Abstract
OBJECTIVES The purpose of this randomized controlled trial was to compare the 24-month success rates of indirect pulp treatment (IPT) and iRoot BP Plus pulpotomy of primary molars with extremely deep caries. MATERIALS AND METHODS Generally healthy children aged 3-7 years requiring general anesthesia for treating primary molars with extremely deep caries or reversible pulpitis were recruited. Patients with systemic disease, mental health problems, or manifestations of irreversible pulpitis were excluded. In total, 175 molars were randomized and blinded for either IPT (n = 87) or iRoot BP Plus pulpotomy (n = 88). All teeth were restored with stainless steel crowns and evaluated after 6, 12, 18, and 24 months by two blinded calibrated investigators. Kaplan-Meier survival curves were used to compare the survival rates between the groups. The correlations between success rate and patient characteristics were explored with the Cox proportional hazards model. RESULTS A total of 168 primary molars in 67 patients (average age: 3.83 years) were evaluated. The cumulative survival probability at 24 months was not significantly different between the IPT (93.8%) and pulpotomy (97.7%) groups (P = 0.238). IPT treatment success was significantly associated with age (odds ratio = 2.347; 95% CI: 1.068-5.156; P = 0.034) and preoperative sensitivity (odds ratio = 9.742; 95% CI: 1.079-87.970; P = 0.043). CONCLUSIONS The 24-month success rates of IPT and iRoot BP Plus pulpotomy performed in primary molars with extremely deep caries were not significantly different. Increasing age and preoperative sensitivity were found to be associated with the cumulative survival probability in IPT-treated primary molars with extremely deep caries. Primary teeth with extremely deep carious lesions without signs of irreversible pulpitis can be treated successfully by either indirect pulp capping or iRoot BP Plus pulpotomy. TRIAL REGISTRATION ChiCTR2000032462.
