Displaying publications 41 - 60 of 68 in total

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  1. Nagendrababu V, Faggion CM, Pulikkotil SJ, Alatta A, Dummer PMH
    Int Endod J, 2022 Jan 26.
    PMID: 35080025 DOI: 10.1111/iej.13693
    AIM: The aims of the study were to assess the methodological quality of systematic reviews with network meta-analyses (NMAs) in Endodontics using the "A MeaSurement Tool to Assess systematic Reviews" (AMSTAR 2) tool, and to evaluate the overall confidence in the results of the individual reviews included in the analysis.

    METHODOLOGY: Systematic reviews with NMAs within the specialty of Endodontics published in English were identified from the PubMed, EbBSCOhost and SCOPUS databases from inception to July 2021. Two reviewers were involved independently in the selection of the reviews, data extraction, methodological quality assessment and overall confidence rating. Disagreements were resolved by discussion between the reviewers to achieve consensus; if disagreements persisted, a third reviewer made the final decision. The methodological quality of the included NMAs was appraised using the AMSTAR 2 checklist, which contains 16 items. The reviewers scored each item - 'Yes' - when the item was fully addressed, 'Partial Yes' - when the item was not fully addressed, or 'No' - when the item was not addressed. The overall confidence in the results of each review was classified as 'High', 'Moderate', 'Low' or 'Critically low' based on the criteria reported by the AMSTAR 2 developers.

    RESULTS: Twelve systematic reviews with NMAs were included. All the NMAs adequately reported Item 1 ("Did the research questions and inclusion criteria for the review include the components of PICO?"), Item 8 ("Did the review authors describe the included studies in adequate detail?"), Item 9 ("Did the review authors use a satisfactory technique for assessing the risk of bias (RoB) in individual studies that were included in the review?") and Item 16 ("Did the review authors report any potential sources of conflict of interest, including any funding they received for conducting the review?") , whereas only one NMA reported Item 10 adequately ("Did the review authors report on the sources of funding for the studies included in the review?"). The overall confidence in the results of eight reviews was categorised as "Critically low", one review was "Low", two reviews were "Moderate" and one review was "High".

    CONCLUSION: The overall confidence in the results for the majority of systematic reviews with NMAs in Endodontics was judged to be 'Critically low' as their methodological quality was below the necessary standard. AMSTAR 2 and PRISMA for NMA guidelines are available to guide authors to produce high quality systematic reviews with NMAs and for Editors and peer-reviewers when assessing submissions to journals.

  2. Nagendrababu V, Abbott PV, Boutsioukis C, Duncan HF, Faggion CM, Kishen A, et al.
    Int Endod J, 2022 Jan 18.
    PMID: 35043398 DOI: 10.1111/iej.13682
    High-quality systematic reviews in the field of Dentistry provide the most definitive overarching evidence for clinicians, guideline developers and healthcare policy makers to judge the foreseeable risks, anticipated benefits, and potential harms of dental treatment. In the process of carrying out a systematic review, it is essential that authors appraise the methodological quality of the primary studies they include, because studies which follow poor methodology will have a potentially serious negative impact on the overall strength of the evidence and the recommendations that can be drawn. In Endodontology, systematic reviews of laboratory studies have used quality assessment criteria developed subjectively by the individual authors as there are no comprehensive, well-structured, and universally accepted criteria that can be applied objectively and universally to individual studies included in reviews. Unfortunately, these subjective criteria are likely to be inaccurately defined, unreliably applied, inadequately analysed, unreasonably biased, defective, and non-repeatable. The aim of the present paper is to outline the process to be followed in the development of comprehensive methodological quality assessment criteria to be used when evaluating laboratory studies, that is research not conducted in vivo on humans or animals, included in systematic reviews within Endodontology. The development of new methodological quality assessment criteria for appraising the laboratory-based studies included in systematic reviews within Endodontology will follow a three-stage process. First, a steering committee will be formed by the project leaders to develop a preliminary list of assessment criteria by modifying and adapting those already available, but with the addition of several new items relevant for Endodontology. The initial draft assessment criteria will be reviewed and refined by a Delphi Group (n = 40) for their relevance and inclusion using a nine-point Likert scale. Second, the agreed items will then be discussed in an online or face-to-face meeting by a group of experts (n = 10) to further refine the assessment criteria. Third, based on the feedback received from the online/face-to-face meeting, the steering committee will revise the quality assessment criteria and subsequently a group of authors will be selected to pilot the new system. Based on the feedback collected, the criteria may be revised further before being approved by the steering committee. The assessment criteria will be published in relevant journals, presented at national and international congresses/meetings, and will be freely available on a dedicated website. The steering committee will update the assessment criteria periodically based on feedback received from end-users.
  3. Taha NA, Al-Rawash MH, Imran ZA
    Int Endod J, 2022 May;55(5):416-429.
    PMID: 35152464 DOI: 10.1111/iej.13707
    AIM: The aim of the study was to compare the outcome of full pulpotomy using 2 calcium silicate-based materials compared with mineral trioxide aggregate (MTA) in symptomatic mature permanent teeth with carious pulp exposure.

