Objective: The aim of this study was to evaluate the clinical efficacy of a low peroxide containing experimental tooth whitener and a commercially available paint on tooth whiteners over a 21 day usage period. Methods: A total of 55 subjects were randomized to Crest® Night EffectsTM, a 19% sodium percarbonate bleaching film, or an experimental film containing 9.7% sodium percarbonate. Both products were supplied in aluminum bottles with disposable brushes for each usage occasion. Study participants were supplied with written instructions for overnight use. Study duration was 21 days. Efficacy and safety measurements at baseline, 7, 14, and 21 days comprised of oral soft tissue examinations and digital image analysis (DIA). Whitening efficacy was determined by evaluating changes from baseline in tooth yellowness (Db*) and tooth brightness (DL*). Statistical analysis was by ANCOVA. Results: Age ranged from 18-47 years, and groups were balanced on both demographic parameters and baseline L*b* tooth color. After 21 days both treatments showed a significant reduction in tooth yellowness and significant increase in tooth brightness (p ≤ 0.0001). Color improved significantly (p < 0.05) from Day 7 to Day 21. After 21 nights, the Crest Night Effects group had adjusted mean (SE) Δb* and ΔL* of –2.0 (0.19) and 1.8 (0.17). For the experimental group, adjusted mean (SE) Δb* was –1.9 (0.17) and ΔL* was 1.7 (0.15). The experimental and control groups did not differ significantly (p > 0.50) on Δb* or ΔL* at Days 7, 14 or 21. Both treatments were well tolerated. Conclusion: The experimental whitener containing 9.7% sodium percarbonate showed a similar efficacy profile to a commercial brush-applied system throughout the 21-day usage period.

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