals prepared with nickel-titanium mechanized systems. Regarding the instruments used, the ProTaper Universal system was the most effective in reducing the bacterial number.

  13. Elevated admission N-terminal pro-brain natriuretic peptide level predicts the development of atrial fibrillation in general surgical intensive care unit patients.

    PubMed

    Chokengarmwong, Nalin; Yeh, Daniel Dante; Chang, Yuchiao; Ortiz, Luis Alfonso; Kaafarani, Haytham M A; Fagenholz, Peter; King, David R; DeMoya, Marc; Butler, Kathryn; Lee, Jarone; Velmahos, George; Januzzi, James Louis; Lee-Lewandrowski, Elizabeth; Lewandrowski, Kent

    2017-09-01

    New onset atrial fibrillation (AF) in critically ill surgical patients is associated with significant morbidity and increased mortality. N-terminal pro-B type natriuretic peptide (NT-proBNP) is released by cardiomyocytes in response to stress and may predict AF development after surgery. We hypothesized that elevated NT-proBNP level at surgical intensive care unit (ICU) admission predicts AF development in a general surgical and trauma population. From July to October 2015, NT-proBNP concentrations were measured at ICU admission. Abnormal NT-proBNP concentrations were defined by age-adjusted cut-offs. We examined the relationship between the development of AF and demographics, clinical variables, and NT-proBNP level using univariate analysis and a multivariable logistic regression model. Three hundred eighty-seven subjects were included in the cohort, none of whom were in AF at ICU admission. The median age was 63 years (52-73 years), and 40.3% were women. The risk of developing AF was higher for abnormal versus normal NT-proBNP (22% vs. 4%; p < 0.0001). Using optimal derived cutoffs (regardless of age), the risk of developing AF was 2% for NT-proBNP less than 600 ng/L, 15% for NT-proBNP of 600 ng/L to 1,999 ng/L, and 27% for NT-proBNP of 2,000 ng/L or greater. Multiple logistic regression analysis identified three independent predictors for new-onset AF: age, older than 70 years (odds ratio [OR], 3.7, 95% confidence interval [CI], 1.5-9.3), history of AF (OR, 25.3; 95% CI, 9.6-67.0), and NT-proBNP of 600 or greater (OR, 4.3; 95% CI, 1.3-14.2). When none or only one predictor was present, AF incidence was less than 1%. When all three predictors were present, AF incidence was 66%. For subjects 70 years or older but no history of AF, AF incidence was 12.8% when NT-proBNP was 600 or greater compared with 0% when NT-proBNP was less than 600. For subjects younger than 70 years with a history of AF, AF incidence was 44.4% when NT-proBNP was 600 or higher compared to 0% when NT-proBNP was less than 600. Elevated NT-proBNP at ICU admission in general surgical and trauma patients is predictive of AF development in the first 3 ICU days. Addition of NT-proBNP measurement to known risk factors can improve predictive power and identify patients who might potentially benefit from evidence-based prophylactic treatment for AF.

  14. Cyclic fatigue resistance, torsional resistance, and metallurgical characteristics of M3 Rotary and M3 Pro Gold NiTi files

    PubMed Central

    2018-01-01

    Objectives To evaluate the mechanical properties and metallurgical characteristics of the M3 Rotary and M3 Pro Gold files (United Dental). Materials and Methods One hundred and sixty new M3 Rotary and M3 Pro Gold files (sizes 20/0.04 and 25/0.04) were used. Torque and angle of rotation at failure (n = 20) were measured according to ISO 3630-1. Cyclic fatigue resistance was tested by measuring the number of cycles to failure in an artificial stainless steel canal (60° angle of curvature and a 5-mm radius). The metallurgical characteristics were investigated by differential scanning calorimetry. Data were analyzed using analysis of variance and the Student-Newman-Keuls test. Results Comparing the same size of the 2 different instruments, cyclic fatigue resistance was significantly higher in the M3 Pro Gold files than in the M3 Rotary files (p < 0.001). No significant difference was observed between the files in the maximum torque load, while a significantly higher angular rotation to fracture was observed for M3 Pro Gold (p < 0.05). In the DSC analysis, the M3 Pro Gold files showed one prominent peak on the heating curve and 2 prominent peaks on the cooling curve. In contrast, the M3 Rotary files showed 1 small peak on the heating curve and 1 small peak on the cooling curve. Conclusions The M3 Pro Gold files showed greater flexibility and angular rotation than the M3 Rotary files, without decrement of their torque resistance. The superior flexibility of M3 Pro Gold files can be attributed to their martensite phase. PMID:29765904

  15. Pro-social cognition: helping, practical reasons, and ‘theory of mind’

    PubMed Central

    Roessler, Johannes; Perner, Josef

    2016-01-01

    There is converging evidence that over the course of the second year children become good at various fairly sophisticated forms of pro-social activities, such as helping, informing and comforting. Not only are toddlers able to do these things, they appear to do them routinely and almost reliably. A striking feature of these interventions, emphasized in the recent literature, is that they show precocious abilities in two different domains: they reflect complex ‘theory of mind’ abilities as well as ‘altruistic motivation’. Our aim in this paper is to present a theoretical hypothesis that bears on both kinds of developments. The suggestion is that children’s ‘instrumental helping’ reflects their budding understanding of practical reasons (in the standard sense of ‘considerations that count in favour of’ someone’s acting in a certain way). We can put the basic idea in the familiar terminology of common coding: toddlers conceive of the goals of others’ actions in the same format as the goals of their own actions: in terms of features of their situation that provide us with reasons to act. PMID:26941589

  16. Pro-social cognition: helping, practical reasons, and 'theory of mind'.

    PubMed

    Roessler, Johannes; Perner, Josef

    2015-12-01

    There is converging evidence that over the course of the second year children become good at various fairly sophisticated forms of pro-social activities, such as helping, informing and comforting. Not only are toddlers able to do these things, they appear to do them routinely and almost reliably. A striking feature of these interventions, emphasized in the recent literature, is that they show precocious abilities in two different domains: they reflect complex 'theory of mind' abilities as well as 'altruistic motivation'. Our aim in this paper is to present a theoretical hypothesis that bears on both kinds of developments. The suggestion is that children's 'instrumental helping' reflects their budding understanding of practical reasons (in the standard sense of 'considerations that count in favour of' someone's acting in a certain way). We can put the basic idea in the familiar terminology of common coding: toddlers conceive of the goals of others' actions in the same format as the goals of their own actions: in terms of features of their situation that provide us with reasons to act.

  17. The In-Situ One-Step Synthesis of a PDC Macromolecular Pro-Drug and the Fabrication of a Novel Core-Shell Micell.

    PubMed

    Yu, Cui-Yun; Yang, Sa; Li, Zhi-Ping; Huang, Can; Ning, Qian; Huang, Wen; Yang, Wen-Tong; He, Dongxiu; Sun, Lichun

    2016-01-01

    The development of slow release nano-sized carriers for efficient antineoplastic drug delivery with a biocompatible and biodegradable pectin-based macromolecular pro-drug for tumor therapy has been reported in this study. Pectin-doxorubicin conjugates (PDC), a macromolecular pro-drug, were prepared via an amide condensation reaction, and a novel amphiphilic core-shell micell based on a PDC macromolecular pro-drug (PDC-M) was self-assembled in situ, with pectin as the hydrophilic shell and doxorubicin (DOX) as the hydrophobic core. Then the chemical structure of the PDC macromolecular pro-drug was identified by both Fourier transform infrared spectroscopy (FTIR) and nuclear magnetic resonance spectroscopy ((1)H-NMR), and proved that doxorubicin combined well with the pectin and formed macromolecular pro-drug. The PDC-M were observed to have an unregularly spherical shape and were uniform in size by scanning electron microscopy (SEM). The average particle size of PDC-M, further measured by a Zetasizer nanoparticle analyzer (Nano ZS, Malvern Instruments), was about 140 nm. The encapsulation efficiency and drug loading were 57.82% ± 3.7% (n = 3) and 23.852% ±2.3% (n = 3), respectively. The in vitro drug release behaviors of the resulting PDC-M were studied in a simulated tumor environment (pH 5.0), blood (pH 7.4) and a lysosome media (pH 6.8), and showed a prolonged slow release profile. Assays for antiproliferative effects and flow cytometry of the resulting PDC-M in HepG2 cell lines demonstrated greater properties of delayed and slow release as compared to free DOX. A cell viability study against endothelial cells further revealed that the resulting PDC-M possesses excellent cell compatibilities and low cytotoxicities in comparison with that of the free DOX. Hemolysis activity was investigated in rabbits, and the results also demonstrated that the PDC-M has greater compatibility in comparison with free DOX. This shows that the resulting PDC-M can ameliorate the hydrophobicity of free DOX. This work proposes a novel strategy for in-situ one-step synthesis of macromolecular pro-drugs and fabrication of a core-shell micelle, demonstrating great potential for cancer chemotherapy.

  18. Interpretation of B-type natriuretic peptides in the era of angiotensin receptor-neprilysin inhibitors.

    PubMed

    Bettencourt, Paulo; Fonseca, Cândida; Franco, Fátima; Andrade, Aurora; Brito, Dulce

    2017-12-01

    Assessment of serum levels of natriuretic peptides, especially the amino-terminal portion (NT-proBNP) and the carboxy-terminal portion (BNP) of pro-B-type natriuretic peptide, has had a highly significant clinical impact on the diagnosis and prognostic stratification of patients with heart failure (HF). They are now an instrument with recognized value in this context and several studies have demonstrated their value in tailoring therapy for these patients. Following the recent advent of angiotensin receptor-neprilysin inhibitors (ARNIs), there is a need to review how these two biomarkers are interpreted in HF. The use of ARNIs is associated with a reduction in NT-proBNP but an increase in BNP levels. The authors of this concise article review the interpretation of natriuretic peptide levels in the light of the most recent evidence. Copyright © 2017 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

  19. Diarrhea-predominant irritable bowel syndrome: creation of an electronic version of a patient-reported outcome instrument by conversion from a pen-and-paper version and evaluation of their equivalence.

    PubMed

    Delgado-Herrera, Leticia; Banderas, Benjamin; Ojo, Oluwafunke; Kothari, Ritesh; Zeiher, Bernhardt

    2017-01-01

    Subjects with diarrhea-predominant irritable bowel syndrome (IBS-D) experience abdominal cramping, bloating, pressure, and pain. Due to an absence of clinical biomarkers for IBS-D severity, evaluation of clinical therapy benefits depends on valid and reliable symptom assessments. A patient-reported outcome (PRO) instrument has been developed, comprising of two questionnaires - the IBS-D Daily Symptom Diary and IBS-D Symptom Event Log - suitable for clinical trials and real-world settings. This program aimed to support instrument conversion from pen-and-paper to electronic format. Digital technology (Android/iOS) and a traditional mode of administration study in the target population were used to migrate or convert the validated PRO IBS-D pen-and-paper measure to an electronic format. Equivalence interviews, conducted in three waves, each had three parts: 1) conceptual equivalence testing between formats, 2) electronic-version report-history cognitive debriefing, and 3) electronic version usability evaluation. After each inter-view wave, preliminary analyses were conducted and modifications made to the electronic version, before the next wave. Final revisions were based on a full analysis of equivalence interviews. The final analysis evaluated subjects' ability to read, understand, and provide meaningful responses to the instruments across both formats. Responses were classified according to conceptual equivalence between formats and mobile-format usability assessed with a questionnaire and open-ended probes. Equivalence interviews (n=25) demonstrated conceptual equivalence between formats. Mobile-application cognitive debriefing showed some subjects experienced difficulty with font/screen visibility and understanding or reading some report-history charts and summary screens. To address difficulties, minor revisions/modifications were made and landscape orientation and zoom-in/zoom-out features incorporated. This study indicates that the two administration modes are conceptually equivalent. Since both formats are conceptually equivalent, both are psychometrically reliable, as established in the pen-and-paper version. Subjects found both mobile applications (Android/iOS) offered many advantages over the paper version, such as real-time assessment of their experience.

  20. Evaluation of the MeltPro TB/STR assay for rapid detection of streptomycin resistance in Mycobacterium tuberculosis.

    PubMed

    Zhang, Ting; Hu, Siyu; Li, Guoli; Li, Hui; Liu, Xiaoli; Niu, Jianjun; Wang, Feng; Wen, Huixin; Xu, Ye; Li, Qingge

    2015-03-01

    Rapid and comprehensive detection of drug-resistance is essential for the control of tuberculosis, which has facilitated the development of molecular assays for the detection of drug-resistant mutations in Mycobacterium tuberculosis. We hereby assessed the analytical and clinical performance of an assay for streptomycin-resistant mutations. MeltPro TB/STR is a closed-tube, dual-color, melting curve analysis-based, real-time PCR test designed to detect 15 streptomycin-resistant mutations in rpsL 43, rpsL 88, rrs 513, rrs 514, rrs 517, and rrs 905-908 of M. tuberculosis. Analytical studies showed that the accuracy was 100%, the limit of detection was 50-500 bacilli per reaction, the reproducibility in the form of Tm variation was within 1.0 °C, and we could detect 20% STR resistance in mixed bacterial samples. The cross-platform study demonstrated that the assay could be performed on six models of real-time PCR instruments. A multicenter clinical study was conducted using 1056 clinical isolates, which were collected from three geographically different healthcare units, including 709 STR-susceptible and 347 STR-resistant isolates characterized on Löwenstein-Jensen solid medium by traditional drug susceptibility testing. The results showed that the clinical sensitivity and specificity of the MeltPro TB/STR was 88.8% and 95.8%, respectively. Sequencing analysis confirmed the accuracy of the mutation types. Among all the 8 mutation types detected, rpsL K43R (AAG → AGG), rpsL K88R (AAG → AGG) and rrs 514 A → C accounted for more than 90%. We concluded that MeltPro TB/STR represents a rapid and reliable assay for the detection of STR resistance in clinical isolates. Copyright © 2014. Published by Elsevier Ltd.

  1. A Comparative Evaluation of Gutta Percha Removal and Extrusion of Apical Debris by Rotary and Hand Files

    PubMed Central

    Ebenezar, A.V. Rajesh; Kumar, Mohan; Sivakumar, A.

    2014-01-01

    Aim: The aim of this study was to evaluate the efficacy of Protaper retreatment files in comparison with RaCe, K3 and H-files for removal of gutta-percha and apically extruded debris using volumetric analysis. Materials and Methods: Forty extracted single rooted maxillary incisor teeth with straight canals and mature apices were selected for the study. After access cavity preparation, apical patency was confirmed with a size 10 K-file extending 1mm beyond the point at which it was first visible at the apical end. Working lengths were determined with the use of size 15 K-file. The canals were prepared in a step-back technique and the master apical file was size 30 for all teeth. 3% sodium hypochlorite was used as an irrigant after each instrumentation. Before final rinse, size 20 K-file was passed 1mm beyond the apex to remove any dentinal shaving plugs and maintain the apical patency. Then the canals were dried with paper points. The root canal was filled using standard gutta-percha points and zinc oxide eugenol sealer under lateral condensation technique. The teeth were then randomly divided into four groups of ten teeth each based on the instrument used for gutta percha removal. All the rotary instruments used in this study were rotated at 300rpm. The instruments used were: Group 1 – RaCe Files, Group 2 – ProTaper retreatment Files, Group 3 – K3 Files and Group 4 – H Files. The volume of the obturating material was calculated before and after removal using volumetric analysis with spiral CT. The removal efficacy with each instrument was calculated and statistically analysed. Results: The results of the study show that the ProTaper retreatment files (Group 2) (97.4%) showed the highest efficiency in the removal of obturating material, which was followed by RaCe (95.74%), K3 (92.86%) and H files (90.14%) with the efficiency in the decreasing order. Similarly the mean apical extrusion in H files (0.000 ± 0.002) was significantly lower than all the rotary instruments. However, the difference among the rotary files were not statistically significant (p>0.05). Conclusion: ProTaper retreatment files show significant difference over other groups in removal of obturating material and can be the system of choice in endodontic retreatment procedures. PMID:25584299

  2. Performance of the PROMIS in Patients After Anterior Cruciate Ligament Reconstruction

    PubMed Central

    Scott, Elizabeth J.; Westermann, Robert; Glass, Nathalie A.; Hettrich, Carolyn; Wolf, Brian R.; Bollier, Matthew J.

