Objective: This research was conducted to evaluate the clinical effectiveness of two direct-to-consumer whitening products and a positive control. Methods: Data from two randomized clinical trials having common entrance criteria were conducted to evaluate a paint-on gel containing 18% carbamide peroxide (Colgate® Simply White™), a dual-phase whitening dentifrice (Crest® Vivid White™) without carbamide peroxide, and a 10% carbamide peroxide, tray-based, positive control (Opalesence®). Subjects were given manufacturer instructions for use. In each trial, whitening was measured objectively on the maxillary anterior teeth via digital image analysis using well-established and standard methods for L*a*b* color change. A meta-analysis was conducted using the pooled raw data from the two clinical trials. Mean change in b* and L* were separately analyzed using a general linear model. Results: The pooled sample included 83 subjects with mean (SD) age of 36 ± 14. Following 2 weeks of use the adjusted mean (SE) for Δb* was -1.83 (0.12) for the positive control group, -0.16 (0.12) for the dual-phase dentifrice group, and -0.04 (0.12) for the paint-on gel group. The positive control group had significant greater improvement in b* than both the dentifrice and paint-on gel groups (p < 0.001). The dual-phase dentifrice group had directional but not significantly different mean improvement relative the paint-on gel group. Results were similar with respect to L*. All treatments were well tolerated over the 14-day treatment period. Conclusion: In this meta-analysis of two randomized, positive-controlled clinical trials, a dual-phase dentifrice exhibited similar whitening efficacy relative to an 18% carbamide peroxide paint-on gel.

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