A 24-week randomized clinical study investigating the anti-gingivitis efficacy of a 0.454% w%#47;w stannous fluoride dentifrice.

Purpose: To evaluate and compare gingival health, as measured by a bleeding index (BI), a modified gingival index (MGI), a dental plaque index (PI), and number of bleeding sites following twice daily use of an anhydrous 0.454% weight/weight (w/w) stannous fluoride dentifrice (Test Dentifrice) compared to a sodium monofluorophosphate (SMFP) dentifrice (Negative Control) over 24 weeks.

Methods: This was a single-center, examiner-blinded, randomized [by gender and baseline mean MGI score (Low ≤ 2.00/High > 2.00)], stratified, two-treatment arm, parallel group, 24-week clinical study in healthy adult volunteers with moderate gingivitis. At baseline, after abstaining from toothbrushing overnight, subjects underwent BI, MGI and PI assessments. Following randomization, eligible subjects underwent a thorough dental prophylaxis and flossing. After 12 and 24 weeks of twice daily brushing with their allocated treatment, subjects returned to the site with overnight plaque (having abstained from oral hygiene procedures for at least 8 hours) for BI, MGI and PI assessments.

Results: Of 109 screened subjects, 104 were randomized and 98 completed the study. Statistically significant differences between treatments were observed in favor of the Test Dentifrice compared to the Negative Control dentifrice for all outcome measures including not only BI, MGI and PI indices but also number of bleeding sites (P< 0.0001 at Week 12 and Week 24 for all). Data observation showed that the percentage of sites that decreased was more, and those that increased was less, with the Test Dentifrice than with the Negative Control dentifrice at both 12 and 24 weeks. 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) and plaque compared to a SMFP dentifrice over a 24-week period.