    2018-01-01

    Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) is designed to advance patient-reported outcome (PRO) instruments by utilizing question banks for major health domains. Purpose: To compare the responsiveness and construct validity of the PROMIS physical function computer adaptive test (PF CAT) with current PRO instruments for patients before and up to 2 years after anterior cruciate ligament (ACL) reconstruction. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: Initially, 157 patients completed the PROMIS PF CAT, Short Form–36 Health Survey (SF-36 physical function [PF] and general health [GH]), Marx Activity Rating Scale (MARS), Knee injury and Osteoarthritis Outcome Score (KOOS activities of daily living [ADL], sport, and quality of life [QOL]), and EuroQol–5 dimensions questionnaire (EQ-5D) at 6 weeks, 6 months, and 2 years after ACL reconstruction. Correlations between instruments, ceiling and floor effects, effect sizes (Cohen d), and standardized response means to describe responsiveness were evaluated. Subgroup analyses compared participants with and without additional arthroscopic procedures using linear mixed models. Results: At baseline, 6 weeks, and 6 months, the PROMIS PF CAT showed excellent or excellent-good correlations with the SF-36 PF (r = 0.75-0.80, P < .01), KOOS-ADL (r = 0.63-0.70, P < .01), and KOOS-sport (r = 0.32-0.69, P < .01); excellent-good correlation with the EQ-5D (r = 0.60-0.71, P < .01); and good correlation with the KOOS-QOL (r = 0.52-0.58, P < .01). As expected, there were poor correlations with the MARS (r = 0.00-0.24, P < .01) and SF-36 GH (r = 0.16-0.34, P < .01 ). At 2 years, the PROMIS PF CAT showed good to excellent correlations with all PRO instruments (r = 0.42-0.72, P < .01), including the MARS (r = 0.42, P < .01), indicating frequent return to preinjury function. The PROMIS PF CAT had the fewest ceiling or floor effects of all instruments tested, and patients answered, on average, 4 questions. There was no significant difference in baseline physical function scores between subgroups; at follow-up, all groups showed improvements in scores that were not statistically different. Conclusion: The PROMIS PF CAT is a valid tool to assess outcomes after ACL reconstruction up to 2 years after surgery, demonstrating the highest responsiveness to change with the fewest ceiling and floor effects and a low time burden among all instruments tested. The PROMIS PF CAT is a beneficial alternative for assessing physical function in adults before and after ACL reconstruction. PMID:29854864

  3. Performance of the PROMIS in Patients After Anterior Cruciate Ligament Reconstruction.

    PubMed

    Scott, Elizabeth J; Westermann, Robert; Glass, Nathalie A; Hettrich, Carolyn; Wolf, Brian R; Bollier, Matthew J

    2018-05-01

    The Patient-Reported Outcomes Measurement Information System (PROMIS) is designed to advance patient-reported outcome (PRO) instruments by utilizing question banks for major health domains. To compare the responsiveness and construct validity of the PROMIS physical function computer adaptive test (PF CAT) with current PRO instruments for patients before and up to 2 years after anterior cruciate ligament (ACL) reconstruction. Cohort study (diagnosis); Level of evidence, 2. Initially, 157 patients completed the PROMIS PF CAT, Short Form-36 Health Survey (SF-36 physical function [PF] and general health [GH]), Marx Activity Rating Scale (MARS), Knee injury and Osteoarthritis Outcome Score (KOOS activities of daily living [ADL], sport, and quality of life [QOL]), and EuroQol-5 dimensions questionnaire (EQ-5D) at 6 weeks, 6 months, and 2 years after ACL reconstruction. Correlations between instruments, ceiling and floor effects, effect sizes (Cohen d ), and standardized response means to describe responsiveness were evaluated. Subgroup analyses compared participants with and without additional arthroscopic procedures using linear mixed models. At baseline, 6 weeks, and 6 months, the PROMIS PF CAT showed excellent or excellent-good correlations with the SF-36 PF ( r = 0.75-0.80, P < .01), KOOS-ADL ( r = 0.63-0.70, P < .01), and KOOS-sport ( r = 0.32-0.69, P < .01); excellent-good correlation with the EQ-5D ( r = 0.60-0.71, P < .01); and good correlation with the KOOS-QOL ( r = 0.52-0.58, P < .01). As expected, there were poor correlations with the MARS ( r = 0.00-0.24, P < .01) and SF-36 GH ( r = 0.16-0.34, P < .01 ). At 2 years, the PROMIS PF CAT showed good to excellent correlations with all PRO instruments ( r = 0.42-0.72, P < .01), including the MARS ( r = 0.42, P < .01), indicating frequent return to preinjury function. The PROMIS PF CAT had the fewest ceiling or floor effects of all instruments tested, and patients answered, on average, 4 questions. There was no significant difference in baseline physical function scores between subgroups; at follow-up, all groups showed improvements in scores that were not statistically different. The PROMIS PF CAT is a valid tool to assess outcomes after ACL reconstruction up to 2 years after surgery, demonstrating the highest responsiveness to change with the fewest ceiling and floor effects and a low time burden among all instruments tested. The PROMIS PF CAT is a beneficial alternative for assessing physical function in adults before and after ACL reconstruction.

  4. Application of non-destructive impedance-based monitoring technique for cyclic fatigue evaluation of endodontic nickel-titanium rotary instruments.

    PubMed

    Chang, Yau-Zen; Liu, Mou-Chuan; Pai, Che-An; Lin, Chun-Li; Yen, Kuang-I

    2011-06-01

    This study investigates the application of non-destructive testing based on the impedance theory in the cyclic fatigue evaluation of endodontic Ni-Ti rotary instruments. Fifty Ni-Ti ProTaper instruments were divided into five groups (n=10 in Groups A to E). Groups A to D were subjected to cyclic fatigue within an artificial canal (Group E was the control group). The mean value of the total life limit (TLL), defined as the instrument being rotated until fracture occurred was found to be 104 s in Group A. Each rotary instrument in Groups B, C and D were rotated until the tested instruments reached 80% (84 s), 60% (62 s) and 40% (42 s) of the TLL. After fatigue testing, each rotary instrument was mounted onto a custom-developed non-destructive testing device to give the tip of the instrument a progressive sideways bend in four mutually perpendicular directions to measure the corresponding impedance value (including the resistance and the reactance). The results indicated that the impedance value showed the same trend as the resistance, implying that the impedance was primarily affected by the resistance. The impedance value for the instruments in the 80% and 60% TLL groups increased by about 6 mΩ (about 7.5%) more than that of the instruments in the intact and 40% TLL groups. The SEM analysis result showed that crack striations were only found at the tip of the thread on the cracked surface of the instrument, consistent with the impedance measurements that found the impedance value of the cracked surface to be significantly different from those in other surfaces. These findings indicate that the impedance value may represent an effective parameter for evaluating the micro-structural status of Ni-Ti rotary instruments subjected to fatigue loading. Copyright © 2010 IPEM. Published by Elsevier Ltd. All rights reserved.

  5. In vitro evaluation of the effectiveness of ProTaper universal rotary retreatment system for gutta-percha removal with or without a solvent.

    PubMed

    Takahashi, Cristiane Midori; Cunha, Rodrigo Sanches; de Martin, Alexandre Sigrist; Fontana, Carlos Eduardo; Silveira, Cláudia Fernandes M; da Silveira Bueno, Carlos Eduardo

    2009-11-01

    Effective removal of gutta-percha in endodontic retreatment is a significant factor to ensure a favorable outcome from failed procedures. The purpose of this study was to evaluate the efficacy of a nickel-titanium rotary instrument system with or without a solvent versus stainless steel hand files for gutta-percha removal. Forty extracted human maxillary anterior teeth were prepared and filled. They were divided into 4 groups: Gates-Glidden and K-files, Gates-Glidden and K-files with chloroform, ProTaper Universal rotary retreatment system, and ProTaper Universal rotary retreatment system with chloroform. The operating time was recorded. The teeth were longitudinally sectioned and photographed. The images were analyzed and the filling remnants were quantified by using the IMAGE TOOL software. With Kruskall-Wallis test, statistical analysis showed that there was no significant difference between the techniques in regard to the amount of the endodontic filling remnants (P < .05); however, the ProTaper Universal rotary retreatment system was faster than the hand files (P < .05). All of the techniques proved helpful for the removal of endodontic filling material, and they were similar in material remaining after retreatment, but the ProTaper Universal rotary retreatment system without chloroform was faster.

  6. Effect of Patency File on Transportation and Curve Straightening in Canal Preparation with ProTaper System

    PubMed Central

    Hasheminia, Seyed Mohsen

    2013-01-01

    The aim of this ex vivo study was to evaluate the effect of using a patency file on apical transportation and curve straightening during canal instrumentation with the ProTaper rotary system. Seventy permanent mandibular first molars with mesiobuccal canals, measuring 18–23 mm in length and with a 25–40° curvature (according to the Schneider method), were selected. The working lengths were determined and the teeth were mounted and divided into two experimental groups: (A) prepared by the ProTaper system without using a patency file (n = 35) and (B) prepared by the ProTaper system using a patency file (n = 35). Radiographs taken before and after the preparation were imported into Photoshop software and the apical transportation, and curve straightening were measured. Data were analyzed using independent t-test. Partial correlation analysis was performed to evaluate the relationship between the initial curvature, transportation, and curve straightening (α = 0.05). Using a patency file during canal preparation significantly decreased both apical transportation and curve straightening (P < 0.001). There were significant relationships between the angle of curvature, transportation and curve straightening in pairs (P < 0.001). Apical patency is recommended during root canal preparation with the ProTaper rotary system. PMID:24159390

  7. Effect of Patency File on Transportation and Curve Straightening in Canal Preparation with ProTaper System.

    PubMed

    Hasheminia, Seyed Mohsen; Farhadi, Nastaran; Shokraneh, Ali

    2013-01-01

    The aim of this ex vivo study was to evaluate the effect of using a patency file on apical transportation and curve straightening during canal instrumentation with the ProTaper rotary system. Seventy permanent mandibular first molars with mesiobuccal canals, measuring 18-23 mm in length and with a 25-40° curvature (according to the Schneider method), were selected. The working lengths were determined and the teeth were mounted and divided into two experimental groups: (A) prepared by the ProTaper system without using a patency file (n = 35) and (B) prepared by the ProTaper system using a patency file (n = 35). Radiographs taken before and after the preparation were imported into Photoshop software and the apical transportation, and curve straightening were measured. Data were analyzed using independent t-test. Partial correlation analysis was performed to evaluate the relationship between the initial curvature, transportation, and curve straightening (α = 0.05). Using a patency file during canal preparation significantly decreased both apical transportation and curve straightening (P < 0.001). There were significant relationships between the angle of curvature, transportation and curve straightening in pairs (P < 0.001). Apical patency is recommended during root canal preparation with the ProTaper rotary system.

  8. The Impacts of Neo-Liberalism on China's Higher Education

    ERIC Educational Resources Information Center

    Mok, Ka Ho; Lo, Yat Wai

    2007-01-01

    It is against such a wider socio-economic background that the private/"minban" higher education providers have paid for much of the sector expansion, leading to revolutionary changes and imparting a growing "privateness" to China's higher education system. The adoption of pro-competition policy instruments along the lines of…

  9. Reporting of health-related quality of life (HRQOL) data in oncology trials: a comparison of the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy-General (FACT-G).

    PubMed

    Smith, Adam B; Cocks, Kim; Parry, David; Taylor, Matthew

    2014-04-01

    The inclusion of patient-reported outcome (PRO) instruments to record patient health-related quality of life (HRQOL) data has virtually become the norm in oncology randomised controlled trials (RCTs). Despite this fact, recent concerns have focused on the quality of reporting of HRQOL. The primary aim of this study was to evaluate the quality of reporting of HRQOL data from two common instruments in oncology RCTs. A meta-review was undertaken of systematic reviews reporting HRQOL data collected using PRO instruments in oncology randomised controlled trials (RCTs). English language articles published between 2000 and 2012 were included and evaluated against a methodology checklist. Four hundred and thirty-five potential articles were identified. Six systematic reviews were included in the analysis. A total of 70,403 patients had completed PROs. The European Organization for Research and Treatment of Cancer QLQ-C30 and Functional Assessment of Cancer Therapy-General questionnaire accounted for 55 % of RCTs. Eighty per cent of RCTs had used psychometrically validated instruments; 70 % reported culturally valid instruments and almost all reported the assessment timing (96 %). Thirty per cent of RCTS reported clinical significance and missing data. In terms of methodological design, only 25 % of RCTs could be categorised as probably robust. The majority of oncology RCTs has shortcomings in terms of reporting HRQOL data when assessed against regulatory and methodology guidelines. These limitations will need to be addressed if HRQOL data are to be used to successfully support clinical decision-making, treatment options and labelling claims in oncology.

  10. Residual Microstrain in Root Dentin after Canal Instrumentation Measured with Digital Moiré Interferometry.

    PubMed

    Lim, Helena; Li, Fang-Chi; Friedman, Shimon; Kishen, Anil

    2016-09-01

    Residual microstrain influences the resistance to crack propagation in a biomaterial. This study evaluated the residual microstrain and microdefects formed in dentin after canal instrumentation in teeth maintained in hydrated and nonhydrated environments. Canals of 18 extracted human premolars with single-root canals were instrumented in accordance with 3 groups: the ProTaper Universal (Dentsply Maillefer, Ballaigues, Switzerland) group: ProTaper Universal (S1, S2, F1, and F2) used in rotation, the WaveOne Primary (Dentsply Maillefer) group: the WaveOne (Primary) used in reciprocal motion, and the control group: hand files. Half the specimens (3/group) were maintained in deionized water (hydrated) and half in ambient relative humidity conditions (22°C, 55% RH) for 72 hours (nonhydrated). Customized high-sensitivity digital moiré interferometry was used to qualitatively evaluate pre- and postinstrumentation dentinal microstrain. Subsequently, specimens were examined for dentinal microdefects with micro-computed tomographic imaging and polarized light microscopy. Digital moiré interferometry showed only minor changes in postinstrumentation microstrain in hydrated dentin in all groups, suggestive of a stress relaxation behavior. Nonhydrated dentin in all groups showed localized concentration of postinstrumentation microstrain, which appeared higher in the WaveOne group than in the other groups. No dentinal microdefects were detected by micro-computed tomographic imaging and polarized light microscopy in hydrated and nonhydrated specimens in all groups. This study suggested that the biomechanical response of root dentin to instrumentation was influenced by hydration. Reciprocating, rotary, and hand instrumentation of well-hydrated roots did not cause an increase in residual microstrain or the formation of microdefects in root dentin. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  11. Comparison of cyclic fatigue resistance of original and counterfeit rotary instruments.

    PubMed

    Ertas, Huseyin; Capar, Ismail Davut; Arslan, Hakan; Akan, Ender

    2014-05-31

    In recent years, with the advances in counterfeiting methods, counterfeit products have reached the dental market. The purpose of this study was to compare the cyclic fatigue resistance of original and counterfeit rotary root canal instruments. The cyclic fatigue of original and counterfeit ProTaper F2 endodontic instruments was tested (n = 20) in 3 mm radius steel canals with a 60° angle of curvature. The number of cycles to fracture (NCF) was calculated, and the data were subjected to the Student's t-test (α = 0.05). The original instruments showed better cyclic fatigue resistance than the counterfeit ones (p < .001). The mean NCF was 483 ± 84 for the original files and 186 ± 86 for the counterfeit files. The cyclic fatigue resistance of the counterfeit instruments was very low. As a result, clinicians should be careful not to purchase counterfeit products.

  12. Using R and WinBUGS to fit a Generalized Partial Credit Model for developing and evaluating patient-reported outcomes assessments

    PubMed Central

    Li, Yuelin; Baser, Ray

    2013-01-01

    The US Food and Drug Administration recently announced the final guidelines on the development and validation of Patient-Reported Outcomes (PROs) assessments in drug labeling and clinical trials. This guidance paper may boost the demand for new PRO survey questionnaires. Henceforth biostatisticians may encounter psychometric methods more frequently, particularly Item Response Theory (IRT) models to guide the shortening of a PRO assessment instrument. This article aims to provide an introduction on the theory and practical analytic skills in fitting a Generalized Partial Credit Model in IRT (GPCM). GPCM theory is explained first, with special attention to a clearer exposition of the formal mathematics than what is typically available in the psychometric literature. Then a worked example is presented, using self-reported responses taken from the International Personality Item Pool. The worked example contains step-by-step guides on using the statistical languages R and WinBUGS in fitting the GPCM. Finally, the Fisher information function of the GPCM model is derived and used to evaluate, as an illustrative example, the usefulness of assessment items by their information contents. This article aims to encourage biostatisticians to apply IRT models in the re-analysis of existing data and in future research. PMID:22362655

  13. Using R and WinBUGS to fit a generalized partial credit model for developing and evaluating patient-reported outcomes assessments.

    PubMed

    Li, Yuelin; Baser, Ray

    2012-08-15

    The US Food and Drug Administration recently announced the final guidelines on the development and validation of patient-reported outcomes (PROs) assessments in drug labeling and clinical trials. This guidance paper may boost the demand for new PRO survey questionnaires. Henceforth, biostatisticians may encounter psychometric methods more frequently, particularly item response theory (IRT) models to guide the shortening of a PRO assessment instrument. This article aims to provide an introduction on the theory and practical analytic skills in fitting a generalized partial credit model (GPCM) in IRT. GPCM theory is explained first, with special attention to a clearer exposition of the formal mathematics than what is typically available in the psychometric literature. Then, a worked example is presented, using self-reported responses taken from the international personality item pool. The worked example contains step-by-step guides on using the statistical languages r and WinBUGS in fitting the GPCM. Finally, the Fisher information function of the GPCM model is derived and used to evaluate, as an illustrative example, the usefulness of assessment items by their information contents. This article aims to encourage biostatisticians to apply IRT models in the re-analysis of existing data and in future research. Copyright © 2012 John Wiley & Sons, Ltd.

