Treatment outcome of partial pulpotomy using two different calcium silicate materials in mature permanent teeth with symptoms of irreversible pulpitis: A randomized clinical trial

AIM: To assess the clinical and radiographic outcome of partial pulpotomy by comparing MTA Angelus and Total Fill BC, as pulpotomy agents, in mature teeth with deep caries and symptoms indicative of irreversible pulpitis. METHODOLOGY: The study was designed as a parallel-two arm, double-blind, randomized superiority clinical trial registered at www. CLINICALTRIALS: gov (NCT04870398). Symptomatic mature permanent teeth with deep caries fulfilling the inclusion criteria were randomly treated using either MTA Angelus or Total Fill BC. A partial pulpotomy was performed and following complete haemostasis, the capping material was placed over the remaining pulp tissue and a postoperative periapical radiograph was taken. Clinical and radiographic follow-up evaluation was performed for a median time of 2 years, whereas levels of pain intensity were evaluated preoperatively and for 7 days after intervention using Visual Analogue Scale. For the primary outcome (failure/success of treatment), the Kaplan-Meier survival curves for the capping materials were plotted and a log-rank test for equality of survivor functions was applied. A multivariable random effects Cox Regression model was also applied. For the secondary outcome (postoperatively reported pain), a multivariable mixed effects ordinal logistic regression was structured. RESULTS: One hundred and thirty-seven teeth in 123 patients underwent partial pulpotomy using randomly either MTA Angelus (N = 74) or Total Fill BC (n = 63). The percentage failure for MTA Angelus and Total Fill BC was 10.8% (8/74) and 17.5% (11/63), respectively, but the difference was not statistically significant [adjusted HR: 1.83; 95% confidence interval (CI): 0.68, 4.91; p = .23]. Weak evidence was found that secondary caries involvement may impose a 3.54 times greater hazard for treatment failure (adjusted HR: 3.54; 95% CI: 1.00, 12.51; p = .05). For each passing minute of procedural bleeding control, there was also a 57% higher hazard for treatment failure (adjusted HR: 1.57; 95% CI: 0.99, 2.48; p = .05). The odds for higher postoperative pain were 4.73 times greater for the Total Fill BC compared to MTA Angelus (adjusted OR: 4.73; 95% CI: 2.31, 9.66; p < .001). CONCLUSIONS: Both materials exhibited similar and favourable outcome rates after partial pulpotomy in teeth with deep caries and symptoms of irreversible pulpitis. Total Fill BC was associated with a higher level of postoperative pain intensities.