Methods: This was a randomized, parallel group, longitudinal, examiner-blinded study to evaluate the efficacy and safety of 10% w/w hydrogen peroxide gel predosed in a flexible tray (experimental product). Seventy-four subjects with a Vita Shade of A3 or greater based on a Shade Guide value-oriented scale were enrolled in the study. At baseline subjects were assigned to either the experimental product to be worn once daily for 45 minutes and toothpaste or toothpaste only to use over a seven day period. The subjects returned to the site for assessments after 5 and 7 days of treatment. After their home application of treatment on Day 3, each subject answered a tooth whitening efficacy question regarding the appearance of their teeth. Vita shade, subject compliance, and safety were assessed at all visits. Efficacy was based on mean change from baseline in Vita shade of the facial surfaces of the maxillary incisors after seven days of active treatment
Results: For subjects using the experimental whitening gel, there was a statistically significant improvement in whitening compared to brushing only of 2.0 and 3.5 shades, respectively for Day 5, and Day 7. 71.4% of subjects using the experimental product responded that their teeth were whiter compared to before they started using the product as compared to 13.9% in the Brushing Only group. Oral soft tissue irritation and tooth sensitivity were similar to what has been reported with the use of marketed whitening products.
Conclusion: The experimental whitening product is safe and effective for the whitening of intrinsic tooth stain.