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  1. Tomson PL, Vilela Bastos J, Jacimovic J, Jakovljevic A, Pulikkotil SJ, Nagendrababu V
    Int Endod J, 2023 Oct;56 Suppl 3:355-369.
    PMID: 36209498 DOI: 10.1111/iej.13844
    BACKGROUND: Pulpitis characterized by spontaneous pain can result in debilitating pain. Dogma has existed to offer only have two treatment options, namely root canal treatment (RCT) or extraction, although pulpotomy has always remained a potential treatment modality.

    OBJECTIVE: This review aimed to answer the following research question: 'Does pulpotomy (partial or full) (I) result in better patient and clinical reported outcomes (O), compared with RCT (C) in permanent teeth with pulpitis characterized by spontaneous pain (P) evaluated at various time intervals?' (T).

    METHODS: Two authors independently performed study selection, data extraction and risk of bias assessment. The literature search was conducted in the following electronic databases: Clarivate Analytics' Web of Science, Scopus, PubMed and Cochrane Central Register of Controlled Trials. English language clinical trials comparing the patient and clinical reported outcomes between RCT and pulpotomy were included. The meta-analysis was performed on a fixed-effect model and the quality of evidence assessed by the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach.

    RESULTS: Two randomized clinical trials were included. Amongst two trials, one has published four reports at different time points involving the same cohorts. The meta-analysis revealed no difference in postoperative pain (Day 7) between RCT and pulpotomy (OR = 0.99, 95% CI 0.63-1.55, I2  = 0%) and quality of evidence was graded as 'High'. Clinical success was high at year 1, 98% for both interventions, however, decreased over time to 78.1% (pulpotomy) and 75.3% (RCT) at 5 years.

    DISCUSSION: Pulpotomy is a definitive treatment modality that is as effective as RCT. This could have a significant impact on treatment of such patients affording the advantages of retaining a vital pulp and preventing the need for RCT.

    CONCLUSION: This review could only include two trials, hence there is insufficient evidence to draw robust conclusions. The clinical data accumulated so far suggests no difference in pain between RCT and pulpotomy at Day 7 postoperatively and a single randomized control trial suggests that the clinical success rate for both treatment modalities is similar long term. There is a need for more well-designed trials by different research groups to develop a stronger evidence base in this area.

    REGISTRATION: PROSPERO database (CRD42021259744).

  2. 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).

  3. Suresh N, Nagendrababu V, Koteeswaran V, Haritha JS, Swetha SD, Varghese A, et al.
    Int Endod J, 2021 Feb;54(2):198-209.
    PMID: 32976660 DOI: 10.1111/iej.13416
    AIM: This randomized, double-blinded, clinical trial evaluated the effect of oral premedication of piroxicam, prednisolone, dexamethasone or placebo on postoperative pain after single-visit root canal treatment in teeth with symptomatic irreversible pulpitis and symptomatic apical periodontitis.

    METHODOLOGY: The trial is reported according to the Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020 guidelines. The protocol was registered at the clinical trial registry (India) (CTRI/2019/06/019818). In total, 160 patients, assigned to four groups, received orally either 20 mg piroxicam, 20 mg prednisolone, 4 mg dexamethasone or a placebo 60 min before root canal treatment. Patients recorded their postoperative pain intensity at 6, 12, 24, 48 and 72 h using a 10-cm visual analogue scale. Intergroup comparison was performed using Kruskal-Wallis tests with post hoc analysis using Dunns test. Incidence of pain was analysed using chi-square tests. A P value  0.05). One patient in the piroxicam group reported gastritis, whereas no adverse effects were recorded in other groups.

    CONCLUSION: Preoperative oral administration of a single dose of 4 mg dexamethasone, 20 mg piroxicam or 20 mg prednisolone reduced the incidence and severity of postoperative pain following single-visit root canal treatment compared to a placebo in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis up to 24 h. The odds of postoperative pain at 24 h for patients premedicated with 4 mg dexamethasone or 20 mg piroxicam or 20 mg prednisolone were 5.3 times, 3.4 times and 2.5 times less compared to the placebo, respectively.

  4. Soo WK, Thong YL, Gutmann JL
    Int Endod J, 2015 Aug;48(8):736-46.
    PMID: 25130364 DOI: 10.1111/iej.12371
    To compare four gutta-percha filling techniques in simulated C-shaped canals based on filling quality at three cross-sectional levels, filling time and the apical extrusion of gutta-percha.
  5. Shah PK, Duncan HF, Abdullah D, Tomson PL, Murray G, Friend TM, et al.
    Int Endod J, 2020 Nov;53(11):1569-1580.
    PMID: 32748456 DOI: 10.1111/iej.13377
    AIM: To compare the educational benefits and user friendliness of two anonymized endodontic case difficulty assessment (CDA) methods.

