Gerlach Robert W, Barker Matthew L, McMillan Donna A, Sagel Paul A, Walden Gary L
Worldwide Clinical Investigations-Oral, The Procter & Gamble Company, Mason, Ohio, USA.
Compend Contin Educ Dent. 2004 Aug;25(8 Suppl 2):14-20.
A clinical trial was conducted to evaluate the peroxide degradation and dilution kinetics of Crest Whitestrips Supreme, a whitening strip carrying a low, fixed amount of a 14% hydrogen-peroxide bleaching gel. Crest Professional Whitestrips--a 6.5% hydrogen-peroxide strip with a well-established clinical efficacy and safety profile--served as the positive experimental control. A total of 17 healthy adults were enrolled in the crossover study (subjects used both products, and each product was used 4 times by each person). Test strips were applied to the maxillary arch, after which hydrogen-peroxide concentration was measured on the strip, teeth, gingiva, and in saliva over a 60-minute period using standard analytical methods. Treatments were compared at individual time points, and overall using the area-under-the-curve (AUC) calculation of total hydrogen-peroxide exposure (concentration over time). For the higher-concentration strip, hydrogen-peroxide concentration from the strip and teeth samples dropped initially at the 5-minute sampling point, then slowly declined over time. At 30 minutes--the nominal treatment time for these 14% hydrogen-peroxide strips--the median hydrogen-peroxide concentration was 6.2% on the strips and 4.4% on the teeth. In contrast, the gingival and salivary hydrogen-peroxide concentrations were already low and/or below the level of detection by 5 minutes, and remained low throughout the sampling period. Treatments generally differed (P < .001) with respect to hydrogen-peroxide concentrations on the strip and teeth, but not on the gingiva or in the saliva. AUC cumulative measurements through 60 minutes demonstrated 77% higher hydrogen-peroxide levels on teeth for the 14% hydrogen-peroxide strip compared to the 6.5% hydrogen-peroxide strip. This research demonstrates the feasibility of vital bleaching with an exceedingly thin layer of 14% hydrogen-peroxide gel, with little gingival or salivary hydrogen-peroxide exposure.
进行了一项临床试验，以评估佳洁士至尊美白牙贴（一种含有低含量、固定剂量14%过氧化氢漂白凝胶的美白牙贴）中过氧化物的降解和稀释动力学。佳洁士专业美白牙贴（一种具有良好临床疗效和安全性的6.5%过氧化氢牙贴）作为阳性实验对照。共有17名健康成年人参与了这项交叉研究（受试者使用两种产品，每人每种产品使用4次）。将测试牙贴应用于上颌牙弓，之后使用标准分析方法在60分钟内测量牙贴上、牙齿、牙龈及唾液中的过氧化氢浓度。在各个时间点对治疗效果进行比较，并总体上使用总过氧化氢暴露量（浓度随时间变化）的曲线下面积（AUC）计算方法进行比较。对于高浓度牙贴而言，牙贴和牙齿样本中的过氧化氢浓度在5分钟采样点时最初有所下降，然后随时间缓慢下降。在30分钟时（这是这些14%过氧化氢牙贴的标称治疗时间），牙贴上过氧化氢浓度的中位数为6.2%，牙齿上为4.4%。相比之下，牙龈和唾液中的过氧化氢浓度在5分钟时就已经很低和/或低于检测水平，并且在整个采样期间一直保持较低水平。牙贴和牙齿上的过氧化氢浓度在治疗效果上通常存在差异（P < .001），但牙龈或唾液中的浓度不存在差异。通过60分钟的AUC累积测量显示，与6.5%过氧化氢牙贴相比，14%过氧化氢牙贴使牙齿上的过氧化氢水平高出77%。这项研究证明了使用极薄层14%过氧化氢凝胶进行活髓漂白的可行性，且牙龈和唾液中过氧化氢暴露量很少。
