Purpose: The purpose of this protocol for a systematic review of randomized controlled trials of primary tooth vital pulp therapy is to describe the reasoning and need for the review, the objectives of the review, and the methodology that will be used to analyse data from the included studies. Publication of a systematic review protocol also helps establish and maintain transparency of the process and accountability for the stated methods and outcomes sought.
Methods: This protocol adheres to PRISMA-P standards for protocol reporting. A variety of relevant databases and resources will be searched. Trials selection, data extraction, and risk of bias assessment will be performed by two independent investigators. Primary outcome measures include clinical and radiographic success. Evidence tables will be generated for included study characteristics. The Cochrane risk of bias assessment tool will be applied to the selected studies. For meta-analysis, results will be pooled to provide estimates of appropriate effect size and heterogeneity of trials. The quality of evidence for outcomes will be determined using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.
Results: The proposed systematic review will provide findings useful for pediatric and general dentists, researchers, guideline developers, policymakers, and public and private insurers and can be the basis for an evidence-based guideline on pulp treatment of vital primary teeth with deep caries approximating the pulp.