AIM: The aim of this multicentre, parallel-group randomized clinical trial was to compare the effectiveness of mineral trioxide aggregate (MTA) and a conventional calcium hydroxide liner (CH) as direct pulp capping materials in adult molars with carious pulpal exposure. METHODOLOGY:Seventy adults aged 18-55 years were randomly allocated to two parallel arms: MTA (White ProRoot, Dentsply, Tulsa Dental, Tulsa, OK, USA; n = 33) and CH (Dycal® , Dentsply DeTrey GmbH, Konstanz, Germany; n = 37). The teeth were temporized for 1 week with glass-ionomer (Fuji IX, GC Corp, Tokyo, Japan) and then permanently restored with a composite resin. The subjects were followed up after 1 week and at six, 12, 24 and 36 months. The primary outcome was the survival of the capped pulps, and the secondary outcome was postoperative pain after 1 week. Survival was defined as a nonsymptomatic tooth that responded to sensibility testing and did not exhibit periapical changes on radiograph. At each check-up, the pulp was tested for sensibility and a periapical radiograph was taken (excluding the radiographs taken at the 1-week follow-up). Kaplan-Meier survival analysis and log-rank test were used to assess the significant difference in the survival curves between groups. Chi-square test was used to assess the association between the materials and preoperative and postoperative pain. RESULTS: At 36 months, the Kaplan-Meier survival analysis showed a cumulative estimate rate of 85% for the MTA group and 52% for the CH group (P = 0.006). There was no significant association between the capping material and postoperative pain. CONCLUSIONS: Mineral trioxide aggregate performed more effectively than a conventional CH liner as a direct pulp capping material in molars with carious pulpal exposure in adult patients. This study has been registered at ClinicalTrials.gov, number NCT01224925.
RCT Entities:
AIM: The aim of this multicentre, parallel-group randomized clinical trial was to compare the effectiveness of mineral trioxide aggregate (MTA) and a conventional calcium hydroxide liner (CH) as direct pulp capping materials in adult molars with carious pulpal exposure. METHODOLOGY: Seventy adults aged 18-55 years were randomly allocated to two parallel arms: MTA (White ProRoot, Dentsply, Tulsa Dental, Tulsa, OK, USA; n = 33) and CH (Dycal® , Dentsply DeTrey GmbH, Konstanz, Germany; n = 37). The teeth were temporized for 1 week with glass-ionomer (Fuji IX, GC Corp, Tokyo, Japan) and then permanently restored with a composite resin. The subjects were followed up after 1 week and at six, 12, 24 and 36 months. The primary outcome was the survival of the capped pulps, and the secondary outcome was postoperative pain after 1 week. Survival was defined as a nonsymptomatic tooth that responded to sensibility testing and did not exhibit periapical changes on radiograph. At each check-up, the pulp was tested for sensibility and a periapical radiograph was taken (excluding the radiographs taken at the 1-week follow-up). Kaplan-Meier survival analysis and log-rank test were used to assess the significant difference in the survival curves between groups. Chi-square test was used to assess the association between the materials and preoperative and postoperative pain. RESULTS: At 36 months, the Kaplan-Meier survival analysis showed a cumulative estimate rate of 85% for the MTA group and 52% for the CH group (P = 0.006). There was no significant association between the capping material and postoperative pain. CONCLUSIONS:Mineral trioxide aggregate performed more effectively than a conventional CH liner as a direct pulp capping material in molars with carious pulpal exposure in adult patients. This study has been registered at ClinicalTrials.gov, number NCT01224925.