  14. Compiling knowledge-based systems specified in KEE to Ada

    NASA Technical Reports Server (NTRS)

    Filman, Robert E.; Feldman, Roy D.

    1991-01-01

    The first year of the PrKAda project is recounted. The primary goal was to develop a system for delivering Artificial Intelligence applications developed in the ProKappa system in a pure-Ada environment. The following areas are discussed: the ProKappa core and ProTalk programming language; the current status of the implementation; the limitations and restrictions of the current system; and the development of Ada-language message handlers in the ProKappa environment.

  15. Development and pilot of an international survey: 'Radiation Therapists and Psychosocial Support'.

    PubMed

    Elsner, Kelly L; Naehrig, Diana; Halkett, Georgia K B; Dhillon, Haryana M

    2018-06-07

    Up to one third of radiation therapy patients are reported to have unmet psychosocial needs. Radiation therapists (RTs) have daily contact with patients and can provide daily psychosocial support to reduce patient anxiety, fear and loneliness. However, RTs vary in their values, skills, training, knowledge and involvement in providing psychosocial support. The aims of this study were to: (1) develop an online survey instrument to explore RT values, skills, training and knowledge regarding patient anxiety and psychosocial support, and (2) pilot the instrument with RT professionals to assess content validity, functionality and length. An online cross-sectional survey, titled 'Radiation therapists and psychosocial support' was developed. Items included patient vignettes, embedded items from RT research, and the Professional Quality of Life Scale (ProQOL5). Four radiation oncology departments volunteered to pilot the survey; each nominated four RT staff to participate. Survey data were analysed descriptively and qualitative feedback grouped and coded to determine whether the survey needed to be refined. Thirteen of sixteen RTs completed the pilot survey and feedback form. Median time to completion was 35 mins, with 54% of respondents stating this was too long. Respondents reported content, questions and response options were relevant and appropriate. Feedback was used to: refine the survey instrument, minimise responder burden and drop out and improve functionality and quality of data collection. This pilot of the 'Radiation therapists and psychosocial support' survey instrument demonstrated content validity and usability. The main survey will be circulated to a representative sample of RTs for completion. © 2018 The Authors. Journal of Medical Radiation Sciences published by John Wiley & Sons Australia, Ltd on behalf of Australian Society of Medical Imaging and Radiation Therapy and New Zealand Institute of Medical Radiation Technology.

  16. Pooling of cross-cultural PRO data in multinational clinical trials: how much can poor measurement affect statistical power?

    PubMed

    Regnault, Antoine; Hamel, Jean-François; Patrick, Donald L

    2015-02-01

    Cultural differences and/or poor linguistic validation of patient-reported outcome (PRO) instruments may result in differences in the assessment of the targeted concept across languages. In the context of multinational clinical trials, these measurement differences may add noise and potentially measurement bias to treatment effect estimation. Our objective was to explore the potential effect on treatment effect estimation of the "contamination" of a cultural subgroup by a flawed PRO measurement. We ran a simulation exercise in which the distribution of the score in the overall sample was considered a mixture of two normal distributions: a standard normal distribution was assumed in a "main" subgroup and a normal distribution which differed either in mean (bias) or in variance (noise) in a "contaminated" subgroup (the subgroup with potential flaws in the PRO measurement). The observed power was compared to the expected power (i.e., the power that would have been observed if the subgroup had not been contaminated). Even if differences between the expected and observed power were small, some substantial differences were obtained (up to a 0.375 point drop in power). No situation was systematically protected against loss of power. The impact of poor PRO measurement in a cultural subgroup may induce a notable drop in the study power and consequently reduce the chance of showing an actual treatment effect. These results illustrate the importance of the efforts to optimize conceptual and linguistic equivalence of PRO measures when pooling data in international clinical trials.

  17. Propulsive Small Expendable Deployer System (ProSEDS)

    NASA Technical Reports Server (NTRS)

    Curtis, Leslie; Johnson, Les; Brown, Norman S. (Technical Monitor)

    2002-01-01

    The Propulsive Small Expendable Deployer System (ProSEDS) space experiment will demonstrate the use of an electrodynamic tether propulsion system to generate thrust in space by decreasing the orbital altitude of a Delta 11 Expendable Launch Vehicle second stage. ProSEDS, which is planned on an Air Force GPS Satellite replacement mission in June 2002, will use the flight proven Small Expendable Deployer System (SEDS) to deploy a tether (5 km bare wire plus 10 km non-conducting Dyneema) from a Delta 11 second stage to achieve approx. 0.4N drag thrust. ProSEDS will utilize the tether-generated current to provide limited spacecraft power. The ProSEDS instrumentation includes Langmuir probes and Differential Ion Flux Probes, which will determine the characteristics of the ambient ionospheric plasma. Two Global Positioning System (GPS) receivers will be used (one on the Delta and one on the endmass) to help determine tether dynamics and to limit transmitter operations to occasions when the spacecraft is over selected ground stations. The flight experiment is a precursor to the more ambitious electrodynamic tether upper stage demonstration mission, which will be capable of orbit raising, lowering and inclination changes-all using electrodynamic thrust. An immediate application of ProSEDS technology is for the removal of spent satellites for orbital debris mitigation. In addition to the use of this technology to provide orbit transfer and debris mitigation it may also be an attractive option for future missions to Jupiter and any other planetary body with a magnetosphere.

  18. Propulsive Small Expendable Deployer System (ProSEDS)

    NASA Technical Reports Server (NTRS)

    Ballance, Judy; Johnson, Les; Rogacki, John R. (Technical Monitor)

    2000-01-01

    The Propulsive Small Expendable Deployer System (ProSEDS) space experiment will demonstrate the use of an electrodynamic tether propulsion system to generate thrust in space by decreasing the orbital altitude of a Delta II Expendable Launch Vehicle (ELV) second stage. ProSEDS, which is planned to fly in 2001, will use the flight proven Small Expendable Deployer System (SEDS) to deploy a tether (5km bare wire plus 10 km spectra or dyneema) from a Delta II second stage to achieve approximately 0.4N drag thrust. ProSEDS will utilize the tether-generated current to provide limited spacecraft power. The ProSEDs instrumentation includes a Langmuir probe and Differential Ion Flux Probe, which will determine the characteristics of the ambient ionospheric plasma. Two Global Positioning System (GPS) receivers will be used (one on the Delta and one on the endmass) to help determine tether dynamics and to limit transmitter operations to occasions when the spacecraft is over selected ground stations, The flight experiment is a precursor to the more ambitious electrodynamic tether upper stage demonstration mission, which will be capable of orbit raising, lowering and inclination changes-all using electrodynamic thrust. An immediate application of ProSEDS technology is for the deorbit of spent satellites for orbital debris mitigation. In addition to the use of this technology to provide orbit transfer and debris mitigation it may also be an attractive option for future missions to Jupiter and any other planetary body with a magnetosphere.

  19. Development and creation of a remote-controlled underwater laser induced breakdown spectrometer for analysis of the chemical composition of sea water and bottom sediments

    NASA Astrophysics Data System (ADS)

    Golik, Sergey S.; Mayor, Alexsander Yu.; Proschenko, Dmitriy Yu.; Ilyin, Alexey A.; Nagorniy, Ivan G.; Biryukova, Yuliya S.; Babiy, Michael Yu.; Golik, Natalia N.; Gevorgyan, Tigran A.; Lisitsa, Vladimir V.; Borovskiy, Anton V.; Kulchin, Yuri N.

    2017-10-01

    The developed underwater laser induced breakdown spectrometer consists of two units: 1- remotely operated vehicle (ROV) with the next main characteristics: work deep - up to 150 meters, maximum speed of immersion 1 m/s, maximum cruise velocity - 2 m/s and 2 - spectrometer unit (SU) consist of a DPSS Nd: YAG laser excitation source (double pulse with 50 mJ energy for each pulse at wavelength 1064 nm, pulse width 12 ns and pulse repetition rate 1-15 Hz, DF251, SOL Instruments), a spectrum recording system (Maya HR4000 or 2000 Pro spectrometer, Ocean Optics) and microcomputer. These two units are connected by Ethernet network and registered spectral data are automatically processed in a MATLAB platform.

  20. Weekday and weekend moderate to vigorous physical activity of young musicians in the context of public health recommendations.

    PubMed

    Nawrocka, Agnieszka; Mynarski, Władysław; Grabara, Małgorzata; Powerska-Didkowska, Aneta; Borek, Zbigniew

    2013-01-01

    Physical activity is very important for the proper mental and physical development of children and youths, especially for the development of the locomotor system. The students of music schools are a unique group of children and youths, because of specific loads on the organs of locomotion, associated with the playing of musical instruments. They can therefore be exposed to a variety of health problems, particularly in the case of insufficient physical activity. The aim of the presented study was to assess the level of physical activity of music schools' students on weekdays and weekends against the parameters of physical efforts beneficial to health. The study involved 225 musicians from the Katowice School of Music, Complex of I and II degrees, aged 10-18 years (138 girls and 87 boys). The level of physical activity was assessed on the basis of moderate to vigorous rates (MVPA). Both on weekdays as well as at the weekends, boys presented a higher level of physical activity of at least moderate intensity (MVPA), which also resulted in a greater total weekly pro-health physical activity. Both boys and girls dedicated significantly more time to beneficial pro-health efforts physical health at weekends (p<0.01). The percentage of young musicians who meet accepted (in this study) standards for the optimal amount of physical activity in both groups was dramatically low (3.6% of girls and 11.5% of boys). Both boys and girls from the music schools often undertake moderate to vigorous physical activity (MVPA) at the weekends. The boys more often than the girls made pro-health physical efforts of moderate and high intensity.

  1. A model for incorporating patient and stakeholder voices in a learning health care network: Washington State's Comparative Effectiveness Research Translation Network.

    PubMed

    Devine, Emily Beth; Alfonso-Cristancho, Rafael; Devlin, Allison; Edwards, Todd C; Farrokhi, Ellen T; Kessler, Larry; Lavallee, Danielle C; Patrick, Donald L; Sullivan, Sean D; Tarczy-Hornoch, Peter; Yanez, N David; Flum, David R

    2013-08-01

    To describe the inaugural comparative effectiveness research (CER) cohort study of Washington State's Comparative Effectiveness Research Translation Network (CERTAIN), which compares invasive with noninvasive treatments for peripheral artery disease, and to focus on the patient centeredness of this cohort study by describing it within the context of a newly published conceptual framework for patient-centered outcomes research (PCOR). The peripheral artery disease study was selected because of clinician-identified uncertainty in treatment selection and differences in desired outcomes between patients and clinicians. Patient centeredness is achieved through the "Patient Voices Project," a CERTAIN initiative through which patient-reported outcome (PRO) instruments are administered for research and clinical purposes, and a study-specific patient advisory group where patients are meaningfully engaged throughout the life cycle of the study. A clinician-led research advisory panel follows in parallel. Primary outcomes are PRO instruments that measure function, health-related quality of life, and symptoms, the latter developed with input from the patients. Input from the patient advisory group led to revised retention procedures, which now focus on short-term (3-6 months) follow-up. The research advisory panel is piloting a point-of-care, patient assessment checklist, thereby returning study results to practice. The cohort study is aligned with the tenets of one of the new conceptual frameworks for conducting PCOR. The CERTAIN's inaugural cohort study may serve as a useful model for conducting PCOR and creating a learning health care network. Copyright © 2013 Elsevier Inc. All rights reserved.

  2. A Model for Incorporating Patient and Stakeholder Voices in a Learning Healthcare Network: Washington State’s Comparative Effectiveness Research Translation Network (CERTAIN)

    PubMed Central

    Devine, EB; Alfonso-Cristancho, R; Devlin, A; Edwards, TC; Farrokhi, ET; Kessler, L; Lavallee, DC; Patrick, DL; Sullivan, SD; Tarczy-Hornoch, P; Yanez, ND; Flum, DR

    2014-01-01

    Objective To describe the inaugural comparative effectiveness research (CER) cohort study of Washington State’s Comparative Effectiveness Research Translation Network (CERTAIN), which compares invasive to non-invasive treatments for peripheral artery disease; to focus on the patient-centeredness of this cohort study by describing it within the context of a newly published conceptual frameworks for patient-centered outcomes research (PCOR). Study Design and Setting The peripheral artery disease study was selected due to clinician-identified uncertainty in treatment selection and differences in desired outcomes between patients and clinicians. Patient-centeredness is achieved through the ‘Patient Voices Project’, a CERTAIN initiative through which patient-reported outcome (PRO) instruments are administered for research and clinical purposes, and a study-specific patient advisory group where patients are meaningfully engaged throughout the life cycle of the trial. A clinician-led research advisory panel follows in parallel. Results Primary outcomes are PRO instruments that measure function, health-related quality of life, and symptoms; the latter developed with input from patients. Input from the patient advisory group led to revised retention procedures, which now focus on short-term (3–6 months) follow-up. The research advisory panel is piloting a point-of-care, patient assessment checklist, there by returning study results to practice. The cohort study is aligned with the tenets of one of the new conceptual frameworks for conducting PCOR. Conclusion CERTAIN’s inaugural cohort study may serve as a useful model for conducting PCOR and creating a Learning Healthcare Network. PMID:23849146

  3. The effect of a manual instrumentation technique on five types of premolar root canal geometry assessed by microcomputed tomography and three-dimensional reconstruction

    PubMed Central

    2011-01-01

    Background Together with diagnosis and treatment planning, a good knowledge of the root canal system and its frequent variations is a necessity for successful root canal therapy. The selection of instrumentation techniques for variants in internal anatomy of teeth has significant effects on the shaping ability and cleaning effectiveness. The aim of this study was to reveal the differences made by including variations in the internal anatomy of premolars into the study protocol for investigation of a single instrumentation technique (hand ProTaper instruments) assessed by microcomputed tomography and three-dimensional reconstruction. Methods Five single-root premolars, whose root canal systems were classified into one of five types, were scanned with micro-CT before and after preparation with a hand ProTaper instrument. Instrumentation characteristics were measured quantitatively in 3-D using a customized application framework based on MeVisLab. Numeric values were obtained for canal surface area, volume, volume changes, percentage of untouched surface, dentin wall thickness, and the thickness of dentin removed. Preparation errors were also evaluated using a color-coded reconstruction. Results Canal volumes and surface areas were increased after instrumentation. Prepared canals of all five types were straightened, with transportation toward the inner aspects of S-shaped or multiple curves. However, a ledge was formed at the apical third curve of the type II canal system and a wide range in the percentage of unchanged canal surfaces (27.4-83.0%) was recorded. The dentin walls were more than 0.3 mm thick except in a 1 mm zone from the apical surface and the hazardous area of the type II canal system after preparation with an F3 instrument. Conclusions The 3-D color-coded images showed different morphological changes in the five types of root canal systems shaped with the same hand instrumentation technique. Premolars are among the most complex teeth for root canal treatment and instrumentation techniques for the root canal systems of premolars should be selected individually depending on the 3-D canal configuration of each tooth. Further study is needed to demonstrate the differences made by including variations in the internal anatomy of teeth into the study protocol of clinical RCT for identifying the best preparation technique. PMID:21676233

  4. Apical extrusion of debris using two hand and two rotary instrumentation techniques.

    PubMed

    Reddy, S A; Hicks, M L

    1998-03-01

    The purpose of this study was to investigate the quantity of apical debris produced in vitro using two hand and two rotary instrumentation techniques. Sixty minimally curved, mature human mandibular premolars with single canals were divided into 4 groups of 15 teeth each and prepared using step-back instrumentation with K-files, balanced force with Flex-R files, Lightspeed nickel-titanium instruments, or .04 taper ProFile Series 29 rotary nickel-titanium files. Debris extruded through the apical foramen during instrumentation was collected on preweighed filters. The mean weight of extruded debris for each group was statistically analyzed using a Kruskal Wallis one-way analysis of variance and a Mann-Whitney U rank sum tested. Although all instrumentation techniques produced apically extruded debris, step-back instrumentation produced significantly more debris than the other methods (p < 0.0001). There was no difference between balanced force hand instrumentation and the two rotary nickel-titanium instrumentation methods (p > 0.05). Hand or engine-driven instrumentation that uses rotation seems to reduce significantly the amount of debris extruded apically when compared with a push-pull (filing) technique. Decreased apical extrusion of debris has strong implications for a decreased incidence of postoperative inflammation and pain.

  5. 77 FR 66848 - Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-07

    ... trials and device study design. Date and Time: The public workshop will be held on November 27, 2012... problem for PRO instruments. There have been various methodological approaches to determine MCID for... rationales for regulatory guidance of clinical trials and device study design. Approximately 45 days after...

