Clinical trial evaluating two peroxide whitening strips used by teenagers.
Double-blind clinical research was conducted to compare the clinical response of a thin, concentrated peroxide whitening strip (relative to a marketed control) among a teenage population with preceding safety and efficacy data. Informed consent and child assent was obtained from 48 teens, 13-17 years of age. After baseline measurements were taken, subjects were divded randomly into two groups, one using a thin 10% hydrogen peroxide whitening strip, the other using a 6.5% hydrogen peroxide strip with a thicker gel layer. Strip use was 30 minutes twice per day for 22 days on the maxillary arch, followed by 22 days on the mandibular arch. Efficacy was measured objectively based on L*a*b* color change from digital images taken every 11 days, where L* indicates lightness and b* indicates blue-to-yellow shade. The mean age was 15.1 (+/-1.5) years. Relative to baseline, both strip groups experienced significant (p < 0.0001) color improvement for yellowness (deltab*) and lightness/brightness (deltaL*) beginning at the first visit (Day 11). Continued use resulted in significant color improvement through Day 22. Groups did not differ significantly (p > 0.33) with respect to combined deltab* or deltaL* at end-of-treatment. Tooth sensitivity and oral irritation represented the most common adverse events. No subject discontinued early due to a treatment-related adverse event. Teenagers who used either 10% hydrogen peroxide gel or 6.5% hydrogen peroxide gel whitening strips twice a day for 44 days saw significant tooth whitening without serious adverse events.