The clinical efficacy of a new tooth whitening dentifrice formulation: a six-month study in adults.
The objective of this double-blind clinical study was to investigate the tooth whitening efficacy of a formulation variant of a commercially available dentifrice (Colgate Total Plus Whitening Toothpaste) obtained by the addition of high-cleaning silica, relative to that of its currently marketed formulation (Colgate Total Toothpaste). Following a baseline examination for extrinsic tooth stain, qualifying adult male and female subjects from New Jersey and Florida were randomized into two treatment groups which were balanced for gender, age, and level of extrinsic tooth stain. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice using a soft-bristled toothbrush. Examinations for extrinsic tooth stain were repeated after six-weeks', three-months' and six-months' use of the study dentifrices. Eighty-six (86) subjects complied with the protocol and completed the entire study. At the six-month examination, subjects assigned to the new dentifrice formulation group exhibited statistically significantly lower levels of extrinsic tooth stain area and extrinsic tooth stain intensity than did those subjects assigned to the Colgate Total Toothpaste group. Thus, the results of this double-blind clinical study support the conclusion that the new dentifrice formulation variant is efficacious, compared to the control dentifrice, for the removal of extrinsic tooth stain.
Singh
Surendra
S
University of Medicine and Dentistry of New Jersey, Newark, NJ, USA.
Mankodi
Suru
S
Chaknis
Patricia
P
Petrone
Margaret E
ME
DeVizio
William
W
Volpe
Anthony R
AR
Proskin
Howard M
HM
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D045424:Complex Mixtures; D003802:Dentifrices / Q000737:chemistry / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005459:Fluorides; D006801:Humans; D008297:Male; D008875:Middle Aged; D011137:Polystyrenes; D012824:Silicic Acid; D012822:Silicon Dioxide; D012969:Sodium Fluoride; D014075:Tooth Discoloration / Q000628:therapy*; D014100:Toothpastes; D016896:Treatment Outcome; D014260:Triclosan
D045424:Complex Mixtures; D003802:Dentifrices; D011137:Polystyrenes; D014100:Toothpastes; C546060:hydrated silica gel-based toothpaste; D012824:Silicic Acid; D014260:Triclosan; D012822:Silicon Dioxide; D012969:Sodium Fluoride; D005459:Fluorides