Plaque Subcmte. puts greater weight on gingivitis reduction/prevention as efficacy endpoint.
This article was originally published in The Rose Sheet
Executive Summary
GINGIVITIS REDUCTION/PREVENTION CONSIDERED "SIGNIFICANT ENDPOINT" in demonstrating the effectiveness of an OTC antiplaque ingredient by FDA'S OTC Plaque Subcommittee. Commenting on appropriate endpoints for efficacy studies at an April 12 meeting, subcommittee member Max Listgarten, DDS, University of Pennsylvania, suggested that "the significant endpoint here is truly gingivitis" rather than plaque reduction.