1457 Positive and Negative-Controlled Trial of 0.1% CPC Rinse on Breath

Saturday, March 24, 2012: 9:45 a.m. - 11 a.m.
Presentation Type: Poster Session
J. WITT, R. CHENG, A. WALANSKI, and R. GERLACH, Health Care Research Center, Procter & Gamble Company, Mason, OH
Objective: This research compared the breath effects of a 0.1% cetylpyridinium chloride rinse to positive and negative rinse controls. 

Method: A 3-treatment, 3-period crossover study was conducted to evaluate the safety and effectiveness of a 0.1% cetylpyridinium chloride (CPC) rinse containing 1.5% hydrogen peroxide in adults with established breath malodor.  After informed consent, enrolled subjects were provided regular oral hygiene acclimation products plus usage instructions.  After 1-week acclimation, overnight breath odor was assessed and subjects were randomly assigned to treatment periods using one of 3 rinses used for 30 s BID (20 ml) over a 4-day period, followed by 1-week acclimation washouts.  The test products were CP which was an alcohol-free CPC rinse containing 1.5% hydrogen peroxide (Crest® Pro-Health Clinical), EO which was an essential oils rinse with 21.6% alcohol (Listerine® Cool Mint), and WA which was tap water.  Overnight breath odor was assessed on Days 0 and 4 using a 6-point organoleptic scale (no odor-to-very strong odor) by 4 trained examiners who were blinded to treatment assignment and graded independently. 

Result: A total 39 subjects age 18-84 were enrolled, and 36 completed the study and were evaluable.   Relative to baseline, both the CP and EO rinse showed significant (p<0.001) reductions in breath odor.  At Day 4, changes in odor scores (mean + SE) vs. baseline were –1.47 + 0.16 for CP, –0.70 + 0.16 for EO, and –0.45 + 0.16 for WA.  The CP group differed significantly (p<0.001) from both EO & WA, while the EO group did not differ (p>0.09) from WA.  All treatments were well-tolerated. 

Conclusion: Use of a 0.1% CPC rinse with 1.5% hydrogen peroxide resulted in significant overnight improvement in bad breath, with odor scores declining from a moderate-strong rating (organoleptic score of 3.56) at baseline to faint (2.09) after 4-days use.   

Keywords: Antimicrobial agents/inhibitors, Clinical trials, Halitosis and Oral hygiene
Presenting author's disclosure statement: employee of Procter & Gamble