Clinical Investigation of Dual Zinc Plus Arginine Dentifrice in Reducing Plaque and Gingivitis

Objectives: To compare the clinical efficacy of a new dual zinc plus arginine dentifrice (Test) in reducing plaque, gingivitis, and bleeding as compared to a stannous fluoride hexametaphosphate dentifrice (Control 1) and a sodium fluoride dentifrice (Control 2).
Methods: The clinical protocol was reviewed and approved by IRB. The study had a randomized, double-blind, parallel-group design. Subjects with initial Quigley-Hein plaque index of at least 1.5 and initial Loe-Silness gingival index of at least 1.0 participated in the study. Assessments were performed at baseline, 3 and 6 months. For bleeding score, a sub-group of subjects who started with GI 2 or 3 at baseline was analyzed.
Results: One hundred and thirty-five subjects (135) enrolled in and 130 completed the 6-month study. At baseline, there were no significant differences in plaque, gingivitis and gingival bleeding scores among the three groups. The 5 subjects who didn’t complete the study were not related to test products, but relocation.

At 3 months, Test group provided statistically significantly 20.8%, 16.3% and 20.6% greater reductions in plaque, gingivitis and gingival bleeding (p<0.05) than Control 2 group, respectively. There were no statistically significantly differences in plaque, gingivitis and gingival bleeding between Test and Control 1 groups.

At 6 weeks, Test group provided statistically significantly 34.4%, 26.6% and 33.9% greater reductions in plaque, gingivitis and gingival bleeding (p<0.05) than Control 2 group, respectively. Test group provided statistically significantly 13.4%, 10.9% and 12.8% greater reductions in plaque, gingivitis and gingival bleeding (p<0.05) than Control 1 group, respectively.
Conclusions: A new dual zinc plus arginine dentifrice is significantly better than both a sodium fluoride dentifrice and a stannous fluoride hexametaphosphate dentifrice in reducing plaque, gingivitis and gingival bleeding at 6 months.