Outcome of full pulpotomy in mature permanent molars using 3 calcium silicate-based materials: A parallel, double blind, randomized controlled trial.

Abstract

The aim of the study was to compare the outcome of full pulpotomy using 2calcium silicate-based materials compared with mineral trioxide aggregate (MTA) in symptomatic mature permanent teeth with carious pulp exposure. This study was designed as a parallel, double blind, randomized controlled trial where symptomatic mature permanent teeth with carious pulp exposure meeting the inclusion criteria were randomly treated with full pulpotomy using one of 3calcium silicate-based materials (ProRoot MTA, Biodentine and TotalFill). Full pulpotomy was performed, and haemostasis was achieved via a cotton pellet moistened with 2.5% NaOCl. A 3-mm layer of the calcium silicate-based material was randomly placed as the pulpotomy agent through a block randomization process followed by a resin-based composite restoration. Postoperative periapical radiograph was taken. Clinical and radiographic evaluation were completed after 6months and 1year. The patient and evaluator were blinded to the type of materials used. Pain levels were scored preoperatively and 7days after treatment. Effect of potential prognosis factors including gender, age, diagnosis, bleeding time and type of caries were also analysed. One hundred and sixty-four teeth in 146 patients received full pulpotomy and were randomly assigned to either the tested or control material through block randomization technique (50MTA, 50 Biodentine and 64TotalFill). The age ranged from 10 to 70years. The diagnosis was irreversible pulpitis in 112 teeth (72%) and reversible pulpitis in 28 teeth (28%). The majority of patients presented with severe pain, during the first week 96.9% reported complete relief of pain or mild pain. Four cases had immediate failure. At 6months the overall success rate was 92.2%, over 1year 156/164 teeth attended follow-up with 12 failures (2 restorative failures and 10 endodontic failures), the overall success of pulpotomy at 1year was 92.3% (144/156); 91.8% in MTA, 93.3% in Biodentine and 91.9% in TotalFill with no significant difference amongst the groups and no side effects observed. No significant association was evident between outcome and the investigated variables. The 1-year success rate of full pulpotomy did not differ significantly between Biodentine pulpotomy, TotalFill pulpotomy, and MTA pulpotomy. The study was registered with clinical trials; registration number (NCT04345263).