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Abstract Background Full pulpotomy has been proposed as an alternative to root canal treatment in teeth with signs and symptoms indicative of irreversible pulpitis (IRP), but the evidence is limited, relying on underpowered studies with a high risk of bias. The aim of this study is to conduct a prospective meta-analysis (PMA) of individual participant data of a series of individual randomised trials to provide robust evidence on the clinical and cost-effectiveness of pulpotomy compared with root canal treatment. Methods Individual participant data will be obtained from a series of randomised trials designed and conducted by a consortium of multi-national investigators with an interest in vital pulp treatment. These individualised trials will be conducted using a specified protocol, defined outcomes, and outcome measures. Ten parallel-group randomised trials currently being conducted in 10 countries will provide data from more than 500 participants. The primary outcome is a composite measure defined as (1) the absence of pain indicative of IRP, (2) the absence of signs and symptoms indicative of acute or chronic apical periodontitis, and (3) the absence of radiographic evidence of failure including radiolucency or resorption. Individual participant data will be obtained, assessed, and checked for quality by two independent reviewers prior to the PMA. Pooled estimates on treatment effects will be generated using a 2-stage meta-analysis approach. The first stage involves a standard regression analysis in each trial to produce aggregate data on treatment effect estimates followed by an inverse variance weighted meta-analysis to combine these aggregate data and produce summary statistics and forest plots. Cost-effectiveness analysis based on the composite outcome will be undertaken as a process evaluation to evaluate treatment fidelity and acceptability by patients and dentists. Results The research question and trial protocol were developed and approved by investigators in all 10 sites. All sites use shared resources including study protocols, data collection forms, participant information leaflets, and consent forms in order to improve flow, consistency, and reproducibility. Each site obtained its own Institutional Review Board approval, and trials were registered in appropriate open access platforms. Patient recruitment has started in most sites, as of July 2023. Discussion PMA offers a rigorous, flexible, and efficient methodology to answer this important research question and provide results with improved generalisability and external validity compared with traditional trials and retrospective meta-analyses. The results of this study will have implications for both the delivery of clinical practice and structured clinical guidelines’ development. Trial registration PROSPERO CRD42023446809. Registered on 08 February 2023.

Abstract Background The outcome of endodontic treatment is generally assessed using a range of patient and clinician-centred, non-standardised clinical and radiographic outcome measures. This makes it difficult to synthesise evidence for systematic analysis of the literature and the development of clinical guidelines. Core outcome sets (COS) represent a standardised list of outcomes that should be measured and reported in all clinical studies in a particular field. Recently, clinical researchers and guideline developers have focussed on the need for the integration of a patient-reported COS with clinician-centred measures. This study aims to develop a COS that includes both patient-reported outcomes and clinician-centred measures for various endodontic treatment modalities to be used in clinical research and practice. Methods To identify reported outcomes (including when and how they are measured), systematic reviews and their included clinical studies, which focus on the outcome of endodontic treatment and were published between 1990 and 2020 will be screened. The COSs will be defined by a consensus process involving key stakeholders using semi-structured interviews and an online Delphi methodology followed by an interactive virtual consensus meeting. A heterogeneous group of key ‘stakeholders’ including patients, general dental practitioners, endodontists, endodontic teachers, clinical researchers, students and policy-makers will be invited to participate. Patients will establish, via interactive interviews, which outcomes they value and feel should be included in a COS. In the Delphi process, other stakeholders will be asked to prioritise outcomes identified from the literature and patient interviews and will have the opportunity at the end of the first round to add outcomes that are not included, but which they consider relevant. Feedback will be provided in the second round, when participants will be asked to prioritise the list again. If consensus is reached, the remaining outcomes will be discussed at an online meeting and agreement established via defined consensus rules of outcome inclusion. If consensus is not reached after the second round, a third round will be conducted with feedback, followed by the online meeting. Following the identification of a COS, we will proceed to identify how and when these outcomes are measured. Discussion Using a rigorous methodology, the proposed consensus process aims to develop a COS for endodontic treatment that will be relevant to stakeholders. The results of the study will be shared with participants and COS users. To increase COS uptake, it will also be actively shared with clinical guideline developers, research funders and the editors of general dental and endodontology journals. Trial registration COMET 1879. 21 May 2021.

