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

Aim To compare the clinical and radiographic efficacy of Biodentine, ProRoot (R) 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 3years 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 +/- 1.23years were included. The teeth were randomized, blinded and allocated to one of the three groups (Biodentine, ProRoot (R) WMTA or Tempophore(TM)) for pulpotomy treatment. All teeth were followed up clinically and radiographically (after 6, 12 and 18months) 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 v21.0 (IBM Corp., Armonk, NK, USA). Results Forty-six patients and 69 teeth were available for follow-up after 18months. Clinical success (radiographic success in parenthesis) was 95.24% (94.4%), 100% (90.9%) and 95.65% (82.4%) in the Biodentine, ProRoot (R) 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((R)) WMTA group at 6months (P=0.008) and 18months (P=0.003). Conclusions After 18-month follow-up, there was no significant difference between Biodentine in comparison with ProRoot (R) WMTA or Tempophore(TM).