    METHODOLOGY: This study was designed as a parallel, double blind, randomized controlled trial where symptomatic mature permanent teeth with carious pulp exposure meeting the inclusion criteria were randomly treated with full pulpotomy using one of 3 calcium silicate-based materials (ProRoot MTA, Biodentine and TotalFill). Full pulpotomy was performed, and haemostasis was achieved via a cotton pellet moistened with 2.5% NaOCl. A 3-mm layer of the calcium silicate-based material was randomly placed as the pulpotomy agent through a block randomization process followed by a resin-based composite restoration. Postoperative periapical radiograph was taken. Clinical and radiographic evaluation were completed after 6 months and 1 year. The patient and evaluator were blinded to the type of materials used. Pain levels were scored preoperatively and 7 days after treatment. Effect of potential prognosis factors including gender, age, diagnosis, bleeding time and type of caries were also analysed.

    RESULTS: One hundred and sixty-four teeth in 146 patients received full pulpotomy and were randomly assigned to either the tested or control material through block randomization technique (50 MTA, 50 Biodentine and 64 TotalFill). The age ranged from 10 to 70 years. The diagnosis was irreversible pulpitis in 112 teeth (72%) and reversible pulpitis in 28 teeth (28%). The majority of patients presented with severe pain, during the first week 96.9% reported complete relief of pain or mild pain. Four cases had immediate failure. At 6 months the overall success rate was 92.2%, over 1 year 156/164 teeth attended follow-up with 12 failures (2 restorative failures and 10 endodontic failures), the overall success of pulpotomy at 1 year was 92.3% (144/156); 91.8% in MTA, 93.3% in Biodentine and 91.9% in TotalFill with no significant difference amongst the groups and no side effects observed. No significant association was evident between outcome and the investigated variables.

    CONCLUSIONS: The 1-year success rate of full pulpotomy did not differ significantly between Biodentine pulpotomy, TotalFill pulpotomy, and MTA pulpotomy. The study was registered with clinical trials; registration number (NCT04345263).

