A 12-Week Randomized Clinical Study Investigating the Anti-Gingivitis Efficacy of a 0.454% w/w Stannous Fluoride Dentifrice
American Journal of Dentistry
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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.
Periodontics and Periodontology
Parkinson, C. R.,
A 12-Week Randomized Clinical Study Investigating the Anti-Gingivitis Efficacy of a 0.454% w/w Stannous Fluoride Dentifrice.
American Journal of Dentistry, 31(2),