A clinical investigation of the efficacy of two dentifrices for the reduction of supragingival calculus formation.
OBJECTIVE
The objective of this double-blind clinical study, conducted in harmony with Volpe-Manhold design for studies of dental calculus, was to compare the efficacy of a dentifrice containing 0.3% triclosan/2.0% polyvinylmethyl ether/maleic acid (PVM/MA) copolymer/0.243% sodium fluoride in a 17% dual silica base (Colgate Total Advanced Toothpaste) to that of a commercially available dentifrice containing 0.243% sodium fluoride in a silica base (Crest Cavity Protection Toothpaste) with respect to the reduction of supragingival calculus formation.


METHODS
Adult male and female subjects from the San Francisco area were entered into the eight-week pre-test phase of the study. Subjects received an evaluation of oral soft and hard tissues and were given a complete oral prophylaxis. They were provided with a non-tartar control placebo dentifrice and a soft-bristled adult toothbrush, and were instructed to brush their teeth twice daily (morning and evening) for one minute. After eight weeks of using the placebo dentifrice, subjects were examined for baseline supragingival calculus formation using the Volpe-Manhold Calculus Index. Qualifying subjects were randomized into two treatment groups which were balanced for gender and baseline calculus scores. All subjects entered into the twelve-week test phase were given a complete oral prophylaxis, and were provided with their assigned dentifrice and a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for one minute twice daily (in the morning and evening). Prior to each study visit, subjects refrained from brushing their teeth and eating and drinking for four hours.


RESULTS
Seventy-seven (77) subjects complied with the protocol and completed the study. At the twelve-week examination, the Test Dentifrice group presented a mean Volpe-Manhold Calculus Index score of 13.22 and the Control Dentifrice group presented a score of 20.29. After twelve weeks of product use, the Test Dentifrice group exhibited 34.8% less supragingival calculus formation than the Control Dentifrice group (statistically significant at p < 0.05).


CONCLUSIONS
The overall results of this double-blind clinical study support the conclusion that after twelve weeks' use of a dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride in a 17% dual silica base provides significantly greater control of supragingival calculus formation relative to that of a commercially available dentifrice containing 0.243% sodium fluoride in a silica base.
Schiff
Thomas
T
Scottsdale Center for Dentistry, San Francisco, CA, USA.
Delgado
Evaristo
E
DeVizio
William
W
Proskin
Howard M
HM
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D045424:Complex Mixtures / Q000737:chemistry / Q000627:therapeutic use*; D003728:Dental Calculus / Q000517:prevention & control*; D003774:Dental Plaque Index; D003802:Dentifrices / Q000737:chemistry / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; 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; 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; 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)