2438 Impact of adverse events on color change during vital bleaching: Meta-analysis of 6 clinical trials

R.W. GERLACH, and M.L. BARKER, The Procter & Gamble Co, Mason, OH, USA

Objective: While tooth sensitivity and oral irritation are commonly reported during bleaching, any relationship between these events and effectiveness has not been established. This meta-analysis was conducted to evaluate the impact of adverse events on objectively measured color change during the vital bleaching process.

Methods: Data from 6 randomized clinical trials were included in the metaanalysis. This inclusive data set represented all clinical trials using common entrance criteria and measurement methods. The pooled data were limited to subjects who used 6.0% hydrogen peroxide bleaching strips twice daily over a 14- day period. In all studies, effectiveness (color change) was measured objectively using digital image analysis of the maxillary teeth, while tooth sensitivity and oral irritation were assessed by subject report. The meta-analysis adjusted for study effects, as well as key demographic and baseline values.

Results: A total of 106 subjects were included in the pooled sample. Of these, 23% reported tooth sensitivity and 19% reported oral irritation by Day 14. Mean ∆b* color change (95% CI) was -2.29 (-2.60, -1.98) for symptomatic subjects compared to -2.00 (- 2.26, -1.74) for asymptomatic subjects. By type, subjects having both tooth sensitivity and oral irritation experienced the greatest color improvement with a mean ∆b* (95% CI) of -2.77 (-3.84, -1.71). Subjects having only tooth sensitivity or oral irritation had higher responses than asymptomatic subjects, averaging -2.17 and -2.39 ∆b*, respectively. Findings were generally consistent at Day 7 and across other color parameters (∆L*, ∆a*, ∆E*).

Conclusion: Common adverse events associated with vital bleaching did not degrade color improvement during 14-day treatment with 6.0% hydrogen peroxide whitening strips. Seq #224 - Clinical Evaluations of Tooth Whitening 1:45 PM-3:45 PM, Friday, 8 March 2002 San Diego Convention Center Room 4 (Upper Level)