Efficacy of a 10% chlorhexidine coating to prevent caries in at-risk community-dwelling adults

Abstract

Objective. The purpose of the study was to determine the efficacy of a 10% chlorhexidine tooth coating in reducing the incidence of cavitated carious lesions in adults. Materials and methods. The trial was a randomized, double-blind, multi-center, placebo controlled study with 983 participants, receiving the application of either the active or the placebo coatings to the entire dentition. Four applications were made in the first month and one at the 7th month. The final examination was performed at 13 months. Results. Coronal caries showed a statistical reduction (p = 0.02). Examination of the results by site showed that the highest risk participants experienced the most significant preventive effect (p = 0.003). When two sites (uninsured and public health) are pooled the treatment p-value is 0.0009, interaction term has a p-value of 0.0001. Conclusion. 10% Chlorhexidine was highly effective in high risk participants with more than two cavities at the initial examination. This trial in conjunction with other published trials of this topical medication indicates that chlorhexidine exerts its action by preventing the transition of D1 lesions to cavitated lesions, not on sound to D1 lesions.

Key Words::

• clinical trial
• antibacterial
• tooth decay

Acknowledgements

We would like to acknowledge Professor A. Papas, Principal Clinical Investigator of PACS, and her team of investigators and recorders for the conduct of the trial. Thanks are also due to Mrs Brenda Turgeon, Vice President Administration of CHX Technologies Inc, for her help in the production of this manuscript. This clinical trial was carried out according to the Helsinki Declaration 1975 revised in 1983. IRB approvals from the various sites are held in the data base, confirmed by the auditor on 2007/1/17, 2007/1/24–25, 2007/1/29–30.

Declaration of interest: Professor Symington and Mr Perry have a financial interest in CHX Technologies Inc. Dr Schiff and Dr Kumar have no conflicts of interest. This study was sponsored by NIDCR, who provided most of the funding, and co-sponsored by CHX Technologies Inc, who provided funding for the microbiology study. The company also provided the study treatments and funding for the cost analysis and were responsible for the initial protocol. This study was conducted under the FDA IND #45466.