OBJECTIVE: The objective of this independent, double-blind, overnight clinical study was to assess 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) for the overnight control of oral malodor and plaque microflora, relative to that of a commercially available dentifrice containing 0.243% sodium fluoride in a silica base (Crest Cavity Protection Toothpaste). METHODS: After a five-day period using a supplied commercially available fluoride toothpaste, adult male and female subjects from the Chengdu, China area reported to the clinical facility in the evening, after having refrained from the use of all oral hygiene procedures, as well as eating and drinking, for at least six hours. Following an assessment of the oral soft and hard tissues, subjects were evaluated for baseline oral malodor by a panel of four trained judges using a nine-point hedonic scale. Plaque samples (baseline) from the teeth on the left side of subjects' mouths were also collected. Subjects who presented a mean baseline oral malodor score between 6.0 and 8.4 were stratified according to their oral malodor score and randomly assigned within strata to one of the two treatment groups. Subjects were provided with their assigned dentifrice and instructed to brush their teeth on the left side of their mouth only, for one minute under supervision. Subjects returned to the testing facility the following morning for an overnight evaluation, having refrained from the use of all oral hygiene procedures, and from eating and drinking. An oral malodor assessment was performed, plaque samples were collected from the teeth on the right side of the mouth, and a final oral soft and hard tissue evaluation was performed. RESULTS:Eighty-one (81) subjects completed the study. At the overnight evaluation, subjects in the triclosan/copolymer/fluoride dentifrice group and the fluoride dentifrice group presented mean oral malodor scores of 4.91 and 6.86, respectively. Relative to the fluoride dentifrice group, at the overnight evaluation the triclosan/copolymer/fluoride dentifrice group presented a statistically significant 28.4% reduction in oral malodor scores. Additionally, at the overnight evaluation, subjects in the triclosan/ copolymer/fluoride dentifrice group and the fluoride dentifrice group presented geometric mean microbial colony forming unit (CFU) scores of 3.15 and 6.07, respectively. Relative to the fluoride dentifrice group, at the overnight evaluation the triclosan/copolymer/ fluoride dentifrice group presented a statistically significant 49.5% reduction in microbial CFU scores. CONCLUSION: The overall results of this double-blind clinical study support the conclusion that a single evening's use of a dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride in a 17% dual silica base provides statistically significantly lower levels of overnight (12-hour) oral malodor and plaque microflora when compared to a commercially available dentifrice containing 0.243% sodium fluoride in a silica base.
RCT Entities:
OBJECTIVE: The objective of this independent, double-blind, overnight clinical study was to assess 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) for the overnight control of oral malodor and plaque microflora, relative to that of a commercially available dentifrice containing 0.243% sodium fluoride in a silica base (Crest Cavity Protection Toothpaste). METHODS: After a five-day period using a supplied commercially available fluoride toothpaste, adult male and female subjects from the Chengdu, China area reported to the clinical facility in the evening, after having refrained from the use of all oral hygiene procedures, as well as eating and drinking, for at least six hours. Following an assessment of the oral soft and hard tissues, subjects were evaluated for baseline oral malodor by a panel of four trained judges using a nine-point hedonic scale. Plaque samples (baseline) from the teeth on the left side of subjects' mouths were also collected. Subjects who presented a mean baseline oral malodor score between 6.0 and 8.4 were stratified according to their oral malodor score and randomly assigned within strata to one of the two treatment groups. Subjects were provided with their assigned dentifrice and instructed to brush their teeth on the left side of their mouth only, for one minute under supervision. Subjects returned to the testing facility the following morning for an overnight evaluation, having refrained from the use of all oral hygiene procedures, and from eating and drinking. An oral malodor assessment was performed, plaque samples were collected from the teeth on the right side of the mouth, and a final oral soft and hard tissue evaluation was performed. RESULTS: Eighty-one (81) subjects completed the study. At the overnight evaluation, subjects in the triclosan/copolymer/fluoride dentifrice group and the fluoride dentifrice group presented mean oral malodor scores of 4.91 and 6.86, respectively. Relative to the fluoride dentifrice group, at the overnight evaluation the triclosan/copolymer/fluoride dentifrice group presented a statistically significant 28.4% reduction in oral malodor scores. Additionally, at the overnight evaluation, subjects in the triclosan/ copolymer/fluoride dentifrice group and the fluoride dentifrice group presented geometric mean microbial colony forming unit (CFU) scores of 3.15 and 6.07, respectively. Relative to the fluoride dentifrice group, at the overnight evaluation the triclosan/copolymer/ fluoride dentifrice group presented a statistically significant 49.5% reduction in microbial CFU scores. CONCLUSION: The overall results of this double-blind clinical study support the conclusion that a single evening's use of a dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride in a 17% dual silica base provides statistically significantly lower levels of overnight (12-hour) oral malodor and plaque microflora when compared to a commercially available dentifrice containing 0.243% sodium fluoride in a silica base.