Two-week extrinsic stain removal efficacy of a sodium fluoride dentifrice with high cleaning silica: results from two randomized, controlled clinical trials.
OBJECTIVE
To evaluate a stannous-containing sodium fluoride dentifrice with high cleaning silica and polychelation technology (test dentifrice) compared to a currently marketed whitening dentifrice, which carries the ADA Seal of Acceptance for whitening, for its efficacy in removing existing natural stain over a 2-week period.


METHODS
Two independent, randomized, positive-controlled, 2-treatment, parallel group, double-blind, 2-week studies with identical protocols were conducted in China. At baseline, subjects received an oral soft tissue (OST) examination followed by a Lobene stain examination. In each study, approximately 60 subjects having a Lobene stain composite score above 1 were randomized to one of two dentifrice products: the test dentifrice or the positive control. Subjects were instructed to brush twice daily for at least 1 minute with their assigned product. Lobene stain and OST examinations were conducted again after 2 weeks of use.


RESULTS
In both studies, the test dentifrice and the positive control dentifrice demonstrated statistically significant reductions in Lobene composite (P<0.0001), area (P<0.0001) and intensity (P<0.0001) stain scores after 2 weeks of use versus baseline. At Week 2, there were no statistically significant differences in stain scores between treatment groups in either study (P>0.12).
Department of Operative Dentistry and Nursing, School of Stomatology, Fourth Military Medical University, Xian, China.
LongXing
L
Ni
Jie
J
Li
Tao
T
He
JinLan
J
Chang
Lily
L
Sun
D000328:Adult; D002614:Chelating Agents / Q000627:therapeutic use; D002681:China; D003802:Dentifrices / Q000737:chemistry / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012824:Silicic Acid / Q000627:therapeutic use; D012822:Silicon Dioxide / Q000627:therapeutic use*; D012969:Sodium Fluoride / Q000627:therapeutic use; D014002:Tin Fluorides / Q000627:therapeutic use; D014075:Tooth Discoloration / Q000188:drug therapy*; D014100:Toothpastes / Q000627:therapeutic use; D055815:Young Adult
D002614:Chelating Agents; D003802:Dentifrices; D014002:Tin Fluorides; D014100:Toothpastes; C546060:hydrated silica gel-based toothpaste; D012824:Silicic Acid; D012822:Silicon Dioxide; D012969:Sodium Fluoride