Clinical Study on the Effectiveness and Side-effects of Hexetedine and Chlorhexidine Mouthrinses vs. a Placebo

Objective: Aim of this double-blind clinical trial was to evaluate the effectiveness and side-effects of two mouthrinses.

Methods: 90 male outpatients with gingivitis were randomly allocated to three groups: Chlorhexamed (0.1% chlorhexidine), Hexoral (0.1% hexetidine) and a placebo compound. The volunteers were instructed to rinse the undiluted mouthrinse (15ml, 30s), provided in coded but otherwise indistinguishable containers, twice daily after toothbrushing over a period of four weeks. At baseline, after two and four weeks, the approximal-plaque-index (API), the bleeding-index (BI), the CPITN, and the gingival-index (GI) as well as a discoloration index were surveyed. Statistical analysis was carried out with the Kruskal-Wallis-Test, Fisher´s Exact-Test and Wilcoxon-Test.

Results: After four weeks of rinsing twice a day, all three groups showed a significant improvement (p£0.05) in the API, the BI, the CPITN, and the GI.

A comparison of the placebo compound with Chlorhexamed and Hexoral yielded a statistically significant difference (p<0.002) in the reduction of the API, while there was no statistically significant difference between the performance of Chlorhexamed and Hexoral. There was no statistically significant difference in the BI or the GI, related to the use of the three compounds. The comparison Chlorhexamed and Hexoral yielded a statistically significant (p=0.0035) difference related to the increase of tooth discoloration. There was no statistically significant difference in the mean discoloration scores comparing Hexoral with the placebo.

Conclusion: This double-blind clinical trial demonstrated Hexoral to be a useful alternative to Chlorhexamed mouthrinse with less discolorations.