Barlow Ashley, Gerlach Robert W, Date Robert F, Brennan Kieran, Struzycka Izabela, Kwiatkowska Anna, Wierzbicka Maria
Procter & Gamble Company, Mason, OH, USA.
J Clin Dent. 2003;14(3):59-63.
A randomized, examiner-blind parallel design study was conducted to evaluate the clinical efficacy and tolerability of two brush-applied, peroxide-based tooth whiteners.
A total of 38 subjects were randomized to Colgate Simply White, an 18% carbamide peroxide paint-on liquid in an applicator bottle, or Crest Night Effects, a 19% sodium percarbonate system in unit dose sachets that dries to form an adherent film. Treatment was for 14 days. The 18% carbamide peroxide gel was applied twice daily, while the 19% sodium percarbonate film was applied for overnight use. Subjects were evaluated at baseline, and again after 7 and 14 days of treatment using digital images to assess tooth color, and oral examinations to establish safety. Whitening efficacy was determined by evaluating the reduction in tooth yellowness (delta b*), increase in tooth brightness (delta L*), reduction in tooth redness (delta a*) and overall tooth color change relative to pure white (delta W*).
After 14 days, the mean change in yellowness (delta b*) was -1.43 +/- 0.20 for the 19% sodium percarbonate film, and -0.44 +/- 0.06 for the 18% carbamide peroxide gel. Mean change in brightness (delta L*) was 1.13 +/- 0.13 and 0.55 +/- 0.13 in the film and gel groups, respectively. Between-group comparisons showed highly significant (p < or = 0.003) whitening for the 19% sodium percarbonate film compared to the 18% carbamide peroxide gel for all 14-day color measurements (delta b*, delta L*, delta a* or delta W). Both products were well-tolerated, with no subjects discontinuing treatment early due to a causal adverse event.
In a direct clinical comparison of two brush-applied products over 14 days, Crest Night Effects provided significant and meaningful improvement in tooth color, representing more than double the whitening measured for the Colgate Simply White.
开展一项随机、研究者设盲的平行设计研究，以评估两种刷涂式过氧化物基牙齿美白剂的临床疗效和耐受性。
共有38名受试者被随机分为两组，一组使用高露洁亮白牙贴（Colgate Simply White），这是一种装在涂抹瓶中的含18%过氧化脲的液体；另一组使用佳洁士夜间美白（Crest Night Effects），这是一种单位剂量小包装中的含19%过碳酸钠的系统，干燥后形成粘附性薄膜。治疗为期14天。含18%过氧化脲的凝胶每天涂抹两次，而含19%过碳酸钠的薄膜则用于夜间使用。在基线时对受试者进行评估，并在治疗7天和14天后再次评估，使用数字图像评估牙齿颜色，并通过口腔检查确定安全性。美白效果通过评估牙齿黄度降低（Δb*）、牙齿亮度增加（ΔL*）、牙齿红度降低（Δa*）以及相对于纯白色的整体牙齿颜色变化（ΔW*）来确定。
14天后，含19%过碳酸钠薄膜组的黄度平均变化（Δb*）为-1.43±0.20，含18%过氧化脲凝胶组为-0.44±0.06。薄膜组和凝胶组的亮度平均变化（ΔL*）分别为1.13±0.13和0.55±0.13。组间比较显示，对于所有14天的颜色测量值（Δb*、ΔL*、Δa或ΔW），含19%过碳酸钠薄膜与含18%过氧化脲凝胶相比，美白效果具有高度显著性（p≤0.003）。两种产品耐受性良好，没有受试者因因果性不良事件而提前终止治疗。
在一项为期14天的两种刷涂式产品的直接临床比较中，佳洁士夜间美白在牙齿颜色方面提供了显著且有意义的改善，其美白效果是高露洁亮白牙贴的两倍多。
