Objective: To compare the efficacy and safety outcomes of a currently marketed, peroxide-containing, tray-based, tooth whitening system to an experimental, peroxide-containing, “trayless” tooth whitening system. Methods: Fifty-seven subjects, 12 to 17 years of age, participated in the study and were divided into two balanced groups. Twelve subjects received custom trays with 10% carbamide peroxide gel Opalescence and were instructed to wear overnight. Forty-five subjects received the experimental 10% hydrogen peroxide on polyethylene strips to wear the for 30 minutes, twice a day. Teeth were bleached for two weeks. Digital image analysis measured efficacy, where DL* indicates lightness, Db* indicates yellowness and DE* represents composite color. Adverse events were recorded. Results: Fifty-one patients completed the study. Twelve subjects (27%) in the polyethylene strip group reported adverse events compared to 5 subjects (42%) in the tray-delivered group. Most reported adverse events (>70%) - were mild. All patients experienced significant color improvement (p < 0.0001) relative to baseline, however, there was no statistically significant difference of whitening between the groups in any of the color parameters.(Db*) for maxillary teeth was -3.38, -3.74 and -2.60, -2.51 for the mandibular teeth, representing the experimental strip group first, then the tray group respectively. DL* for maxillary teeth was 2.36, 2.44 and 1.96, 2.17 for mandibular teeth, representing the experimental strip group first, then the tray group respectively. DE* for maxillary teeth in the strip group was 4.35 and 4.68 in the tray group. DE* for mandibular teeth was 3.53 for the strip group and 3.62 for the tray group. Conclusions: Both experimental groups significantly whitened (p<0.0001); there were no significant differences between the two groups any of the color parameters; both whitening systems were well tolerated, most adverse events being mild in severity. This research was supported, in part, by the Procter and Gamble Co.

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