Initial Gingivitis Effects of Therapeutic Paste-Rinse Regimen Versus Controls

Objectives: This clinical trial evaluated the initial effects of a therapeutic dentifrice and rinse combination relative to two controls. Methods: A randomized, positive and negative controlled clinical trial was conducted among adult volunteers with gingivitis. Subjects were assigned to one of three treatments: an experimental regimen with 0.454% stannous fluoride sodium hexametaphosphate dentifrice (Crest® ProHealth™) and 0.07% cetylpyridinium chloride rinse (Crest® ProHealth™ Rinse), a positive control consisting of prophylaxis with regular brushing, or regular brushing, which was the negative control. Initial response was measured using a 3-point provocative bleeding scale (GBI) at 1 and 8 weeks to assess a prophylaxis effect with the positive control. Results: A total of 75 adults were enrolled, with a mean (SD) age of 33.1 (12.4) years. Groups were balanced (p>0.45) on pertinent demographics and baseline GBI. At Week 1, the lowest adjusted mean (SE) GBI score was 0.66 (0.042) in the positive control, with the post-prophylaxis exhibiting significantly (p<0.03) less bleeding. Bleeding increased in the prophylaxis group at Week 8, but remained flat in the paste+rinse combination. At Week 8, adjusted mean (SE) GBI scores were 0.80 (0.042) in the combination group, 0.82 (0.041) in the prophylaxis group, and 0.94 (0.38) in the brushing group without prophylaxis. Both the regimen (p<0.02) and prophylaxis (p<0.04) groups differed significantly from the negative control. Conclusion: In a positive and negative controlled clinical trial, 8-weeks use of a stannous fluoride sodium hexametaphosphate dentifrice and cetylpyridinium chloride rinse combination resulted in a significant reduction in gingival bleeding.