Effect of two new chlorhexidine mouthrinses on the development of dental plaque, gingivitis, and discolouration. A randomized, investigator-blind, placebo-controlled, 3-week experimental gingivitis study

Objectives: The aim of this experimental gingivitis study was to assess the efficacy and safety of two new chlorhexidine (CHX) mouthrinses. Materials and Methods: Ninety volunteers participated in this investigator-blind, randomized, clinical-controlled trial in parallel groups. During the treatment period, no oral hygiene measures except rinsing with non-alcoholic 0.2% CHX or 0.2% CHX/0.055% sodium fluoride mouthrinses, a positive control, or a negative control were permitted. The primary parameter was the gingival index; the secondary parameters were plaque index, discolouration index, and bleeding on probing. Clinical examinations were conducted 14 days before the start of the study, at baseline, and after 7, 14, and 21 days. The two sample t-test, ANOVA, and ANCOVA were used for the statistical analysis. Results: No difference in efficacy was found between the two new CHX formulations and the positive control. On day 21, statistically significantly less gingival inflammation and plaque accumulation compared with placebo were observed. Besides discolouration and taste irritations, no adverse events were recorded. Conclusion: The two new CHX mouthrinses were able to inhibit plaque re-growth and gingivitis. Neither the omission of alcohol nor the supplementation with sodium fluoride had weakened the clinical efficacy of CHX with respect to the analysed clinical parameters.