Effectiveness of Full Pulpotomy Compared with Root Canal Treatment in Managing Teeth with Signs and SymptOms Indicative of Irreversible Pulpitis: A Protocol for ProspectiVE Meta-analysis of Individual Participant Data of Randomised Clinical Trials (PROVE).

Abstract

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 interest in vital pulp treatment. These individualized trials will be conducted using a specified protocol, defined outcomes, and outcomes 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) absence of pain indicative of IRP; 2) absence of signs and symptoms indicative of acute or chronic apical periodontitis; and 3) absence of radiographic evidence of failure including radiolucency or resorption. Individual participants, 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 trials protocol were developed and approved by investigators in all 10 sites. All sites use shared resources including study protocols, data collection forms, and participant information leaflets and consent forms in order to improve flow, consistency and reproducibility. Each site obtained their 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 generalizability and external validity compared with traditional trials and retrospective meta-analysis. This is particularly relevant to dental research, where the burden of dental disease is high, and funding of large prospective studies is limited. Protocol Registration: PROSPERO number CRD42023446809