A short-term brushing model for assessing antiplaque/antigingivitis dentifrice effectiveness: a pilot study.
This pilot clinical study was conducted to evaluate the utility of a short-term brushing model for assessing the inhibition of supragingival plaque and gingivitis by an essential oil-containing dentifrice formulation. Forty-two qualifying subjects entered and completed this double-blind, parallel group, controlled study. At baseline, subjects received an oral soft and hard tissue examination and were also scored for plaque, gingivitis and bleeding, both visually and invasively. Subjects received a supragingival prophylaxis and were randomly assigned to an experimental essential oil-containing dentifrice or its vehicle control. Subjects brushed unsupervised for one minute, twice daily for three weeks, after which all clinical examinations were repeated. All examinations were performed by a qualified and calibrated examiner. Analyses of covariance were used to compare inter-group means for each of the three outcome variables. Compared to its vehicle control, the experimental dentifrice produced statistically significant (p < 0.0001) reductions of 39.6% for plaque, 10.8% for gingivitis, and 65.4% for bleeding. No adverse events were observed or reported. The results of this pilot study suggest that three weeks of conventional use may be an adequate duration to demonstrate effectiveness of an essential oil-containing dentifrice. Confirmation of these results in a duplicate study is desirable to assess the reliability of the model. Furthermore, the utility of this model to determine the effects of formula modifications to the antiplaque and antigingivitis activity of active agents needs to be explored.
Kohut
B
B
Warner-Lambert Co., Morris Plains, NJ, USA.
Coelho
J
J
Sharma
N C
NC
Galustians
J
J
Proskin
H M
HM
D000293:Adolescent; D000328:Adult; D000368:Aged; D016009:Chi-Square Distribution; D002986:Clinical Trials as Topic / Q000379:methods*; D003773:Dental Plaque / Q000517:prevention & control*; D003774:Dental Plaque Index; D018865:Dental Research / Q000379:methods*; D003802:Dentifrices / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005891:Gingivitis / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009822:Oils, Volatile; D010512:Periodontal Index; D010865:Pilot Projects; D015203:Reproducibility of Results; D012107:Research Design; D014099:Toothbrushing
D003802:Dentifrices; D009822:Oils, Volatile