Determination of the Efficacy and Safety of Tooth Whitening Agents

Objectives: To compare the tooth whitening efficacy and tolerance on the maxillary and mandibular arches of two commercially available hydrogen peroxide whitening products after five and seven days of treatment. Methods:  One hundred sixty one subjects were randomized to one of two treatments: Aquafresh^® White Trays™ 11.2% w/w HP (AWT) or Crest Whitestrips Premium 10% w/w HP (CWSP) in this parallel and examiner-blind study.  To participate subjects needed two maxillary and mandibular incisors at a Vita Shade score of A2 or greater.  Subjects began 7 days treatment on the maxillary teeth followed by the same treatment on the mandibular teeth for 7 days.  AWT was worn for 45 minutes once daily, and CWSP twice daily for 30 minutes (manufacturers' instructions).  Subjects brushed twice daily for one minute with a standard toothpaste.  Compliance, efficacy and safety were assessed after 5 and 7 days of treatment.  Results:  After 5 and 7 days of treatment both products produced statistically significant whole mouth tooth whitening from baseline.  Averaging the maxillary and mandibular results, the reduction in Vita Shade for AWT as compared to CWSP was greater by 0.7 shades after 5 days of treatment and by 1.0 shade after 7 days of treatment. The number of subjects experiencing treatment –related oral adverse events, including tooth sensitivity, was statistically significantly lower in the AWT group than in the CWSP group. Conclusion: The AWT formulation demonstrated better whitening efficacy and significantly fewer subjects with oral adverse events as compared to CWSP.