Comparative tooth whitening efficacy of 18% carbamide peroxide liquid whitening gel using three different regimens.
OBJECTIVE
Recently, a novel paint-on liquid whitening gel--Colgate Simply White Clear Whitening Gel--which contains 18% carbamide peroxide, has been developed as a self-administered tooth bleaching system. The purpose of the present study was to determine the efficacy and safety of this product using alternate exaggerated or simplified treatment regimens.


METHODS
This was a three-week clinical trial using a parallel, double-blind, stratified protocol with three different instructions for application: 1) twice-daily, no air-drying, and 15 minutes without eating/drinking; 2) three times daily, 30-second air-drying and 30 minutes without eating/drinking; or 3) four times daily, 30-second air-drying and 30 minutes without eating/drinking. One-hundred and twenty (120) healthy volunteers were balanced into three equal groups based on shade scores (A3 or darker). Clinical evaluations (shade guide, oral tissue health, gingival index and visual analog sensitivity score) were performed on each group at baseline and weekly for the next 21 days. At the conclusion of the study, a survey of the subjects' opinions on their assigned product regimen was also conducted.


RESULTS
Subjects who used Colgate Simply White Clear Whitening Gel three and four times daily achieved the greatest shade improvement (5.88 +/- 1.53 shades, and 5.57 +/- 1.54, respectively). However, these values were only about one shade better than the value observed for the more convenient, twice-daily, "no-dry" regimen (4.51 +/- 1.77 shades), though they were statistically significant (p < 0.05). The result for the four-times daily protocol was not statistically different from the three-times group. Also, no differences were observed between the groups concerning oral tissue health, gingival index or tooth sensitivity, and no adverse effects were observed or reported regardless of the regimen used. Surveys completed by the subjects showed that those who used the twice-daily, "no-dry" regimen found the product to be the easiest to use, the most comfortable and the most pleasant tasting.


CONCLUSIONS
It can be concluded from the clinical data that three or four applications of Colgate Simply White Clear Whitening Gel per day provided better efficacy. In addition, the use of the whitening gel twice daily, even without "dry time" and only 15 minutes without eating/drinking, yielded results that were comparable to previously reported results using the original on-label directions. The potential additional benefit to the "simplified regimen" is that it was perceived to be the most convenient and comfortable. The use of Colgate Simply White Clear Whitening Gel up to four times daily for up to three weeks is also safe, and the tendency of abusing the product with more frequent daily use may be deterred by the inconvenience reported by the study subjects.
Li
Yiming
Y
Loma Linda University School of Dentistry, Loma Linda, CA, USA.
Lee
Sean S
SS
Cartwright
Susan
S
Wilson
Alisa C
AC
DeVizio
William
W
Petrone
Margaret
M
Volpe
Anthony R
AR
Zhang
Yun Po
YP
D000328:Adult; D000704:Analysis of Variance; D045424:Complex Mixtures; D003742:Dental Devices, Home Care; D003802:Dentifrices / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D016877:Oxidants / Q000008:administration & dosage*; D017060:Patient Satisfaction; D010545:Peroxides; D014073:Tooth Bleaching / Q000379:methods*
C475021:Colgate Simply White Clear Whitening Gel; D045424:Complex Mixtures; D003802:Dentifrices; D016877:Oxidants; D010545:Peroxides