A Clinical Study to Evaluate the Safety and Efficacy of a New Whitening System

Dental whitening is a fast way to recover the natural whiteness of the smile, and lighter teeth are considered synonymous with good hygiene, beauty and health. Today whitening has become a well-accepted aesthetic procedure. Objective: This was a randomized, multi-center, double-blind study with parallel groups to evaluate the safety and efficacy of a whitening dental system using polyethylene strips coated with a 6.5% H₂O₂ gel. Methods: Strips were worn for 30 minutes two times a day for 3 weeks. Efficacy was evaluated using digital image analysis measuring L*a*b* tooth color. Safety was assessed based on oral irritation, tooth sensitivity, and adverse events. Results: Thirty subjects were randomized into two groups. The first group (n=15) used strips containing H₂O₂. At the end of treatment, baseline results were compared with those obtained at 21 days for reduction in yellowness (Db*), giving an adjusted mean and standard errors of –4.59 ± 0.227. Results for the second group (n=15) using placebo strips were –0.66 ± 0.234. The difference between both groups was –3.93 ± 0.326, differing significantly (p < 0.0001). Both treatments were well-tolerated. Conclusion: The strips offer comfort, convenience and brief contact time compared to other professional whitening systems. (This study was supported by The Procter & Gamble Co.)