2.9%过氧化氢牙贴临床美白效果及安全性评价

The Clinical Whitening Effect and Safety Evaluation of 2.9%Hydrogen Peroxide Tooth Patch

目的验证某款成分为2.9%过氧化氢牙贴的牙齿美白效果,并评价其安全性。方法于某院纳入75名受试者,采用单中心、自身对照试验,每位受试者连续使用试验样品21日,每日使用1次,统计受试者使用后牙齿色阶值和不良反应情况。以实验前(V0)的检测结果为基线数据,分别对使用1周(V1)、2周(V2)、3周(V3)访视的数据与V0访视数据进行配对t检验,检验水准为α=0.025。结果受试者的牙齿在使用牙贴后的1周、2周、3周均可观测到牙齿色阶的改善;与V0相比,V1、V2、V3分别改善了2.24、3.72及5.22,差异具有统计学意义(P≤0.05)。试验期间部分受试者出现牙齿敏感、口腔粘滞及牙龈和唇粘膜酸痛等不适感,但没有受试者报告出现严重的口腔硬组织损伤。结论某款含2.9%过氧化氢的牙贴在使用一周后开始有效改善牙齿色阶,具有美白效果,且不会对使用者的口腔软硬组织产生损伤。

Objectives To verify the whitening effect of a tooth paste with efficacy component of 2.9%hydrogen peroxide,and evaluate the and safety.Methods Seventy-five subjects were enrolled in this study at this Hospital.The single-center,self-controlled experiment was conducted.After informed consent of each subject,they used the test samples for 21 consecutive days,once a day.And the color levels of teeth and adverse reactions of subjects were counted.Paired T-test(α=0.025)was performed on the data from 1 week(V1),2 weeks(V2),and 3 weeks(V3)visits with V0 visits.Results After 21 days,an improvement in the teeth color value was observed.Comparing to V0,the color level of V1,V2 and V3 improved 2.24,3.72 and 5.22,respectively.The teeth whitening effect of the subjects was significantly improved after 1,2 and 3 weeks(P≤0.05).During the test,some of the subjects appeared discomfort such as tooth sensitivity,oral viscosity and sore gums and lip mucosa,but no subjects reported serious oral hard tissue injury.Conclusions 2.9%hydrogen peroxide used in this clinical trial effectively improve the whitening levels of teeth after one week without causing damage to the user's oral soft and hard tissues.