Randomized controlled trial on the efficacy of new alcohol-free chlorhexidine mouthrinses after 8 weeks

Abstract

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: One hundred and sixty healthy volunteers were enrolled in the randomized controlled trial. Participants were randomly and equally assigned to four groups: (i) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-containing rinse, positive control); (ii) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-free experimental rinse); (iii) toothbrushing + rinsing (0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free experimental rinse); (iv) toothbrushing alone (negative control). At baseline, Quigley-Hein plaque index (QHI), modified proximal plaque index (MPPI), and papillary bleeding index (PBI) were recorded. All subjects brushed their teeth as usual during the study. Additionally, groups 1-3 rinsed twice daily. Eight weeks after baseline, indices were recorded again. anova with Bonferroni adjustment served for statistical analysis.

Results: One hundred and fifty-five participants were included into final analysis (i: n = 39, 2: n = 39, 3: n = 37, 4: n = 40). Experimental rinses (ii, iii) reduced QHI and MPPI to a higher extent than the negative control (iv), whereas no significant difference to the positive control was found. QHI: (i) 36.6%, (ii) 32.3%, (iii) 36.8%, (iv) 21.6%; MPPI: (i) 11.9%, (ii) 12.2%, (iii) 13.6%, (iv) 3.5%. For PBI, no statistically significant difference was found between groups: (i) 80.2%, (ii) 77.8%, (iii) 76.5% and (iv) 78.8%.

Conclusions: With respect to QHI and MPPI, toothbrushing in combination with any rinse was more effective than toothbrushing alone. No statistically significant differences were found between the alcohol-free and the alcohol-containing control rinses.

Keywords: chlorhexidine; controlled clinical trial; mouthrinse; random allocation; single-blind-method.