Clinical Equivalence Study of Prevocare versus Concise^TM Under Field Conditions

Objective: The purpose of this study was to compare the clinical success of sealants between Prevocare, a Thai dental product, with a post-etched drying agent and Concise™ (3M ESPE, U.S.A.) under field conditions. Methods: One hundred and forty-four pairs of contralateral first permanent molars from 126 hill-tribe school students aged 6-12 years old in Chiangrai province were selected. A matched pair experimental design was used in which Prevocare (Opaque) plus post-etched drying agent (Chulalongkorn University, Bangkok, Thailand) and Concise™ (3M ESPE, U.S.A.) were randomly allocated to one of the teeth within each pair under field condition. The treatment was performed by three pediatric dentists. After 6 and 12 months, another dentist evaluated the retention and caries of the sealed molars by using visual and tactile method. Sealant was judged to be success if it was fully retained in all primary grooves and failure if it was partially loss or completely loss. The Data were analyzed by statistical programs SPSS (version 11) and STATA (version 7). A confidence interval approach was used to compare the retention of the two sealants. In this study, Clinical equivalence of the two sealants was accepted when the retention rate difference was within 10%. Results: After 6 months, the retention rates of Prevocare and Concise™ were 91.0% and 89.6%, respectively. After 12 months the retention slightly dropped to 87.4% and 85.8%. The mean difference in retention rates was 1.5% (95%, CI–5.1, 8.1%) at 6 months and 1.6% (95%, CI–6.8, 9.9%) at 12 months. One tooth became carious in the Concise™ group. Conclusion: The retention rate of Prevocare plus post-etched drying agent was equivalent to that of Concise™ under field condition at 12 months follow-up. This study was supported by Graduated Grants 2004, Chulalongkorn University and Faculty of Dentistry Research Fund, Chulalongkorn University.