1. Assessment of the Effects of a 0.454% Stannous Fluoride Dentifrice on Gingivitis in a 2-Month Positive-Controlled Clinical Trial

Assessment of the Effects of a 0.454% Stannous Fluoride Dentifrice on Gingivitis in a 2-Month Positive-Controlled Clinical Trial

Reference: He T, Barker ML, Goyal CR, Biesbrock AR. Am J Dent. 2012;25:136-140

KEY CLINICAL RESULTS

  • Baseline values were balanced across the treatment groups (P>0.36) with overall baseline means of 2.09 for gingivitis, 15.8 for gingival bleeding and 15.6 for number of bleeding sites. Relative to baseline, both the stannous fluoride dentifrice group and the positive control group demonstrated a statistically significant (P<0.0001) reduction in gingivitis, gingival bleeding, and number of bleeding sites at Month 2.
  • Between-treatment group comparisons for change from baseline showed the improvement from baseline for the stannous fluoride group was 45% greater for gingivitis, 60% greater for gingival bleeding and 62% greater for number of bleeding sites versus that of the positive control group (P<0.0001). See Figures 1–3.
  • At Month 2, the stannous fluoride dentifrice group demonstrated statistically significantly lower adjusted mean scores versus the positive control group for all 3 measures (P<0.0001).

Figure 1. Analysis of Covariance Summary for gingivitis (MGI). Improvement from baseline at Month 2.

Analysis of Covariance Summary for gingivitis (MGI). Improvement from baseline at Month 2

Figure 2 - Analysis of Covariance Summary for gingival bleeding (GBI). Improvement from baseline at Month 2.

Analysis of Covariance Summary for gingival bleeding (GBI). Improvement from baseline at Month 2

Figure 3 - Analysis of Covariance Summary for number of bleeding sites. Improvement from baseline at Month 2.

Analysis of Covariance Summary for number of bleeding sites. Improvement from baseline at Month 2

OBJECTIVE

To assess the effects of a 0.454% stannous fluoride dentifrice on the treatment of gingivitis as compared to a positive control dentifrice in a 2-month clinical trial.

STUDY DESIGN

  • This was a randomized, positive-controlled, double-blind, parallel-group, single-center study with two treatment groups composed of healthy adult volunteers.
  • 200 qualified subjects were enrolled; each treatment group contained 100 subjects. 99 subjects in the stannous fluoride group and 97 in the positive control group completed the study.
  • During the treatment phase, subjects performed their treatment routine unsupervised using their assigned dentifrice (Crest® PRO-HEALTH Clinical Gum Protection with 0.454% stannous fluoride, Procter & Gamble, or Colgate® Total with 0.3% triclosan and 0.32% sodium fluoride, Colgate-Palmolive) per manufacturers’ instructions (twice daily for stannous fluoride dentifrice; three times daily for the control) for 2 months. Both groups used an ADA soft reference manual toothbrush.
  • Efficacy measurements were obtained at Baseline and 2-months post-treatment. Antigingivitis efficacy was determined using mean Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI).
  • Oral soft tissue and hard tissue assessments were conducted at each examination interval.
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