Objective: This article reported the cumulative findings from three controlled, randomized clinical trials evaluating the efficacy and tolerability of tooth whitening in children and adolescents using disposable polyethylene strip systems.
Materials and Methods: The study population included 132 children and adolescents, ages 10 to 18 years. (Please note that 71 of these subjects were identified in the previous review.) Fifty‐three percent of the subjects were female and 47% were male, with a mean age of 14.4 years. Subjects were divided into experimental treatment groups by balancing groups with respect to demographic characteristics and baseline tooth colors.
Subiects were treated with either 5.3% or 6.5% hydrogen peroxide gel polyethylene strips. All subjects had to have all permanent anterior teeth erupted, a baseline Vita shade (Vita Zahnfabrik, Bad Säckingen, Germany) score of A2 or darker, and a desire that their teeth be whitened. One study included subjects who had previously received comprehensive orthodontic treatment.
Digital images were collected for all subjects at baseline, 2 weeks, and 4 weeks. Oral examinations and interviews were conducted at each appointment to evaluate adverse events.
Color change was calculated from the digital images in the same manner previously described.
Results: The 5.3% and 6.5% hydrogen peroxide strips used for 30 minutes twice a day yielded significant tooth whitening (p < .0001) after 14 days. For the primary whitening parameter, δb*, continued treatment during the 14‐ to 28‐day period resulted in significant additional reduction in yellowness (p < .0001). Subjects treated with 6.5% hydrogen peroxide strips experienced significantly (p < .03) greater reduction in yellowness (approximately 0.8 δb* units) compared with those who used the 5.3 hydrogen peroxide strips.
The hydrogen peroxide strips were tolerated well in all of these studies, with minor tooth sensitivity and oral irritation being the primary complaints. Eighteen subjects (14%) reported oral irritation, whereas 30 subjects (23%) reported tooth sensitivity. All adverse events were relieved upon discontinuance of product use.
Conclusion: The 5.3% and 6.5% hydrogen peroxide gel strips used for 30 minutes twice a day effectively whitened teeth, and both regimens were well tolerated.