1. A Randomized 2-Month Clinical Trial Evaluating the Anti-Gingivitis Efficacy of a Stabilized Stannous Fluoride Dentifrice versus a Triclosan Dentifrice

A Randomized 2-Month Clinical Trial Evaluating the Anti-Gingivitis Efficacy of a Stabilized Stannous Fluoride Dentifrice versus a Triclosan Dentifrice

Reference: CR Goyal1, JG Qaqish1, T He2, R Eusebio2. 1All Sum Research, Mississauga, Ontario, Canada. 2Procter & Gamble, Mason, OH USA

KEY CLINICAL FINDINGS

  • After 2 months of use, the stabilized stannous fluoride (SnF2) test dentifrice group had 21.8% fewer bleeding sites versus the triclosan positive control dentifrice group (P<0.001).
  • Both groups showed statistically significant reductions in bleeding sites from Baseline (P<0.0001).

Figure 1. Number of bleeding sites per group

Number of bleeding sites per group

* Significant difference between groups at Month 2, P<0.001. Groups were not significantly different at Baseline (P>0.05).

OBJECTIVE

To compare the anti-gingivitis efficacy of a stabilized SnF2 dentifrice versus a positive control triclosan dentifrice over a 2-month period.

METHODS

  • This was a randomized, positive-controlled, double-blind, parallel-group clinical trial involving generally healthy adults with mild to moderate gingivitis.
  • Qualifying subjects were randomized to one of two treatment groups:
  • - 0.454% stabilized SnF2 dentifrice (Crest® PRO-HEALTH Clean Mint [Smooth Formula], Procter & Gamble)

    or

    - Positive control dentifrice with 0.3% triclosan and 0.243% sodium fluoride (Colgate® Total®, Colgate-Palmolive)

     

  • Dentifrice was distributed over-labeled or over-tubed for blinding purposes, with a soft manual flat-trim toothbrush (Oral-B® Indicator, Procter & Gamble). Subjects were instructed to brush with their respective dentifrice according to each manufacturer’s instructions.
  • The following efficacy and safety evaluations were conducted at Baseline and Month 2: Gingival Bleeding Index; Modified Gingival Index; and Oral Soft Tissue.
  • Treatment groups were compared using analysis of covariance with Baseline value as covariate. All statistical tests were two-sided with a 5% level of significance.

CLINICAL COMMENT

Gingival bleeding is an important early sign of gingivitis, the initial stage of periodontal disease. Reducing gingival bleeding is the ultimate goal of treating gingivitis, since research indicates the absence of gingival bleeding is a reliable indicator for sustained periodontal health.* This clinical trial showed subjects using the SnF2 dentifrice had significantly fewer (21.8%) bleeding sites than those using a positive control triclosan dentifrice after 2 months of use. Based on these findings, dental professionals should consider recommending the SnF2 dentifrice to patients with gingivitis to reduce bleeding and improve periodontal health.

* Lang NP. et al. J Clin Periodontol. 1990 Nov;17(10):714-21.

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