Athena Papas
Tufts University School of Dental Medicine, USA
Title: RCT of 10% chlorhexidine coating for the prevention of adult caries
Biography
Biography: Athena Papas
Abstract
Objective: The prevention of adult caries study, an NIDCR-funded multicenter, double-blind, randomized clinical trial, enrolled 983
adults (aged 18-80) at high risk for developing caries to test the efficacy of a chlorhexidine diacetate 10% weight per volume (w/v)
dental coating (CHX).
Methods: A computer randomly assigned participants to receive either the CHX coating (n=490) or a placebo control (n=493).
Coatings were applied weekly for four weeks and a fifth time 6 months later. The primary outcome (total net D1-2FS increment) was
the weighted sum of changes in tooth surface status over 13-months. Additionally a small sub set was followed for an additional 6
months for safety.
Results: We observed no significant difference between the two treatment arms in either the intention-to-treat or per-protocol
analyses. Analysis of three protocol-specified secondary outcomes produced similar findings. The safety of 10% (w/v) chlorhexidine
diacetate coating was verified by microbial analysis.
Conclusion: This trial failed to find that 10% (w/v) chlorhexidine diacetate coating was superior to placebo coating for prevention
of new caries.