A randomized controlled clinical trial of premixed calcium silicate-based cements for pulpotomy in primary molars

Abstract

Objectives: This study aimed to verify the non-inferiority of Endocem MTA Premixed and Well-Root PT, compared with ProRoot MTA in the pulpotomy of primary molars. In addition, we tried to determine the factors that affect the prognosis of pulpotomy in primary molars.

Methods: This randomized clinical trial enrolled 158 molars of 52 children; 153 teeth were finally included and divided into three groups: ProRoot MTA (n = 50), Endocem MTA Premixed (n = 53), and Well-Root PT (n = 50). Clinical and radiographic follow-up was performed at 3, 6, and 12 months postoperatively and at the last visit post-treatment. Data were analyzed using the Fisher's exact test, Cox regression analysis, and the Kaplan-Meier survival curve method.

Results: The success rates in the ProRoot MTA, Endocem MTA Premixed, and Well-Root PT were 92, 84.9 and 82%, respectively. The cumulative survival rates did not differ significantly among the materials. Among the investigated variables, only ΔF and ΔF max significantly affected the success rates. In the multivariate survival tree model, significant unfavorable survival was observed when the ΔF value was -14.4 or less (hazard ratio, 7.56; P = 0.0295).

Conclusions: Considering the clinical effectiveness of Endocem MTA Premixed and Well-Root PT and the operational convenience as a premixed type, they can be used as advantageous materials in the pulpotomy of primary molars in pediatric patients. The QLF method is a useful diagnostic method that can establish treatment plans and determine the prognosis of pulpotomy based on the ΔF value in primary molars.

Clinical significance: Endocem MTA Premixed and Well-Root PT can confer high success rates and are non-inferior to ProRoot MTA in pulpotomy for primary molars. We also showed that QLF technology can be applied to predict the success/failure and prognosis of pulpotomies in primary molars.