Background: Development of a standardized set of topic-specific outcomes known as a Core Outcome Set (COS) is important to address issues of heterogeneity in reporting research findings in order to streamline evidence synthesis and clinical decision making., Aim: The aim of the current international consensus study is to identify "what" outcomes to include in the Core Outcome Set for Endodontic Treatments (COSET). Outcomes of various endodontic treatments (non-surgical root canal treatment, surgical endodontics, vital pulp treatment and revitalization procedures) performed on permanent teeth were considered., Methods: A standard validated methodology for COS development and reporting was adopted. The process involved identification of existing outcomes through four published scoping reviews. This enabled creation of a list of outcomes to be prioritized via semi-structured patient interviews, e-Delphi process and a consensus meeting with a range of relevant global stakeholders. Outcomes were prioritized using a 1-9 Likert scale, with outcomes rated 7-9 considered critical, 4-6 are important and 1-3 are less important. Outcomes rated 7-9 by ≥70% and 1-3 by <15% of participants were considered to achieve consensus for inclusion in the COS. The outcomes that did not achieve consensus in the first round were considered for further prioritization in the second Delphi round and consensus meeting. Final decisions about the outcomes to include in COSET were made by voting during the consensus panel meeting using the Zoom Poll function., Results: A total of 95 participants including patients contributed to the COS development process. The consensus panel recommended, with strong consensus, eight outcomes shared across all treatment modalities for inclusion in COSET: pain; signs of infection (swelling, sinus tract); further intervention/exacerbation; tenderness to percussion/palpation; radiographic evidence of disease progression/healing; function; tooth survival; and patient satisfaction. Additional treatment specific outcomes were also recommended., Discussion: Many of the outcomes included in COSET are patient reported. All should be included in future outcomes studies., Conclusion: COSET identified outcomes that are important for patients and clinicians and validated these using a rigorous methodology. Further work is ongoing to determine "how" and "when" these outcomes should be measured., (© 2023 The Authors. International Endodontic Journal published by John Wiley & Sons Ltd on behalf of British Endodontic Society.)

Background: Inflammatory biomarkers are potentially useful targets for pulpal diagnostic tests that can identify pulp status and predict vital pulp treatment (VPT) outcome, however, their accuracy is unknown., Objectives: (1) Calculate sensitivity, specificity and diagnostic odds ratio (DOR) of previously investigated pulpitic biomarkers; (2) Determine if biomarker levels discriminate between clinical diagnoses of pulpitis based on the presence or absence of spontaneous pain (3) Evaluate if biomarker level can predict VPT outcome., Methods: Searches: PubMed/MEDLINE, Ovid SP, Cochrane Central Register of Controlled Trials (CENTRAL), International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov, Embase, Web of Science and Scopus in May 2023., Inclusion: prospective and retrospective observational studies and randomized trials. Participants were humans with vital permanent teeth and a well-defined pulpal diagnosis., Exclusion: deciduous teeth, in vitro and animal studies. Risk of bias was assessed with modified-Downs and Black quality assessment checklist. Meta-analysis was performed using bivariate random effect model in Meta-DiSc 2.0 and RevMan and the quality of the evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation., Results: Fifty-six studies were selected, reporting >70 individual biomolecules investigating pulpal health and disease at the gene and protein level. Most studies were of low and fair quality. Among the biomolecules investigated, IL-8 and IL-6 demonstrated a level of diagnostic accuracy with high sensitivity, specificity and DOR to discriminate between healthy pulps and those exhibiting spontaneous pain suggestive of IRP (low-certainty evidence). However, none was shown to have high DOR and the ability to discriminate between pulpitic states (very low certainty evidence). Limited data suggests high levels of matrix metalloproteinase 9 correlate with poorer outcomes of full pulpotomy., Discussion: The inability of identified molecular inflammatory markers to discriminate between dental pulps with spontaneous and non-spontaneous pain should shift the focus to improved study quality or the pursuit of other molecules potentially associated with healing and repair., Conclusions: Low-quality evidence suggests IL-8 and IL-6 demonstrated level of diagnostic accuracy to discriminate between healthy pulps and those exhibiting spontaneous pain. There is a need for standardized biomarker diagnostic and prognostic studies focusing on solutions that can accurately determine the degree of pulp inflammation., Registration: PROSPERO CRD42021259305., (© 2023 The Authors. International Endodontic Journal published by John Wiley & Sons Ltd on behalf of British Endodontic Society.)