  6. An Evaluation of "Forests of the World," a Project Learning Tree Secondary Module

    ERIC Educational Resources Information Center

    Ghent, Cynthia; Parmer, Giavanna; Haines, Sarah

    2013-01-01

    This study sought to determine whether a secondary level curricular model based on enhancing knowledge and awareness of global forest issues would have an effect on students' self-perceived knowledge of forest issues, actual content knowledge of these issues, and pro-environmental attitudes. The study instrument is the secondary module…

  7. Association of the Environmental Attitudes "Preservation" and "Utilization" with Pro-Animal Attitudes

    ERIC Educational Resources Information Center

    Binngießer, Janine; Randler, Christoph

    2015-01-01

    The relevance of environmental attitudes is obvious and attitudes towards farm and companion animals and animal welfare in medical research are an important aspect of education. However, both have rarely been linked with each other, and animal attitudes are only sparsely represented within environmental education assessment instruments. Linking…

  8. An In vitro Comparison of Apically Extruded Debris Using Reciproc, ProTaper Universal, Neolix and Hyflex in Curved Canals

    PubMed Central

    Labbaf, Hossein; Nazari Moghadam, Kiumars; Shahab, Shahriar; Mohammadi Bassir, Mahshid; Fahimi, Mohammad Amin

    2017-01-01

    Introduction: As a consequence of root canal preparation, dentinal chips, irrigants and pulp remnants are extruded into preradicular space. This phenomenon may lead to post endodontic flare-ups. The purpose of this study was to compare the amount of extruded debris with four endodontic NiTi engine-driven systems. Methods and Materials: Sixty mesiobuccal roots of maxillary molars with 15-30˚ curvature were divided randomly into four groups (n=15). Each group was instrumented up to apical size of 25 using Reciproc, ProTaper Universal, Neolix and Hyflex. Bidistilled water was used as irrigant and extruded debris was collected in pre-weighted Eppendorf tubes. Tubes were stored in incubator for drying the debris. Extruded debris were weighted in electronic microbalance with accuracy of 0.0001 g. The raw data was analyzed with one way analysis of variance (ANOVA) and Tukey’s HSD post hoc test. Level of significance was set at 0.05. Results: The debris extrusion with Reciproc files was significantly higher than the other groups (P<0.05). Hyflex significantly extruded less debris than other files (P<0.05). There was no significant difference between ProTaper Universal and Neolix regarding the amount of extruded debris (P=0.98). Conclusion: All systems extruded debris during the instrumentation. Reciproc system significantly extruded more debris. Caution should be taken when interpreting the results of this study and applying it to the real clinical situation. PMID:28808456

  9. Few items in the thyroid-related quality of life instrument ThyPRO exhibited differential item functioning.

    PubMed

    Watt, Torquil; Groenvold, Mogens; Hegedüs, Laszlo; Bonnema, Steen Joop; Rasmussen, Åse Krogh; Feldt-Rasmussen, Ulla; Bjorner, Jakob Bue

    2014-02-01

    To evaluate the extent of differential item functioning (DIF) within the thyroid-specific quality of life patient-reported outcome measure, ThyPRO, according to sex, age, education and thyroid diagnosis. A total of 838 patients with benign thyroid diseases completed the ThyPRO questionnaire (84 five-point items, 13 scales). Uniform and nonuniform DIF were investigated using ordinal logistic regression, testing for both statistical significance and magnitude (∆R(2) > 0.02). Scale level was estimated by the sum score, after purification. Twenty instances of DIF in 17 of the 84 items were found. Eight according to diagnosis, where the goiter scale was the one most affected, possibly due to differing perceptions in patients with auto-immune thyroid diseases compared to patients with simple goiter. Eight DIFs according to age were found, of which 5 were in positively worded items, which younger patients were more likely to endorse; one according to gender: women were more likely to report crying, and three according to educational level. The vast majority of DIF had only minor influence on the scale scores (0.1-2.3 points on the 0-100 scales), but two DIF corresponded to a difference of 4.6 and 9.8, respectively. Ordinal logistic regression identified DIF in 17 of 84 items. The potential impact of this on the present scales was low, but items displaying DIF could be avoided when developing abbreviated scales, where the potential impact of DIF (due to fewer items) will be larger.

  10. Trials with patient-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR).

    PubMed

    Mercieca-Bebber, Rebecca; Williams, Douglas; Tait, Margaret-Ann; Roydhouse, Jessica; Busija, Lucy; Sundaram, Chindhu Shunmuga; Wilson, Michelle; Langford, Ailsa; Rutherford, Claudia; Roberts, Natasha; King, Madeleine; Vodicka, Elisabeth; Devine, Beth

    2018-06-18

    It is important to understand the number, types and regions of trials that include patient-reported outcomes (PROs) to appreciate how patient experiences have been considered in studies of health and interventions. Twenty-seven percent of trials registered with ClinicalTrials.gov (2007-2013) included PROs; however, a regional breakdown was not provided and no reviews have been conducted of the Australia New Zealand Clinical Trials Registry (ANZCTR). We aimed to identify trials registered with ANZCTR with PRO endpoints and describe their characteristics. ANZCTR was systematically searched from inception (2005) to 31 March 2017 for trials with PRO endpoints. Search terms included PRO measures listed in Patient-Reported Outcomes Quality of Life Instrument Database and Grid-Enabled Measures, as well as generic PRO terms (e.g. "quality of life" (QOL)). Trial endpoints were individually coded using an established framework to identify trials with PROs for the analysis. Of 13,666 registered trials, 6168 (45.1%) included a PRO. The proportion of studies including PROs increased between 2006 and 2016 (r = 0.74, p = 0.009). Among the 6168 trials, there were 17,961 individual PRO endpoints, including symptoms/functional outcomes/condition-specific QOL (65.6%), generic QOL (13.2%), patient-reported experiences (9.9%), patient-reported behaviours (7.9%). Mental health was the most common category (99.8% included PROs), followed by physical medicine/rehabilitation (65.6%), musculoskeletal (63.5%), public health (63.1%), and cancer (54.2%). Our findings suggest growing use of PROs in the assessment of health and interventions in ANZ. Our review identifies trial categories with limited patient-reported information and provides a basis for future work on the impact of PRO findings in clinical care.

  11. Evaluation of the incidence of microcracks caused by Mtwo and ProTaper Next rotary file systems versus the self-adjusting file: A scanning electron microscopic study

    PubMed Central

    Saha, Suparna Ganguly; Vijaywargiya, Neelam; Saxena, Divya; Saha, Mainak Kanti; Bharadwaj, Anuj; Dubey, Sandeep

    2017-01-01

    Introduction: To evaluate the incidence of microcrack formation canal preparation with two rotary nickel–titanium systems Mtwo and ProTaper Next along with the self-adjusting file system. Materials and Methods: One hundred and twenty mandibular premolar teeth were selected. Standardized access cavities were prepared and the canals were manually prepared up to size 20 after coronal preflaring. The teeth were divided into three experimental groups and one control group (n = 30). Group 1: The canals were prepared using Mtwo rotary files. Group 2: The canals were prepared with ProTaper Next files. Group 3: The canals were prepared with self-adjusting files. Group 4: The canals were unprepared and used as a control. The roots were sectioned horizontally 3, 6, and 9 mm from the apex and examined under a scanning electron microscope to check for the presence of microcracks. The Pearson's Chi-square test was applied. Results: The highest incidence of microcracks were associated with the ProTaper Next group, 80% (P = 0.00), followed by the Mtwo group, 70% (P = 0.000), and the least number of microcracks was noted in the self-adjusting file group, 10% (P = 0.068). No significant difference was found between the ProTaper Next and Mtwo groups (P = 0.368) while a significant difference was observed between the ProTaper Next and self-adjusting file groups (P = 0.000) as well as the Mtwo and self-adjusting file groups (P = 0.000). Conclusion: All nickel–titanium rotary instrument systems were associated with microcracks. However, the self-adjusting file system had significantly fewer microcracks when compared with the Mtwo and ProTaper Next. PMID:29386786

  12. Cyclic fatigue of three types of rotary nickel-titanium files in a dynamic model.

    PubMed

    Yao, James H; Schwartz, Scott A; Beeson, Thomas J

    2006-01-01

    The cyclic fatigue resistance of three types of nickel-titanium rotary files was compared in a model using reciprocating axial movement. The influence of file size and taper was also investigated and fracture patterns were examined under SEM. The 10 experimental groups consisted of ProFiles, K3s, and RaCe files, size 25 in .04 and .06 tapers, as well as ProFiles and K3s, size 40 in .04 and .06 tapers. Each file was rotated freely at 300 rpm inside a stainless steel tube with a 60 degree and 5 mm radius of curvature. A continuous 3 mm oscillating axial motion was applied at 1 cycle per second by attaching an electric dental handpiece to the most inferior load cell of an Instron machine using a custom-made jig. The number of rotations to failure was determined and analyzed using analysis of variance and Tukey's post hoc tests. Overall, K3 25/.04 files were significantly more resistant to cyclic fatigue compared to any other group in this study. In the 25/.04 category, K3s were significantly more resistant to failure than ProFiles and RaCe files. Also in the same category, ProFiles significantly outlasted RaCe files. In the 25/.06 group, K3s and ProFiles were significantly more resistant to failure than RaCe files, but K3s were not significantly different than ProFiles. In the 40/.04 and 40/.06 groups, K3s were significantly more resistant to cyclic fatigue than ProFiles. SEM observations demonstrated mostly a ductile mode of fracture. The results suggest that different cross-sectional designs, diameters, and tapers all contribute to a nickel-titanium instrument's vulnerability to cyclic failure.

  13. Case Study: Application of Isometric Progressive Resistance Oropharyngeal Therapy Using the Madison Oral Strengthening Therapeutic Device

    PubMed Central

    Juan, Junerose; Hind, Jacqueline; Jones, Corinne; McCulloch, Timothy; Gangnon, Ron; Robbins, JoAnne

    2013-01-01

    Purpose Isometric progressive resistance oropharyngeal (I-PRO) therapy improves swallowing function; however, current devices utilize a single sensor that provides limited information or are prohibitively expensive. This single-subject study presents results of I-PRO therapy, detraining, and maintenance using the 5-sensor Madison Oral Strengthening Therapeutic (MOST) device combined with upper esophageal sphincter (UES) dilatation. Methods A 56-year-old female nurse who was 27 months post stroke and subsequent to traditional behavioral interventions and UES dilatations presented limited to gastrostomy tube intake only and expectorating all saliva. She completed 8 weeks of I-PRO therapy, 5 weeks of detraining, and 9 weeks of I-PRO maintenance (reduced frequency) followed by a third UES dilatation post intervention. Data included diet inventory, lingual pressures (MOST), lingual volume (magnetic resonance imaging), postswallow residue (videofl uoroscopy), UES and pharyngeal pressures (high-resolution manometry), and quality of life (QOL). Results Findings after 8 weeks of I-PRO therapy were progression to general oral diet, 15 lb weight gain, increased isometric pressures (Δ >16 kPa) with transference to swallowing pressures, increased lingual volume (8.3%), reduced pharyngeal wall residue (P = .03), increased pharyngeal pressures (Δ > 43 mm Hg) and increased UES opening (nadir) pressures (Δ > 9 mm Hg) with improved temporopressure coordination across the pharynx, and improved QOL. After detraining, decreased isometric pressures and reduced UES opening were noted. After I-PRO maintenance, isometric anterior lingual pressures returned to levels noted after the 8 weeks of intervention. Conclusion I-PRO therapy, facilitated by the MOST device combined with instrumental UES dilatation, improved swallow safety, increased oropharyngeal intake, and facilitated UES opening while enriching QOL. PMID:24091287

  14. Evaluation of the incidence of microcracks caused by Mtwo and ProTaper Next rotary file systems versus the self-adjusting file: A scanning electron microscopic study.

    PubMed

    Saha, Suparna Ganguly; Vijaywargiya, Neelam; Saxena, Divya; Saha, Mainak Kanti; Bharadwaj, Anuj; Dubey, Sandeep

    2017-01-01

    To evaluate the incidence of microcrack formation canal preparation with two rotary nickel-titanium systems Mtwo and ProTaper Next along with the self-adjusting file system. One hundred and twenty mandibular premolar teeth were selected. Standardized access cavities were prepared and the canals were manually prepared up to size 20 after coronal preflaring. The teeth were divided into three experimental groups and one control group ( n = 30). Group 1: The canals were prepared using Mtwo rotary files. Group 2: The canals were prepared with ProTaper Next files. Group 3: The canals were prepared with self-adjusting files. Group 4: The canals were unprepared and used as a control. The roots were sectioned horizontally 3, 6, and 9 mm from the apex and examined under a scanning electron microscope to check for the presence of microcracks. The Pearson's Chi-square test was applied. The highest incidence of microcracks were associated with the ProTaper Next group, 80% ( P = 0.00), followed by the Mtwo group, 70% ( P = 0.000), and the least number of microcracks was noted in the self-adjusting file group, 10% ( P = 0.068). No significant difference was found between the ProTaper Next and Mtwo groups ( P = 0.368) while a significant difference was observed between the ProTaper Next and self-adjusting file groups ( P = 0.000) as well as the Mtwo and self-adjusting file groups ( P = 0.000). All nickel-titanium rotary instrument systems were associated with microcracks. However, the self-adjusting file system had significantly fewer microcracks when compared with the Mtwo and ProTaper Next.

  15. Does the Reciproc file remove root canal bacteria and endotoxins as effectively as multifile rotary systems?

    PubMed

    Marinho, A C S; Martinho, F C; Gonçalves, L M; Rabang, H R C; Gomes, B P F A

    2015-06-01

    To evaluate the effectiveness of Reciproc for the removal of cultivable bacteria and endotoxins from root canals in comparison with multifile rotary systems. The root canals of forty human single-rooted mandibular pre-molars were contaminated with an Escherichia coli suspension for 21 days and randomly assigned to four groups according to the instrumentation system: GI - Reciproc (VDW); GII - Mtwo (VDW); GIII - ProTaper Universal (Dentsply Maillefer); and GIV -FKG Race(™) (FKG Dentaire) (n = 10 per group). Bacterial and endotoxin samples were taken with a sterile/apyrogenic paper point before (s1) and after instrumentation (s2). Culture techniques determined the colony-forming units (CFU) and the Limulus Amebocyte Lysate assay was used for endotoxin quantification. Results were submitted to paired t-test and anova. At s1, bacteria and endotoxins were recovered in 100% of the root canals investigated (40/40). After instrumentation, all systems were associated with a highly significant reduction of the bacterial load and endotoxin levels, respectively: GI - Reciproc (99.34% and 91.69%); GII - Mtwo (99.86% and 83.11%); GIII - ProTaper (99.93% and 78.56%) and GIV - FKG Race(™) (99.99% and 82.52%) (P < 0.001). No statistical difference were found amongst the instrumentation systems regarding bacteria and endotoxin removal (P > 0.01). The reciprocating single file, Reciproc, was as effective as the multifile rotary systems for the removal of bacteria and endotoxins from root canals. © 2014 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  16. Functional Status Assessment of COPD Based on Ability to Perform Daily Living Activities: A Systematic Review of Paper and Pencil Instruments.

    PubMed

    Monjazebi, Fateme; Dalvandi, Asghar; Ebadi, Abbas; Khankeh, Hamid Reza; Rahgozar, Mehdi; Richter, Jörg

    2015-08-06

    Activity of daily living (ADL) is an important predictor of mortality in patients with chronic obstructive pulmonary disease (COPD). Increasing ADL is important in patients with COPD and assessment of ADL is one of the best ways to evaluate the status of COPD patients. The objective of this systematic review was to provide an overview of the psychometric properties of paper and pencil instruments measuring ADL in patients with COPD. English papers published from 1980 to 2014 regarding ADL in patients with COPD were searched in  Web of Science, MEDLINE, Google Scholar, Cochrane, PubMed, ProQuest, and CINAHL databases using the following keywords: "COPD", "ADL", "activities of daily living", "daily activities", "instrument", "questionnaire", "paper-and-pencil instruments", and "measure". Following the Internet search, manual search was also done to find article references. A total of 186 articles were found. Of those, 31 met the inclusion criteria. Full texts of articles meeting the inclusion criteria were studied. Consensus-based standards for the selection of health measurement instruments"(COSMIN) were used to assess the quality of the studies. Data extraction form based on research aims developed by researchers and psychometric experts, with 17 questions was used. In these articles, 14 pen and paper instruments were identified for examining ADL in patients with COPD; of which, 4 dealt directly with ADL while 9 assessed other criteria i.e. dyspnea as ADL indicator. The majority of instruments only dealt with two main dimensions of ADL: Basic Activities of Daily Living (BADL) and Instrumental Activities of Daily Living (IADL), and did not consider Advanced Activities of Daily Living (AADL), which is influenced by cultural and motivational factors. Despite several ADL instruments identified, complete psychometric processes have only been done in a few of them. Selection of the appropriate instrument should focus on the aim of the study and the target construct.

