Clinical equivalence study of Chula Dent sealant versus an imported sealant on first permanent molars assessed at 6 months

Abstract

Objectives : To evaluate the effectiveness of a recently developed local sealant (Chula Dent) by comparing its retention on lower first permanent molars with that of a standard imported sealant material (Concise™) at the period of 6 months and to assess the type(s), location(s) of sealant loss and caries development for both sealants. Design : Double blind randomized controlled trial Setting : Nongkae District Hospital, Saraburi Province Participants : One hundred and twenty children aged 6-9 who satisfy the eligibility criteria Methodology : The study group comprised 120 pairs of contralateral lower first permanent molars. A matched pair experimental design was used in which the Chula Dent (Chulalongkorn University, Bangkok, Thailand) and Concise™ (3M Dental Products, St. Paul, U.S.A.) sealants were randomly allocated to one of the teeth within each pair. The sealed teeth were checked for retention and caries after 6 months. Results : Mean retention rate at 6 months in the experimental group (Chula Dent) was 98.3% with the 95% Cl of 95.9 -100%. Mean retention rate of the conventional group (Concise™) was 97.4% (95% Cl 94.5,100). The mean difference in retention rates between the two groups was 0.9% with the 95% Cl of -3.8 to 5.5%. None of the sealant was completely loss and no carious lesions developed in the sealed teeth during the trial. Conclusion : The experimental local sealant, Chula Dent, was clinically equivalent to the standard imported sealant, Concise™, in terms of retention and caries prevention on first permanent molars at the period of 6 months.