Anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice. A controlled 6-month clinical trial

Abstract 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.