Three-Year Clinical and Economic Evaluation of Selective Caries Removal and Full Pulpotomy for Extensive Caries: An Exploratory Randomised Controlled Trial

Abstract

Aim: The aim of this study was to compare pulp survival following selective caries removal (SCR) and full pulpotomy treatment in teeth with extensive caries over 3 years. Methodology: This two-arm, exploratory randomised controlled trial included vital mature permanent teeth with extensive primary or secondary caries diagnosed radiographically as being at least 75% or more into the thickness of dentine, without clinical signs of symptomatic irreversible pulpitis or radiographic evidence of a periapical lesion. Carious teeth were randomly allocated to receive either SCR or full pulpotomy. All teeth were reviewed clinically and radiographically at 6 months, 1 year, and 3 years post-treatment. Log-rank tests and Cox proportional hazards regressions were used to compare the outcomes of SCR and pulpotomy, adjusting for clustering using a robust variance estimator. Cost-effectiveness analysis was carried out using the healthcare system and societal perspectives. Significance level was set at 5%. Results: At 3 years, 44/58 teeth (75.9%) in the SCR group and 37/55 teeth (67.3%) in the full pulpotomy group were reviewed. A total of 13 teeth in the SCR group (29.5%) and 4 teeth in the pulpotomy group (10.8%) required further intervention with root canal treatment (RCT) or extraction (p = 0.039). Survival rates were 74% for SCR and 89% for pulpotomy (p = 0.041). Overall, 79.0% of teeth treated with either SCR or pulpotomy survived without requiring further intervention over the 3-year period. In this study with more than two-thirds of the enrolled teeth classified as extremely deep lesions, pulpotomy was more cost-effective than SCR in the management of extensive caries above a willingness-to-pay threshold of $917 and $928 to avoid one tooth extraction or RCT from the healthcare system and societal perspective, respectively. Conclusion: Full pulpotomy demonstrated greater effectiveness than SCR in avoiding further intervention over a 3-year period in teeth with extensive caries, of which the majority were extremely deep lesions. Further long-term studies and broader health economic evaluations are warranted to guide clinical decision-making and policy development. Trial Registration: ClinicalTrials.gov identifier: NCT04672070.