  4. Nagendrababu V, Kishen A, Murray PE, Nekoofar MH, de Figueiredo JAP, Priya E, et al.
    Int Endod J, 2021 Jun;54(6):848-857.
    PMID: 33450080 DOI: 10.1111/iej.13477
    Animal testing is crucial in situations when research on humans is not allowed because of unknown health risks and ethical concerns. The current project aims to develop reporting guidelines exclusively for animal studies in Endodontology, using an established consensus-based methodology. The guidelines have been named: Preferred Reporting Items for Animal Studies in Endodontology (PRIASE) 2021. Nine individuals (PD, VN, AK, PM, MN, JF, EP, JJ and SJ), including the project leaders (PD, VN) formed a steering committee. The steering committee developed a novel checklist by adapting and integrating their animal testing and peer review experience with the Animals in Research: Reporting In Vivo Experiments (ARRIVE) guidelines and also the Clinical and Laboratory Images in Publications (CLIP) principles. A PRIASE Delphi Group (PDG) and PRIASE Online Meeting Group (POMG) were also formed. Thirty-one PDG members participated in the online Delphi process and achieved consensus on the checklist items and flowchart that were used to formulate the PRIASE guidelines. The novel PRIASE 2021 guidelines were discussed with the POMG on 9 September 2020 via a Zoom online video call attended by 21 individuals from across the globe and seven steering committee members. Following the discussions, the guidelines were modified and then piloted by several authors whilst writing a manuscript involving research on animals. The PRIASE 2021 guidelines are a checklist consisting of 11 domains and 43 individual items together with a flowchart. The PRIASE 2021 guidelines are focused on improving the methodological principles, reproducibility and quality of animal studies in order to enhance their reliability as well as repeatability to estimate the effects of endodontic treatments and usefulness for guiding future clinical studies on humans.
  5. Nagendrababu V, Kishen A, Murray PE, Nekoofar MH, de Figueiredo JAP, Priya E, et al.
    Int Endod J, 2021 Jun;54(6):858-886.
    PMID: 33492704 DOI: 10.1111/iej.13481
    Laws and ethics require that before conducting human clinical trials, a new material, device or drug may have to undergo testing in animals in order to minimize health risks to humans, unless suitable supporting grandfather data already exist. The Preferred Reporting Items for Animal Studies in Endodontology (PRIASE) 2021 guidelines were developed exclusively for the specialty of Endodontology by integrating and adapting the ARRIVE (Animals in Research: Reporting In Vivo Experiments) guidelines and the Clinical and Laboratory Images in Publications (CLIP) principles using a validated consensus-based methodology. Implementation of the PRIASE 2021 guidelines will reduce potential sources of bias and thus improve the quality, accuracy, reproducibility, completeness and transparency of reports describing animal studies in Endodontology. The PRIASE 2021 guidelines consist of a checklist with 11 domains and 43 individual items and a flowchart. The aim of the current document is to provide an explanation for each item in the PRIASE 2021 checklist and flowchart and is supplemented with examples from the literature in order for readers to understand their significance and to provide usage guidance. A link to the PRIASE 2021 explanation and elaboration document and PRIASE 2021 checklist and flowchart is available on the Preferred Reporting Items for study Designs in Endodontology (PRIDE) website (http://pride-endodonticguidelines.org/priase/).
  6. Nagendrababu V, Chong BS, McCabe P, Shah PK, Priya E, Jayaraman J, et al.
    Int Endod J, 2020 May;53(5):619-626.
    PMID: 32090342 DOI: 10.1111/iej.13285
    Case reports can provide early information about new, unusual or rare disease(s), newer treatment strategies, improved therapeutic benefits and adverse effects of interventions or medications. This paper describes the process that led to the development of the Preferred Reporting Items for Case reports in Endodontics (PRICE) 2020 guidelines through a consensus-based methodology. A steering committee was formed with eight members (PD, VN, BC, PM, PS, EP, JJ and SP), including the project leaders (PD, VN). The steering committee developed an initial checklist by combining and modifying the items from the Case Report (CARE) guidelines and Clinical and Laboratory Images in Publications (CLIP) principles. A