School of Dentistry, Federal University of Amazonas, R Ministro Waldemar Pedrosa, n. 1539, Praça 14 de Janeiro, Manaus, AM, 69025-050, Brazil.
Restorative Dentistry, Ponta Grossa State University, Av. General Carlos Cavalcanti, 4748, Ponta Grossa, PR, 84030-900, Brazil.
Clin Oral Investig. 2019 May;23(5):2199-2206. doi: 10.1007/s00784-018-2659-8. Epub 2018 Oct 2.
This single-blind, parallel, randomized clinical trial evaluated the genotoxic potential and effectiveness of 10% hydrogen peroxide (HP) in patients submitted to at-home bleaching.
Sixty young volunteers with maxillary incisors equal to or darker than M1.5 were included in the study. Patients were submitted to bleaching for 14 days (30 min/day) with one of the three 10% HP treatments: the bleaching agent was delivered in a bleaching tray (White Class, FGM), whitening strips (White Strips, Oral-b), or in prefilled disposable trays (Opalescence Go, Ultradent). The color change was evaluated with the Vita Bleachedguide, and the micronucleus test of exfoliative oral mucosa was carried out, starting from a count of 1000 cells, at the baseline, immediately after and 30 days after the end of the treatment. The micronucleus data were evaluated with the Kruskal-Wallis and Wilcoxon tests and color change with the two-way ANOVA test and the Tukey test (α = 0.05).
Significant whitening was observed for all groups after 14 days (p = 0.001) and was maintained after 30 days, with no difference between groups (p = 0.42). The micronucleus count did not indicate genotoxic potential in any of the groups studied (p = 0.32), irrespective of the time intervals (p = 0.62).
No genotoxic effects of 10% HP were observed in patients submitted to at-home bleaching systems (30 min/day for 14 days), even 30 days after the end of treatment.
It is safe to use different systems to deliver 10% HP during at-home bleaching according to the manufacturers' recommendations, with no risk of genotoxic effects applied.
本单盲、平行、随机临床试验评估了 10%过氧化氢（HP）在家用漂白中对患者的遗传毒性潜力和效果。
共有 60 名上颌切牙与 M1.5 等深或更暗的年轻志愿者纳入研究。患者接受三种 10%HP 治疗中的一种，持续 14 天（每天 30 分钟）进行漂白：漂白剂在漂白托盘（FGM 的 White Class）、美白条（Oral-b 的 White Strips）或预填充一次性托盘（Ultradent 的 Opalescence Go）中输送。使用 Vita Bleachedguide 评估颜色变化，在基线、治疗结束后即刻和 30 天后，从 1000 个细胞开始进行脱落口腔黏膜微核试验。微核数据采用 Kruskal-Wallis 和 Wilcoxon 检验进行评估，颜色变化采用双向方差分析和 Tukey 检验（α=0.05）。
所有组在 14 天后均观察到显著的美白效果（p=0.001），并且在 30 天后保持不变，各组之间无差异（p=0.42）。无论时间间隔如何（p=0.62），研究组的微核计数均未表明遗传毒性潜力（p=0.32）。
在家用漂白系统（每天 30 分钟，持续 14 天）中，即使在治疗结束后 30 天，使用 10%HP 也未观察到遗传毒性作用。
根据制造商的建议，在家用漂白中使用不同的系统输送 10%HP 是安全的，不会产生遗传毒性作用。
