IADR Abstract Archives
Effect of 0.454% Stannous Fluoride Toothpaste on Plaque/Gingivitis
Objectives: To investigate clinical efficacy on plaque and gingivitis of a 0.454% stannous fluoride dentifrice stabilized with K+ and polyphosphates (Test) compared to a regular fluoride toothpaste (Negative Control) containing 0.76% sodium monofluorophosphate after 3 and 6 months of product use.
Methods: A randomized, double-blind, parallel-group clinical study was conducted with healthy subjects (18-70 years) in the Chengdu, China area. Subjects were divided into two groups, and instructed to use their assigned dentifrice twice daily. Oral Soft and Hard Tissue, Loe and Silness Gingival Index and Quigley-Hein Plaque Index assessments were conducted at baseline and after 3 and 6 months of product use.
For gingival severity (bleeding) and plaque severity scores, the proportion of sites with gingival index score 2 or 3 or with plaque index score 3 or 4 or 5, respectively, were analyzed at baseline and after 3 and 6 months. For gingival interproximal and plaque interproximal scores, the mesio-facial, disto-facial, mesio-lingual and disto-lingual sites were analyzed.
Results: Eighty subjects were enrolled; seventy-six complied with the protocol and completed the study. Four subjects were withdrawn for reasons unrelated to the products. No adverse events were noted.
At 3 months, the test group showed significantly greater (p<0.001) reductions in gingivitis (17.4%), plaque (21.9%), gingival severity (27.5%), plaque severity (48.3%), and gingival and plaque interproximal scores (16.8% and 21.7%), respectively. At 6 months, the test group again showed significantly greater reductions in gingivitis (34.1%), plaque (32.3%), gingival severity (54.4%), plaque severity (57.4%), and gingival and plaque interproximal scores (32.3% and 31.6%), respectively.
Conclusions: A dentifrice containing 0.454% stannous fluoride, when used twice daily, demonstrated significantly more effectiveness than a dentifrice containing 0.76% sodium monofluorophosphate in reducing plaque and gingivitis over three and six month periods.
Methods: A randomized, double-blind, parallel-group clinical study was conducted with healthy subjects (18-70 years) in the Chengdu, China area. Subjects were divided into two groups, and instructed to use their assigned dentifrice twice daily. Oral Soft and Hard Tissue, Loe and Silness Gingival Index and Quigley-Hein Plaque Index assessments were conducted at baseline and after 3 and 6 months of product use.
For gingival severity (bleeding) and plaque severity scores, the proportion of sites with gingival index score 2 or 3 or with plaque index score 3 or 4 or 5, respectively, were analyzed at baseline and after 3 and 6 months. For gingival interproximal and plaque interproximal scores, the mesio-facial, disto-facial, mesio-lingual and disto-lingual sites were analyzed.
Results: Eighty subjects were enrolled; seventy-six complied with the protocol and completed the study. Four subjects were withdrawn for reasons unrelated to the products. No adverse events were noted.
At 3 months, the test group showed significantly greater (p<0.001) reductions in gingivitis (17.4%), plaque (21.9%), gingival severity (27.5%), plaque severity (48.3%), and gingival and plaque interproximal scores (16.8% and 21.7%), respectively. At 6 months, the test group again showed significantly greater reductions in gingivitis (34.1%), plaque (32.3%), gingival severity (54.4%), plaque severity (57.4%), and gingival and plaque interproximal scores (32.3% and 31.6%), respectively.
Conclusions: A dentifrice containing 0.454% stannous fluoride, when used twice daily, demonstrated significantly more effectiveness than a dentifrice containing 0.76% sodium monofluorophosphate in reducing plaque and gingivitis over three and six month periods.