Pascolutti Mauro, Tomic Alex, Milleman Kimberly R, Milleman Jeffery L, Walsh Laurence J
Hismile, Burleigh, QLD 4220, Australia.
Salus Research Inc., Fort Wayne, IN 46825, USA.
Dent J (Basel). 2024 Jun 27;12(7):197. doi: 10.3390/dj12070197.
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 Lab*). 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 ( < 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 ( = 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.
牙齿颜色是面部美学的主要驱动力。虽然通过漂白和修复可以实现牙齿色泽的永久性改变，但仍需要能够引起可逆颜色变化的美容产品。这项随机对照临床研究评估了一种新型色彩校正产品（Hismile™ V34色彩校正精华液™）与安慰剂（不含变色染料的赋形剂对照）的有效性和安全性。采用了单中心、随机、对照、检查者盲法、两组平行设计的一次性研究设计。将测试产品涂在棉签上30秒，然后冲洗掉。使用Vita Bleachedguide 3D-Master比色板和EasyShade Advanced 4.0分光光度计（用于测定Lab值）在基线、即刻、30分钟和60分钟时测量上颌中切牙的牙齿颜色。受试者（N = 60）的基线颜色为1M2（第9级）或更深。根据比色板，单次使用测试产品可立即显著改善三个色阶（26.2%）（P < 0.001），同样显著的效果持续到30分钟和60分钟。安慰剂产品未改变牙齿颜色（P = 0.326）。这些变化伴随着L值（白度）在30分钟内显著改善，以及b值（黄度）在60分钟内降低。在一项调查中，使用测试产品的受试者中有三分之二表示他们的牙齿看起来更白更亮。使用测试产品或赋形剂对照均未出现安全问题。这些结果表明，使用色彩校正剂可在长达60分钟内实现牙齿颜色的显著变化。