    METHODOLOGY: A cohort (n = 206) of fourth-year undergraduate dental students were recruited from four different Dental Schools and divided randomly into two groups (Group A and B). The participants assessed six test endodontic cases using anonymized versions of the American Association of Endodontists (AAE) case difficulty assessment form (AAE Endodontic Case Difficulty Assessment Form and Guidelines, 2006) and EndoApp, a web-based CDA tool. Group A (n = 107) used the AAE form for assessment of the first three cases, followed by EndoApp for the latter. Group B (n = 99) used EndoApp for the initial three cases and switched to the AAE form for the remainder. Data were collected online and analysed to assess participants' knowledge reinforcement and agreement with the recommendation generated. Statistical analysis was performed using the two-way mixed model anova, Cohen's Kappa (κ) and independent t-tests, with the levels of significance set at P 

  6. Saber SEDM, Ahmed MHM, Obeid M, Ahmed HMA
    Int Endod J, 2019 Mar;52(3):267-278.
    PMID: 30225932 DOI: 10.1111/iej.13016
    AIM: To investigate the number of roots and root canal configurations using two coding systems and the root canal diverging and merging levels in extracted maxillary premolars in an Egyptian subpopulation using cone beam computed tomography (CBCT).

    METHODOLOGY: A total of 700 maxillary premolars were examined using CBCT in an Egyptian subpopulation. The number of roots was identified, and root canal configurations were classified according to Vertucci's classification and a new system for classifying root and canal morphology. In addition, the position where roots bifurcated and the levels where canals merged or diverged were identified. Fisher's exact test and independent t-test were used for statistical analysis, and the level of significance was set at 0.05 (P = 0.05).

    RESULTS: More than half of maxillary first premolars were double-rooted, and the majority of maxillary second premolars were single-rooted (P 

  7. Pulikkotil SJ, Nagendrababu V, Veettil SK, Jinatongthai P, Setzer FC
    Int Endod J, 2018 Sep;51(9):989-1004.
    PMID: 29480930 DOI: 10.1111/iej.12912
    This systematic review (SR; PROSPERO database: CRD42017075160) and network meta-analysis (NMA) identified the most effective oral premedication for anaesthetic success of inferior alveolar nerve blocks (IANB) in cases of irreversible pulpitis. Medline and Ebscohost databases were searched up until 10/2017. Randomized controlled trials (RCT) studying the effect of oral premedication, alone or in combination, on the success of IANB for cases of irreversible pulpitis, compared to placebo or other oral premedications, were included. Quality of the included studies was appraised by the revised Cochrane risk of bias tool for randomized trials. Pairwise analysis, NMA and quality of evidence assessment using GRADE criteria were performed. Nineteen studies (n = 1654 participants) were included. NMA demonstrated that compared to placebo, dexamethasone was most effective in increasing anaesthetic success (RR, 2.92 [95% CI 1.74,4.91]; SUCRA = 0.96), followed by NSAIDs (RR, 1.92 [95% CI 1.63,2.27], SUCRA = 0.738) and Tramadol (RR, 2.03 [95% CI 1.18,3.49], SUCRA = 0.737). Premedication with acetaminophen added to NSAIDs demonstrated similar efficacy as NSAIDs alone (RR, 1.06 [95% CI 0.79,1.43]). Sensitivity analyses proved the superiority of dexamethasone or NSAIDs over any other premedications. Subgroup analyses of specific dosages in comparison with placebo demonstrated that dexamethasone 0.5 mg was most effective, followed by ketorolac 10 mg, piroxicam 20 mg, ibuprofen 400 mg + acetaminophen 500 mg and Tramadol 50 mg. Ibuprofen 400 mg, 600 mg and 800 mg had a significantly improved IANB success, while Ibuprofen 300 mg had no effect. Oral premedication with dexamethasone, NSAIDs or Tramadol significantly increased anaesthetic success. More trials are needed to evaluate the premedication effects of dexamethasone or Tramadol for improved anaesthetic success of IANB when treating irreversible pulpitis.
  8. Plotino G, Abella Sans F, Duggal MS, Grande NM, Krastl G, Nagendrababu V, et al.
    Int Endod J, 2020 Dec;53(12):1636-1652.
    PMID: 32869292 DOI: 10.1111/iej.13396
    Surgical extrusion is defined as the procedure in which the remaining tooth structure is repositioned at a more coronal/supragingival position in the same socket in which the tooth was located originally. Intentional replantation is defined as the deliberate extraction of a tooth and after evaluation of root surfaces, endodontic manipulation and repair, placement of the tooth back into its original position. Tooth autotransplantation is defined as the transplantation of an unerupted or erupted tooth in the same individual, from one site to another extraction site or a new surgically prepared socket. The advent of titanium implant rehabilitation has reduced the use of these treatments in day-by-day clinical practice; however, the re-emerging trend to conserve and preserve natural sound tissues has led to a rediscovery of these treatments. All three distinct surgical methods are closely related, as they act to treat teeth that cannot be predictably treated using other more conventional procedures in endodontics, periodontics and restorative dentistry. Furthermore, these procedures share the same treatment approach and include the atraumatic extraction of a tooth, visual inspection of the tooth/root and its subsequent replantation. The clinical procedures for surgical extrusion, intentional replantation and tooth autotransplantation treatment have undergone several changes in recent years, and currently, there are no clear clinical treatment protocols/guidelines available. The clinician should be aware of the outcome of these treatments. Hence, the aim of this narrative review is to provide the background, clinical procedures and outcomes of surgical extrusion, intentional replantation and tooth autotransplantation.
  9. Ordinola-Zapata R, Peters OA, Nagendrababu V, Azevedo B, Dummer PMH, Neelakantan P
    Int Endod J, 2020 Jan;53(1):36-52.
    PMID: 31454086 DOI: 10.1111/iej.13210
    AIM: To report the most common terminology used in titles of scientific papers published in the International Endodontic Journal (IEJ) and Journal of Endodontics (JOE) between 1980 and 2019 and to identify the most-cited papers in these journals.

