Objectives: A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate clinical response with a brush-applied, peroxide-based, overnight tooth whitener. Materials and Methods: A total of 34 adults were randomized to a 9.7% sodium percarbonate gel that dries as a film (Crest® Night Effects™ Sensitivity) or placebo. Treatment was brush-applied after oral hygiene for 18 nights, and all use was unsupervised. Subjects were evaluated at baseline, Day 10 (intermediate) and Day 19 (end-of-treatment). Efficacy was determined by evaluating reduction in tooth yellowness (Db*) and increase in tooth brightness (DL*) from standardized maxillary digital images, and safety was assessed from clinical examination and interview. Results: Age ranged from 18-65, with females comprising 56% of the sample. Relative to baseline, the 9.7% sodium percarbonate film group had significant (p < 0.02) reduction in yellowness at the intermediate visit, with improvement continuing through end-of-treatment. Relative to placebo, Day 19 adjusted mean (SE) differences were -1.00 (0.202) for Db* and 0.55 (0.256) for DL*, with groups differing significantly (p < 0.05). Both treatments were generally well-tolerated. In the percarbonate group, 2 subjects (12%) had mild oral irritation, while none (0%) had tooth sensitivity. Conclusion: This randomized, double-blind, placebo-controlled clinical trial demonstrated significant tooth whitening for a 9.7% sodium percarbonate film over 18 nights without appreciable tooth sensitivity.

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