  17. Development of a hospital-based patient-reported outcome framework for lung cancer patients: a study protocol.

    PubMed

    Moloczij, Natasha; Gough, Karla; Solomon, Benjamin; Ball, David; Mileshkin, Linda; Duffy, Mary; Krishnasamy, Mei

    2018-01-11

    Patient-reported outcome (PRO) data is central to the delivery of quality health care. Establishing sustainable, reliable and cost-efficient methods for routine collection and integration of PRO data into health information systems is challenging. This protocol paper describes the design and structure of a study to develop and pilot test a PRO framework to systematically and longitudinally collect PRO data from a cohort of lung cancer patients at a comprehensive cancer centre in Australia. Best-practice guidelines for developing registries aimed at collecting PROs informed the development of this PRO framework. Framework components included: achieving consensus on determining the purpose of the framework, the PRO measures to be included, the data collection time points and collection methods (electronic and paper), establishing processes to safeguard the quality of the data collected and to link the PRO framework to an existing hospital-based lung cancer clinical registry. Lung cancer patients will be invited to give feedback on the PRO measures (PROMs) chosen and the data collection time points and methods. Implementation of the framework will be piloted for 12 months. Then a mixed-methods approach used to explore patient and multidisciplinary perspectives on the feasibility of implementing the framework and linking it to the lung cancer clinical registry, its clinical utility, perceptions of data collection burden, and preliminary assessment of resource costs to integrate, implement and sustain the PRO framework. The PRO data set will include: a quality of life questionnaire (EORTC-QLQ-C30) and the EORTC lung cancer specific module (QLQC-LC-13). These will be collected pre-treatment (baseline), 2, 6 and 12 months post-baseline. Also, four social isolation questions (PROMIS) will be collected at baseline. Identifying and deciding on the overall purpose, clinical utility of data and which PROs to collect from patients requires careful consideration. Our study will explore how PRO data collection processes that link to a clinical data set can be developed and integrated; how PRO systems that are easy for patients to complete and professionals to use in practice can be achieved, and will provide indicative costs of developing and integrating a longitudinal PRO framework into routine hospital data collection systems. This study is not a clinical trial and is therefore not registered in any trial registry. However, it has received human research ethics approval (LNR/16/PMCC/45).

  18. Patient-reported outcomes in idiopathic pulmonary fibrosis research.

    PubMed

    Swigris, Jeffrey J; Fairclough, Diane

    2012-08-01

    Patient-reported outcomes (PROs) include questionnaires or surveys that ask patients for their perceptions about things like symptoms they are experiencing or quality of life. For incurable, morbid, life-shortening conditions like idiopathic pulmonary fibrosis (IPF), PROs are particularly germane: They elucidate for clinicians and researchers what it is like for patients to live with such a disease, and they may detect important treatment effects not captured by other metrics (eg, pulmonary physiology). However, a relative paucity of research on PROs in IPF has left significant knowledge gaps in this area and contributed to the timidity investigators have about using PROs as prominent outcomes in IPF drug trials. Additional research on existing instruments is needed to establish or bolster their basic psychometric properties in IPF. When PROs are used as end points in therapeutic trials, analyzing PRO response data can be challenging, but these challenges can be overcome with a transparent, thoughtful, and sophisticated statistical approach. In this article, we discuss some of the basics of PRO assessment, existing knowledge gaps in IPF-related PRO research, and the potential usefulness of using PROs in IPF trials and conclude by offering specific recommendations for an approach to analyzing repeated-measures PRO data from IPF trials.

  19. Performance Comparison of Wireless Sensor Network Standard Protocols in an Aerospace Environment: ISA100.11a and ZigBee Pro

    NASA Technical Reports Server (NTRS)

    Wagner, Raymond S.; Barton, Richard J.

    2011-01-01

    Standards-based wireless sensor network (WSN) protocols are promising candidates for spacecraft avionics systems, offering unprecedented instrumentation flexibility and expandability. Ensuring reliable data transport is key, however, when migrating from wired to wireless data gathering systems. In this paper, we conduct a rigorous laboratory analysis of the relative performances of the ZigBee Pro and ISA100.11a protocols in a representative crewed aerospace environment. Since both operate in the 2.4 GHz radio frequency (RF) band shared by systems such as Wi-Fi, they are subject at times to potentially debilitating RF interference. We compare goodput (application-level throughput) achievable by both under varying levels of 802.11g Wi-Fi traffic. We conclude that while the simpler, more inexpensive ZigBee Pro protocol performs well under moderate levels of interference, the more complex and costly ISA100.11a protocol is needed to ensure reliable data delivery under heavier interference. This paper represents the first published, rigorous analysis of WSN protocols in an aerospace environment that we are aware of and the first published head-to-head comparison of ZigBee Pro and ISA100.11a.

  20. Highly robust thin-film composite pressure retarded osmosis (PRO) hollow fiber membranes with high power densities for renewable salinity-gradient energy generation.

    PubMed

    Han, Gang; Wang, Peng; Chung, Tai-Shung

    2013-07-16

    The practical application of pressure retarded osmosis (PRO) technology for renewable blue energy (i.e., osmotic power generation) from salinity gradient is being hindered by the absence of effective membranes. Compared to flat-sheet membranes, membranes with a hollow fiber configuration are of great interest due to their high packing density and spacer-free module fabrication. However, the development of PRO hollow fiber membranes is still in its infancy. This study aims to open up new perspectives and design strategies to molecularly construct highly robust thin film composite (TFC) PRO hollow fiber membranes with high power densities. The newly developed TFC PRO membranes consist of a selective polyamide skin formed on the lumen side of well-constructed Matrimid hollow fiber supports via interfacial polymerization. For the first time, laboratory PRO power generation tests demonstrate that the newly developed PRO hollow fiber membranes can withstand trans-membrane pressures up to 16 bar and exhibit a peak power density as high as 14 W/m(2) using seawater brine (1.0 M NaCl) as the draw solution and deionized water as the feed. We believe that the developed TFC PRO hollow fiber membranes have great potential for osmotic power harvesting.

  1. Shaping ability of two M-wire and two traditional nickel-titanium instrumentation systems in S-shaped resin canals.

    PubMed

    Ceyhanli, K T; Kamaci, A; Taner, M; Erdilek, N; Celik, D

    2015-01-01

    The aim of this study was to evaluate the shaping effects of two M-wire and two traditional nickel-titanium (NiTi) rotary systems in simulated S-shaped resin canals. Forty simulated S-shaped canals in resin blocks were instrumented with two traditional (ProTaper, Sendoline S5) and two M-wire (WaveOne, GT series X) NiTi systems according to the manufacturers' instructions. Ten resin blocks were used for each system. Pre- and post-instrumentation images were captured using a stereomicroscope and superimposed with an image program. Canal transportation, material removal, and aberrations were evaluated and recorded as numeric parameters. Data were analyzed using one-way ANOVA and post-hoc Tukey tests with a 95% confidence interval. There were significant differences between systems in terms of transportation and material removal (P<0.05). Coronal danger zone was the most common aberration. Within the limits of this ex vivo study, it was found that the manufacturing methods (M-wire or traditional NiTi) and kinematics (rotary or reciprocating motion) did not affect the shaping abilities of the systems. The extended file designs of highly tapered NiTi systems (ProTaper, WaveOne) resulted in greater deviations from the original root canal trace and more material removal when compared to less tapered systems (Sendoline S5, GT series X).

  2. Intracerebroventricular infusion of the (Pro)renin receptor antagonist PRO20 attenuates deoxycorticosterone acetate-salt-induced hypertension.

    PubMed

    Li, Wencheng; Sullivan, Michelle N; Zhang, Sheng; Worker, Caleb J; Xiong, Zhenggang; Speth, Robert C; Feng, Yumei

    2015-02-01

    We previously reported that binding of prorenin to the (pro)renin receptor (PRR) plays a major role in brain angiotensin II formation and the development of deoxycorticosterone acetate (DOCA)-salt hypertension. Here, we designed and developed an antagonistic peptide, PRO20, to block prorenin binding to the PRR. Fluorescently labeled PRO20 bound to both mouse and human brain tissues with dissociation constants of 4.4 and 1.8 nmol/L, respectively. This binding was blocked by coincubation with prorenin and was diminished in brains of neuron-specific PRR-knockout mice, indicating specificity of PRO20 for PRR. In cultured human neuroblastoma cells, PRO20 blocked prorenin-induced calcium influx in a concentration- and AT(1) receptor-dependent manner. Intracerebroventricular infusion of PRO20 dose-dependently inhibited prorenin-induced hypertension in C57Bl6/J mice. Furthermore, acute intracerebroventricular infusion of PRO20 reduced blood pressure in both DOCA-salt and genetically hypertensive mice. Chronic intracerebroventricular infusion of PRO20 attenuated the development of hypertension and the increase in brain hypothalamic angiotensin II levels induced by DOCA-salt. In addition, chronic intracerebroventricular infusion of PRO20 improved autonomic function and spontaneous baroreflex sensitivity in mice treated with DOCA-salt. In summary, PRO20 binds to both mouse and human PRRs and decreases angiotensin II formation and hypertension induced by either prorenin or DOCA-salt. Our findings highlight the value of the novel PRR antagonist, PRO20, as a lead compound for a novel class of antihypertensive agents and as a research tool to establish the validity of brain PRR antagonism as a strategy for treating hypertension. © 2014 American Heart Association, Inc.

  3. Intracerebroventricular Infusion of the (Pro)renin Receptor Antagonist PRO20 Attenuates Deoxycorticosterone Acetate-Salt–Induced Hypertension

    PubMed Central

    Li, Wencheng; Sullivan, Michelle N.; Zhang, Sheng; Worker, Caleb J.; Xiong, Zhenggang; Speth, Robert C.; Feng, Yumei

    2016-01-01

    We previously reported that binding of prorenin to the (pro)renin receptor (PRR) plays a major role in brain angiotensin II formation and the development of deoxycorticosterone acetate (DOCA)-salt hypertension. Here, we designed and developed an antagonistic peptide, PRO20, to block prorenin binding to the PRR. Fluorescently labeled PRO20 bound to both mouse and human brain tissues with dissociation constants of 4.4 and 1.8 nmol/L, respectively. This binding was blocked by coincubation with prorenin and was diminished in brains of neuron-specific PRR-knockout mice, indicating specificity of PRO20 for PRR. In cultured human neuroblastoma cells, PRO20 blocked prorenin-induced calcium influx in a concentration- and AT1 receptor–dependent manner. Intracerebroventricular infusion of PRO20 dose-dependently inhibited prorenin-induced hypertension in C57Bl6/J mice. Furthermore, acute intracerebroventricular infusion of PRO20 reduced blood pressure in both DOCA-salt and genetically hypertensive mice. Chronic intracerebroventricular infusion of PRO20 attenuated the development of hypertension and the increase in brain hypothalamic angiotensin II levels induced by DOCA-salt. In addition, chronic intracerebroventricular infusion of PRO20 improved autonomic function and spontaneous baroreflex sensitivity in mice treated with DOCA-salt. In summary, PRO20 binds to both mouse and human PRRs and decreases angiotensin II formation and hypertension induced by either prorenin or DOCA-salt. Our findings highlight the value of the novel PRR antagonist, PRO20, as a lead compound for a novel class of antihypertensive agents and as a research tool to establish the validity of brain PRR antagonism as a strategy for treating hypertension. PMID:25421983

  4. Technology evaluation: PRO-542, Progenics Pharmaceuticals inc.

    PubMed

    Mukhtar, M; Parveen, Z; Pomerantz, R J

    2000-12-01

    Progenics's rCD4-IgG2 (PRO-542) is a recombinant fusion protein, which has been developed using the company's Universal Antiviral Binding (UnAB) technology, and is in phase I/II clinical trials for the treatment of human immunodeficiency virus type I (HIV-1) infection [273391]. At the beginning of 1997, Progenics received a Phase II Small Business Innovation Research Program (SBIR) grant from the National Institute of Allergy and Infectious diseases (NIAID) to fund the development of PRO-542 [236048]. A further grant of $2.7 million was awarded in August 1998 for the clinical evaluation of PRO-542 and other anti-HIV therapies [294200]. Progenics is collaborating with the Aaron Diamond AIDS Research Center (ADARC) in New York and the Center for Disease Control and Prevention in Atlanta [178410]. In February 2000, Progenics and Genzyme Transgenics Corp signed an agreement to continue the development of a transgenic source of PRO-542. Genzyme will develop transgenic goats that produce PRO-542 in their milk in exchange for undisclosed fees and milestone payments. Genzyme will supply PRO-542 to Progenics for clinical trials with a possibility for eventual commercial supply [357291]. Following on from this, in October 2000, Progenics received an SBIR grant to fund a two-year project with Genzyme Transgenics into the development of cost-effective methods for the manufacture of PRO-542, by optimization of the production of the drug in the milk of transgenic dairy animals [385982]. In August 2000, Punk, Ziegel & Company predicted that Progenics Pharmaceuticals will become sustainably profitable in 2003 following the launch of PRO-542 and GMK (Progenics Pharmaceuticals) in 2002 [390063].

  5. A new generation of x-ray spectrometry UHV instruments at the SR facilities BESSY II, ELETTRA and SOLEIL

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Lubeck, J., E-mail: janin.lubeck@ptb.de; Fliegauf, R.; Holfelder, I.

    A novel type of ultra-high vacuum instrument for X-ray reflectometry and spectrometry-related techniques for nanoanalytics by means of synchrotron radiation (SR) has been constructed and commissioned at BESSY II. This versa-tile instrument was developed by the PTB, Germany’s national metrology institute, and includes a 9-axis manipulator that allows for an independent alignment of the samples with respect to all degrees of freedom. In addition, it integrates a rotational and translational movement of several photodiodes as well as a translational movement of a beam-geometry-defining aperture system. Thus, the new instrument enables various analytical techniques based on energy dispersive X-ray detectors suchmore » as reference-free X-Ray Fluorescence (XRF) analysis, total-reflection XRF, grazing-incidence XRF, in addition to optional X-Ray Reflectometry (XRR) measurements or polarization-dependent X-ray absorption fine structure analyses (XAFS). Samples having a size of up to (100 × 100) mm{sup 2}; can be analyzed with respect to their mass deposition, elemental, spatial or species composition. Surface contamination, nanolayer composition and thickness, depth pro-file of matrix elements or implants, nanoparticles or buried interfaces as well as molecular orientation of bonds can be accessed. Three technology transfer projects of adapted instruments have enhanced X-Ray Spectrometry (XRS) research activities within Europe at the synchrotron radiation facilities ELETTRA (IAEA) and SOLEIL (CEA/LNE-LNHB) as well as at the X-ray innovation laboratory BLiX (TU Berlin) where different laboratory sources are used. Here, smaller chamber requirements led PTB in cooperation with TU Berlin to develop a modified instrument equipped with a 7-axis manipulator: reduced freedom in the choice of experimental geometry modifications (absence of out-of-SR-plane and reference-free XRS options) has been compensated by encoder-enhanced angular accuracy for GIXRF and XRR.« less

  6. LuFLA1PRO and LuBGAL1PRO promote gene expression in the phloem fibres of flax (Linum usitatissimum).

    PubMed

    Hobson, Neil; Deyholos, Michael K

    2013-04-01

    Cell type-specific promoters were identified that drive gene expression in an industrially important product. To identify flax (Linum usitatissimum) gene promoters, we analyzed the genomic regions upstream of a fasciclin-like arabinogalactan protein (LuFLA1) and a beta-galactosidase (LuBGAL1). Both of these genes encode transcripts that have been found to be highly enriched in tissues bearing phloem fibres. Using a beta-glucuronidase (GUS) reporter construct, we found that a 908-bp genomic sequence upstream of LuFLA1 (LuFLA1PRO) directed GUS expression with high specificity to phloem fibres undergoing secondary cell wall development. The DNA sequence upstream of LuBGAL1 (LuBGAL1PRO) likewise produced GUS staining in phloem fibres with developing secondary walls, as well as in tissues of developing flowers and seed bolls. These data provide further evidence of a specific role for LuFLA1 in phloem fibre development, and demonstrate the utility of LuFLA1PRO and LuBGAL1PRO as tools for biotechnology and further investigations of phloem fibre development.

  7. Initial development of a patient-reported outcome measure of experience with cognitive impairment associated with schizophrenia.

    PubMed

    Welch, Lisa C; Trudeau, Jeremiah J; Silverstein, Steven M; Sand, Michael; Henderson, David C; Rosen, Raymond C

    2017-01-01

    Cognitive impairment is a serious, often distressing aspect of schizophrenia that affects patients' day-to-day lives. Although several interview-based instruments exist to assess cognitive functioning, a reliable measure developed based on the experiences of patients facing cognitive difficulties is needed to complement the objective performance-based assessments. The present article describes the initial development of a patient-reported outcome (PRO) measure to assess the subjective experience of cognitive impairment among patients with schizophrenia, the Patient-Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS). The phases of development included the construction of a conceptual model based on the existing knowledge and two sets of qualitative interviews with patients: 1) concept elicitation interviews to ensure face and content validity from the perspective of people with schizophrenia and 2) cognitive debriefing of the initial item pool. Input from experts was elicited throughout the process. The initial conceptual model included seven domains. The results from concept elicitation interviews (n=80) supported these domains but yielded substantive changes to concepts within domains and to terminology. Based on these results, an initial pool of 53 items was developed to reflect the most common descriptions and languages used by the study participants. Cognitive debriefing interviews (n=22) resulted in the removal of 18 items and modification of 22 other items. The remaining 35 items represented 23 concepts within six domains plus two items assessing bother. The draft PRO measure is currently undergoing psychometric testing as a precursor to broad-based clinical and research use.

