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^™ .

Keywords: Biodentine; Tempophore; mineral trioxide aggregate; pulp therapy; pulpotomy.