Clinical Efficacy of New Alcohol Free Mouthrinses after 8 weeks

Objectives: To evaluate the efficacy of two alcohol-free antimicrobial mouthrinses in reducing plaque and gingivitis compared to an alcohol-containing rinse and toothbrushing alone. Methods: 160 healthy volunteers were enrolled in the parallel-design examiner-blind study. After screening and stratification by sex and papillary bleeding index (PBI), participants were randomly and equally assigned to four groups: (1) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-containing rinse,; positive control); (2) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-free experimental rinse); (3) toothbrushing + rinsing (0.06% CHX + 0,03% CPC + 0.025% NaF, alcohol-free experimental rinse); (4) toothbrushing alone (negative control). At baseline, QUIGLEY-HEIN plaque index (PI), the modified proximal plaque index (MPPI), and PBI were recorded. All subjects were advised to brush their teeth as usual during the eight weeks study period using Dr. Best multi aktiv toothpaste and Dr. Best plus toothbrush (medium stiffness). Additionally, groups 1-3 were instructed to rinse twice daily (30 sec. each). Eight weeks after baseline, indices were recorded again. ANOVA with Bonferroni adjustment was used for statistical analysis. Results: After eight weeks, 155 participants were included into final analysis (1: n=39, 2: n=39, 3: n=37, 4: n=40). The two experimental rinses (2, 3) performed better than the negative control (4) with respect to PI and MPPI with no significant difference vs positive control at p<0.05: PI: (1) 1.66, (2) 1.82, (3) 1.65, (4) 2.07; MPPI: (1) 1.85, (2) 1.87, (3) 1.85, (4) 1.95. For PBI, no statistically significant difference was found between groups: (1) 0.21, (2) 0.22, (3) 0.24, (4) 0.25. Conclusion: With respect to PI and MPPI, toothbrushing in combination with experimental alcohol-free antimicrobial mouthrinses was more effective than toothbrushing alone and as effective as an alcohol-containing control rinse. This study was sponsored by GlaxoSmithKline Consumer Healthcare.