Oral Tolerability of Hydrogen Peroxide Whitening Gel Formulations

Objectives: To evaluate the oral tolerability and efficacy of three hydrogen peroxide whitening gel formulations after seven days of treatment. Methods: This was a randomized, parallel group, longitudinal, examiner-blinded study to evaluate the efficacy and safety of 3 experimental approximately 10% hydrogen peroxide (HP) gels predosed in a flexible tray. One hundred fifty seven subjects with a Vita® Shade of A1 or greater (value-oriented scale) on two of the four maxillary incisors were randomized to one of three treatments to be used once daily for 45 minutes. These products were as follows: Experimental Product 1 Carbopol/silica 11.2% HP gel (CS), Experimental Product 2 Carbopol 11.2% HP gel (C 11.2) or Experimental Product 3 Carbopol 10.5% HP gel (C 10.5). Vita shade, subject compliance, and safety were assessed at all visits. Results:For all three treatment legs the number and type of oral findings were similar to what has been reported with the use of marketed whitening products. The number of subjects with findings in the CS leg was directionally lower than in the two other legs after seven days of treatment. (9.65% vs 19.6% for C 11.2 and 18.5% for C 10.5).Reductions in Vita Shade were 3.3, 3.5 and 3.3 for CS, C 11.2 and C 10.5 respectively. Conclusion: The Carbopol/Silica formulation demonstrated a similar safety profile to the two other experimental products and had a lower incidence of oral findings. Similar whitening efficacy between the three formulations was demonstrated.