Background: Revitalization is a type of regenerative endodontic treatment (RET) that offers the exciting prospect of revitalizing damaged tissue, therefore improving outcomes for non-vital immature teeth. To evaluate its potential, there needs to be consistency in outcome reporting of clinical studies investigating revitalization to allow for evidence synthesis and inform clinical decision making., Objectives: The aim of this scoping review was to identify outcomes that are reported in systematic reviews on revitalization including how and when these outcomes are measured. Additionally, evidence of selective reporting bias in the reviews was assessed., Methods: A comprehensive electronic search of healthcare databases and grey literature was conducted to identify systematic reviews published in the English language reporting outcomes of revitalization in permanent immature teeth. There was no restriction on the date of publication. Outcome data was extracted by four reviewers independently and mapped with a healthcare taxonomy into five core areas: survival, clinical/physiological changes, life impact, resource use and adverse events. Selective reporting bias and how it was measured was assessed independently by two reviewers., Results: Twenty-six systematic reviews were included in this scoping review. There was lack of standardization in reporting and significant heterogeneity across reviews in outcome endpoints. The outcomes reported could be aligned within the five core areas of the taxonomy including tooth survival which was reported in nine reviews. Patient-reported outcomes were generally limited and no review reported on Oral Health Related Quality of Life. Many of the reviews reporting on randomized control trials were at low risk of selective reporting bias whilst other study designs were at higher risk., Discussion: Consistency in outcome reporting is necessary to realize the benefits of old but particularly novel therapies. Data from this review confirmed heterogeneity in reporting outcomes of revitalization and the need for development of a core outcome set (COS)., Conclusions: Several important outcomes including survival, root development, tooth discolouration and periapical healing have been identified in this review which could inform the development of a COS in this area., Registration: Core Outcome Measures in Effectiveness Trials (COMET) database (registration no. 1879)., (© 2022 The Authors. International Endodontic Journal published by John Wiley & Sons Ltd on behalf of British Endodontic Society.)

Background: A large number of research reports on vital pulp treatment (VPT) has been published over the last two decades. However, heterogeneity in reporting outcomes of VPT is a significant challenge for evidence synthesis and clinical decision-making., Objectives: To identify outcomes assessed in VPT studies and to evaluate how and when outcomes are measured. A subsidiary aim was to assess evidence for selective reporting bias in the included studies. The results of this review will be used to inform the development of a core outcome set (COS) for endodontic treatments., Methods: Multiple healthcare bibliographic databases, including PubMed/MEDLINE, Ovid EMBASE, Scopus, Cochrane Database of Systematic Reviews and Web of Science were searched for systematic reviews published between 1990 and 2020, reporting on VPT. Screening, data extraction and risk of bias assessment were completed independently by two reviewers. Outcomes' information was extracted and aligned with a healthcare taxonomy into five core areas: survival, clinical/physiological changes, life impact, resource use and adverse events., Results: Thirty-six systematic reviews were included, 10 reporting on indirect pulp capping or selective caries removal, nine on direct pulp capping, eight on pulpotomy and nine on combined VPTs. There was considerable variation in the outcomes reported in these reviews and their included studies. Clinician-reported outcomes were used considerably more often than patient-reported outcomes. A range of instruments and time points were used for measuring outcomes. Several of the reviews were assessed as having low risk of selective reporting bias, but many did not specifically report this domain, whilst others did not provide risk of bias assessment at all., Discussion: Considerable variation in selection of outcomes and how and when they are measured and reported was evident, and this heterogeneity has implications for evidence synthesis and clinical decision-making., Conclusions: Whilst there is a lack of consistency, several potentially important outcomes for VPT, including pulp survival, incidence of post-operative pain and need for further intervention, have been identified which could inform the development of a COS for endodontic treatment., Registration: Core Outcome Measures in Effectiveness Trials (COMET) (No. 1879)., (© 2022 The Authors. International Endodontic Journal published by John Wiley & Sons Ltd on behalf of British Endodontic Society.)

Objectives: Management of carious teeth with signs and symptoms indicative of irreversible pulpitis is traditionally invasive, but emerging evidence suggests successful treatment outcomes with less invasive vital pulp treatment such as coronal pulpotomy. The objective of this systematic review is to determine whether coronal pulpotomy is clinically effective in treating carious teeth with signs and symptoms indicative of irreversible pulpitis., Sources: MEDLINE; PubMed; Embase, Web of Science, Cochrane Central Register of Controlled Trials, International Clinical Trials Registry Platform and ClinicalTrials.gov were searched until December 2018., Study Selection: Prospective, retrospective and randomised clinical trials investigating coronal pulpotomy or comparing pulpotomy to root canal treatment in permanent mature carious teeth with signs and symptoms indicative of irreversible pulpitis were included. Studies were independently assessed for risk of bias using Cochrane Systematic Reviews of intervention criteria and modified Downs and Black quality assessment checklist., Data: Eight articles were selected for analysis. The average success rate for coronal pulpotomy was 97.4% clinical and 95.4% radiographic at 12 month follow-up. This was reduced to 93.97% clinical and 88.39% radiographic success at 36 months follow-up. Results from the only comparative clinical trial showed pulpotomy to have comparable success to root canal treatment at 12, 24 and 60 month follow-up., Conclusions: The evidence suggests high success for pulpotomy for teeth with signs and symptoms of irreversible pulpitis, however, results are based on heterogeneous studies with high risk of bias. Well-designed, adequately powered randomised controlled trials are required for evidence to change clinical practice., Clinical Significance: Management of carious teeth with irreversible pulpitis is traditionally invasive, but emerging evidence suggests potentially successful treatment outcomes with less invasive therapies such as coronal pulpotomy., (Crown Copyright © 2019. Published by Elsevier Ltd. All rights reserved.)