A 12-Week Randomized Clinical Study Investigating the Anti-Gingivitis Efficacy of a 0.454% w/w Stannous Fluoride Dentifrice

PURPOSE: To evaluate and compare gingival health, as measured by a bleeding index (BI), a modified gingival index (MGI), number of bleeding sites, and blood in expectorate following twice daily use of a non-aqueous 0.454% weight/weight (w/w) stannous fluoride dentifrice ('Test dentifrice') compared to a sodium monofluorophosphate (SMFP) dentifrice (' Negative Control') over 12 weeks, in subjects with moderate gingivitis and gingival bleeding following tooth brushing. METHODS: This was a single-center, examiner-blinded, randomized, stratified, two-treatment arm, parallel group, 12-week clinical study in healthy adult volunteers with moderate gingivitis who demonstrated gingival bleeding following tooth brushing. Subjects were assessed at baseline for MGI, visible blood in dentifrice expectorate and BI. Following randomization, eligible subjects underwent a thorough dental prophylaxis and flossing. After 4 and 12 weeks of twice daily brushing with their allocated treatment, subjects returned to the site for MGI, visible blood in dentifrice expectorate, and BI assessments. RESULTS: Of 317 screened subjects, 253 were randomized, and 238 completed the study. Statistically significant differences between treatments were observed in favor of the Test dentifrice compared to the Negative Control dentifrice in terms of gingival bleeding (number of bleeding sites and bleeding index), and visual signs of gingival inflammation (MGI) (P< 0.0001 at Weeks 4 and 12 for all). The visual assessment of the level of blood in expectorate following brushing demonstrated large reductions from baseline, however no significant difference between treatments was observed. Treatments were generally well tolerated. CLINICAL SIGNIFICANCE: Use of a dentifrice containing 0.454% w/w stannous fluoride led to significantly greater control of gingivitis (gingival bleeding and visual signs of gingival inflammation) compared to a SMFP dentifrice over a 12-week period. This study was conducted in subjects with moderate gingivitis and in a population represented by individuals who experience gingival bleeding on brushing, and is therefore considered representative of individuals who may opt for treatment therapies in the form of a daily use toothpaste.