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Background The outcome of vital pulp treatment after carious pulp exposure is multifactorial and related to the procedure, biomaterial and pre-operative pulpal diagnosis. Objectives To conduct a systematic review and meta-analysis determining the outcome of direct pulp capping (DPC) in mature permanent teeth with a cariously exposed pulp and a clinical diagnosis of reversible pulpitis, and ascertain whether the capping material influences the outcome. Methods Sources: MEDLINE Ovid-SP, Cochrane Central Register of Controlled Trials (CENTRAL), International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov, Embase and Web of Science until April 2020. Inclusion: Prospective, retrospective cohort studies and randomized trials investigating DPC outcome or comparing different capping materials after carious pulp exposure. Exclusion: Primary teeth, mechanical, traumatic or not specified pulp exposure, teeth with irreversible pulpitis or no pulpal diagnosis. Risk of bias assessed using Cochrane and modified Downs and Black quality assessment checklist. Meta-analysis on combined clinical/radiographic outcome was performed using a random effect model. Success was defined as absence of signs and symptoms of irreversible pulpitis, apical periodontitis or loss of pulp vitality. Results Quality assessment highlighted four non-randomized studies to be of fair and five of poor quality. Four randomized trials had a high risk of bias. The pooled success rate differed based on material and follow-up. Calcium hydroxide success rate was 74% at 6-months, 65% at 1-year, 59% at 2-3 years and 56% at 4-5 years. Mineral trioxide aggregate (MTA) success was 91%, 86%, 84% and 81% at the same time points. Biodentine success was 96% at 6-months, 86% at 1 year and 86% at 2-3 years. The meta-analysis revealed MTA had better success than calcium hydroxide at 1-year (OR 2.66, 95% CI; 1.46- 4.84, P = 0.001) and 2- to 3-year follow-up (OR 2.21, 95% CI; 1.42-3.44, P = 0.0004). There was no difference between MTA and Biodentine. Discussion These results were based on poor methodological quality studies. The effect size for of MTA vs Ca(OH)2, although modest, was consistent with narrow CI. Conclusions Low-quality evidence suggests a high success rate for direct pulp capping in teeth with cariously exposed pulps with better long-term outcomes for MTA and Biodentine compared with calcium hydroxide.

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.