Abstract

Purpose The objective of this multicentre randomised controlled trial was to compare the clinical/radiographic outcomes of cervical pulpotomy using calcium-enriched mixture cement (PCEM) and pulpectomy using Metapex (PM) in primary molars with irreversible pulpitis (IP). Methods A total of 134 primary molars from 94 children were randomly assigned to two intervention groups: the PCEM group (n = 74) and the PM group (n = 60). Baseline characteristics including age/gender/molar type/tooth type/jaw were recorded. The primary outcome measures were clinical/radiographic success rates assessed at the first and second follow-up appointments. Secondary outcomes included reasons for clinical/radiographic failures. Multiple logistic regression analysis was performed to determine the impact of various factors on the success rates. Results The mean age of the participants in both groups was similar (PCEM group: 5.4 years, PM group: 5.5 years). Gender distribution, molar type, tooth type, jaw, and number of practitioners were comparable between the groups. The clinical success rate at the first follow-up was 98.6 in the PCEM group and 96.4 in the PM group. At the second follow-up, the clinical success rate was 97.1 in the PCEM group and 91.1 in the PM group. The radiographic success rates at the first and second follow-up were 98.6 and 96.4 in the PCEM group and 96.4 and 91.1 in the PM group, respectively. Multiple logistic regression analysis did not reveal any significant association between the success rates and age/gender/molar type/jaw, or treatment groups (P > 0.05). Conclusion In primary molars with IP, both simple/conservative cervical pulpotomy using calcium-enriched mixture cement and pulpectomy using Metapex demonstrated high clinical/radiographic success rates. No significant differences were observed between the two treatment modalities. These findings suggest that both techniques can be considered effective treatment options for managing primary molars with IP. Trial registration number Trial registration number: IRCT20201226049838N1, retrospectively registered on 12 January 2021.