OBJECTIVE:Stannous fluoride is a broad-spectrum anti-microbial agent that has been used in dentistry as a chemical adjunct to prevent dental caries and gingivitis. The objective of this study was to assess the anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice relative to a negative control. METHODS: This was a randomized, 6-month, double-blind, parallel-group gingivitis study conducted according to the guidelines for evaluating chemotherapeutic products for the control of gingivitis outlined by the American Dental Association. A stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice was tested against a commercially available negative control dentifrice. Following baseline measurements, subjects received a dental prophylaxis. Subjects were then instructed to brush twice daily for 60 s using their assigned product. Oral soft-hard-tissue examinations and clinical examinations using the Modified Gingival Index, Gingival Bleeding Index, and the Turesky modification of the Quigley-Hein Plaque Index were performed at baseline, 3 and 6 months post-treatment. RESULTS:A total of 143 subjects were enrolled and 130 of them completed the 6-month study. After 6 months of product usage, the experimental group had 21.7% less gingivitis (p<0.001), 57.1% less bleeding (p<0.001), and 6.9% less plaque (p=0.01) on average compared with the negative control group. No adverse oral soft-hard-tissue effects or extrinsic tooth staining was observed in the study. CONCLUSION: The results demonstrate that use of the stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice over a 6-month period provided statistically significant reductions in gingivitis, gingival bleeding, and plaque when compared with a negative control dentifrice. Copyright Blackwell Munksgaard, 2004.
RCT Entities:
OBJECTIVE:Stannous fluoride is a broad-spectrum anti-microbial agent that has been used in dentistry as a chemical adjunct to prevent dental caries and gingivitis. The objective of this study was to assess the anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice relative to a negative control. METHODS: This was a randomized, 6-month, double-blind, parallel-group gingivitis study conducted according to the guidelines for evaluating chemotherapeutic products for the control of gingivitis outlined by the American Dental Association. A stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice was tested against a commercially available negative control dentifrice. Following baseline measurements, subjects received a dental prophylaxis. Subjects were then instructed to brush twice daily for 60 s using their assigned product. Oral soft-hard-tissue examinations and clinical examinations using the Modified Gingival Index, Gingival Bleeding Index, and the Turesky modification of the Quigley-Hein Plaque Index were performed at baseline, 3 and 6 months post-treatment. RESULTS: A total of 143 subjects were enrolled and 130 of them completed the 6-month study. After 6 months of product usage, the experimental group had 21.7% less gingivitis (p<0.001), 57.1% less bleeding (p<0.001), and 6.9% less plaque (p=0.01) on average compared with the negative control group. No adverse oral soft-hard-tissue effects or extrinsic tooth staining was observed in the study. CONCLUSION: The results demonstrate that use of the stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice over a 6-month period provided statistically significant reductions in gingivitis, gingival bleeding, and plaque when compared with a negative control dentifrice. Copyright Blackwell Munksgaard, 2004.