Topical application of Otosporin® before in-office bleaching: a split mouth, triple-blind, multicenter randomized clinical trial

OBJECTIVES To evaluate if the topical application of Otosporin® before in-office bleaching with a 35% hydrogen peroxide (HP) gel reduces the risk and intensity of tooth sensitivity (TS), as well as the bleaching effectiveness. MATERIALS AND METHODS Twenty participants were selected for this split mouth, triple-blind, multicenter randomized clinical trial. Before each bleaching session, the placebo was applied in the patient's hemi-arch and the other half received the Otosporin®, according to the randomization procedure. Both products were applied topically for 10 min. The 35% HP was applied in two sessions with a 1-week interval. The risk and intensity of TS were assessed using the Numerical Scale (NRS) and the Visual Analog Scale (VAS). The bleaching effectiveness were evaluated with the visual scales and with a digital spectrophotometer. The absolute risk of TS was compared by McNemar's test. To compare the intensity of TS, the Wilcoxon signed-rank test was used to evaluate the NRS, while the paired t test was used to evaluate VAS. Bleaching effectiveness (ΔSGUs and ΔEab, ΔE00, and ΔWID) was compared between groups using the paired t-test (α = 0.05). RESULTS No significant difference at risk (p = 1.0) and intensity of TS (p > 0.59; VAS and p = 1.00 for NRS) was detected between groups. For both groups, a significant bleaching was observed after 30 days of evaluation (p