Gerlach Robert W, Barker Matthew L
Procter & Gamble Co., Mason, Ohio, USA.
Compend Contin Educ Dent. 2003 Jun;24(6):458, 461-4, 466 passim.
A randomized, examiner-blind, parallel-group, 3-week clinical trial evaluated the efficacy and safety of 3, popular, direct-to-consumer whitening products: a paint-on gel, a whitening dentifrice, and whitening strips. Both the paint-on gel (18% carbamide peroxide) and the whitening strips (6% hydrogen peroxide) were peroxide-based systems, while the dual-phase whitening dentifrice incorporated surface cleaning agents and sodium fluoride, but contained no peroxide. Treatment consisted of twice-daily use over 3 weeks following label instructions, except that strips were applied only during the first 14 days as per the manufacturer's instructions. Tooth color was measured on the maxillary anterior teeth from polarized digital images. Safety was assessed by examination and subject report. A total of 48 healthy adults were randomized, and 42 completed 1 or more post-baseline visits. For the primary efficacy variable delta b*, the adjusted mean +/- standard error reduction in yellowness was -0.06 +/- 0.131 for the dentifrice with no peroxide and -0.21 +/- 0.109 for the 18% carbamide peroxide paint-on gel, compared with -2.53 +/- 0.244 for the whitening strip control. Only the strip group exhibited significant (P < 0.0001) delta b* improvement. Between-group comparisons demonstrated significant and improved whitening for the strip treatment compared with the whitening dentifrice or paint-on peroxide gel, as evidenced by the more than 2-unit improvement in delta b* at week 3. Regardless of the parameter (delta b*, delta L*, delta a*, or delta E*), this represented a significant (P < 0.0001) color improvement for the whitening strips relative to both of the comparative treatments. There were no significant differences in color improvement for the 18% carbamide peroxide paint-on gel used for up to 3 weeks continuously, compared with normal brushing with a dual-phase whitening dentifrice. All products were well tolerated, with no subjects discontinuing treatment early because of adverse events. In head-to-head testing conditions, 14-day use of the 6% hydrogen peroxide whitening strips resulted in superior improvement in tooth color compared with either of the experimental controls.
一项随机、研究者盲法、平行组、为期3周的临床试验评估了3种流行的面向消费者的美白产品的疗效和安全性：一种涂抹式凝胶、一种美白牙膏和美白牙贴。涂抹式凝胶（18%过氧化脲）和美白牙贴（6%过氧化氢）均为基于过氧化物的系统，而双相美白牙膏含有表面清洁剂和氟化钠，但不含过氧化物。治疗方法是按照标签说明在3周内每天使用两次，不过牙贴按照制造商的说明仅在前14天使用。通过偏振数字图像测量上颌前牙的牙齿颜色。通过检查和受试者报告评估安全性。共有48名健康成年人被随机分组，42人完成了1次或更多次基线后访视。对于主要疗效变量Δb*，不含过氧化物的牙膏使牙齿黄度的调整后平均降低值±标准误为-0.06±0.131，18%过氧化脲涂抹式凝胶为-0.21±0.109，而美白牙贴对照组为-2.53±0.244。只有牙贴组的Δb有显著改善（P<0.0001）。组间比较表明，与美白牙膏或涂抹式过氧化物凝胶相比，牙贴治疗的美白效果显著且有所改善，第3周时Δb改善超过2个单位即可证明。无论参数是（Δb*、ΔL*、Δa还是ΔE），相对于两种对照治疗，这都表明白美白牙贴的颜色有显著改善（P<0.0001）。连续使用3周的18%过氧化脲涂抹式凝胶与使用双相美白牙膏正常刷牙相比，在颜色改善方面没有显著差异。所有产品耐受性良好，没有受试者因不良事件提前停止治疗。在直接对比测试条件下，使用6%过氧化氢美白牙贴14天导致牙齿颜色改善优于任何一种实验对照。