  8. Evaluation of apically extruded debris during root canal retreatment with two different rotary systems followed by a self-adjusting file.

    PubMed

    Cakici, Fatih; Cakici, Elif B; Küçükekenci, Funda Fundaoglu

    2016-02-01

    To compare the amount of apically extruded debris during root canal retreatment using ProTaper retreatment system (Dentsply Maillefer, Ballaigues, Switzerland), ProTaper retreatment system with Self-Adjusting File (SAF) system (ReDent-Nova, Ra'anana, Israel), Mtwo retreatment system (VDW, Munich, Germany), Mtwo retreatment system with SAF instruments. In total, 72 extracted human mandibular incisor teeth were used. All root canals were prepared with ProTaper universal (Dentsply Maillefer) up to F2 file and filled with gutta percha and AH plus sealer using cold lateral condensation before being assembled randomly into 4 groups (n = 18 each). Root canal filling materials were removed using the ProTaper retreatment system, the ProTaper retreatment system followed by SAF system, Mtwo retreatment system and Mtwo retreatment system followed by SAF system. Debris extruded apically during the removal of canal filling material was collected into preweighed Eppendorf tubes. The tubes were then stored in an incubator at 70°C for 5 days. The weight of the dry extruded debris was established by subtracting the preretreatment and postretreatment weight of the Eppendorf tubes for each group. The data obtained were analyzed using Kruskal-Wallis test. All retreatment techniques caused the apical extrusion of debris. There was no significant difference between the groups statistically (p>0.05). The results of this study showed that SAF system after Mtwo retreatment system and ProTaper retreatment system for improving retreatment has no significant effect on the amount of debris extruded apically.

  9. In vitro Comparison of Apical Debris Extrusion Using Rotary and Reciprocating Systems in Severely Curved Root Canals

    PubMed Central

    Delvarani, Abbas; Mohammadzadeh Akhlaghi, Nahid; Aminirad, Raana; Tour Savadkouhi, Sohrab; Vahdati, Seyed Aliakbar

    2017-01-01

    Introduction: The aim of this in vitro study was to compare the amount of apically extruded debris after root canal preparation using rotary and reciprocating systems in severely curved root canals. Methods and Materials: Thirty six extracted human mandibular first molars with 25-35° curvature in their mesiobuccal (MB) canal (according to Schneider’s method) were cleaned and shaped with ProTaper and WaveOne systems. The extruded debris was collected and their net weight was calculated. To compare the efficiency of the two systems, the operation time was also measured. The data were analyzed with t-test. Results: The amount of extruded debris in WaveOne group was significantly greater in comparison with ProTaper group (26%). The operating time for ProTaper was however, significantly longer than WaveOne. Conclusion: Both root preparation systems caused some degree of debris extrusion through the apical foramen. However, this amount was greater in WaveOne instruments. PMID:28179921

  10. Smear layer production by 3 rotary reamers with different cutting blade designs in straight root canals: a scanning electron microscopic study.

    PubMed

    Jeon, In-Soo; Spångberg, Larz S W; Yoon, Tai-Cheol; Kazemi, Reza B; Kum, Kee-Yeon

    2003-11-01

    The design of the cutting blade of rotary instruments may affect the outcome of root canal instrumentation in terms of cleanliness. The aim of this scanning electron microscopic study was to compare the quality and amount of smear layer generated in the apical third of straight root canals by 2 rotary nickel-titanium reamers and 1 rotary steel reamer with different cutting blade designs. Seventy intact, single-rooted human mandibular premolars with straight, fully developed roots were selected for this study. Before instrumentation, the cervical portion of all teeth was removed by using a microtome (Isomet), leaving 13-mm-long roots. Automated preparation was performed with ProFile (n = 20) and Hero 642 (n = 20) reamers by using the crown-down technique and with a stainless steel engine reamer (Mani; n = 20) by using a reaming motion. All root canals were instrumented to No. 40. A control group (pulp extirpation with barbed broaches; n = 10) was also included. Irrigation with 3 mL of a 1% sodium hypochlorite (NaOCl) solution was performed after each instrumentation. After the instrumentation, each root was split longitudinally, and a scanning electron microscope was used to examine the selected areas of the canal walls at the apical third from 2 different perspectives. A 4-category scoring system for smear layer was used, and the resulting scores were statistically analyzed. The least smear layer remained in the Hero 642 group at the selected apical third of straight root canals (P < .05). However, all instruments left a smear layer. The surface texture of the smear layer, in addition to the depth and the frequency of packed materials into the dentinal tubules, varied with instrument type. These data revealed that the design of the cutting blade of rotary instruments can affect root canal cleanliness in straight root canals. This information may be useful in the selection of nickel-titanium rotary reamers.

  11. Patient-Reported Outcome (PRO) Assessment in Clinical Trials: A Systematic Review of Guidance for Trial Protocol Writers

    PubMed Central

    Calvert, Melanie; Kyte, Derek; Duffy, Helen; Gheorghe, Adrian; Mercieca-Bebber, Rebecca; Ives, Jonathan; Draper, Heather; Brundage, Michael; Blazeby, Jane; King, Madeleine

    2014-01-01

    Background Evidence suggests there are inconsistencies in patient-reported outcome (PRO) assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers. Methods and Findings We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013) for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts). 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3%) recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency. Conclusions PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in appropriate trial protocols, in order to facilitate rigorous collection/reporting of PRO data, to effectively inform patient care. PMID:25333995

  12. Molecular evolution and transcriptional regulation of the oilseed rape proline dehydrogenase genes suggest distinct roles of proline catabolism during development.

    PubMed

    Faës, Pascal; Deleu, Carole; Aïnouche, Abdelkader; Le Cahérec, Françoise; Montes, Emilie; Clouet, Vanessa; Gouraud, Anne-Marie; Albert, Benjamin; Orsel, Mathilde; Lassalle, Gilles; Leport, Laurent; Bouchereau, Alain; Niogret, Marie-Françoise

    2015-02-01

    Six BnaProDH1 and two BnaProDH2 genes were identified in Brassica napus genome. The BnaProDH1 genes are mainly expressed in pollen and roots' organs while BnaProDH2 gene expression is associated with leaf vascular tissues at senescence. Proline dehydrogenase (ProDH) catalyzes the first step in the catabolism of proline. The ProDH gene family in oilseed rape (Brassica napus) was characterized and compared to other Brassicaceae ProDH sequences to establish the phylogenetic relationships between genes. Six BnaProDH1 genes and two BnaProDH2 genes were identified in the B. napus genome. Expression of the three paralogous pairs of BnaProDH1 genes and the two homoeologous BnaProDH2 genes was measured by real-time quantitative RT-PCR in plants at vegetative and reproductive stages. The BnaProDH2 genes are specifically expressed in vasculature in an age-dependent manner, while BnaProDH1 genes are strongly expressed in pollen grains and roots. Compared to the abundant expression of BnaProDH1, the overall expression of BnaProDH2 is low except in roots and senescent leaves. The BnaProDH1 paralogs showed different levels of expression with BnaA&C.ProDH1.a the most strongly expressed and BnaA&C.ProDH1.c the least. The promoters of two BnaProDH1 and two BnaProDH2 genes were fused with uidA reporter gene (GUS) to characterize organ and tissue expression profiles in transformed B. napus plants. The transformants with promoters from different genes showed contrasting patterns of GUS activity, which corresponded to the spatial expression of their respective transcripts. ProDHs probably have non-redundant functions in different organs and at different phenological stages. In terms of molecular evolution, all BnaProDH sequences appear to have undergone strong purifying selection and some copies are becoming subfunctionalized. This detailed description of oilseed rape ProDH genes provides new elements to investigate the function of proline metabolism in plant development.

  13. The pro1(+) gene from Sordaria macrospora encodes a C6 zinc finger transcription factor required for fruiting body development.

    PubMed Central

    Masloff, S; Pöggeler, S; Kück, U

    1999-01-01

    During sexual morphogenesis, the filamentous ascomycete Sordaria macrospora differentiates into multicellular fruiting bodies called perithecia. Previously it has been shown that this developmental process is under polygenic control. To further understand the molecular mechanisms involved in fruiting body formation, we generated the protoperithecia forming mutant pro1, in which the normal development of protoperithecia into perithecia has been disrupted. We succeeded in isolating a cosmid clone from an indexed cosmid library, which was able to complement the pro1(-) mutation. Deletion analysis, followed by DNA sequencing, subsequently demonstrated that fertility was restored to the pro1 mutant by an open reading frame encoding a 689-amino-acid polypeptide, which we named PRO1. A region from this polypeptide shares significant homology with the DNA-binding domains found in fungal C6 zinc finger transcription factors, such as the GAL4 protein from yeast. However, other typical regions of C6 zinc finger proteins, such as dimerization elements, are absent in PRO1. The involvement of the pro1(+) gene in fruiting body development was further confirmed by trying to complement the mutant phenotype with in vitro mutagenized and truncated versions of the pro1 open reading frame. Southern hybridization experiments also indicated that pro1(+) homologues are present in other sexually propagating filamentous ascomycetes. PMID:10224253

  14. The pro1(+) gene from Sordaria macrospora encodes a C6 zinc finger transcription factor required for fruiting body development.

    PubMed

    Masloff, S; Pöggeler, S; Kück, U

    1999-05-01

    During sexual morphogenesis, the filamentous ascomycete Sordaria macrospora differentiates into multicellular fruiting bodies called perithecia. Previously it has been shown that this developmental process is under polygenic control. To further understand the molecular mechanisms involved in fruiting body formation, we generated the protoperithecia forming mutant pro1, in which the normal development of protoperithecia into perithecia has been disrupted. We succeeded in isolating a cosmid clone from an indexed cosmid library, which was able to complement the pro1(-) mutation. Deletion analysis, followed by DNA sequencing, subsequently demonstrated that fertility was restored to the pro1 mutant by an open reading frame encoding a 689-amino-acid polypeptide, which we named PRO1. A region from this polypeptide shares significant homology with the DNA-binding domains found in fungal C6 zinc finger transcription factors, such as the GAL4 protein from yeast. However, other typical regions of C6 zinc finger proteins, such as dimerization elements, are absent in PRO1. The involvement of the pro1(+) gene in fruiting body development was further confirmed by trying to complement the mutant phenotype with in vitro mutagenized and truncated versions of the pro1 open reading frame. Southern hybridization experiments also indicated that pro1(+) homologues are present in other sexually propagating filamentous ascomycetes.

  15. Development of the Flight Tether for ProSEDS

    NASA Technical Reports Server (NTRS)

    Curtis, Leslie; Vaughn, Jason; Welzyn, Ken; Carroll, Joe; Brown, Norman S. (Technical Monitor)

    2002-01-01

    The Propulsive Small Expendable Deployer System (ProSEDS) space experiment will demonstrate the use of an electrodynamic tether propulsion system to generate thrust in space by decreasing the orbital altitude of a Delta 11 Expendable Launch Vehicle second stage. ProSEDS will use the flight-proven Small Expendable Deployer System to deploy a newly designed and developed tether which will provide tether generated drag thrust of approx. 0.4 N. The development and production of very long tethers with specific properties for performance and survivability will be required to enable future tether missions. The ProSEDS tether design and the development process may provide some lessons learned for these future missions. The ProSEDS system requirements drove the design of the tether to have three different sections of tether each serving a specialized purpose. The tether is a total of 15 kilometers long: 10 kilometers of a non-conductive Dyneema lead tether; 5 km of CCOR conductive coated wire; and 220 meters of insulated wire with a protective Kevlar overbraid. Production and joining of long tether lengths involved many development efforts. Extensive testing of tether materials including ground deployment of the full-length ProSEDS tether was conducted to validate the tether design and performance before flight.

  16. Systematic Evaluation of the Patient-Reported Outcome (PRO) Content of Clinical Trial Protocols

    PubMed Central

    Kyte, Derek; Duffy, Helen; Fletcher, Benjamin; Gheorghe, Adrian; Mercieca-Bebber, Rebecca; King, Madeleine; Draper, Heather; Ives, Jonathan; Brundage, Michael; Blazeby, Jane; Calvert, Melanie

    2014-01-01

    Background Qualitative evidence suggests patient-reported outcome (PRO) information is frequently absent from clinical trial protocols, potentially leading to inconsistent PRO data collection and risking bias. Direct evidence regarding PRO trial protocol content is lacking. The aim of this study was to systematically evaluate the PRO-specific content of UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme trial protocols. Methods and Findings We conducted an electronic search of the NIHR HTA programme database (inception to August 2013) for protocols describing a randomised controlled trial including a primary/secondary PRO. Two investigators independently reviewed the content of each protocol, using a specially constructed PRO-specific protocol checklist, alongside the ‘Standard Protocol Items: Recommendations for Interventional Trials’ (SPIRIT) checklist. Disagreements were resolved through discussion with a third investigator. 75 trial protocols were included in the analysis. Protocols included a mean of 32/51 (63%) SPIRIT recommendations (range 16–41, SD 5.62) and 11/33 (33%) PRO-specific items (range 4–18, SD 3.56). Over half (61%) of the PRO items were incomplete. Protocols containing a primary PRO included slightly more PRO checklist items (mean 14/33 (43%)). PRO protocol content was not associated with general protocol completeness; thus, protocols judged as relatively ‘complete’ using SPIRIT were still likely to have omitted a large proportion of PRO checklist items. Conclusions The PRO components of HTA clinical trial protocols require improvement. Information on the PRO rationale/hypothesis, data collection methods, training and management was often absent. This low compliance is unsurprising; evidence shows existing PRO guidance for protocol developers remains difficult to access and lacks consistency. Study findings suggest there are a number of PRO protocol checklist items that are not fully addressed by the current SPIRIT statement. We therefore advocate the development of consensus-based supplementary guidelines, aimed at improving the completeness and quality of PRO content in clinical trial protocols. PMID:25333349

  17. Feasibility of using the patient-reported outcomes measurement information system in academic health centers: case series design on pain reduction after chiropractic care.

    PubMed

    Burke, Jeanmarie R

    2014-09-01

    The purpose of this study was to test the utility of Patient-Reported Outcomes Measurement Information System (PROMIS) as a resource for collecting data on patient-reported outcomes (PRO) within academic health centers at a chiropractic college; and, to describe changes in PRO following pragmatic chiropractic care incorporating instrument-assisted soft tissue mobilization (IASTM) on pain symptoms. This was a pre-post intervention design without a control group (case series) involving 25 patients (14 females and 11 males; 40.5 ± 16.39 years, range 20-70 years) who completed their chiropractic care and their baseline and post-treatment pain assessments. The pragmatic chiropractic care intervention included both spinal manipulation and IASTM to treat pain symptoms. PRO's were collected using PROMIS to measure pain behavior, pain interference and pain intensity. The average pre-post assessment interval was 33 ± 22.5 days (95% CI, 23-42 days). The durations of treatments ranged from one week to 10 weeks. The median number of IASTM treatments was six. Pre-post decreases in T-scores for pain behavior and pain interference were 55.5 to 48.4 and 57.7 to 48.4, respectively (P < .05). Only 12 patients had a baseline T-score for pain intensity greater than 50. The pre-post decrease in pain intensity T-scores for these 12 patients was from 53.4 to 40.9. Within the limitations of a case series design, these data provide initial evidence on the utility of PROMIS instruments for clinical and research outcomes in chiropractic patients.

  18. Impact of heat treatments on the fatigue resistance of different rotary nickel-titanium instruments.

    PubMed

    Braga, Lígia Carolina Moreira; Faria Silva, Ana Cristina; Buono, Vicente Tadeu Lopes; de Azevedo Bahia, Maria Guiomar

    2014-09-01

    The aim of this study was to assess the influence of M-Wire (Dentsply Tulsa Dental Specialties, Tulsa, OK) and controlled memory technologies on the fatigue resistance of rotary nickel-titanium (NiTi) files by comparing files made using these 2 technologies with conventional NiTi files. Files with a similar cross-sectional design and diameter were chosen for the study: new 30/.06 files of the EndoWave (EW; J. Morita Corp, Osaka, Japan), HyFlex (HF; Coltene/Whaledent, Inc, Cuyahoga Falls, OH), ProFile Vortex (PV; Dentsply Tulsa Dental Specialties, Tulsa, OK), and Typhoon (TYP; Clinician's Choice Dental Products, New Milford, CT) systems together with ProTaper Universal F2 instruments (PTU F2; Dentsply Maillefer, Ballaigues, Switzerland). The compositions and transformation temperatures of the instruments were analyzed using x-ray energy-dispersive spectroscopy and differential scanning calorimetry, whereas the mean file diameter values at 3 mm from the tip (D3) were measured using image analysis software. The average number of cycles to failure was determined using a fatigue test device. X-ray energy-dispersive spectroscopy analysis showed that, on average, all the instruments exhibited the same chemical composition, namely, 51% Ni-49% Ti. The PV, TYP, and HF files exhibited increased transformation temperatures. The PTU F2, PV, and TYP files had similar D3 values, which were less than those of the EW and HF files. The average number of cycles to failure values were 150% higher for the TYP files compared with the PV files and 390% higher for the HF files compared with the EW files. M-Wire and controlled memory technologies increase the fatigue resistance of rotary NiTi files. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  19. The effect of cervical preflaring using different rotary nickel-titanium systems on the accuracy of apical file size determination.