PRICE Delphi Group (PDG) and PRICE Face-to-Face Meeting Group (PFMG) were then formed. The members of the PDG were invited to participate in an online Delphi process to achieve consensus on the wording and utility of the checklist items and the accompanying flow chart that was created to complement the PRICE 2020 guidelines. The revised PRICE checklist and flow chart developed by the online Delphi process was discussed by the PFMG at a meeting held during the 19th European Society of Endodontology (ESE) Biennial Congress in Vienna, Austria, in September 2019. Following the meeting, the steering committee created a final version of the guidelines, which were piloted by several authors during the writing of a case report. In order to help improve the clarity, completeness and quality of case reports in Endodontics, we encourage authors to use the PRICE 2020 guidelines.
  7. Nagendrababu V, Chong BS, McCabe P, Shah PK, Priya E, Jayaraman J, et al.
    Int Endod J, 2020 Jul;53(7):922-947.
    PMID: 32221975 DOI: 10.1111/iej.13300
    Case reports play a key role in showcasing new, unusual or rare disease(s), and the impact of newer therapeutic approaches or interventions. The Preferred Reporting Items for Case reports in Endodontics (PRICE) 2020 guidelines are being introduced exclusively for Endodontics by adapting and integrating the CAse REport (CARE) guidelines and Clinical and Laboratory Images in Publications principles. The PRICE 2020 guidelines have been developed to help authors improve the completeness, accuracy and transparency of case reports in Endodontics and thus enhance the standard of manuscripts submitted for publication. The aim of this document is to provide a comprehensive explanation for each item in the PRICE 2020 checklist along with examples from the literature that demonstrate compliance with these guidelines. This information will highlight the importance of each item and provide practical examples to help authors understand the necessity of providing comprehensive information when preparing case reports. A link to this PRICE 2020 explanation and elaboration document is available on the Preferred Reporting Items for study Designs in Endodontology website at http://www.pride-endodonticguidelines.org.
  8. Nagendrababu V, Murray PE, Ordinola-Zapata R, Peters OA, Rôças IN, Siqueira JF, et al.
    Int Endod J, 2021 Sep;54(9):1482-1490.
    PMID: 33938010 DOI: 10.1111/iej.13542
    Reproducible, skilfully conducted and unbiased laboratory studies provide new knowledge, which can inform clinical research and eventually translate into better patient care. To help researchers improve the quality and reproducibility of their research prior to a publication peer-review, this paper describes the process that was followed during the development of the Preferred Reporting Items for Laboratory studies in Endodontology (PRILE) 2021 guidelines and which used a well-documented consensus-based methodology. A steering committee was created with eight individuals (PM, RO, OP, IR, JS, EP, JJ and SP), plus the project leaders (PD, VN). The steering committee prepared an initial checklist by combining and adapting items from the modified Consolidated Statement of Reporting Trials checklist for reporting in vitro studies of dental materials and the Clinical and Laboratory Images in Publications principles as well as adding several new items. The steering committee then formed a PRILE Delphi Group (PDG) and PRILE Online Meeting Group (POMG) to provide expert advice and feedback on the initial draft checklist and flowchart. The members of the PDG participated in an online Delphi process to achieve consensus on the items within the PRILE 2021 checklist and the accompanying flowchart for clarity and suitability. The PRILE checklist and flowchart developed by the online Delphi process were discussed further by the POMG. This online meeting was conducted on 12 February 2021 via the Zoom platform. Following this meeting, the steering committee developed a final version of the PRILE 2021 guidelines and flowchart, which was piloted by several authors when writing up a laboratory study for publication. Authors are encouraged to use the PRILE 2021 guidelines and flowchart to improve the clarity, completeness and quality of reports describing laboratory studies in Endodontology. The PRILE 2021 checklist and flowchart are freely available and downloadable from the Preferred Reporting Items for study Designs in Endodontology website (http://pride-endodonticguidelines.org/prile/).
