Objective: This research evaluated the efficacy and safety of 6% hydrogen peroxide whitening strips using an extensive clinical trials database collected over a multi-year period at a single site. Methods: The inclusive meta-analysis used data from 7 different randomized clinical trials conducted at a single site. Each clinical study used 6% hydrogen peroxide whitening strips twice daily for 30 minutes over a 2-week period. Common efficacy (digital images) and safety (examination and interview) methods were used across studies. Pooled subject-level data were analyzed using a general linear mixed model to determine overall response, and the effect of treatment duration on whitening. Results: The 148 treated subjects ranged from 18-71 years of age, with b* (yellowness) ranging from 12-22, and L* (lightness) ranging from 69-80. After 1-week strip use, the adjusted mean (SE) for Db* was –1.6 (0.08), differing significantly from baseline (p < 0.0001). After 2-weeks, the adjusted mean (SE) for Db* was –2.3 (0.07), differing significantly from Week 1 (p < 0.0001). The estimated correlation between Weeks 1 & 2 for Db* was 0.74. Study-to-study variation, a random model effect, contributed less than 2% of all Db* variability. Results were similar for DL*, with Week 1 & Week 2 estimated means (SE) of 1.5 (0.13) and 2.0 (0.12). Tooth sensitivity (20%) and oral irritation (22%) was generally mild and transient. Other side effects were unremarkable, and only 1 subject (0.7%) discontinued treatment early due to an adverse event. Conclusion: The meta-analysis of multiple studies conducted at a single clinical site over a period of years establishes consistent, effective and safe vital bleaching with 6% hydrogen peroxide whitening strips.

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