This practice-based, randomized clinical trial evaluated and compared the success of direct pulp capping in permanent teeth with MTA (mineral trioxide aggregate) or CaOH (calcium hydroxide). Thirty-five practices in Northwest PRECEDENT were randomized to perform direct pulp caps with either CaOH (16 practices) or MTA (19 practices). Three hundred seventy-six individuals received a direct pulp cap with CaOH (n = 181) or MTA (n = 195). They were followed for up to 2 yrs at regular recall appointments, or as dictated by tooth symptoms. The primary outcomes were the need for extraction or root canal therapy. Teeth were also evaluated for pulp vitality, and radiographs were taken at the dentist's discretion. The probability of failure at 24 mos was 31.5% for CaOH vs. 19.7% for MTA (permutation log-rank test, p = .046). This large randomized clinical trial provided confirmatory evidence for a superior performance with MTA as a direct pulp-capping agent as compared with CaOH when evaluated in a practice-based research network for up to 2 yrs.
Trial registration: ClinicalTrials.gov NCT00812887.
Keywords: clinical research; dental cavity liner; dental pulp; dental pulp exposure; pulp-capping agents; sodium hypochlorite.