One-year radiographic and clinical performance of bioactive materials in primary molar pulpotomy: A randomized controlled trial

Abstract

Objectives: Mineral Trioxide Aggregate (MTA) is considered the gold standard material for pulpotomy procedures. However, some drawbacks such as poor handling and long setting time are challenging when it is used as pulpotomy dressing in primary molars in children. Hence, the purpose of this study was to compare the radiographic and clinical performance of a premixed, fast setting bioceramic root repair material (BC RRM-F) with MTA in vital pulpotomy procedures of primary molars, with or without the added seal of a stainless steel crown (SSC).

Methods: In this double blinded, four-arm, parallel group randomized contolled trial (RCT), 64 primary molars were randomly allocated to one of the four treatment groups: MTA (PDTM MTA WHITE)+SSC, MTA+GI (bulk fill glass ionomer with glass hybrid technology GC EQUIA Forte® HT), BC RRM-F+GI and BC RRM-F+SCC. All molars were evaluated clinically and radiographically according to the modified Zurn and Seale criteria at 1, 3, 6, and 12 months follow up. Multivariate cox regression models and Kaplan-Meier curves were used for survival analysis.

Results: There was no statistically significant difference between the success of both pulp capping materials used. Overall survival analysis showed that using GI instead of SCC as a final restorative material was significantly associated with increased risk of failure.

Conclusions: TotalFill® BC RRM™ Fast Set Putty can be used as an alternative to MTA in primary molar pulpotomy. Regardless of the pulp capping material, one year survival of pulpotomized primary molars restored with SSC is higher compared to those restored with GC EQUIA Forte® HT.

Clinical significance: Clinicians' preference and cost effectiveness may justify the use of either material in primary molar pulpotomy. Parents insisting on tooth-colored restorations for their children's pulpotomized teeth cannot be told that the expectation for success is the same as those restored with SSC, even if calcium silicate-based pulp capping materials are used.

Trial registration: ClinicalTrials.gov NCT04795830.

Keywords: Bioceramic root repair material; Biomimetic; Glass hybrid bulk fill; MTA; Vital pulp treatment.