Nathoo Salim, Stewart Bernal, Petrone Margaret E, Chaknis Pat, Zhang Yun Po, DeVizio William, Volpe Anthony R
Oral Health Clinical Services, Piscataway, NJ, USA.
J Clin Dent. 2003;14(3):64-9.
The objective of this randomized, double-blind, parallel-group clinical study was to compare the tooth whitening efficacy of two tooth whitening gel products--Colgate Simply White Night Clear Whitening Gel containing either 25% carbamide peroxide, or 8.7% hydrogen peroxide--when used once daily at night.
Following a baseline tooth shade evaluation using the Vita Shade Guide, qualifying adult male and female subjects from the Central New Jersey area were randomized into two treatment groups, which were balanced for baseline Vita Shade Guide scores, gender and age. The treatment groups were: 1) a tooth whitening gel containing 25% carbamide peroxide; or 2) a tooth whitening gel containing 8.7% hydrogen peroxide. All subjects were given a commercially available, non-whitening dentifrice and a soft-bristled toothbrush at the beginning of the study. In addition, they were also given one of the two tooth whitening gel products. All subjects were instructed to brush their teeth for one minute twice daily (morning and evening) with the non-whitening toothpaste. The subjects were further instructed to apply their assigned tooth whitening gel product once daily at night, per the instructions provided. Evaluations of tooth shade for each subject were repeated after two weeks, and again after three weeks of product use.
Fifty-nine (59) subjects complied with the protocol and completed the three-week study. At both the two-week and three-week examinations, all subjects exhibited statistically significant (p < 0.05) tooth shade lightening relative to baseline tooth shade. Further, there was no statistically significant difference in tooth shade lightening between the two tooth whitening gel products.
The results of this clinical study indicate that after once daily use at night for two or three weeks, a tooth whitening gel containing 25% carbamide peroxide and a tooth whitening gel containing 8.7% hydrogen peroxide both provided statistically significant tooth shade lightening relative to baseline tooth shade. The results also showed that there was no statistical difference in tooth whitening efficacy between the two tooth whitening gel products.
本随机、双盲、平行组临床研究的目的是比较两种牙齿美白凝胶产品——含25%过氧化脲的高露洁夜间亮白清新美白凝胶或含8.7%过氧化氢的该款凝胶——每晚使用一次时的牙齿美白效果。
使用Vita比色板进行基线牙齿色度评估后，来自新泽西州中部地区符合条件的成年男性和女性受试者被随机分为两个治疗组，两组在基线Vita比色板评分、性别和年龄方面保持均衡。治疗组分别为：1）含25%过氧化脲的牙齿美白凝胶；2）含8.7%过氧化氢的牙齿美白凝胶。在研究开始时，所有受试者均获得一种市售的非美白牙膏和一把软毛牙刷。此外，他们还获得两种牙齿美白凝胶产品中的一种。所有受试者均被指示每天早晚用非美白牙膏刷牙各一分钟。受试者还被进一步指示按照提供的说明每晚使用一次分配给他们的牙齿美白凝胶产品。在产品使用两周后以及三周后，对每位受试者的牙齿色度进行重复评估。
59名受试者遵守了方案并完成了为期三周的研究。在两周和三周检查时，所有受试者相对于基线牙齿色度均表现出具有统计学意义（p < 0.05）的牙齿色度变浅。此外，两种牙齿美白凝胶产品在牙齿色度变浅方面没有统计学意义上的差异。
本临床研究结果表明，每晚使用一次，持续两到三周后，含25%过氧化脲的牙齿美白凝胶和含8.7%过氧化氢的牙齿美白凝胶相对于基线牙齿色度均提供了具有统计学意义的牙齿色度变浅。结果还表明，两种牙齿美白凝胶产品在牙齿美白效果上没有统计学差异。