    PubMed

    Tennert, Christian; Herbert, Josef; Altenburger, Markus Jörg; Wrbas, Karl-Thomas

    2010-10-01

    An exact determination of the apical root canal diameter is crucial for correct cleaning and shaping of a root canal. The aim of this study was to investigate the discrepancies of the initial apical root canal diameter and the diameter that is measured by the initial apical file (IAF) after cervical flaring using current rotary nickel-titanium systems. Mesiobuccal canals of 40 extracted mandibular molars were randomly assigned to four groups. In the first group, root canals were not flared. Root canals of the other groups were preflared using FlexMaster (VDW, Munich, Germany), ProTaper (Dentsply, Konstanz, Germany), or RaCe (FKG Dentaire, Genf, Switzerland) instruments. The tooth length was determined by inserting an ISO 06 K-file to the apical foramen. The working length (WL) was set 1 mm short of the apical foramen. File sizes were increased after binding sensation was felt at the WL. Transversal sections of the WL regions were examined under stereomicroscope, and the diameter of the root canal and the IAF at WL were assessed. Canals preflared with RaCe instruments had the lowest discrepancy between the apical root canal diameter and the IAF diameter (15.7 ± 9.7 μm) followed by ProTaper (22.2 ± 11.0 μm) and FlexMaster (35.0 ± 17.2 μm). Preflaring of root canals prevents underestimation of the actual apical root canal diameter. The type of instruments used for preflaring show differences on the accuracy of IAF determination. Preflaring with larger tapered instruments leads to a more accurate apical sizing, and this information is crucial concerning the appropriate final diameter for complete apical shaping. Copyright © 2010 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  20. A comparison of nickel-titanium rotary instruments manufactured using different methods and cross-sectional areas: ability to resist cyclic fatigue.

    PubMed

    Oh, So-Ram; Chang, Seok-Woo; Lee, Yoon; Gu, Yu; Son, Won-Jun; Lee, Woocheol; Baek, Seung-Ho; Bae, Kwang-Shik; Choi, Gi-Woon; Lim, Sang-Min; Kum, Kee-Yeon

    2010-04-01

    This study examined the effect of the manufacturing methods (ground, electropolished, and twisted) and the cross-sectional area (CSA) of nickel-titanium (NiTi) rotary instruments on their cyclic fatigue resistance. A total of 80 NiTi rotary instruments (ISO 25/.06 taper) from 4 brands (K3, ProFile, RaCe, and TF) were rotated in a simulated root canal with pecking motion until fracture. The number of cycles to failure (NCF) was calculated. The CSA at 3 mm from the tip of new instruments of each brand was calculated. The correlation between the CSA and NCF was evaluated. All fractured surfaces were analyzed using a scanning electron microscope to determine the fracture mode. The TF instruments were the most resistant to fatigue failure. The resistance to cyclic failure increased with decreasing CSA. All fractured surfaces showed the coexistence of ductile and brittle properties. The CSA had a significant effect on the fatigue resistance of NiTi rotary instruments. Copyright 2010 Mosby, Inc. All rights reserved.

  1. A critical analysis of test-retest reliability in instrument validation studies of cancer patients under palliative care: a systematic review

    PubMed Central

    2014-01-01

    Background Patient-reported outcome validation needs to achieve validity and reliability standards. Among reliability analysis parameters, test-retest reliability is an important psychometric property. Retested patients must be in a clinically stable condition. This is particularly problematic in palliative care (PC) settings because advanced cancer patients are prone to a faster rate of clinical deterioration. The aim of this study was to evaluate the methods by which multi-symptom and health-related qualities of life (HRQoL) based on patient-reported outcomes (PROs) have been validated in oncological PC settings with regards to test-retest reliability. Methods A systematic search of PubMed (1966 to June 2013), EMBASE (1980 to June 2013), PsychInfo (1806 to June 2013), CINAHL (1980 to June 2013), and SCIELO (1998 to June 2013), and specific PRO databases was performed. Studies were included if they described a set of validation studies. Studies were included if they described a set of validation studies for an instrument developed to measure multi-symptom or multidimensional HRQoL in advanced cancer patients under PC. The COSMIN checklist was used to rate the methodological quality of the study designs. Results We identified 89 validation studies from 746 potentially relevant articles. From those 89 articles, 31 measured test-retest reliability and were included in this review. Upon critical analysis of the overall quality of the criteria used to determine the test-retest reliability, 6 (19.4%), 17 (54.8%), and 8 (25.8%) of these articles were rated as good, fair, or poor, respectively, and no article was classified as excellent. Multi-symptom instruments were retested over a shortened interval when compared to the HRQoL instruments (median values 24 hours and 168 hours, respectively; p = 0.001). Validation studies that included objective confirmation of clinical stability in their design yielded better results for the test-retest analysis with regard to both pain and global HRQoL scores (p < 0.05). The quality of the statistical analysis and its description were of great concern. Conclusion Test-retest reliability has been infrequently and poorly evaluated. The confirmation of clinical stability was an important factor in our analysis, and we suggest that special attention be focused on clinical stability when designing a PRO validation study that includes advanced cancer patients under PC. PMID:24447633

  2. A critical enquiry into the psychometric properties of the professional quality of life scale (ProQol-5) instrument.

    PubMed

    Hemsworth, David; Baregheh, Anahita; Aoun, Samar; Kazanjian, Arminee

    2018-02-01

    This study had conducted a comprehensive analysis of the psychometric properties of Proqol 5, professional quality of work instrument among nurses and palliative care-workers on the basis of three independent datasets. The goal is to see the general applicability of this instrument across multiple populations. Although the Proqol scale has been widely adopted, there are few attempts that have thoroughly analyzed this instrument across multiple datasets using multiple populations. A questionnaire was developed and distributed to palliative care-workers in Canada and Nurses at two hospitals in Australia and Canada, this resulted in 273 datasets from the Australian and 303 datasets from the Canadian nurses and 503 datasets from the Canadian palliative care-workers. A comprehensive psychometric property analysis was conducted including inter-item correlations, tests of reliability, and both convergent and discriminant validity as well as construct validity analyses. In addition, to test for the reverse coding artifacts in the BO scale, exploratory factor analysis was adopted. The psychometric property analysis of Proqol 5 was satisfactory for the compassion satisfaction construct. However, there are concerns with respect to the burnout and secondary trauma stress scales and recommendations are made regarding the coding and specific items which should improve the reliability and validity of these scales. This research establishes the strengths and weaknesses of the Proqol instrument and demonstrates how it can be improved. Through specific recommendations, the academic community is invited to revise the burnout and secondary traumatic stress scales in an effort to improve Proqol 5 measures. Copyright © 2017. Published by Elsevier Inc.

  3. Analysis of gene expression and Ig transcription in PU.1/Spi-B-deficient progenitor B cell lines.

    PubMed

    Schweitzer, Brock L; DeKoter, Rodney P

    2004-01-01

    A number of presumptive target genes for the Ets-family transcription factor PU.1 have been identified in the B cell lineage. However, the precise function of PU.1 in B cells has not been studied because targeted null mutation of the PU.1 gene results in a block to lymphomyeloid development at an early developmental stage. In this study, we take advantage of recently developed PU.1(-/-)Spi-B(-/-) IL-7 and stromal cell-dependent progenitor B (pro-B) cell lines to analyze the function of PU.1 and Spi-B in B cell development. We show that contrary to previously published expectations, PU.1 and/or Spi-B are not required for Ig H chain (IgH) gene transcription in pro-B cells. In fact, PU.1(-/-)Spi-B(-/-) pro-B cells have increased levels of IgH transcription compared with wild-type pro-B cells. In addition, high levels of Igkappa transcription are induced after IL-7 withdrawal of wild-type or PU.1(-/-)Spi-B(-/-) pro-B cells. In contrast, we found that Iglambda transcription is reduced in PU.1(-/-)Spi-B(-/-) pro-B cells relative to wild-type pro-B cells after IL-7 withdrawal. These results suggest that Iglambda, but not IgH or Igkappa, transcription, is dependent on PU.1 and/or Spi-B. The PU.1(-/-)Spi-B(-/-) pro-B cells have other phenotypic changes relative to wild-type pro-B cells including increased proliferation, increased CD25 expression, decreased c-Kit expression, and decreased RAG-1 expression. Taken together, our observations suggest that reduction of PU.1 and/or Spi-B activity in pro-B cells promotes their differentiation to a stage intermediate between late pro-B cells and large pre-B cells.

  4. Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance.

    PubMed

    Banerjee, Anjan K; Okun, Sally; Edwards, I Ralph; Wicks, Paul; Smith, Meredith Y; Mayall, Stephen J; Flamion, Bruno; Cleeland, Charles; Basch, Ethan

    2013-12-01

    The Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium was convened to improve safety reporting by better incorporating the perspective of the patient. PROSPER comprises industry, regulatory authority, academic, private sector and patient representatives who are interested in the area of patient-reported outcomes of adverse events (PRO-AEs). It has developed guidance on PRO-AE data, including the benefits of wider use and approaches for data capture and analysis. Patient-reported outcomes (PROs) encompass the full range of self-reporting, rather than only patient reports collected by clinicians using validated instruments. In recent years, PROs have become increasingly important across the spectrum of healthcare and life sciences. Patient-centred models of care are integrating shared decision making and PROs at the point of care; comparative effectiveness research seeks to include patients as participatory stakeholders; and industry is expanding its involvement with patients and patient groups as part of the drug development process and safety monitoring. Additionally, recent pharmacovigilance legislation from regulatory authorities in the EU and the USA calls for the inclusion of patient-reported information in benefit-risk assessment of pharmaceutical products. For patients, technological advancements have made it easier to be an active participant in one's healthcare. Simplified internet search capabilities, electronic and personal health records, digital mobile devices, and PRO-enabled patient online communities are just a few examples of tools that allow patients to gain increased knowledge about conditions, symptoms, treatment options and side effects. Despite these changes and increased attention on the perceived value of PROs, their full potential has yet to be realised in pharmacovigilance. Current safety reporting and risk assessment processes remain heavily dependent on healthcare professionals, though there are known limitations such as under-reporting and discordant perspectives between patient reports and clinician perceptions of adverse outcomes. PROSPER seeks to support the wider use of PRO-AEs. The scope of this guidance document, which was completed between July 2011 and March 2013, considered a host of domains related to PRO-AEs, including definitions and suitable taxonomies, the range of datasets that could be used, data collection mechanisms, and suitable analytical methodologies. PROSPER offers an innovative framework to differentiate patient populations. This framework considers populations that are prespecified (such as those in clinical trials, prospective observational studies and some registries) and non-prespecified populations (such as those in claims databases, PRO-enabled online patient networks, and social websites in general). While the main focus of this guidance is on post-approval PRO-AEs from both prespecified and non-prespecified population groups, PROSPER has also considered pre-approval, prespecified populations. The ultimate aim of this guidance is to ensure that the patient 'voice' and perspective feed appropriately into collection of safety data. The guidance also covers a minimum core dataset for use by industry or regulators to structure PRO-AEs (accessible in the online appendix) and how data, once collected, might be evaluated to better inform on the safe and effective use of medicinal products. Structured collection of such patient data can be considered both a means to an end (improving patient safety) as well as an end in itself (expressing the patient viewpoint). The members of the PROSPER Consortium therefore direct this PRO-AE guidance to multiple stakeholders in drug safety, including industry, regulators, prescribers and patients. The use of this document across the entirety of the drug development life cycle will help to better define the benefit-risk profile of new and existing medicines. Because of the clinical relevance of 'real-world' data, PROs have the potential to contribute important new knowledge about the benefits and risks of medicinal products, communicated through the voice of the patient.

  5. Fatigue testing of controlled memory wire nickel-titanium rotary instruments.

    PubMed

    Shen, Ya; Qian, Wei; Abtin, Houman; Gao, Yuan; Haapasalo, Markus

    2011-07-01

    To improve the fracture resistance of nickel-titanium (NiTi) files, manufacturers have introduced new alloys to manufacture NiTi files and developed new manufacturing processes. This study was aimed to examine the fatigue behavior of NiTi instruments from a novel controlled memory NiTi wire (CM Wire). Instruments of ProFile, Typhoon (TYP), Typhoon CM (TYP CM), DS-SS0250425NEYY (NEYY), and DS-SS0250425NEYY CM (NEYY CM) (DS Dental, Johnson City, TN) all size 25/.04 were subjected to rotational bending at the curvature of 35° and 45° in air at the temperature of 23° ± 2°C, and the number of revolutions to fracture (N(f)) was recorded. The fracture surface of all fragments was examined by a scanning electron microscope. The crack-initiation sites, the percentage of dimple area to the whole fracture cross-section, and the surface strain amplitude (ε(a)) were noted. The new alloy yielded an improvement of over three to eight times in N(f) of CM files than that of conventional NiTi files (P < .05). The vast majority of CM instruments (50%-92%) showed multiple crack origins, whereas most instruments made from conventional NiTi wire (58%-100%) had one crack origin. The values of the fraction area occupied by the dimple region were significantly smaller on CM NiTi instruments compared with conventional NiTi instruments (P < .01). The square (NEYY CM) versus the triangular (TYP CM) configuration showed a significantly different lifetime on CM wire at both curvatures (P < .01). The material property had a substantial impact on fatigue lifetime. Instruments made from CM Wire had a significantly higher N(f) and lower surface strain amplitude than the conventional NiTi wire files with identical design. Copyright © 2011 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  6. Volumetric analysis of hand, reciprocating and rotary instrumentation techniques in primary molars using spiral computed tomography: An in vitro comparative study.

    PubMed

    Jeevanandan, Ganesh; Thomas, Eapen

    2018-01-01

    This present study was conducted to analyze the volumetric change in the root canal space and instrumentation time between hand files, hand files in reciprocating motion, and three rotary files in primary molars. One hundred primary mandibular molars were randomly allotted to one of the five groups. Instrumentation was done using Group I; nickel-titanium (Ni-Ti) hand file, Group II; Ni-Ti hand files in reciprocating motion, Group III; Race rotary files, Group IV; prodesign pediatric rotary files, and Group V; ProTaper rotary files. The mean volumetric changes were assessed using pre- and post-operative spiral computed tomography scans. Instrumentation time was recorded. Statistical analysis to access intergroup comparison for mean canal volume and instrumentation time was done using Bonferroni-adjusted Mann-Whitney test and Mann-Whitney test, respectively. Intergroup comparison of mean canal volume showed statistically significant difference between Groups II versus IV, Groups III versus V, and Groups IV versus V. Intergroup comparison of mean instrumentation time showed statistically significant difference among all the groups except Groups IV versus V. Among the various instrumentation techniques available, rotary instrumentation is the considered to be the better instrumentation technique for canal preparation in primary teeth.

  7. Conceptual and Analytical Considerations toward the Use of Patient-Reported Outcomes in Personalized Medicine.

    PubMed

    Alemayehu, Demissie; Cappelleri, Joseph C

    2012-07-01

    Patient-reported outcomes (PROs) can play an important role in personalized medicine. PROs can be viewed as an important fundamental tool to measure the extent of disease and the effect of treatment at the individual level, because they reflect the self-reported health state of the patient directly. However, their effective integration in personalized medicine requires addressing certain conceptual and methodological challenges, including instrument development and analytical issues. To evaluate methodological issues, such as multiple comparisons, missing data, and modeling approaches, associated with the analysis of data related to PRO and personalized medicine to further our understanding on the role of PRO data in personalized medicine. There is a growing recognition of the role of PROs in medical research, but their potential use in customizing healthcare is not widely appreciated. Emerging insights into the genetic basis of PROs could potentially lead to new pathways that may improve patient care. Knowledge of the biologic pathways through which the various genetic predispositions propel people toward negative or away from positive health experiences may ultimately transform healthcare. Understanding and addressing the conceptual and methodological issues in PROs and personalized medicine are expected to enhance the emerging area of personalized medicine and to improve patient care. This article addresses relevant concerns that need to be considered for effective integration of PROs in personalized medicine, with particular reference to conceptual and analytical issues that routinely arise with personalized medicine and PRO data. Some of these issues, including multiplicity problems, handling of missing values-and modeling approaches, are common to both areas. It is hoped that this article will help to stimulate further research to advance our understanding of the role of PRO data in personalized medicine. A robust conceptual framework to incorporate PROs into personalized medicine can provide fertile opportunity to bring these two areas even closer and to enhance the way a specific treatment is attuned and delivered to address patient care and patient needs.

