Randomised controlled trial of elmex gelée in high caries-risk adolescents

Objectives: To assess the caries preventive efficacy of two years of twice weekly, supervised use of a high fluoride gel (12,000 ppm fluoride as amine fluoride), elmex gelée on schooldays compared to weekly, similarly supervised use in children at high caries risk. The secondary objective was to assess the caries preventive efficacy of two years of twice weekly, supervised use on schooldays of elmex gelée in children at high caries risk compared to a group of similar children who continued with their usual oral hygiene care. Methods: The trial was conducted in Merseyside as a single centre study across 32 sites (secondary schools). The trial was randomised with parallel groups comprising two test groups (once and twice a week application) and one control group. The control group was an untreated control with no placebo. The dental examiner was blind to the group allocation and intra and inter reliability checks were conducted on the examinations. Results: 1380 pupils aged between 12-13 years at recruitment took part in the study. 1075 pupils were followed up after 2 years. The results show that children who brushed their teeth with elmex gelée at least 60 times over a 2-year period under supervision at school developed significantly fewer carious lesions into dentine (29%; p=0.027 D3FT clinical + FOTI) than did children who followed their usual oral hygiene routine. No reduction in relation to lesions confined to enamel was found over the same time. Conclusions: Since a significant benefit was shown following a minimum brushing of 60 times with the gelée, it is recommended that the gelée is used by brushing twice a week within a school based programme over a 2 year period. This study was funded by GABA International AG.