A clinical investigation of the efficacy of three commercially available dentifrices for controlling established gingivitis and supragingival plaque.
OBJECTIVE
To assess the efficacy ofa dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride for controlling established gingivitis and supragingival plaque relative to that of a dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate, and a dentifrice containing 0.243% sodium fluoride as a negative control.


METHODS
Following a baseline examination for gingivitis and supragingival plaque, qualifying adult male and female subjects from the Piscataway, NJ, USA area were randomized into three dentifrice groups. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice and a soft-bristled toothbrush. Examinations for gingivitis and supragingival plaque were repeated after six weeks of product use.


RESULTS
One-hundred and seventy-one (171) subjects complied with the protocol and completed the study. Relative to the group using the dentifrice with 0.243% sodium fluoride alone, the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride group exhibited statistically significant reductions in gingival index and supragingival plaque index scores of 25.3% and 33.0%, respectively, after six weeks of product use. Similarly, relative to the group using the 0.243% sodium fluoride dentifrice, the 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate dentifrice group exhibited statistically significant reductions in gingival index and plaque index scores of 8.1% and 14.1% after six weeks of product use. Further, relative to the 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate dentifrice group, the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride dentifrice group exhibited statistically significant reductions in gingival index and plaque index scores of 18.7% and 22%, respectively.


CONCLUSIONS
The overall results of this double-blind clinical study support the conclusion that a dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride is efficacious for the control of established gingivitis and supragingival plaque as compared to a regular fluoride dentifrice, and that it provides a greater level of efficacy for the control of gingivitis and supragingival plaque than does a dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate.
UMDNJ, New Jersey Dental School, Newark, NJ, USA.
Surrendra
S
Singh
Patricia
P
Chaknis
William
W
DeVizio
Margaret
M
Petrone
Fotinos S
FS
Panagakos
Howard M
HM
Proskin
D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D016009:Chi-Square Distribution; D003773:Dental Plaque / Q000517:prevention & control*; D003774:Dental Plaque Index; D003802:Dentifrices / Q000737:chemistry / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005891:Gingivitis / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008298:Maleates / Q000627:therapeutic use; D008875:Middle Aged; D010512:Periodontal Index; D010710:Phosphates / Q000737:chemistry / Q000627:therapeutic use*; D011095:Polyethylenes / Q000627:therapeutic use; D012824:Silicic Acid / Q000737:chemistry / Q000627:therapeutic use; D012969:Sodium Fluoride / Q000627:therapeutic use; D018709:Statistics, Nonparametric; D014002:Tin Fluorides / Q000737:chemistry / Q000627:therapeutic use*; D014100:Toothpastes / Q000737:chemistry / Q000627:therapeutic use*; D014260:Triclosan / Q000627:therapeutic use; D055815:Young Adult; D017967:Zinc Compounds / Q000627:therapeutic use
C510825:Crest Pro-Health Dentifrice; D003802:Dentifrices; D004338:Drug Combinations; D008298:Maleates; D010710:Phosphates; D011095:Polyethylenes; D014002:Tin Fluorides; D014100:Toothpastes; D017967:Zinc Compounds; C546060:hydrated silica gel-based toothpaste; D012824:Silicic Acid; D014260:Triclosan; D012969:Sodium Fluoride; C043105:poly(methyl vinyl ether-co-maleic anhydride); C009285:sodium polymetaphosphate