A Clinical Investigation of the Efficacy of a Dual Zinc plus Arginine Dentifrice for Controlling Oral Malodor.

Objectives: The objective of this independent, double-blind clinical study was to assess the efficacy of a new Dual Zinc plus Arginine dentifrice (Colgate-Palmolive Co., New York, NY, USA) containing zinc (zinc oxide, zinc citrate) 0.96%, 1.5% arginine, and 1450 ppm F as sodium fluoride in a silica base for the 12-hour overnight oral malodor reduction after three weeks of product use, relative to that of a regular fluoride dentifrice containing 1450 ppm F as sodium fluoride in a silica base (Colgate-Palmolive Co., New York, NY, USA).

Methods: A total of eighty (80) adult male and female subjects from Chengdu, People's Republic of China, were enrolled in this clinical study. Following an assessment of the oral soft and hard tissues, subjects were evaluated for baseline oral malodor by a panel of four trained and calibrated judges using a nine-point organoleptic hedonic scale. They were then randomly assigned to one of two treatment groups (Dual Zinc plus Arginine - test; regular fluoride dentifrice - control). Subjects were provided with their assigned dentifrice and toothbrush and instructed to brush their teeth twice daily (morning and evening) for one minute. After three weeks, subjects returned to the study site for their follow-up evaluation of malodor after having refrained from brushing for 12 hours (overnight).

Results: Eighty (80) subjects completed the study. After three weeks of product use, subjects in the Dual Zinc plus Arginine dentifrice group and the regular fluoride dentifrice group showed statistically significant (p < 0.001) reductions of 38.9% and 11.6%, respectively, in organoleptic scores as compared to baseline. Relative to the regular fluoride dentifrice group, subjects in the Dual Zinc plus Arginine dentifrice group exhibited a statistically significant (p< 0.001) reduction of 30.8% in oral malodor. The quality of breath for subjects in the Dual Zinc plus Arginine dentifrice group was in the range corresponding to pleasant breath, whereas the quality of breath for subjects in the regular fluoride dentifrice group was in the range corresponding to unpleasant breath.

Conclusions: The overall results of this double-blind clinical study support the conclusion that a new Dual Zinc plus Arginine dentifrice containing zinc (zinc oxide, zinc citrate) 0.96%, 1.5% arginine, and 1450 ppm fluoride as sodium fluoride in a silica base provides a significantly greater reduction in oral malodor as compared to a regular fluoride dentifrice containing 1450 ppm fluoride as sodium fluoride in a silica base 12 hours post-brushing (overnight) after 3 weeks of product use.