    METHODOLOGY: The Web of Science database was searched to retrieve all the manuscripts published in the IEJ and JOE between 1980 and 2019. The articles were analysed using the VOS viewer software and the terms within the titles extracted. The top-10 terms were categorized according to the number of occurrences and the decade of publication. Maps were created using the text data for each decade of publication. Classic papers were identified when the number of citations was >400. During the same period of time, highly cited studies were identified including the authors, institutions and countries associated with these papers.

    RESULTS: Terms such as canal, molar and periapical lesion were the most commonly used in titles between 1980 and 1999. The terms instruments, expression, case report and cell were the most often terms used between 2000 and 2019. During the last 10 years, an increase in the number of reviews and papers on cone beam computed tomography occurred. The organizations with the largest number of citations in each decade were University of São Paulo, University College London, Loma Linda University and United States Army. The country with the largest number of citations and greatest number of top 10 and top 100 manuscripts was the United States. A paper had to be associated with more than 167 citations to be included in the top-100 most-cited list; at least 14 papers met the criteria to be categorized as a citation classic (>400 citations).

    CONCLUSION: While many diverse areas of endodontics have been explored in the last 40 years within the IEJ and JOE, only a relatively few topics are highly cited and can be considered as classics.

  10. Ngeow WC, Thong YL
    Int Endod J, 1998 Sep;31(5):367-71.
    PMID: 9823142
    Dental pulp is prone to dystrophic mineralization; this mineralization can be so extensive that the entire root canal system is obliterated. As a result, root canal treatment can become a difficult if not impossible task. This article presents the endodontic management of a tooth with an obliterated pulp chamber and associated with a discharging sinus in a teenage patient. The role of a calcium hydroxide lining to induce mineralization and cause the obliteration of the pulpal space is also discussed.
  11. Neelakantan P, Ahmed HMA, Wong MCM, Matinlinna JP, Cheung GSP
    Int Endod J, 2018 Aug;51(8):847-861.
    PMID: 29377170 DOI: 10.1111/iej.12898
    The aim of this systematic review was to address the question: Do different irrigating protocols have an impact on the dislocation resistance of mineral trioxide aggregate (MTA)-based materials? The review was performed using a well-defined search strategy in three databases (PubMed, Scopus, Web of Science) to include laboratory studies performed between January 1995 and May 2017, in accordance with PRISMA guidelines. Two reviewers analysed the papers, assessed the risk of bias and extracted data on teeth used, sample size, size of root canal preparation, type of MTA-based material, irrigants, canal filling method, storage method and duration, region of roots and the parameters of push-out testing (slice thickness, plunger dimensions and plunger loading direction), the main results and dislocation resistance values (in MPa). From 255 studies, 27 were included for full-text analysis. Eight papers that met the inclusion criteria were included in this review. There was a wide variation in dislocation resistance due to differences in irrigation sequence, time and concentration of irrigants, storage method and duration, and the parameters of push-out bond strength testing. A meta-analysis was not done but qualitative synthesis of the included studies was performed. No definitive conclusion could be drawn to evaluate the effect of irrigation protocols on dislocation resistance of MTA-based materials. Recommendations have been provided for standardized testing methods and reporting of future studies, so as to obtain clinically relevant information and to understand the effects of irrigating protocols on root canal sealers and their interactions with the dentine walls of root canals.
