Objectives: This randomized, examiner-blind, parallel-group, clinical trial evaluated the efficacy and safety of a whitening pre-brushing mouthrinse compared to a strip control. Methods: 48 subjects were randomly assigned to the 2% hydrogen peroxide pre-rinse (Listerine® Whitening Pre-Brush Rinse) or 10% hydrogen peroxide strips (Crest® Whitestrips® Premium Plus). Following the manufacturer's instructions, the pre-rinse group rinsed with 15 mL twice daily for 16 days (one 473 mL bottle), while the control group wore strips for 30 min twice daily over a 10 day period. Efficacy and safety were evaluated at Baseline and again at Days 2, 3, 11, and 17. Tooth color (L*a*b*) was measured objectively from standardized digital images of the maxillary anterior teeth, while safety was assessed from clinical examination and subject report. Results: The study population (63% female) ranged in age from 19-62 years. After 1 day's use, the mean (SD) for Db* yellowness was –0.43 (0.49) for the strip group, compared to –0.04 (0.31) for the peroxide rinse group. Outcomes were similar for DL* brightness, with only the strip group exhibiting significant (p < 0.0003) color improvement from baseline at this initial timepoint. The strip group continued to exhibit significant (p < 0.0001) color improvement over time through Day 11 (end-of-treatment for strips), while the peroxide rinse showed no evidence of color improvement with continued use. At Day 17, mean (SE) Db* was –1.8 (0.15) for the strip group compared to +0.2 (0.16) for the peroxide rinse. Groups differed significantly (p < 0.0001) for Db*, as well as other color parameters. Minor tooth sensitivity and oral irritation were the most common adverse events. Conclusion: One day use of hydrogen peroxide whitening strips yielded significantly greater whitening than 1 bottle of peroxide rinse used over a 16 day period.

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