Objectives: The objective of this 6-Month, single-center, parallel-group, two-cell, double-blind, and randomized clinical study was to evaluate the clinical efficacy of a Mouthwash containing 0.075% Cetylpyridinium Chloride (Test group) as compared to a Placebo Control Mouthwash (Control group) in controlling established dental plaque and gingivitis after 6-Months of product use.
Methods: ... [Show full abstract] Prospective adult male and female subjects reported to the clinical facility after having refrained from all oral hygiene procedures for 12 hours and from eating, drinking or smoking for 4 hours prior to their visit. Qualifying subjects who presented Gingival Index scores of at least 1.0, and Plaque Index scores of at least 1.5 were included. Subjects were randomly assigned to one of two treatment groups according to their baseline gingival and plaque scores. Subjects were instructed to rinse their mouth with 20ml of their assigned mouthwash at twice daily for thirty seconds, and to use only the products provided. Oral hard and soft tissues, Gingivitis, and plaque assessments were conducted after 3-Months and 6-Months of product use.
Results: One-hundred-ten (110) subjects entered the clinical study, complied with the protocol, and completed the 6-Month study. After 6-Months of product use, the Test Mouthwash group exhibited statistically significant reductions from baseline with respect to gingivitis of 33.5% and plaque of 33.6% index scores.
After 6-Months of product use, the Test Mouthwash group exhibited statistically significant reductions in gingivitis of 38.1% and plaque 36.5% index scores as compared to the Control Mouthwash group.
Conclusions: This clinical study support's the conclusions that: A Mouthwash containing 0.075% Cetylpyridinium Chloride provides a significant reduction in dental plaque and gingivitis after 6-Months of product use; and provides a greater level efficacy in controlling established dental plaque and gingivitis after 6-Months of product use as compared to a Placebo Control Mouthwash. 0-2010