42 Antiplaque/Antigingivitis Efficacy of an Alcohol-Free Essential Oil Containing Mouthrinse

Wednesday, March 21, 2012: 2:30 p.m. - 4 p.m.
Presentation Type: Oral Session
P. AMINI1, R.M. COSTA2, H. SHANG3, J. QAQISH4, J. GALLOB5, and M.W. ARAUJO2, 1BioSci Research, Las Vegas, NV, 2Oral Healthcare R&D, Johnson & Johnson Consumer Companies Inc, Morris Plains, NJ, 3Global Biometrics and Clinical Data System R&D, Johnson & Johnson Consumer Companies Inc, Shanghai, China, 4Biosci Research Canada, Ltd, Mississauga, ON, Canada, 5BioSci Research America, Inc, Las Vegas, NV
Objectives: The experimental gingivitis model has previously been used as a predictive model for the long term use of mouthrinses (Amini et al, 2009). Essential oil containing mouthrinses significantly reduce supragingival plaque and gingivitis (Charles et al, 2001). The purpose of this study was to determine the Antiplaque/Antigingivitis efficacy of an alcohol-free essential oil containing mouthrinse using the experimental gingivitis model for this novel product.

Methods: In this study, 92 subjects were randomized into two groups: an alcohol free essential oil containing mouthrinse (AFEO) and a 5% hydroalcohol mouthrinse as a negative control (C). At baseline examination, the examiner assessed the levels of Plaque and Gingivitis using the Turesky Modification of the Quigley-Hein Plaque Index (PI) and the Modified Gingival Index (MGI). The subjects then received a full-mouth supragingival prophylaxis. Each subject used their assigned test product as directed, (20 ml for 30 sec, twice daily) as their sole method of oral hygiene, refraining from any and all mechanical cleaning.  Weekday product use was supervised and repeated twice daily at the research site to maintain compliance, and in addition, subjects maintained a diary for weekend use of the product. At day 15, subjects returned to the clinical site for a final assessment of PI and MGI. Statistical comparison was made based on one-way analysis of covariance (ANCOVA) model with treatment as a factor and the corresponding baseline value as a covariate.

Results: After 14 days the PI results showed a reduction of 23.9% (p<0.001) and MGI showed a reduction of 10.4% (p<0.001) for the AFEO group versus the negative control. No adverse events were observed during the course of the trial.

Conclusions: The alcohol-free essential oil containing mouthrinse has shown to be effective and safe on the control of plaque and gingivitis, in a two week period.

Keywords: Clinical trials, Gingivitis, Mouthrinses, Oral hygiene and Plaque
Presenting author's disclosure statement: I work for the manufacturer of the product tested in this clinical study.
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