Gerlach Robert W, Zhou Xiaojie
Worldwide Clinical Investigations-Oral, The Procter & Gamble Company, Mason, Ohio, USA.
Compend Contin Educ Dent. 2004 Aug;25(8 Suppl 2):33-40.
A randomized clinical trial was conducted to compare the whitening effectiveness and tolerability of two daytime, professional, hydrogen-peroxide, vital-bleaching systems. Adults who had never bleached their teeth were randomly assigned to use either 14% hydrogen-peroxide whitening strips or a marketed 9.5% hydrogen-peroxide custom-tray-based system. Maxillary arch treatment was twice daily for 30 minutes for 9 to 21 days, depending on the labeled instructions for use. Whitening response was measured objectively as Lab* (which represent three-dimensional tooth color from light to dark, green to red, and blue to yellow, respectively) from digital images of the maxillary anterior teeth, while comparative at-home tolerability was assessed from bleaching tolerability severity days (BTSD) scores. A total of 31 participants aged 18 to 64 were evaluated. At the end of treatment, the adjusted mean (standard deviation [SD]) delta b* was -3.35 (0.37) for the strips and -1.67 (0.344) for the trays. Treatments differed significantly (P < .05) with respect to delta b*, as well as to delta L* and delta W* values at the end of treatment. Overall, at-home strip use was better tolerated, especially with respect to oral irritation. BTSD means (SD) were 0.09 (0.25) and 0.38 (0.49), with treatments differing significantly (P = .036), favoring the strips. This comparative research demonstrated that at the end of treatment, the 14% hydrogen-peroxide whitening strips resulted in a superior, twofold reduction in yellowness and better in-use tolerability compared to the 9.5% hydrogen-peroxide custom-tray system.
开展了一项随机临床试验，以比较两种日间专业过氧化氢牙齿美白系统的美白效果和耐受性。从未进行过牙齿美白的成年人被随机分配使用14%过氧化氢美白牙贴或市售的9.5%过氧化氢定制牙托系统。根据标签上的使用说明，对上颌牙弓进行每日两次、每次30分钟、持续9至21天的治疗。通过上颌前牙数字图像的Lab值（分别代表从亮到暗、从绿到红、从蓝到黄的三维牙齿颜色）客观测量美白效果，同时根据漂白耐受性严重程度天数（BTSD）评分评估在家使用时的相对耐受性。共评估了31名年龄在18至64岁之间的参与者。治疗结束时，牙贴组调整后的平均（标准差[SD]）Δb为-3.35（0.37），牙托组为-1.67（0.344）。两组治疗在Δb以及治疗结束时的ΔL和ΔW*值方面存在显著差异（P < .05）。总体而言，在家使用牙贴的耐受性更好，尤其是在口腔刺激方面。BTSD平均值（SD）分别为0.09（0.25）和0.38（0.49），两组治疗存在显著差异（P = .036），牙贴组更具优势。这项比较研究表明，治疗结束时，与9.5%过氧化氢定制牙托系统相比，14%过氧化氢美白牙贴使牙齿黄度降低了两倍，且使用耐受性更好。
