1. A 24-Hour Dental Plaque Prevention Study with a Stannous Fluoride Dentifrice

Anti-Gingivitis Efficacy of a Stabilized 0.454% Stannous Fluoride Dentifrice: A Controlled 6-Month Clinical Trial

Reference: Mankodi S, Bartizek RD, Winston JL, et al. J Clin Periodontol. 2005;32(1):75-80.

CONCLUSION

Over a 6-month period a 0.454% stabilized stannous fluoride (Crest® PRO-HEALTH) dentifrice showed a statistically significant and clinically relevant effect on the control and prevention of gingivitis compared to a negative control dentifrice (Colgate® Cavity Protection).

OBJECTIVE

To investigate the long-term anti-gingivitis efficacy of a 0.454% stabilized stannous fluoride dentifrice (with sodium hexametaphosphate for cosmetic benefits) compared to a negative control dentifrice.

MATERIALS AND METHODS

  • 0.454% stabilized stannous fluoride experimental dentifrice (Crest® PRO-HEALTH) was compared to a negative control dentifrice (Colgate® Cavity Protection).
  • Study subjects were 143 generally healthy adults with a minimum of 18 natural teeth, a baseline Modified Gingival Index score of 1.75-2.3, and a Turesky Plaque Index score of ≥ 1.5.
  • Subjects were randomly assigned to either the experimental stannous fluoride dentifrice or the negative control dentifrice to use over 6 months and were instructed to brush twice daily for 1 minute with a manual soft toothbrush.
  • At baseline, oral soft tissue was examined. Subjects were scored for gingivitis (Modified Gingival Index), plaque (Turesky Plaque Index), and gingival bleeding (Gingival Bleeding Index), and received a dental prophylaxis.
  • At months 3 and 6 plaque, gingivitis, gingival bleeding, and safety were reassessed.

RESULTS

  • 130 subjects completed the 6-month study.
  • At 6 months, scores for the experimental group compared to the negative control group were significantly reduced for gingivitis (Modified Gingival Index) (21.7%; P<0.001), for bleeding (Gingival Bleeding Index) (57.1%; P<0.001), and for plaque (Plaque Index) (6.9%; P=0.01).
  • No adverse oral soft-hard-tissue effects or extrinsic tooth staining were observed.
Anti-gingivitis efficacy 6 month results

a Adjusted means and standard errors from analysis of covariance with baseline score as covariate.
b Percent reduction = 100% x (control-experimental mean)/control mean.

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