Purpose: This randomized, single center, examiner-blind, controlled, parallel-group, 4-week clinical study compared the antiplaque/anti-gingivitis efficacy of an essential oil (EO) containing mouthrinse versus a 0.075% cetylpyridinium chloride (CPC) containing mouthrinse. A 5% hydroalcohol solution was included as a control group.

Methods: 165 systemically healthy volunteers (18-72 years of age), with mild to moderate plaque-related gingivitis were enrolled in this clinical trial; 162 subjects completed the study. At baseline and 4-week visits, subjects received an oral examination, gingivitis (MGI), gingival bleeding (BI) and plaque (PI) assessments. Following randomization, subjects began rinsing with 20 mL of the assigned mouthrinse for 30 seconds, in conjunction with their usual oral hygiene, twice daily for the duration of the study.

Results: All rinses were well tolerated by the subjects. EO was statistically significantly superior to CPC with a reduction in mean MGI of 5.9%, and in mean PI of 6.4%. Statistically significant reductions in gingivitis, bleeding and plaque were observed for both EO and CPC when compared to the negative control; mean MGI and mean PI were reduced by 13.0% and 18.9% for EO and by 7.6% and 13.3% for CPC. EO also statistically significantly reduced the proportion of gingival bleeding sites compared to CPC by 7.6% (P = 0.012) and compared to control by 10.6% (P < 0.001). For the post hoc sitewise analyses, at 4 weeks, the mean percentage of healthy sites for EO, CPC and Control were 7.4%, 1.1% and 0.8%, respectively and the mean percentage of virtually plaque free sites for EO, CPC and control were 5.4%, 3.8% and 0.4% respectively. The mean percentages of more inflamed gingival sites for EO, CPC and control were 20.4%, 26.2% and 45.7%, respectively. The mean percentage of tooth surfaces with heavier accumulations of plaque (PI scores ≥ 3) was 50.9% for EO, 56.1% for CPC and 81.1% for control. Reduction of gingival inflammation and dental plaque was statistically significantly superior for EO compared to both 0.075% CPC and negative control. Both marketed antimicrobial mouthrinses showed a beneficial result in gingival health and in reducing plaque accumulation as early as 4 weeks.

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