Abstract

Objective: This clinical study evaluated the efficacy and tolerability of tooth whitening in children and adolescents, using a marketed, tray- based tooth-whitening system and a disposable polyethylene strip system. Materials and Methods: A study population of 106 children and adolescents, ages 11 to 18 years, participated in this study. There were 61 girls and 45 boys, with a mean age of 14.7 years. Subjects were divided into two experimental treatment groups, the groups being balanced with respect to demographic characteristics and baseline tooth color. All subjects had to have all permanent anterior teeth erupted, a baseline Vita shade (Vita Zahnfabrik, Bad Sackingen, Germany) score of A2 or darker, and the desire to whiten their teeth. One experimental group included 71 subjects who used a 6.5% hydrogen peroxide strip system (Crest Whitestrips Professional Strength, Procter & Gamble, Mason, OH, USA) for 30 minutes twice daily. The other experimental group included 35 subjects who used a 10% carbamide peroxide tray system (Opalescence, Ultradent Products, South Jordan, UT, USA) overnight. Subjects who had previously vital bleached their teeth, exhibited apparent caries or periodontal problems, had orthodontic appliances or anterior restorations, or reported dentin hypersensitivity were excluded. The study population was treated in two separate cohorts, by two independent investigations, to minimize the effects of examiner bias. Digital images were collected for all subjects at baseline, 2 weeks, and 4 weeks, with the maxillary and mandibular arches being treated separately for 4-week intervals. An oral examination was conducted at baseline and at all recall intervals. Subjects reported any adverse events in interviews. Color change was calculated from digital images where L* indicated lightness, a* redness, and b* yellowness. Comparisons between the two experimental groups were made using a two-sided analysis of covariance with a 5% significance level. Results: Both experimental systems exhibited significant (p < .001) tooth-whitening improvement relative to the baseline. Color change was greater in the maxillary teeth than in the mandibular teeth for both systems evaluated. The color change for maxillary teeth was not significantly different between the two systems evaluated; however, the tray system demonstrated significantly (p < .05) greater toothwhitening effectiveness for the mandibular teeth. Both treatment regimens were well tolerated. Minor tooth sensitivity and oral irritation were the most commonly reported adverse events, being reported by 49% of the subjects assigned to the strip group and 43% of the subjects in the tray group. All reported that adverse events were relieved immediately upon discontinuance of product use. Conclusion: The 6.5% hydrogen peroxide gel strips and the 10% carbamide peroxide gel delivered overnight in customized trays effectively whitened teeth, and both treatment regimens were well tolerated.

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