1049 Extrinsic Stain Clinical Trial Comparing H2O2 Rinse and Whitening Dentifrice

Friday, March 23, 2012: 3:30 p.m. - 4:45 p.m.
Presentation Type: Poster Session
M. DOYLE1, R. CHENG1, J. WITT1, R. GERLACH1, and L. FRIESEN2, 1Health Care Research Center, Procter & Gamble Company, Mason, OH, 2University of Missouri -Kansas City, Kansas City, MO
Objective: This clinical trial evaluated the safety and effectiveness of extrinsic stain removal with a hydrogen peroxide rinse compared to a whitening dentifrice.

Method: Institutional review and informed consent were obtained, and adults with established extrinsic dental stain were screened and enrolled in a clinical trial.  Balancing of baseline stain, subjects were randomly assigned to one of two groups: hydrogen peroxide rinse (MR) or whitening dentifrice (TP).  The extent and severity of visible stain was measured on selected facial tooth surfaces by a trained examiner using the modified Lobene Index.  All test products were dispensed with a manual brush in blinded kits.  The MR group received a 1.5% hydrogen peroxide rinse (Crest® 3DWhite™ Multi-Care Whitening) along with a regular anticavity dentifrice, while the TP group received a whitening dentifrice (the experimental control) along with instructions for post-brushing water rinsing.  Daily treatment followed marketed instructions for use, and subjects were evaluated after 7-days to assess change in extrinsic tooth stain. 

Result: A total of 40 subjects were enrolled (age ranging from 19-67), groups were balanced on baseline demographics and stain levels, and 39 subjects completed the study.  Both the MR & TP groups had significant (p<0.0001) stain removal after 7-days use approximating 82-93% reductions in median stain from baseline levels.  At Day 7, adjusted mean (SD) Lobene composite scores were 0.28 (0.23) in the MR group and 0.63 (0.35) in the TP control, with groups differing significantly (p=0.0001) in stain removal.  Stain area and intensity scores showed similar outcomes to those seen with the Lobene composite endpoint.  Both treatments were well-tolerated, with 4 mild adverse events reported (1 in MR and 3 in TP).

Conclusion: In a randomized controlled trial, twice daily use of a 1.5% hydrogen peroxide rinse with routine hygiene resulted in a 93% reduction in visible extrinsic stain in a 7-day period.     

This abstract is based on research that was funded entirely or partially by an outside source: Research sponsored by Procter & Gamble

Keywords: Clinical trials, Dentifrices, Mouthrinses, Oral hygiene and Stain
Presenting author's disclosure statement: Employee of Procter & Gamble
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