Comparative efficacy and tolerability of two direct-to-consumer tooth whitening systems.
OBJECTIVE
To compare the clinical response of two self-directed vital bleaching systems under market use conditions.


METHODS
A randomized, parallel-group clinical trial was conducted. A total of 20 healthy adults were randomized to either a 6.0% hydrogen peroxide strip-based bleaching system or a combination system involving a 10% carbamide peroxide gel in a stock tray along with an anticavity whitening dentifrice and after-bleaching whitening mouthrinse. Only the maxillary arch was bleached over a 14-day period. Subjects were evaluated at 3, 8 and 15 days. Efficacy was measured objectively using digital image analysis to derive individual color parameters (L*a*b*) and overall color change (deltaE*).


RESULTS
After 14 days, the adjusted mean reduction in yellow (Ab*) was -2.23 +/- 0.157 for the whitening strips compared to -0.97 +/- 0.188 for the combination system. This represented a highly statistically significant (P< 0.0001), two-fold superior reduction in yellowness for the whitening strip group compared to the marketed control. Similar results were seen for other color parameters, with the whitening strip group exhibiting two-fold color improvement relative to the tray/dentifrice/rinse combination. With respect to tolerability, tooth sensitivity and oral irritation were the most common findings. Considering event duration and severity, median bleaching tolerability severity-days scores were 0.07 and 0.58 for the strip and combination systems respectively, with these treatments differing statistically (P= 0.04 1) favoring the whitening strips.
Gerlach
R W
RW
The Procter & Gamble Company, Mason, OH 45040-9462, USA. gerlach.rw@pg.com
Barker
M L
ML
Sagel
P A
PA
D000328:Adult; D000704:Analysis of Variance; D000077463:Carbamide Peroxide; D002327:Cariostatic Agents / Q000627:therapeutic use; D003116:Color; D003802:Dentifrices / Q000627:therapeutic use; D003807:Dentin Sensitivity / Q000139:chemically induced; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D006861:Hydrogen Peroxide / Q000008:administration & dosage / Q000627:therapeutic use; D007091:Image Processing, Computer-Assisted; D008297:Male; D008437:Maxilla; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects; D009067:Mouthwashes / Q000627:therapeutic use; D016877:Oxidants / Q000008:administration & dosage / Q000627:therapeutic use; D017060:Patient Satisfaction; D010545:Peroxides / Q000008:administration & dosage / Q000627:therapeutic use; D012969:Sodium Fluoride / Q000627:therapeutic use; D013223:Statistics as Topic; D018709:Statistics, Nonparametric; D014070:Tooth / Q000473:pathology; D014073:Tooth Bleaching / Q000295:instrumentation / Q000379:methods*; D016896:Treatment Outcome; D014508:Urea / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use
D002327:Cariostatic Agents; D003802:Dentifrices; D004338:Drug Combinations; D005782:Gels; D009067:Mouthwashes; D016877:Oxidants; D010545:Peroxides; D000077463:Carbamide Peroxide; D014508:Urea; D012969:Sodium Fluoride; D006861:Hydrogen Peroxide