  9. Nagendrababu V, Murray PE, Ordinola-Zapata R, Peters OA, Rôças IN, Siqueira JF, et al.
    Int Endod J, 2021 Sep;54(9):1491-1515.
    PMID: 33982298 DOI: 10.1111/iej.13565
    Guidance to authors is needed to prevent their waste of talent, time and resources in writing manuscripts that will never be published in the highest-quality journals. Laboratory studies are probably the most common type of endodontic research projects because they make up the majority of manuscripts submitted for publication. Unfortunately, most of these manuscripts fail the peer-review process, primarily due to critical flaws in the reporting of the methods and results. Here, in order to guide authors, the Preferred Reporting Items for study Designs in Endodontology (PRIDE) team developed new reporting guidelines for laboratory-based studies: the Preferred Reporting Items for Laboratory studies in Endodontology (PRILE) 2021 guidelines. The PRILE 2021 guidelines were developed exclusively for the area of Endodontology by integrating and adapting the modified CONSORT checklist of items for reporting in vitro studies of dental materials and the Clinical and Laboratory Images in Publications (CLIP) principles. The process of developing the PRILE 2021 guidelines followed the recommendations of the Guidance for Developers of Health Research Reporting Guidelines. The aim of the current document is to provide authors with an explanation for each of the items in the PRILE 2021 checklist and flowchart with examples from the literature, and to provide advice from peer-reviewers and editors about how to solve each problem in manuscripts prior to their peer-review. The Preferred Reporting Items for study Designs in Endodontology (PRIDE) website (http://pride-endodonticguidelines.org/prile/) provides a link to the PRILE 2021 explanation and elaboration document as well as to the checklist and flowchart.
  10. Nagendrababu V, Duncan HF, Bjørndal L, Kvist T, Priya E, Jayaraman J, et al.
    Int Endod J, 2020 Jun;53(6):764-773.
    PMID: 32196696 DOI: 10.1111/iej.13294
    In evidence-based health care, randomized clinical trials provide the most accurate and reliable information on the effectiveness of an intervention. This project aimed to develop reporting guidelines, exclusively for randomized clinical trials in the dental specialty of Endodontology, using a well-documented, validated consensus-based methodology. The guidelines have been named Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020. A total of eight individuals (PD, VN, HD, LB, TK, JJ, EP and SP), including the project leaders (PD and VN) formed a steering committee. The committee developed a checklist based on the items in the Consolidated Standards of Reporting Trials (CONSORT) guidelines and Clinical and Laboratory Images in Publications (CLIP) principles. A PRIRATE Delphi Group (PDG) and PRIRATE Face-to-Face Meeting group (PFMG) were also formed. Thirty PDG members participated in the online Delphi process and achieved consensus on the checklist items and flowchart that make up the PRIRATE guidelines. The guidelines were discussed at a meeting of the PFMG at the 19th European Society of Endodontology (ESE) Biennial congress, held on 13 September 2019 in Vienna, Austria. A total of 21 individuals from across the globe and four steering committee members (PD, VN, HD and LB) attended the meeting. As a consequence of the discussions, the guidelines were modified and then piloted by several authors whilst writing a manuscript. The PRIRATE 2020 guidelines contain a checklist consisting of 11 sections and 58 individual items as well as a flowchart, considered essential for authors to include when writing manuscripts for randomized clinical trials in Endodontics.
  11. Nagendrababu V, Duncan HF, Bjørndal L, Kvist T, Priya E, Jayaraman J, et al.
    Int Endod J, 2020 Jun;53(6):774-803.
    PMID: 32266988 DOI: 10.1111/iej.13304
