Partial pulpotomy with two bioactive cements in permanent teeth of 6- to 18-year-old patients with signs and symptoms indicative of irreversible pulpitis: a noninferiority randomized controlled trial

Aim: To compare the outcome of partial pulpotomy using two cements, ProRoot MTA (Dentsply, Tulsa Dental Specialties, Tulsa, OK, USA) and Biodentine (Septodont, Saint-Maur-des-Fossés, France), in permanent teeth of 6- to 18-year-old patients with signs and symptoms indicative of irreversible pulpitis. Furthermore, the frequencies of perceptible grey discoloration caused by the cements were compared.

Methodology: Sixty-nine permanent first molars with signs and symptoms indicative of irreversible pulpitis, from 69 patients, were included. All operators performed partial pulpotomy under a standardized protocol. Teeth were allocated, using a website-generated number of simple randomization, to partial pulpotomy with either ProRoot MTA (37 teeth) or Biodentine (32 teeth) and were restored with composite resin or stainless steel crowns. Patients were recalled every 6 months. To be categorized as having success, the evaluated tooth must have had both clinical and radiographic success. In addition, photographs of treated teeth were evaluated for frequency of perceptible grey discoloration. Success rates between the two cements were compared using the Fisher exact test. The frequencies of perceptible grey discoloration were compared using the chi-square test. The percentage difference was estimated by 95% confidence interval, and the level of significant difference was P < 0.05.

Results: At a mean follow-up of 32.2 ± 17.9 months, a total of 67 teeth, 37 with ProRoot MTA and 30 with Biodentine, were available for evaluation. The mean age of participants was 10 ± 2.1 years and, there were no differences in the baseline variables (gender, age, tooth type, periapical status, stage of root development, final restoration and follow-up period) between the groups. The overall success in both groups was 90%, with 92% for ProRoot MTA and 87% for Biodentine (difference, 5%; 95% confidence interval, -9% to 19%, P = 0.487), suggesting that Biodentine was noninferior to ProRoot MTA. Perceptible grey discoloration was observed in both groups, 80% for teeth treated with ProRoot MTA and 27% for teeth treated with Biodentine, with a significant difference between the materials (P < 0.001).

Conclusions: Permanent teeth with signs and symptoms indicative of irreversible pulpitis in 6- to 18-year-old patients were successfully treated with partial pulpotomy using both cements. Biodentine exhibited significantly less frequency of discoloration than did ProRoot MTA.