A controlled 6-month clinical trial to study the effects of a stannous fluoride dentifrice on gingivitis.

OBJECTIVES: This study was conducted to assess anti-plaque and anti-gingivitis benefits of a stabilized stannous fluoride (SnF(2))/sodium hexametaphosphate (SHMP) dentifrice versus a negative control. MATERIAL AND METHODS: This was a randomized, 6-month, stratified, single-centre, double-blind, parallel group, clinical study conducted in harmony with the guidelines for evaluating chemotherapeutic products for the control of gingivitis outlined by the American Dental Association. A stabilized 0.454% SnF(2)/SHMP dentifrice was tested against a commercially available negative control dentifrice. Following baseline measurements, subjects received a dental prophylaxis. Subjects were instructed to brush twice daily for 60 s using their assigned product. Efficacy measurements were obtained at baseline, 3 and 6 months post treatment using the Modified Gingival Index, Gingival Bleeding Index and the Turesky Modified Quigley-Hein Plaque Index. Oral tissue examinations were performed at all visits. RESULTS: A total of 140 subjects were enroled and 128 completed the study. RESULTS after 6 months showed the SnF(2) dentifrice delivered a 16.9% reduction in gingivitis (p<0.001), a 40.8% reduction (p<0.001) in gingival bleeding, and an 8.5% reduction in plaque (p=0.001) versus the negative control. Both treatments were well tolerated. CONCLUSIONS: Twice daily use of the SnF(2)/SHMP dentifrice over 6 months provided statistically significant anti-plaque and anti-gingivitis benefits relative to a negative control.

A 6-month clinical trial to study the effects of a cetylpyridinium chloride mouthrinse on gingivitis and plaque.

PURPOSE: To evaluate the effects of a novel mouthrinse containing 0.07% high bioavailable cetylpyridinium chloride (Crest Pro-Health Rinse) on the development of gingivitis and plaque versus a placebo control over a period of 6 months. METHODS: This was a randomized, 6-month, placebo-controlled, parallel groups, double blind, single center clinical trial. One hundred thirty-nine generally healthy adults with mild-to-moderate gingivitis were enrolled in the study. Subjects were given Modified Gingival Index (MGI), Gingival Bleeding Index (GBI) and Modified Quigley-Hein Plaque Index (MQH) examinations followed by a dental prophylaxis. Subjects were then randomly assigned to either the cetylpyridinium chloride (CPC) rinse or placebo rinse and instructed to begin rinsing twice a day with 20 ml of their assigned mouthrinse for 30 seconds after brushing their teeth. Subjects were assessed for MGI, GBI and MQH scores after 3 and 6 months of product use. Oral hard and soft tissue examinations were also performed at all visits. RESULTS: 124 subjects were evaluable at Month 3 and 119 at Month 6. After 6 months, subjects rinsing with the CPC rinse showed 15.4% less gingival inflammation, 33.3% less gingival bleeding, and 15.8% less plaque relative to the placebo group. All reductions were highly statistically significantly different (P< 0.01). Results were similar at 3 months. Both treatments were well-tolerated. CLINICAL SIGNIFICANCE: This study demonstrates that the Crest Pro-Health 0.07% CPC mouthrinse provided significant antiplaque and antigingivitis benefits when used twice daily for 6 months as an adjunct to toothbrushing.