  12. Nagendrababu V, Dilokthornsakul P, Jinatongthai P, Veettil SK, Pulikkotil SJ, Duncan HF, et al.
    Int Endod J, 2020 Feb;53(2):232-249.
    PMID: 31520403 DOI: 10.1111/iej.13217
    A systematic review aims to answer a focussed research question through a structured review of the evidence, using a predefined methodology, which often includes a meta-analysis. A meta-analysis is a statistical method used to combine the effect estimates from the individual studies included in a systematic review. Systematic reviews and meta-analyses are positioned at the highest level in the hierarchy of clinical evidence. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was introduced in 2009 to help authors improve the quality and reliability of systematic reviews and meta-analyses. Recently, the volume of systematic reviews and meta-analyses in the field of Endodontology has increased; however, the quality of the published manuscripts has been reported to be sub-optimal, which does not take account of the systematic reviews that were rejected because of more obvious deficiencies. The aim of this paper is to present a comprehensive glossary of terminology commonly used in systematic reviews and meta-analyses in an attempt to provide easily understood definitions and explanations to assist authors when reporting systematic reviews and meta-analyses and to allow those wishing to read them to become better informed.
  13. Nagendrababu V, Duncan HF, Whitworth J, Nekoofar MH, Pulikkotil SJ, Veettil SK, et al.
    Int Endod J, 2020 Feb;53(2):200-213.
    PMID: 31491042 DOI: 10.1111/iej.13215
    BACKGROUND: Pain management can be challenging during root canal treatment of teeth with irreversible pulpitis.

    AIM: To identify whether articaine or lidocaine is the most appropriate local anaesthetic solution for teeth with irreversible pulpitis undergoing root canal treatment.

    DATA SOURCE: The protocol of this umbrella review is registered in the PROSPERO database (CRD42019137624). PubMed, EBSCHO host and Scopus databases were searched until June 2019.

    STUDY ELIGIBILITY CRITERIA, PARTICIPANTS AND INTERVENTIONS: Systematic reviews published in English comparing the effectiveness of local anaesthesia following administration of articaine or lidocaine in patients undergoing root canal treatment of teeth diagnosed with irreversible pulpitis were included. Two independent reviewers selected the studies and carried out the data extraction and the appraisal of the included reviews. Disagreements were resolved in consultation with a third reviewer.

    STUDY APPRAISAL AND SYNTHESIS METHODS: The quality of the included reviews was appraised by two independent reviewers using the AMSTAR tool (a measurement tool to assess systematic reviews). Each of the 11 AMSTAR items was given a score of 1 if the specific criterion was met, or 0 if the criterion was not met or the information was unclear.

    RESULTS: Five systematic reviews with meta-analyses were included. The AMSTAR score for the reviews ranged from 8 to 11, out of a maximum score of 11, and all reviews were categorized as 'high' quality. Two reviews scored 0 for item 8 in AMSTAR because the scientific quality of the clinical trials included in these reviews was not used in the formulation of the conclusions.

    LIMITATIONS: Systematic reviews published only in the English language were included. Only a small number of studies were available to assess pain intensity during the injection phase, the time until the onset of anaesthesia and the occurrence of adverse events.

    CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: Articaine is more effective than lidocaine for local anaesthesia of teeth with irreversible pulpitis undergoing root canal treatment. There is limited evidence that injection of articaine is less painful, has more rapid onset and has fewer adverse events compared with lidocaine.

