Clinical investigation of the antiplaque efficacy of a new variant of a commercially available triclosan/copolymer/fluoride dentifrice.
OBJECTIVE
The objective of two single-blind, three-treatment, crossover design, clinical studies was to evaluate the antiplaque efficacy using the Modified Gingival Margin Plaque Index (MGMPI) scores of three dentifrices: 1) a dentifrice containing 0.3% triclosan/2.0% polyvinylmethyl ether/maleic acid (PVM/MA) copolymer/sodium fluoride in a 17% dual silica base (Colgate Total Advanced Toothpaste-Test Dentifrice); 2) a commercially available dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/sodium fluoride in a 10% high-cleaning silica base (Colgate Total Toothpaste-Positive Control Dentifrice); and 3) a commercially available dentifrice containing 0.243% sodium fluoride in a regular silica base (Colgate Winterfresh Gel-Negative Control Dentifrice).


METHODS
In each study, subjects reported to the clinical facility, and those who met the inclusion/exclusion criteria were given a complete oral prophylaxis, a soft-bristled toothbrush, and a commercially available dentifrice (Colgate Cavity Protection Fluoride Toothpaste). They were instructed to use these products exclusively for seven days (washout period), after which time they reported back to the clinical facility and were randomized into three treatment groups. All subjects then brushed their teeth for one minute with a full ribbon (approximately 1.5 gm) of Colgate Cavity Protection Fluoride Toothpaste, and immediately followed with a one-minute brushing using a full ribbon of one of the three study dentifrices. Subjects then rinsed with a red disclosing solution (Butler Red-Cote) and had their teeth and gums examined to assess their plaque content. They returned to the clinical facility after 24 hours of no oral hygiene to again have their teeth and gums examined to assess their plaque content. As per the crossover clinical design, the same methods and materials were used until all subjects used all three study treatments.


RESULTS
Seventeen subjects in the first study and 16 subjects in the second study complied with the protocol and completed all phases of the study. Two-way ANOVA results from both studies showed that there was no difference in mean delta MGMPI scores between the groups using the Test Dentifrice and the Positive Control Dentifrice. Results also showed that there was a statistically significant difference (p < 0.05) in delta MGMPI scores between both the Test Dentifrice treatment and the Positive Control Dentifrice treatment when compared to the Negative Control Dentifrice.


CONCLUSIONS
A new improved dentifrice containing 0.2% triclosan/3.0% PVM/MA copolymer/sodium fluoride in a 17% dual silica base is comparable in controlling dental plaque when compared to a Positive Control Dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/sodium fluoride in a 10% high-cleaning silica base, and is statistically significantly better in controlling dental plaque when compared to a Negative Control Dentifrice containing 0.243% sodium fluoride in a silica base.
Barnes
Virginia M
VM
Colgate-Palmolive Technology Center, Piscataway, NJ, USA. virginia_barnes@colpal.com
Richter
Rose
R
Vandeven
Mark
M
Xu
Tao
T
DeVizio
William
W
D000293:Adolescent; D000368:Aged; D000704:Analysis of Variance; D045424:Complex Mixtures / Q000737:chemistry / Q000627:therapeutic use*; D018592:Cross-Over Studies; D003773:Dental Plaque / Q000517:prevention & control*; D003774:Dental Plaque Index; D003802:Dentifrices / Q000737:chemistry / Q000627:therapeutic use*; D005260:Female; D005459:Fluorides / Q000737:chemistry / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008298:Maleates / Q000737:chemistry / Q000627:therapeutic use*; D008875:Middle Aged; D009910:Oral Hygiene / Q000379:methods; D011095:Polyethylenes / Q000737:chemistry / Q000627:therapeutic use*; D012824:Silicic Acid; D012822:Silicon Dioxide / Q000737:chemistry / Q000627:therapeutic use; D016037:Single-Blind Method; D012969:Sodium Fluoride / Q000737:chemistry / Q000627:therapeutic use*; D014099:Toothbrushing / Q000379:methods; D014100:Toothpastes; D016896:Treatment Outcome; D014260:Triclosan / Q000737:chemistry / Q000627:therapeutic use*; D055815:Young Adult
C540913:Colgate Total Advanced; C408633:Colgate Winterfresh Fluoride Gel; D045424:Complex Mixtures; D003802:Dentifrices; D008298:Maleates; D011095:Polyethylenes; D014100:Toothpastes; C546060:hydrated silica gel-based toothpaste; D012824:Silicic Acid; D014260:Triclosan; D012822:Silicon Dioxide; D012969:Sodium Fluoride; C043105:poly(methyl vinyl ether-co-maleic anhydride); D005459:Fluorides