Comparative investigation of the efficacy of triclosan/copolymer/sodium fluoride and stannous fluoride/sodium hexametaphosphate/zinc lactate dentifrices for the control of established supragingival plaque and gingivitis in a six-month clinical study.
OBJECTIVE
This double-blind clinical study, conducted at the University of Puerto Rico, San Juan, Puerto Rico, was designed to compare the efficacy of two commercially available dentifrices for the control of supragingival plaque and gingivitis.


METHODS
Qualifying adult male and female subjects from the San Juan, Puerto Rico area were randomly assigned to one of two treatment groups: 1) a commercially available dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, and 0.243% sodium fluoride (Colgate Total); and 2) a commercially available dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate (Crest Pro-Health). All subjects received an oral soft and hard tissue examination, and were dispensed their assigned dentifrice product, along with a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for one minute, twice daily (morning and evening), using only the dentifrice provided. Examinations for supragingival plaque and gingivitis, and oral soft and hard tissue assessments were repeated after six weeks, three months, and six months of product use.


RESULTS
One-hundred and nine (109) subjects complied with the protocol and completed the six-month examinations. At the six-month examination, both treatment groups exhibited statistically significant reductions from baseline with respect to supragingival plaque and gingivitis scores. Relative to the Crest Pro-Health Toothpaste group, the Colgate Total Toothpaste group exhibited statistically significant reductions in supragingival plaque index scores of 18.5%, 20.7%, and 25.8% after six weeks, three months, and six months of product use, respectively. For gingival index scores, statistically significant reductions of 20.5%, 18.9%, and 17.1% were exhibited after six weeks, three months, and six months of product use, respectively.


CONCLUSIONS
The results of this double-blind clinical study support the conclusion that a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, and 0.243% sodium fluoride provides a significant reduction in established supragingival plaque and gingivitis, as compared to a dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate when used over a period of six months.
University of Puerto Rico, San Juan, Puerto Rico.
Augusto Elias
AE
Boneta
Mauricio Montero
MM
Aguilar
Ferdinand Lugo
FL
Romeu
Bernal
B
Stewart
William
W
DeVizio
Howard M
HM
Proskin
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; 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