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 & UDelta;F and & UDelta;F max significantly affected the success rates. In the multivariate survival tree model, significant unfavorable survival was observed when the & UDelta;F 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 oper-ational 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 & UDelta;F 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.