Abstract:
Tooth color is a major driver of facial esthetics. While permanent changes in tooth shade can be achieved by bleaching and restorations, there is a need for cosmetic products that can cause reversible color changes. This randomized controlled clinical study assessed the effectiveness and safety of a novel color-correcting product (Hismile™ V34 Color Corrector Serum™) versus a placebo (vehicle control lacking the color-change dyes). A single-center, randomized, controlled, examiner-blind, two-group, parallel design, single-use study design was followed. The test products were applied on a cotton bud for 30 s, and then, rinsed off. Tooth shade for maxillary central incisors was measured at baseline, immediately, and at 30 and 60 min, using the Vita Bleachedguide 3D-Master® Shade Guide and the EasyShade Advanced 4.0 spectrophotometer (for determining values of L*a*b*). The subjects (N = 60) had a baseline shade of 1M2 (rank 9) or darker. A single application of the test product resulted in an immediate and significant (p < 0.001) three shade improvement (26.2%) according to the shade guide, and the same significant benefits extended to 30 and 60 min. The placebo product did not alter tooth shade (p = 0.326). These changes were accompanied by significant improvements in the L value (whiteness) up to 30 min, and a reduction in b* (yellowness) for up to 60 min. Two-thirds of subjects using the test product stated in a survey that their teeth appeared both whiter and brighter. No safety issues arose from the use of the test product or vehicle control. These results indicate that using a color corrector can achieve worthwhile changes to tooth shade for up to 60 min.
摘要:
牙齿颜色是面部美学的主要驱动力。虽然牙齿色调的永久变化可以通过漂白和修复来实现,需要能够引起可逆颜色变化的化妆品。这项随机对照临床研究评估了新型颜色校正产品(Hismile™V34ColorCorrectorSerum™)与安慰剂(缺乏变色染料的媒介物对照)的有效性和安全性。单中心,随机化,控制,检查官盲,两组,并行设计,采用一次性研究设计.将测试产品应用于棉签上30s,然后,冲洗掉。在基线测量上颌中切牙的牙齿阴影,立即,在30分钟和60分钟,使用VitaBleachedguide3D-Master®Shade指南和EasyShadeAdvanced4.0分光光度计(用于确定L*a*b*值)。受试者(N=60)具有1M2(等级9)或更暗的基线阴影。根据遮阳指南,测试产品的单次施用导致立即且显着的(p<0.001)三个遮阳改善(26.2%),和相同的显着的好处延长到30和60分钟。安慰剂产品没有改变牙齿色调(p=0.326)。这些变化伴随着长达30分钟的L值(白度)的显着改善,和b*(黄色)的减少长达60分钟。三分之二的使用测试产品的受试者在一项调查中表示,他们的牙齿看起来更白更亮。使用测试产品或车辆控制没有安全问题。这些结果表明,使用颜色校正器可以在长达60分钟的时间内实现对牙齿阴影的有价值的改变。