902 6-Week Combination Oral Hygiene Effects on Plaque and Gingivitis

Friday, March 23, 2012: 2 p.m. - 3:15 p.m.
Presentation Type: Poster Session
P. AMINI1, M.L. BARKER2, S. BARRETT2, M. GABBARD2, A. WALANSKI2, and R. GERLACH2, 1BioSci Research Canada Ltd, Mississauga, ON, Canada, 2Oral Care Clinical Research, Procter & Gamble Company, Mason, OH
Objectives: A 6-week randomized controlled, examiner-blind, parallel-group clinical trial was conducted to evaluate the effect of combination oral hygiene on gingivitis and overnight plaque.  Methods: After IRB review and informed consent, 80 healthy adults were randomly assigned equally to either combination oral hygiene or negative control.  The combination oral hygiene regimen consisted of a 0.454% stannous fluoride dentifrice (Crest Pro-Health® Clinical Gum Protection), a 0.07% CPC/10.8% alcohol mouth rinse (Crest Pro-Health® Multiprotection Invigorating Clean), a soft manual toothbrush (Oral-B® Pro-Health Cross-Action), and floss (Oral-B® Glide® Pro-Health Clinical Protection), while the negative control group received anti-cavity dentifrice and a regular flat-trim manual toothbrush.  Subjects followed manufacturers instructions for use.  Number of Bleeding Sites (bleeding), Modified Gingival Index (MGI), and Rustogi Modified Navy Plaque Index (RMNPI) were measured at Baseline, and Weeks 2 and 6.  Analysis of covariance and Fisher’s Exact test were used to compare mean and categorical responses, respectively.  Results: Mean age was 39 (range: 18 to 67 years) and 78 subjects completed the research.  Groups were balanced at Baseline with overall means of 20.91 bleeding, 2.17 MGI, and 0.68 RMNPI.  At Weeks 2 and 6, respectively, the combination group demonstrated significantly (p<0.0001) lower mean gingivitis and plaque versus the control by 46% and 74% bleeding, 12% and 22% for MGI, and, 20% and 39% for overnight RMNPI.  In addition, groups differed significantly (p<0.001) on categorical improvement in gingivitis and plaque at both 2 and 6 weeks.  Conclusions: Use of a combination stannous fluoride dentifrice, CPC/alcohol mouth rinse, criss-cross bristle manual toothbrush, and floss demonstrated significant improvements in both plaque and gingivitis relative to a regular anti-cavity toothpaste and brush negative control.

Keywords: Antimicrobial agents/inhibitors, Clinical trials, Gingivitis, Plaque and Therapeutics
Presenting author's disclosure statement: Procter & Gamble employee
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