Purpose: This randomized, single center, examiner-blind, controlled, parallel-group, 6-month clinical study compared the antiplaque/antigingivitis potential of an essential oil (EO) versus a 0.07% cetylpyridinium chloride (CPC)-containing mouthrinse. A 5% hydroalcohol solution was included as a control group.
Methods: 354 healthy volunteers (18-71 years of age) were enrolled in this clinical trial; 338 subjects completed the study. At baseline, 1-, 3-, and 6-month visits, subjects received an oral examination, gingivitis (MGI), gingival bleeding (BI) and plaque assessments (PI). Following randomization, subjects received a prophylaxis and began brushing twice daily with the provided fluoride toothpaste and rinsing twice daily with 20 mL of the assigned mouthrinse for 30 seconds.
Results: All rinses were well tolerated by the subjects, with the exception of extrinsic tooth stain complaints in 13 subjects in the CPC group between the 3- and 6-month exams. Statistically significant reductions in gingivitis, bleeding and plaque were observed for both EO and CPC at all post-baseline time-points when compared to the negative control. At 6 months MGI and PI were reduced by 42.6% and 42.0% for EO and by 17.1% and 13.9% respectively, for CPC vs. control. When compared to CPC, EO was statistically significantly superior at all post-baseline time-points. EO showed increasing reductions in MGI of 10.5%, 20.3% and 30.7% as well as reductions in PI of 12.7%, 23.7% and 32.6% at 1, 3 and 6 months, respectively. When analyzing the number of healthy sites (MGI scores of 0 or 1), the beneficial effect of the EO-containing mouthrinse is 45.8% greater than using a CPC-containing mouthrinse and 59.8% greater than placebo.
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