INTRODUCTION: This randomized, examiner-blind, parallel group, two-week controlled clinical trial investigated the antiplaque/antigingivitis efficacy of an essential oil-containing mouthrinse formulation with 0.02% sodium fluoride (EOF) and an essential oil-containing mouthrinse (EO) without fluoride (Listerine® Antiseptic) compared to a negative control rinse (5% hydroalcohol), using the experimental gingivitis model. METHOD: 200 evaluable subjects completed the study. Following a complete dental prophylaxis, subjects with gingivitis and dental plaque were randomized to one of the three mouthrinses and instructed to rinse with 20 ml twice daily, for 30 seconds, over a two-week period. The primary efficacy variables were mean Modified Gingival Index (MGI) and mean Plaque Index (PI) at two weeks. RESULTS: The EOF rinse exhibited statistically significantly lower mean Modified Gingival Index (MGI) and mean Plaque Index than the negative control after two weeks of treatment (p<0.001). The percentage reductions in means were 12.3% and 30.0%, respectively, relative to the negative control. The mean Modified Gingival Index and mean Plaque Index at two weeks for EO rinse (the positive control) were statistically significantly lower than the corresponding means of the negative control (p<0.001). The percentage reductions were 14.8% and 28.4%, relative to the negative control, respectively. The EOF rinse was considered “at least as good as” the EO rinse, the positive control, as the upper limits of the one-sided 97.5% confidence intervals for the per cent difference between the means for the EOF rinse and the positive control for both mean Modified Gingival Index and mean Plaque Index, 6.1% and 3.8% respectively, were below the 10% limit. CONCLUSIONS: In this two-week no oral hygiene model, the EOF rinse was significantly more effective in reducing gingival inflammation and plaque than the negative control and was “at least as good as” the currently marketed EO mouthrinse.

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