    Well-designed and properly conducted randomized clinical trials provide a true estimate of the effects of interventions and are acknowledged as the gold standard in terms of clinical study design. However, the quality of randomized clinical trials published in the field of Endodontics is suboptimal. The Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020 guidelines were developed exclusively for Endodontics by integrating and adapting the CONsolidated Standards of Reporting Trials (CONSORT) statement and Clinical and Laboratory Images in Publications (CLIP) principles, through an accepted and well-documented consensus process. Full implementation of the PRIRATE 2020 guidelines will minimize potential sources of bias and thus enhance the standard of manuscripts submitted for publication, which will ultimately improve the reporting of randomized clinical trials in Endodontics. The aim of this document is to provide an explanation for each item in the PRIRATE 2020 checklist and flowchart with examples from the literature in order to help authors understand their rationale and significance. A link to this PRIRATE 2020 explanation and elaboration document is available on the Preferred Reporting Items for study Designs in Endodontology (PRIDE) website at http://www.pride-endodonticguidelines.org/prirate/.
  12. Nagendrababu V, Duncan HF, Tsesis I, Sathorn C, Pulikkotil SJ, Dharmarajan L, et al.
    Int Endod J, 2019 Mar 19.
    PMID: 30891775 DOI: 10.1111/iej.13118
    An abstract is a brief overview of a scientific, clinical or review manuscript as well as a stand-alone summary of a conference abstract. Scientists, clinician-scientists and clinicians rely on the summary information provided in the abstracts of systematic reviews to assist in subsequent clinical decision-making. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) for Abstracts checklist was developed to improve the quality, accuracy and completeness of abstracts associated with systematic reviews and meta-analyses. The PRISMA for Abstracts checklist provides a framework for authors to follow, which helps them provide in the abstract the key information from the systematic review that is required by stakeholders. The PRISMA for Abstracts checklist contains 12 items (title, objectives, eligibility criteria, information sources, risk of bias, included studies, synthesis of results, description of the effect, strength and limitations, interpretation, funding and systematic review registration) under six sections (title, background, methods, results, discussion, other). The current article highlights the relevance and importance of the items in the PRISMA for Abstracts checklist to the specialty of Endodontology, while offering explanations and specific examples to assist authors when writing abstracts for systematic reviews when reported in manuscripts or submitted to conferences. Strict adherence to the PRISMA for Abstracts checklist by authors, reviewers, and journal editors will result in the consistent publication of high-quality abstracts within Endodontology. This article is protected by copyright. All rights reserved.
  13. Nagendrababu V, Duncan HF, Fouad AF, Kirkevang LL, Parashos P, Pigg M, et al.
    Int Endod J, 2023 Feb 27.
    PMID: 36851874 DOI: 10.1111/iej.13909
    Observational studies play a critical role in evaluating the prevalence and incidence of conditions or diseases in populations as well as in defining the benefits and potential hazards of health-related interventions. There are currently no reporting guidelines for observational studies in the field of Endodontics. The Preferred Reporting Items for study Designs in Endodontology (PRIDE) team has developed and published new reporting guidelines for observational-based studies called the 'Preferred Reporting items for OBservational studies in Endodontics (PROBE) 2023' guidelines. The PROBE 2023 guidelines were developed exclusively for the speciality of Endodontics by integrating and adapting the 'STrengthening the Reporting of OBservational studies in Epidemiology (STROBE)' checklist and the 'Clinical and Laboratory Images in Publications (CLIP)' principles. The recommendations of the Guidance for Developers of Health Research Reporting Guidelines were adhered to throughout the process of developing the guidelines. The purpose of this document is to serve as a guide for authors by providing an explanation for each of the items in the PROBE 2023 checklist along with relevant examples from the literature. The document also offers advice to authors on how they can address each item in their manuscript before submission to a journal. The PROBE 2023 checklist is freely accessible and downloadable from the PRIDE website (http://pride-endodonticguidelines.org/probe/).
  14. Decurcio DA, Lim E, Chaves GS, Nagendrababu V, Estrela C, Rossi-Fedele G
    Int Endod J, 2019 Aug;52(8):1153-1161.
    PMID: 30883828 DOI: 10.1111/iej.13116
    AIM: To compare the educational outcomes using artificial teeth versus extracted teeth for pre-clinical endodontic training.

