A Non-inferiority Randomized Control Trial Comparing Two Calcium Silicate-based Cements as Pulp Capping Material for Partial Pulpotomy in Permanent Teeth with Cariously Exposed Pulp in Adult Patients
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Abstract
ProRoot® MTA is a conventional calcium silicate-based cement which has been widely used as a pulp capping material owing to its distinctly high biocompatibility and clinical success. However, it poses some known disadvantages such as high cost and tooth discoloration potential. Biodentine™ is a new calcium silicate–based cement which has revised the disadvantages of ProRoot® MTA. Currently, there is limited clinical evidence of partial pulpotomy using Biodentine™. The purpose of the present study is to investigate the outcomes of partial pulpotomy using Biodentine™ as a pulp capping material compared to that of ProRoot® MTA in adults with carious exposure. A non-inferiority randomized trial design with a prestated margin of 10% difference was implemented. Fifty-eight (58) teeth with carious pulp exposures were randomly assigned to either the ProRoot® MTA or the Biodentine™ group. Partial pulpotomy was performed. Patients were asked to report the post-operative symptoms at 24 hours, 7 days and 3 months. Patients were recalled at the first mean follow-up time of 6.23±0.79 months and the secondary mean follow-up time of 12.45±1.17 months there were 2 out of 58 participants loss to follow-up. The overall success rate was 96.4% with 92.6% for ProRoot® MTA and 100% for Biodentine™ (difference, -7.4%; 95% CI, -7.3% to 2.47%, P=0.14). At 24 hours after treatment, most patients experienced mild pain or sensitivity. Most patients get better in 7 days and all became symptom-free within 3 months. Perceptible gray discoloration was observed in only ProRoot® MTA group with significant difference (p=0.02) to Biodentine™ group. These favorable outcomes suggested that partial pulpotomy in adults’ teeth using Biodentine™ was non-inferior to ProRoot® MTA at the mean 12.45±1.17 - month period. Biodentine™ may be used as an alternative to ProRoot® MTA.
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