The clinical effectiveness of a dentifrice containing triclosan and a copolymer for providing long-term control of breath odor measured chromatographically.
The objective of this double-blind clinical study was to investigate the effectiveness of a commercially available dentifrice containing triclosan and a copolymer (Colgate Total Toothpaste) for controlling long-term, i.e., seven-hour and overnight breath odor. In particular, a comparison was made between the level of control of breath odor provided by the test dentifrice, and that provided by a placebo dentifrice which did not contain triclosan or a copolymer. This study followed a two-treatment, two-period crossover design. Prospective subjects were provided with a supply of a commercially available fluoride dentifrice, which was used for a one-week period prior to the two seven-day treatment periods. During each treatment period, subjects were instructed to brush their teeth twice a day, morning and evening, for sixty seconds with their assigned study dentifrice, using the soft-bristled toothbrush which had been provided. On the morning following the seventh day of each treatment period, subjects reported to the clinical facility for overnight breath odor assessments. Directly following this, subjects brushed their teeth, ate and drank normally, and reported once again to the clinical facility at seven hours post-toothbrushing for another breath odor assessment. Prior to the overnight breath odor assessments, subjects refrained from brushing their teeth, rinsing their mouths or using breath mints, and from eating or drinking anything on the morning of the evaluation. Subjects refrained from the use of tobacco products, and from eating onions, garlic, or strong spices throughout the entire study. Breath odor was instrumentally evaluated by measuring the level of volatile sulfur compounds in the mouth air using a 565 Tracor gas chromatograph equipped with a flame photometric detector. Measurements were taken in duplicate, and then averaged. Levels of volatile sulfur compounds were expressed in nanograms per milliliter (ng/ml) of mouth air. The two dentifrices exhibited statistically significant differences (p < 0.05) with respect to both overnight breath odor and seven-hour post-toothbrushing breath odor. The mean overnight breath odor scores were 9.63 ng/ml for Colgate Total Toothpaste, and 12.64 ng/ml for the placebo dentifrice. For seven-hour breath odor, the mean scores were 5.62 ng/ml for Colgate Total Toothpaste, and 7.10 ng/ml for the placebo dentifrice. Thus, the results of this double-blind clinical study on 19 subjects support the conclusion that Colgate Total Toothpaste provides effective seven-hour and overnight control of breath odor.
Niles
H P
HP
Colgate-Palmolive Technology Center, Piscataway, NJ, USA. Holly_Niles@Colpal.com
Vazquez
J
J
Rustogi
K N
KN
Williams
M
M
Gaffar
A
A
Proskin
H M
HM
D000328:Adult; D000704:Analysis of Variance; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use; D002849:Chromatography, Gas; D045424:Complex Mixtures; D018592:Cross-Over Studies; D003802:Dentifrices / Q000737:chemistry / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005459:Fluorides; D006209:Halitosis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008298:Maleates / Q000627:therapeutic use; D008875:Middle Aged; D011095:Polyethylenes / Q000627:therapeutic use; D011145:Polyvinyls / Q000627:therapeutic use; D011446:Prospective Studies; D012824:Silicic Acid; D014100:Toothpastes; D016896:Treatment Outcome; D014260:Triclosan / Q000627:therapeutic use
D000891:Anti-Infective Agents, Local; D045424:Complex Mixtures; D003802:Dentifrices; D008298:Maleates; D011095:Polyethylenes; D011145:Polyvinyls; D014100:Toothpastes; C546060:hydrated silica gel-based toothpaste; C058026:polyvinylmethoxyethylene-maleic anhydride copolymer; D012824:Silicic Acid; D014260:Triclosan; C043105:poly(methyl vinyl ether-co-maleic anhydride); D005459:Fluorides