    DATA SOURCES: Literature searches of PubMed, Scopus, Cochrane Library, Trip Database, Web of Science and Open Grey databases were conducted from their inception until November 2018 with no language restriction. Hand searching of most likely relevant journals was performed. The review followed the PRISMA guidelines.

    STUDY ELIGIBILITY CRITERIA, PARTICIPANTS AND INTERVENTIONS: Studies that compared pre-clinical endodontic training using extracted teeth and artificial teeth were included.

    STUDY APPRAISAL AND SYNTHESIS METHODS: The quality of included studies was appraised by Joanna Briggs Institute Critical Appraisal tools. The findings were tabulated and summarized according to their outcomes with distinct narrative syntheses.

    RESULTS: Five studies were included. The component studies included 359 operators in total, mainly consisting of undergraduate students (97%, n = 349) and 10 endodontists (3%). Forty-seven per cent (n = 170) operated on artificial teeth only, whilst 19% (n = 67) worked primarily on extracted teeth, with the final treatment outcome being evaluated by independent observers using objective criteria. Operators in two studies (34%, n = 122) used both artificial teeth and ET and compared their experiences in surveys. Regarding technical outcomes, no significant differences between training with artificial teeth and extracted teeth were found, but the performance tended to be better in artificial teeth than extracted teeth. Operators trained solely on artificial teeth appeared to be adequately educated for subsequent root canal treatment (RCT) in the clinical setting.

    LIMITATIONS: Due to the scarcity of research on the topic overall, and the methodological variation between the studies, it was not possible to perform a quantitative analysis (meta-analysis).

    CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: Based on the available evidence, the use of artificial teeth for pre-clinical endodontic training achieved similar educational outcomes compared to extracted teeth. However, the experiences reported by the operators diverged. Further studies assessing other artificial teeth available in the market testing other RCT procedures are necessary.

