Clinical trial of long-term color stability of hydrogen peroxide strips and sodium percarbonate film.
OBJECTIVE
To compare initial and sustained clinical response of 6% hydrogen peroxide whitening strips and a 19% sodium percarbonate film in a randomized controlled trial.


METHODS
Informed consent was obtained, after which 72 subjects were randomized to 6% hydrogen peroxide whitening strips (Crest Whitestrips), 19% sodium percarbonate brush-applied gel that dries as a film (Crest Night Effects), or placebo brush-applied gel without peroxide. Efficacy (digital imaging) and safety (clinical examination and interview) were assessed after 2 weeks treatment, and again at up to eight post-treatment timepoints over an 18-month post-treatment period.


RESULTS
For Deltab* (yellowness), end-of-treatment adjusted means +/- standard errors (SE) were -2.37 +/- 0.088 for the strip group, -1.36 +/- 0.091 for the film group, and -0.08 +/- 0.090 for the placebo group. For DeltaL* (brightness), end-of-treatment adjusted means +/- SE were 2.40 +/- 0.121 for the strip group, 1.47 +/- 0.125 for the film group, and 0.06 +/- 0.122 for the placebo group. Groups differed significantly (P< 0.02) at end-of-treatment and throughout post-treatment. All treatments were well-tolerated, both peroxide-containing systems exhibited appreciable color retention throughout the 18-month post-treatment period, and there were no meaningful, persistent adverse events seen with long-term follow-up.
Bizhang
Mozhgan
M
Department of Operative and Preventive Dentistry and Endodontics, Heinrich-Heine University, Düsseldorf, Germany. mozhgan.bizhang@med.uni-duesseldorf.de
Müller
Mario
M
Phark
Jin-Ho
JH
Barker
Matthew L
ML
Gerlach
Robert W
RW
D000293:Adolescent; D000328:Adult; D002254:Carbonates / Q000008:administration & dosage / Q000627:therapeutic use*; D003116:Color; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006861:Hydrogen Peroxide / Q000008:administration & dosage / Q000627:therapeutic use*; D007091:Image Processing, Computer-Assisted / Q000379:methods; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D016877:Oxidants / Q000008:administration & dosage / Q000627:therapeutic use*; D023861:Photography, Dental / Q000379:methods; D010919:Placebos; D012449:Safety; D014070:Tooth / Q000473:pathology; D014073:Tooth Bleaching / Q000295:instrumentation* / Q000379:methods; D014075:Tooth Discoloration / Q000473:pathology / Q000628:therapy; D016896:Treatment Outcome; D055815:Young Adult
D002254:Carbonates; D016877:Oxidants; D010919:Placebos; D006861:Hydrogen Peroxide; C034738:sodium percarbonate