Placebo-controlled trial evaluating safety with 12-months continuous use of 6% hydrogen peroxide whitening strips.
OBJECTIVE
To assess the safety and tolerability of 6% hydrogen peroxide whitening strips over 12 months.


METHODS
80 adults were randomly assigned equally to one of two treatments: 6% hydrogen peroxide strips or placebo strips. Strips were worn 5 min daily for 12 months. Safety and tolerability were assessed via oral status interviews and oral examinations at baseline and after 1, 2, 3, 6, 9, and 12 months of use.


RESULTS
Tooth sensitivity and oral irritation were the two most common adverse events. After 12 months use, tooth sensitivity was reported by 10% of subjects in the 6% strip group with a 95% confidence interval (CI) of (2.8%, 23.7%) and 5% of subjects in the placebo group with a 95% CI of (0.6%, 16.9%). The occurrence of reported oral irritation was 0% in the 6% strip group with a 95% CI of (0%, 8.8%) and 2.5% in the placebo strip group with a 95% CI of (0.1%, 13.2%). The occurrence of observed oral irritation was also similar between groups. The groups did not differ significantly (p>0.67) for the percent of subjects with each type of adverse event. In the 6% strip group, two subjects discontinued product use due to an adverse event (tooth sensitivity) compared to no subjects in the placebo group. Groups did not differ significantly (p>0.49) with respect to this outcome.


CONCLUSIONS
Use of 6% hydrogen peroxide whitening strips over 12 months resulted in a safety profile similar to that seen with placebo strips.
Farrell
S
S
The Procter & Gamble Company, 8700 Mason-Montgomery Road, Mason, OH, USA. farrell.s.2@pg.com
Barker
M L
ML
McMillan
D A
DA
Gerlach
R W
RW
D000328:Adult; D003807:Dentin Sensitivity / Q000139:chemically induced*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005882:Gingival Diseases / Q000139:chemically induced; D006801:Humans; D006861:Hydrogen Peroxide / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D014073:Tooth Bleaching / Q000379:methods*; D055815:Young Adult
C488279:Crest whitestrips; D006861:Hydrogen Peroxide