  15. Nagendrababu V, Kishen A, Murray PE, Nekoofar MH, de Figueiredo JAP, Priya E, et al.
    Int Endod J, 2019 Sep;52(9):1290-1296.
    PMID: 30985938 DOI: 10.1111/iej.13125
    The regulated use of animals in endodontic research is often necessary to investigate the biological mechanisms of endodontic diseases and to measure the preclinical efficacy, biocompatibility, toxicology and safety of new treatments, biomaterials, sealers, drugs, disinfectants, irrigants, devices and instruments. Animal testing is most crucial in situations when research on humans is not ethical, practical or has unknown health risks. Currently, there is a wide variability in the quality of manuscripts that report the results of animal studies. Towards the goal of improving the quality of publications, guidelines for preventing disability, pain, and suffering to animals, and enhanced reporting requirements for animal research have been developed. These guidelines are referred to as Animals in Research: Reporting In Vivo Experiments (ARRIVE). Henceforth, causing any form of animal suffering for research purposes is not acceptable and cannot be justified under any circumstances. The present report describes a protocol for the development of welfare and reporting guidelines for animal studies conducted in the specialty of Endodontology: the Preferred Reporting Items for Animal Studies in Endodontology (PRIASE) guidelines. The PRIASE guidelines will be developed by adapting and modifying the ARRIVE guidelines and the Clinical and Laboratory Images in Publication (CLIP) principles. The development of the new PRIASE guidelines will include a five-step consensus process. An initial draft of the PRIASE guidelines will be developed by a steering committee. Each item in the draft guidelines will then be evaluated by members of a PRIASE Delphi Group (PDG) for its clarity using a dichotomous scale (yes or no) and suitability for its inclusion using a 9-point Likert scale. The online surveys will continue until each item achieves this standard, and a set of items are agreed for further analysis by a PRIASE Face-to-face Consensus Meeting Group (PFCMG). Following the consensus meeting, the steering committee will finalize and confirm the PRIASE guidelines taking into account the responses and comments of the PFCMG. The PRIASE guidelines will be published and disseminated internationally and updated periodically based on feedback from stakeholders.
  16. Nagendrababu V, Duncan HF, Bjørndal L, Kvist T, Priya E, Pulikkotil SJ, et al.
    Int Endod J, 2019 Jul;52(7):974-978.
    PMID: 30702139 DOI: 10.1111/iej.13087
    Randomized clinical trials are acknowledged as the most appropriate methodology for demonstrating the efficacy or effectiveness of one intervention as opposed to another and thus play a major role in clinical decision-making. However, it is recognized that despite the existence of various guidelines, for example, the Consolidated Standards for Reporting Trials (CONSORT) statement, the quality of manuscripts describing randomized trials is often suboptimal. The current project aims to develop and disseminate new guidelines, Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE), to improve the planning and reporting quality of randomized trials in the field of Endodontics. The project leads (VN, PD) designed a robust process to develop the PRIRATE guidelines. At first, a steering committee of eight members, including the project leads, was formed. Thereafter, a five-stage consensus process will be followed: initial steps, pre-meeting activities, face-to-face consensus meeting, post-meeting activities and post-publication activities. The steering committee will develop the first draft of the PRIRATE guidelines by identifying relevant and important items from various sources including the CONSORT guidelines and the Clinical and Laboratory Images in Publications (CLIP) principles. This will be followed by the establishment of a PRIRATE Delphi Group (PDG) consisting of 30 members. The individual items of the first draft of the PRIRATE guidelines developed by the steering committee will be evaluated and scored on a 9-point Likert scale by the PDG members. Items with a score of seven and above by more than 70% of PDG members will be included in the second draft of the guidelines, and the Delphi process will be repeated until each item fulfils the set conditions. After obtaining consensus from the PDG, the PRIRATE guidelines will be discussed by 20 selected individuals within a PRIRATE Face-to-face Consensus Meeting Group (PFCMG) to arrive at a final consensus. The final PRIRATE guidelines will be accompanied with an explanation and elaboration document developed by the steering committee and approved by six members, three from the PDG and three from the PFCMG. The PRIRATE guidelines will be published in journals and actively disseminated to educational institutions, national and international academic societies and presented at scientific meetings. The steering committee will periodically revise and update the PRIRATE guidelines based on feedback from stakeholders.
  17. Nagendrababu V, Duncan HF, Fouad AF, Kirkevang LL, Parashos P, Pigg M, et al.
    Int Endod J, 2020 Sep;53(9):1199-1203.
    PMID: 32365401 DOI: 10.1111/iej.13318
    Observational studies have a significant role in establishing the prevalence and incidence of diseases in populations, as well as determining the benefits and risks associated with health-related interventions. Observational studies principally encompass cohort, case-control, case series and cross-sectional designs. Inadequate reporting of observational studies is likely to have a negative impact on decision-making in day-to-day clinical practice; however, no reporting guidelines have been published for observational studies in Endodontics. The aim of this project is to develop reporting guidelines for authors when creating manuscripts describing observational studies in the field of Endodontology in an attempt to improve the quality of publications. The new guidelines for observational studies will be named: 'Preferred Reporting items for OBservational studies in Endodontics (PROBE)'. A steering committee was formed by the project leaders (PD, VN) to develop the guidelines through a five-phase consensus process. The steering committee will review and adapt items from the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement and the Clinical and Laboratory Images in Publications (CLIP) principles, as well as identify new items that add value to Endodontics. The steering committee will create a PROBE Delphi Group (PDG), consisting of 30 members across the globe to review and refine the draft checklist items and flowchart. The items will be assessed by the PDG on a nine-point Likert scale for relevance and inclusion. The agreed items will then be discussed by a PROBE Face-to-Face meeting group (PFMG) made up of 20 individuals to further refine the guidelines. After receiving feedback from the PFMG, the steering committee will pilot and finalize the guidelines. The approved PROBE guidelines will be disseminated through publication in relevant journals, and be presented at national and international conferences. The PROBE checklist and flowchart will be available and downloadable from the Preferred Reporting Items for study Designs in Endodontics (PRIDE) website: www.pride-endodonticguidelines.org. The PROBE steering committee encourages clinicians, researchers, editors and peer reviewers to provide feedback on the PROBE guidelines to inform the steering group when the guidelines are updated.
  18. Ahmed HMA, Versiani MA, De-Deus G, Dummer PMH
    Int Endod J, 2018 Oct;51(10):1182-1183.
    PMID: 30191599 DOI: 10.1111/iej.12928
  19. Nagendrababu V, Duncan HF, Dummer PMH
    Int Endod J, 2020 Apr;53(4):437-439.
    PMID: 32170984 DOI: 10.1111/iej.13272
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