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PLAQUE REDUCTION WITH CONCURRENT REDUCTION/PREVENTION OF GINGIVITIS

This article was originally published in The Rose Sheet

Executive Summary

PLAQUE REDUCTION WITH CONCURRENT REDUCTION/PREVENTION OF GINGIVITIS are the most appropriate endpoints for demonstrating effectiveness of OTC plaque products, according to a draft "points to consider" document prepared by members of FDA's OTC Plaque Subcommittee and discussed at a Dec. 7 meeting. Under a subheading on clinical trials contained in a section on evaluating effectiveness, the document states that "the effectiveness of an OTC antiplaque or antiplaque-related ingredient can best be demonstrated by the evidence of clinically significant endpoints, specifically, a reduction of dental plaque associated with a concurrent reduction and/or prevention of gingivitis."
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