  8. Test Review: L. Brown, R. J. Sherbenou, & S. K. Johnsen "Test of Nonverbal Intelligence-4" (Toni-4). Austin, TX--PRO-ED, 2010

    ERIC Educational Resources Information Center

    Ritter, Nicola; Kilinc, Emin; Navruz, Bilgin; Bae, Yunhee

    2011-01-01

    This article reviews Test of Nonverbal Intelligence-Fourth Edition (TONI-4), an individually administered instrument created to assess intelligence. The distinguishing characteristic of the TONI-4 is the nonverbal, motor-reduced format that assesses common elements of intelligence without the confounding effects of motor or linguistic skills. The…

  9. Confirmatory Factor Analysis of U.S. Merit Systems Protection Board's Survey of Sexual Harassment: The Fit of a Three-Factor Model.

    ERIC Educational Resources Information Center

    Stockdale, Margaret S.; Hope, Kathryn G.

    1997-01-01

    Factor analysis of data from 1,070 federal employees, 575 undergraduates and 575 graduate students, faculty, and staff uncovered some weaknesses in the Merit Systems Protection Board's sexual harassment survey instrument. This type of survey does not adequately measure sexual coercion or quid pro quo forms of harassment. (SK)

  10. Italian version of the M.D. Anderson Symptom Inventory--Head and Neck Module: linguistic validation.

    PubMed

    Greco, A; Orlandi, E; Mirabile, A; Takanen, S; Fallai, C; Iacovelli, N A; Rimedio, A; Russi, E; Sala, M; Monzani, D; Rosenthal, D I; Gunn, G B; Steca, P; Licitra, L; Bossi, P

    2015-12-01

    Head and neck cancer (HNC) patients can experience symptoms due to the tumor itself or to the treatment, with an impact on health-related quality of life (HRQoL). Patient-reported outcome (PRO) measures pertaining to HRQoL are used in medical research and to support clinical decisions. PRO instrument applicability and cultural adaptation must be tested for each population. The aim of this study is to linguistically validate the Italian translation of the M.D. Anderson Symptom Inventory--Head and Neck Module (MDASI-HN). Following forward and backward translation of the items of the English MDASI-HN into Italian, it was administered along with a cognitive debriefing to HNC patients able to read and understand Italian language. Individual and group responses are presented using descriptive statistics. From May 2013 through September 2013, 56 patients with HNC (18 during curative treatment, 20 in palliative chemotherapy, and 18 in follow-up period) completed the MDASI-HN followed by accompanying cognitive debriefing. Ninety-nine percent of the individual MDASI-HN items were completed. Average time to complete the MDASI-HN was 8.5 min (range 3-15). Results suggested overall ease of completion, relevance, and comprehensibleness of this translated self-report instrument in this Italian patient population. The Italian version of the MDASI-HN is linguistically valid; future research should explore dimensionality, reliability, and convergent, discriminant, and predictive validity of this patient-reported instrument, in order to use this translated version in outcomes research and clinical settings.

  11. PRO development: rigorous qualitative research as the crucial foundation.

    PubMed

    Lasch, Kathryn Eilene; Marquis, Patrick; Vigneux, Marc; Abetz, Linda; Arnould, Benoit; Bayliss, Martha; Crawford, Bruce; Rosa, Kathleen

    2010-10-01

    Recently published articles have described criteria to assess qualitative research in the health field in general, but very few articles have delineated qualitative methods to be used in the development of Patient-Reported Outcomes (PROs). In fact, how PROs are developed with subject input through focus groups and interviews has been given relatively short shrift in the PRO literature when compared to the plethora of quantitative articles on the psychometric properties of PROs. If documented at all, most PRO validation articles give little for the reader to evaluate the content validity of the measures and the credibility and trustworthiness of the methods used to develop them. Increasingly, however, scientists and authorities want to be assured that PRO items and scales have meaning and relevance to subjects. This article was developed by an international, interdisciplinary group of psychologists, psychometricians, regulatory experts, a physician, and a sociologist. It presents rigorous and appropriate qualitative research methods for developing PROs with content validity. The approach described combines an overarching phenomenological theoretical framework with grounded theory data collection and analysis methods to yield PRO items and scales that have content validity.

  12. PRO development: rigorous qualitative research as the crucial foundation

    PubMed Central

    Marquis, Patrick; Vigneux, Marc; Abetz, Linda; Arnould, Benoit; Bayliss, Martha; Crawford, Bruce; Rosa, Kathleen

    2010-01-01

    Recently published articles have described criteria to assess qualitative research in the health field in general, but very few articles have delineated qualitative methods to be used in the development of Patient-Reported Outcomes (PROs). In fact, how PROs are developed with subject input through focus groups and interviews has been given relatively short shrift in the PRO literature when compared to the plethora of quantitative articles on the psychometric properties of PROs. If documented at all, most PRO validation articles give little for the reader to evaluate the content validity of the measures and the credibility and trustworthiness of the methods used to develop them. Increasingly, however, scientists and authorities want to be assured that PRO items and scales have meaning and relevance to subjects. This article was developed by an international, interdisciplinary group of psychologists, psychometricians, regulatory experts, a physician, and a sociologist. It presents rigorous and appropriate qualitative research methods for developing PROs with content validity. The approach described combines an overarching phenomenological theoretical framework with grounded theory data collection and analysis methods to yield PRO items and scales that have content validity. PMID:20512662

  13. Comparative evaluation of canal transportation, centering ability, and remaining dentin thickness between WaveOne and ProTaper rotary by using cone beam computed tomography: An in vitro study

    PubMed Central

    Jain, Aditi; Asrani, Hemant; Singhal, Abhinav Chand; Bhatia, Taranjeet Kaur; Sharma, Vaibhav; Jaiswal, Pragya

    2016-01-01

    Aims: To compare the canal transportation, centering ability, and remaining dentin thickness of WaveOne and ProTaper systems using cone beam computed tomography. Subjects and Methods: Forty extracted human single-rooted premolars were used in the present study. Preinstrumentation scanning of all teeth was taken; canal curvatures were calculated, and the samples were randomly divided into two groups, with twenty samples in each group; one group was instrumented with WaveOne system and the other group with ProTaper rotary system. Postinstrumentation scans were performed, and the two scans were compared to determine canal transportation, centering ability, and remaining dentin thickness at 3 mm, 6 mm, and 9 mm from the root apex. Statistical Analysis Used: Student's unpaired t-test. Results: Using Student's unpaired t-test, results were as follows: for canal transportation, Group 1 showed significant difference at 3 mm and 6 mm and insignificant difference at 9 mm while Group 2 showed insignificant difference in all the three regions. For centering ability and remaining dentin thickness, Group 1 showed insignificant difference at 3 mm and 9 mm while significant difference at 6 mm was obtained. When comparison of remaining dentin thickness was done at three levels using two groups WaveOne and ProTaper, there was no significant difference between two groups. Conclusions: (1) WaveOne single reciprocation file system respected better canal anatomy better than ProTaper. (2) Individually, centering ability of WaveOne was better at 3 mm, 6 mm, and 9 mm levels. (3) However, ProTaper individually was better centered at 3 mm (apical third) and 9 mm (coronal 3rd) levels than 6 mm level (middle third). PMID:27656063

  14. 24 CFR 203.462 - Pro rata payment of premium before termination.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Pro rata payment of premium before termination. No contract of insurance shall be terminated until the lender has paid to the Commissioner the pro rata portion of the current annual insurance premium. ... 24 Housing and Urban Development 2 2010-04-01 2010-04-01 false Pro rata payment of premium before...

  15. 24 CFR 203.462 - Pro rata payment of premium before termination.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Pro rata payment of premium before termination. No contract of insurance shall be terminated until the lender has paid to the Commissioner the pro rata portion of the current annual insurance premium. ... 24 Housing and Urban Development 2 2011-04-01 2011-04-01 false Pro rata payment of premium before...

  16. Ordering human CD34+CD10−CD19+ pre/pro-B-cell and CD19− common lymphoid progenitor stages in two pro-B-cell development pathways

    PubMed Central

    Sanz, Eva; Muñoz-A., Norman; Monserrat, Jorge; Van-Den-Rym, Ana; Escoll, Pedro; Ranz, Ismael; Álvarez-Mon, Melchor; de-la-Hera, Antonio

    2010-01-01

    Studies here respond to two long-standing questions: Are human “pre/pro-B” CD34+CD10−CD19+ and “common lymphoid progenitor (CLP)/early-B” CD34+CD10+CD19− alternate precursors to “pro-B” CD34+CD19+CD10+ cells, and do the pro-B cells that arise from these progenitors belong to the same or distinct B-cell development pathways? Using flow cytometry, gene expression profiling, and Ig VH-D-JH sequencing, we monitor the initial 10 generations of development of sorted cord blood CD34highLineage− pluripotential progenitors growing in bone marrow S17 stroma cocultures. We show that (i) multipotent progenitors (CD34+CD45RA+CD10−CD19−) directly generate an initial wave of Pax5+TdT− “unilineage” pre/pro-B cells and a later wave of “multilineage” CLP/early-B cells and (ii) the cells generated in these successive stages act as precursors for distinct pro-B cells through two independent layered pathways. Studies by others have tracked the origin of B-lineage leukemias in elderly mice to the mouse B-1a pre/pro-B lineage, which lacks the TdT activity that diversifies the VH-D-JH Ig heavy chain joints found in the early-B or B-2 lineage. Here, we show a similar divergence in human B-cell development pathways between the Pax5+TdT− pre/pro-B differentiation pathway that gives rise to infant B-lineage leukemias and the early-B pathway. PMID:20231472

  17. The Effects of Super-Flux (High Performance) Dialyzer on Plasma Glycosylated Pro-B-Type Natriuretic Peptide (proBNP) and Glycosylated N-Terminal proBNP in End-Stage Renal Disease Patients on Dialysis

    PubMed Central

    Nakagawa, Yasuaki; Nishikimi, Toshio; Kuwahara, Koichiro; Yasuno, Shinji; Kinoshita, Hideyuki; Kuwabara, Yoshihiro; Nakao, Kazuhiro; Minami, Takeya; Yamada, Chinatsu; Ueshima, Kenji; Ikeda, Yoshihiro; Okamoto, Hiroyuki; Horii, Kazukiyo; Nagata, Kiyoshi; Kangawa, Kenji; Minamino, Naoto; Nakao, Kazuwa

    2014-01-01

    Background Plasma BNP levels are predictive of prognosis in hemodialysis patients. However, recent studies showed that the current BNP immunoassay cross-reacts with glycosylated proBNP, and the NT-proBNP assay underestimates glycosylated NT-proBNP. In addition, the recently developed high performance dialyzer removes medium-sized molecular solutes such as β2-microgloburin. We therefore investigated the effects of high performance dialysis on measured levels of glycosylated proBNP, glycosylated NT-proBNP and other BNP-related peptides in end-stage renal disease (ESRD) patients on hemodialysis. Method The relationships between clinical parameters and BNP-related molecule were also investigated. We used our newly developed immunoassay to measure plasma total BNP and proBNP in 105 normal subjects and 36 ESRD patients before and after hemodialysis. Plasma NT-proBNP was measured using Elecsys II after treatment with or without deglycosylating enzymes. We also measured plasma ANP and cGMP using radioimmunoassays. Results All the measured BNP-related peptides were significantly higher in ESRD patients than healthy subjects. Total BNP (−38.9%), proBNP (−29.7%), glycoNT-proBNP (−45.5%), nonglycoNT-proBNP (−53.4%), ANP (−50.4%) and cGMP (−72.1%) were all significantly reduced after hemodialysis, and the magnitude of the reduction appeared molecular weight- dependent. Both the proBNP/total BNP and glycoNT-proBNP/nonglycoNT-proBNP ratios were increased after hemodialysis. The former correlated positively with hemodialysis vintage and negatively with systolic blood pressure, while the latter correlated positively with parathyroid hormone levels. Conclusion These results suggest that hemodialysis using super-flux dialyzer removes BNP-related peptides in a nearly molecular weight-dependent manner. The ProBNP/total BNP and glycoNT-proBNP/nonglycoNT-proBNP ratios appear to be influenced by hemodialysis-related parameters in ESRD patients on hemodialysis. PMID:24667631

  18. Computational modeling of the bat HKU4 coronavirus 3CLpro inhibitors as a tool for the development of antivirals against the emerging Middle East respiratory syndrome (MERS) coronavirus.

    PubMed

    Abuhammad, Areej; Al-Aqtash, Rua'a A; Anson, Brandon J; Mesecar, Andrew D; Taha, Mutasem O

    2017-11-01

    The Middle East respiratory syndrome coronavirus (MERS-CoV) is an emerging virus that poses a major challenge to clinical management. The 3C-like protease (3CL pro ) is essential for viral replication and thus represents a potential target for antiviral drug development. Presently, very few data are available on MERS-CoV 3CL pro inhibition by small molecules. We conducted extensive exploration of the pharmacophoric space of a recently identified set of peptidomimetic inhibitors of the bat HKU4-CoV 3CL pro . HKU4-CoV 3CL pro shares high sequence identity (81%) with the MERS-CoV enzyme and thus represents a potential surrogate model for anti-MERS drug discovery. We used 2 well-established methods: Quantitative structure-activity relationship (QSAR)-guided modeling and docking-based comparative intermolecular contacts analysis. The established pharmacophore models highlight structural features needed for ligand recognition and revealed important binding-pocket regions involved in 3CL pro -ligand interactions. The best models were used as 3D queries to screen the National Cancer Institute database for novel nonpeptidomimetic 3CL pro inhibitors. The identified hits were tested for HKU4-CoV and MERS-CoV 3CL pro inhibition. Two hits, which share the phenylsulfonamide fragment, showed moderate inhibitory activity against the MERS-CoV 3CL pro and represent a potential starting point for the development of novel anti-MERS agents. To the best of our knowledge, this is the first pharmacophore modeling study supported by in vitro validation on the MERS-CoV 3CL pro . MERS-CoV is an emerging virus that is closely related to the bat HKU4-CoV. 3CL pro is a potential drug target for coronavirus infection. HKU4-CoV 3CL pro is a useful surrogate model for the identification of MERS-CoV 3CL pro enzyme inhibitors. dbCICA is a very robust modeling method for hit identification. The phenylsulfonamide scaffold represents a potential starting point for MERS coronavirus 3CL pro inhibitors development. Copyright © 2017 John Wiley & Sons, Ltd.

  19. Evaluative studies in nuclear medicine research: emission computed tomography assessment. Final report, January 1-December 31, 1981

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Potchen, E.J.; Harris, G.I.; Gift, D.A.

    The report provides information on an assessment of the potential short and long term benefits of emission computed tomography (ECT) in biomedical research and patient care. Work during the past year has been augmented by the development and use of an opinion survey instrument to reach a wider representation of knowledgeable investigators and users of this technology. This survey instrument is reproduced in an appendix. Information derived from analysis of the opinion survey, and used in conjunction with results of independent staff studies of available sources, provides the basis for the discussions given in following sections of PET applications inmore » the brain, of technical factors, and of economic implications. Projections of capital and operating costs on a per study basis were obtained from a computerized, pro forma accounting model and are compared with the survey cost estimates for both research and clinical modes of application. The results of a cash-flow model analysis of the relationship between projected economic benefit of PET research to disease management and the costs associated with such research are presented and discussed.« less

  20. ProBDNF and mature BDNF as punishment and reward signals for synapse elimination at mouse neuromuscular junctions.

    PubMed

    Je, H Shawn; Yang, Feng; Ji, Yuanyuan; Potluri, Srilatha; Fu, Xiu-Qing; Luo, Zhen-Ge; Nagappan, Guhan; Chan, Jia Pei; Hempstead, Barbara; Son, Young-Jin; Lu, Bai

    2013-06-12

    During development, mammalian neuromuscular junctions (NMJs) transit from multiple-innervation to single-innervation through axonal competition via unknown molecular mechanisms. Previously, using an in vitro model system, we demonstrated that the postsynaptic secretion of pro-brain-derived neurotrophic factor (proBDNF) stabilizes or eliminates presynaptic axon terminals, depending on its proteolytic conversion at synapses. Here, using developing mouse NMJs, we obtained in vivo evidence that proBDNF and mature BDNF (mBDNF) play roles in synapse elimination. We observed that exogenous proBDNF promoted synapse elimination, whereas mBDNF infusion substantially delayed synapse elimination. In addition, pharmacological inhibition of the proteolytic conversion of proBDNF to mBDNF accelerated synapse elimination via activation of p75 neurotrophin receptor (p75(NTR)). Furthermore, the inhibition of both p75(NTR) and sortilin signaling attenuated synapse elimination. We propose a model in which proBDNF and mBDNF serve as potential "punishment" and "reward" signals for inactive and active terminals, respectively, in vivo.

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