Objective: This integrated research was conducted to evaluate the efficacy and safety response of a direct application percarbonate tooth whitening system. Methods: A total of 6 randomized, parallel group, placebo controlled clinical trials were conducted involving 218 subjects (aged 12-55 years). All subjects received either a 19% sodium percarbonate bleaching film or its equivalent non-percarbonate placebo to use in the evening, once per day, for 14 days. Product was applied directly to the facial surfaces of anterior teeth leaving the film in situ on the teeth overnight until removal in the morning. Efficacy (L*a*b*) and safety (oral soft tissue examinations) measures were made at baseline and then after 14 days of treatment. In these trials, digital image analysis was used to objectively measure pre- and post-treatment, anterior tooth color in CIE Lab color space as b* (yellow-blue), L* (lightness) and a* (green-red) values. Results: A meta-analysis examining change from baseline of the pooled subject data revealed a significant (p<0.001) change in tooth colour relative to baseline and versus placebo for those subjects assigned to the active bleaching product. An adjusted mean Db* value (with standard error) of –1.59 (0.06) and adjusted mean DL* value of 1.61 (0.07) were recorded for the percarbonate film versus –0.08 (0.07) and 0.22 (0.07) respectively for the placebo product. Analysis of the composite parameters DE* and DW* revealed similar findings. Reports of tooth sensitivity were higher for the active treatment vs placebo ranging 0 – 15% whilst observed/ reported tissue irritation ranged 0 – 32% being similar across both groups. Conclusions: Composite results from these 6 multi-national studies confirm the direct application bleaching film to be well-tolerated and provide a significant tooth whitening benefit after 14 days treatment.

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