Efficacy of three different pulpotomy agents in primary molars: a randomized control trial.

ABSTRACT

AIM: To compare the clinical and radiographic efficacy of Biodentine™ , ProRoot® White Mineral Trioxide Aggregate (WMTA) and Tempophore™ as pulpotomy medicaments in the treatment of carious primary molars. METHODOLOGY: A parallel-design, randomized controlled trial was developed. Patients above 3 years of age with carious primary teeth with vital pulps without spontaneous pain or history of swelling were included. Fifty-eight patients (82 teeth) with a mean age of 4.79 ± 1.23 years were included. The teeth were randomized, blinded and allocated to one of the three groups (Biodentine™ , ProRoot® WMTA or Tempophore™ ) for pulpotomy treatment. All teeth were followed up clinically and radiographically (after 6, 12 and 18 months) by two blinded calibrated investigators. A generalized estimating equation (GEE), Wald chi-square test and an intention-to-treat analysis (ITT) with 'last carried forward' approach were performed using Statistical Package for Social Sciences v 21.0 (IBM Corp., Armonk, NK, USA). RESULTS: Forty-six patients and 69 teeth were available for follow-up after 18 months. Clinical success (radiographic success in parenthesis) was 95.24% (94.4%), 100% (90.9%) and 95.65% (82.4%) in the Biodentine™ , ProRoot® WMTA and Tempophore™ groups, respectively, but the difference was not significant. Pulp canal obliteration was significantly different amongst the experimental groups as the Biodentine™ group exhibited significantly more pulp canal obliteration when compared to the ProRoot® WMTA group at 6 months (P = 0.008) and 18 months (P = 0.003). CONCLUSIONS: After 18-month follow-up, there was no significant difference between Biodentine™ in comparison with ProRoot® WMTA or Tempophore™ .