38 Randomized Controlled Trial with Concurrent Plaque and Gingivitis Image Analysis

Wednesday, March 21, 2012: 2:30 p.m. - 4 p.m.
Presentation Type: Oral Session
R. GERLACH, M. RUBUSH, M.L. BARKER, and A. BIESBROCK, Health Care Research Center, Procter & Gamble Company, Mason, OH
Objectives: A 3-week randomized controlled clinical trial was conducted to evaluate concurrent use of plaque and gingivitis image analysis methods to assess clinical response. 

Methods: After IRB review, informed consent was obtained from healthy adults with overnight plaque.  Subjects were randomly assigned to a combination oral hygiene regimen with a manual flexible crisscross bristle brush, 0.454% stannous fluoride dentifrice, 0.07% cetylpyridinium chloride rinse and floss or routine oral hygiene (the experimental control).  Response was measured each week with non-invasive instrumental photographic methods using high-resolution images of the anterior facial dentition and standard lighting.  Gingivitis image analysis assessed red-green-blue (RGB) values on marginal gingiva, with the primary response as change in DG.  Plaque image analysis assessed fluorescein-disclosed surface area coverage (% of all surfaces).  Images were compared to assess longitudinal response, and anatomical maps were generated.

Results: Mean (SD) age of the 54 enrolled subjects was 26.8 (7.5) years, groups were balanced on baseline parameters, and all subjects completed the study.  Relative to baseline, only the experimental group exhibited significant (p<0.0001) improvements in plaque and gingivitis beginning at Week 1 and continuing through Week 3.  Between-group comparisons showed significant (p<0.0008) differences in both plaque and gingivitis at each timepoint favoring the combination.  At Week 3, overnight mean (SE) area coverage was 4.8 % (0.92) for the combination and 19.4% (2.79) for the control (p<0.0001), while mean (SE) DG was 6.8 (0.97) for the combination and 1.3 (0.94) for the control (p=0.0002). 

Conclusions: This research establishes the feasibility of using non-invasive instrumental methods concurrently to measure plaque and gingivitis response, and demonstrates a 5-8 fold greater improvement in both plaque and gingivitis after 3-weeks combination regimen use versus routine hygiene.    

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

Keywords: Clinical trials, Digital image analysis, Gingivitis, Oral hygiene and Plaque
Presenting author's disclosure statement: Employee of Procter & Gamble
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