摘要
目的评价含10%过氧化氢的美白牙贴对牙齿的美白效果和安全性。方法采用双盲、单中心的临床研究方法。根据数字成像系统记录的上前牙的牙齿颜色、性别和年龄将54名研究对象随机地分为两组,使用实验和对照牙贴,每天两贴,每贴30分钟,7天共用14贴。于基线、使用牙贴第9天,检查研究对象数字成像系统记录的牙齿颜色变化、口腔软组织的健康状况。结果共有50名研究对象完成了该研究。7天使用14贴牙贴后:实验组使用牙贴后与使用前比较,牙齿各项颜色指标都有明显变化(P<0.001),其中△b*值为-1.96±0.085,△L*值为2.16±0.136;实验组与对照组比较,各项颜色指标也都有显著改变(P<0.001),其中△b*的组间差值为-1.75±0.118,△L*的组间差值为1.87±0.154。牙齿的白度(b*)和亮度(L*)都有明显改善,差异具有明显统计学意义。实验组有轻度口腔黏膜刺激症状的占16%,有牙本质过敏症状的占60%,这些不良反应都在停用产品2周内基本消失。结论7天使用14贴含10%过氧化氢的美白牙贴,能使牙齿明显亮白,没有明显不良反应。
Objective A placebo controlled clinical trial was conducted to evaluate the clinical effectiveness and safety of a 10 % hydrogen peroxide whitening strip. Methods In this double - blind clinical trial, 54 adults were randomized to either a group with the 10 % hydrogen peroxide whitening strip or a group with the placebo strip, The strips were applied unsupervised to the maxillary teeth twice daily,30 minutes each application for 7 days with a total of 14 applications. Efficacy was determined by comparing the color changes of the digital images and the health status of the oral soft tissue between the baseline and the Day 9th （the end of the trial）, Results Comparing to the placebo, the 10 % strip group showed a significant（ P 〈0.001） color improvement for all color parameters at the end of the trial. The △b＊ means± standard errors were -1.96±0.085 and -0.22±0.830 for the hydrogen peroxide and placebo groups, respectively, The △L＊ means standard ± errors were 2.16± 0.136 in the hydrogen peroxide group and 0. 29± 0. 072 in the placebo, Oral irritation was reported by 16% of the users and increased tooth sensitivity was reported by 60% of the users in the hydrogen peroxide group. These adverse events were recovered within 2 weeks after the application. Conclusion This placebo- controlled clinical trial demonstrated that the use of a 10 % hydrogen peroxide strip twice a day yielded significant tooth whitening effect within one week without significant side effects.
出处
《现代口腔医学杂志》
CAS
CSCD
北大核心
2005年第6期584-587,共4页
Journal of Modern Stomatology
关键词
美白牙贴
有效性
安全性
数字成像
Whitening strip Efficacy Safety Digital image system
