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Evaluation of BreathRx Antibacterial Mouth rinse for the Prevention of Plaque and Gingivitis
Background During the 1990s, FDA convened a Dental Products Panel and a Dental Plaque Subcommittee in order to review various over-the-counter (OTC) dental products and active ingredients for the reduction or prevention of plaque and gingivitis. A thorough review of the data and information submitted by a number of dental companies resulted in a selection of three active ingredients suitable for this purpose. Cetylpyridinium Chloride was one of the selected active ingredients. The Subcommittee recommended Cetylpyridinium Chloride (CPC) as an antiplaque, antigingivitis active ingredient for topical use on the mucous membranes of the mouth and throat. The Subcommittee also concluded that CPC at concentrations of 0.045 to 0.1 percent is safe and effective for use in mouth rinse formulations as an OTC antiplaque, antigingivitis agent. CPC-containing mouth rinses have been used in the United States since 1940 and have also been marketed internationally. The 55-year United States marketing history is significant with respect to its safety. The Subcommittee recommended that OTC antigingivitis, anti plaque drug products demonstrate their effectiveness through the testing described below. This testing is required to demonstrate the effectiveness of Category I antigingivitis, antiplaque active ingredients in traditional dosage forms (dentifrice, gel, paste, or rinse). Minimum Inhibitory Concentration (MIC) was recommended as one of the tests by the Subcommittee for determining the product efficacy. MIC is defined as the lowest concentration of an antimicrobial agent that inhibits growth of a micro-organism. The BreathRx® Anti-Bacterial Mouth Rinse was also evaluated utilizing Minimum Bactericidal Concentration (MBC) although this test was not required. MBC is defined as the lowest concentration of an antimicrobial agent that kills 99.9 % of the test inoculum. The representative organisms for both tests include: Actinomyces viscosus, Fusobacterium nucleatum, Porphyomas gingivalis, Prevotella intermedia, Bacteroides forsythus, Candida species, Streptococcus mutans, and gram negative enteric rods. The organisms selected by the Subcommittee have been shown to cause plaque and gingivitis. E-coli was included with the test organisms because of its extreme resistance to antibacterial agents and its wide presence. Results The above referenced testing was performed by Loma Linda University on BreathRx® Anti-Bacterial Mouth Rinse which contains 0.075% Cetylpyridinium Chloride as the active ingredient. The results and conclusions of the test are as follows: "'t is concluded that, under the conditions of the present study, BreathRx® Anti-Bacterial Mouth Rinse at highly diluted concentrations has significant bacteriostatic and bactericidal effects on S.mutans, A. viscosus, C. albicans. P. gingiva lis, P. intermedia, F. nucleatum, B. forsythus, as determined using the MIC and MBC methods. BreathRx® Anti-Bacterial Mouth Rinse also effectively inhibits the growth of E. coli at 1 :8 dilution and kills E. coli at 1:2 dilution." |
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