  14. Nagendrababu V, Chong BS, McCabe P, Shah PK, Priya E, Jayaraman J, et al.
    Int Endod J, 2019 Jun;52(6):775-778.
    PMID: 30586165 DOI: 10.1111/iej.13067
    Case reports are used to communicate interesting, new or rare condition/s, innovative treatment approaches or novel techniques. Apart from informing readers, such information has the potential to contribute towards further scientific studies and the development of newer management modalities. In that context, it is important that case reports are presented accurately and deliver all the necessary and pertinent information to the reader. Reporting guidelines are used to inform authors of the quality standards required to ensure their manuscripts are accurate, complete and transparent. The aim of this project is to develop and disseminate new guidelines - Preferred Reporting Items for Case reports in Endodontics (PRICE). The primary aim is to aid authors when constructing case reports in the field of Endodontics to ensure the highest possible reporting standards are adopted. The project leaders (PD and VN) formed a steering committee comprising six additional members. Subsequently, a five-phase consensus process will be used. The steering committee will develop the PRICE guidelines (PRICE checklist and flow chart) by identifying relevant items (quality standards) derived from the CAse REport guidelines and Clinical and Laboratory Images in Publications principles, focussing on the content of case reports. Following this, the steering committee will identify a PRICE Delphi Group (PDG) consisting of 30 members including academicians, practitioners, and members of the public. The individual items (components) of the PRICE checklist will be evaluated by the PDG based on a 9-point Likert scale. Only items scored between 7 and 9 by 70% or more members will be included in the draft checklist. The Delphi process will be continued until a consensus is reached and a final set of items agreed by the PDG members. Following this, a PRICE Face-to-Face meeting group (PFMG) will be formed with 20 members to achieve a final consensus. The final consensus-based checklist and flow chart will be evaluated and approved by selected members of the PDG and PFMG. The approved PRICE guidelines will be published in relevant journals and disseminated via contacts in academic institutions and national endodontic societies, as well as being presented at scientific/clinical meetings.
  15. Nagendrababu V, Murray PE, Kishen A, Nekoofar MH, de Figueiredo JAP, Dummer PMH
    Int Endod J, 2019 Sep;52(9):1253-1254.
    PMID: 31407362 DOI: 10.1111/iej.13137
  16. Nagendrababu V, Murray PE, Ordinola-Zapata R, Peters OA, Rôças IN, Siqueira JF, et al.
    Int Endod J, 2019 Aug;52(8):1089.
    PMID: 31297848 DOI: 10.1111/iej.13122
  17. Nagendrababu V, Pulikkotil SJ, Suresh A, Veettil SK, Bhatia S, Setzer FC
    Int Endod J, 2019 Jun;52(6):779-789.
    PMID: 30638269 DOI: 10.1111/iej.13072
    The management of pain during root canal treatment is important. The aim of this systematic review and network meta-analysis was to identify the anaesthetic solution that would provide the best pulpal anaesthesia for inferior alveolar nerve blocks (IANB) treating mandibular teeth with irreversible pulpitis. Two electronic databases (PubMed and Scopus) were searched to identify studies up to October 2018. Randomized clinical trials comparing at least two anaesthetic solutions (lidocaine (lignocaine), articaine, bupivacaine, prilocaine or mepivacaine) used for IANB for treatment of irreversible pulpitis were included. The revised Cochrane risk of bias tool for randomized trials was used to assess the quality of the included studies. Pairwise meta-analysis, network meta-analysis using a random-effects model, and SUCRA ranking were performed. The network meta-analysis estimated the probability of each treatment performing best. The quality of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations approach. In total, 11 studies (n = 750) were included in the meta-analysis. The network meta-analysis revealed that only mepivacaine significantly increased the success rate of IANB compared to lidocaine (RR, 1.42 [95% CI 1.04-1.95]). However, no significant differences in the success rate of IANB were observed between mepivacaine and other anaesthetic agents (articaine and bupivacaine). Of all anaesthetic agents, mepivacaine (SUCRA = 0.81) ranked first in increasing the success rate of IANB, followed by prilocaine (SUCRA = 0.62), articaine (SUCRA = 0.54), bupivacaine (SUCRA = 0.41) and lidocaine (SUCRA = 0.13). The overall quality of evidence was very low to moderate. In conclusion, based on the evidence from the randomized clinical trials included in this review, mepivacaine with epinephrine demonstrated the highest probability of providing effective pulpal anaesthesia using IANB for teeth with irreversible pulpitis compared to prilocaine, articaine, bupivacaine and lidocaine. Further, high-quality clinical trials are needed to support the conclusion of this review.
  18. 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.
  19. 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.
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