RESUMEN
OBJECTIVE: This study was designed to evaluate the clinical efficacy of an antiplaque alcohol-free mouthwash containing 0.075% cetylpyridinium chloride (CPC) and 0.05% sodium fluoride (NaF), as compared to a control mouthwash containing only 0.05% NaF, in controlling established dental plaque and gingivitis after three and six months of product use. METHODS: This was a single-center, parallel-group, two-cell, double-blind, randomized clinical study. Prospective adult male and female subjects from San Jose, Costa Rica reported to the clinical facility having refrained from all oral hygiene procedures for 12 hours, and from eating, drinking, or smoking for four hours prior to their visit. Qualifying subjects who presented with Gingival Index scores (Löe and Silness Index) of at least 1.0 and Plaque Index scores (Turesky Modified Quigley-Hein Index) of at least 1.5 were allowed to participate in this study. Subjects were randomly assigned to one of two treatment groups according to their baseline gingival and plaque scores. In the first treatment group (Test), subjects used an alcohol-free mouthwash containing 0.075% CPC and 0.05% NaF, whereas in the second treatment group (Control), subjects used a mouthwash containing only 0.05% NaF. Gingivitis and plaque assessments, and examinations of oral hard and soft tissues were conducted after three months and six months of product use. RESULTS: One-hundred and ten (110) subjects complied with the protocol and completed the six-month study. After six months of product use, the Test Mouthwash group exhibited statistically significant reductions from baseline with respect to Gingival (33.5%), Gingival Interproximal (34.5%), Gingival Severity (63.2%), Plaque (33.6%), Plaque Interproximal (30.0%), and Plaque Severity (73.6%) Index scores. After six months of product use, the Control Mouthwash group exhibited statistically significant increases from baseline with respect to Gingival (6.9%), Plaque Interproximal (7.2%), and Plaque Severity (32.7%) Index scores. Furthermore, after six months of product use, the Control Mouthwash group exhibited reductions from baseline with respect to Plaque (6.1%), Gingival Interproximal (3.6%), and Gingival Severity (1.1%) Index scores which were not statistically significant. After three months of product use, the Test Mouthwash group exhibited statistically significant reductions in Gingival (25.0%), Gingival Interproximal (22.3%), Gingival Severity (38.9%), Plaque (26.1%), Plaque Interproximal (22.4%), and Plaque Severity (75.0%) Index scores as compared to the Control Mouthwash group. After six months of product use, the Test Mouthwash group exhibited statistically significant reductions in Gingival (38.1%), Gingival Interproximal (37.1%), Gingival Severity (63.6%), Plaque (36.5%), Plaque Interproximal (33.2%), and Plaque Severity (78.5%) Index scores as compared to the Control Mouthwash group. CONCLUSION: The results of this double-blind clinical study support that 1) an alcohol-free mouthwash containing a combination of 0.075% CPC and 0.05% NaF produces statistically significant reductions in dental plaque and gingivitis after three and six months compared to baseline, and 2) the alcohol-free CPC mouthwash provides a statistically significantly greater level of efficacy in controlling established dental plaque and gingivitis after three and six months of product use as compared to the Control Mouthwash containing only NaF.