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过氧化氢条和过碳酸钠膜长期颜色稳定性的临床试验

Clinical trial of long-term color stability of hydrogen peroxide strips and sodium percarbonate film.

作者信息

Bizhang Mozhgan, Müller Mario, Phark Jin-Ho, Barker Matthew L, Gerlach Robert W

机构信息

Department of Operative and Preventive Dentistry and Endodontics, Heinrich-Heine University, Düsseldorf, Germany.

出版信息

Am J Dent. 2007 Sep;20 Spec No A:23A-27A.

PMID:19681255
Abstract

PURPOSE

To compare initial and sustained clinical response of 6% hydrogen peroxide whitening strips and a 19% sodium percarbonate film in a randomized controlled trial.

METHODS

Informed consent was obtained, after which 72 subjects were randomized to 6% hydrogen peroxide whitening strips (Crest Whitestrips), 19% sodium percarbonate brush-applied gel that dries as a film (Crest Night Effects), or placebo brush-applied gel without peroxide. Efficacy (digital imaging) and safety (clinical examination and interview) were assessed after 2 weeks treatment, and again at up to eight post-treatment timepoints over an 18-month post-treatment period.

RESULTS

For Deltab* (yellowness), end-of-treatment adjusted means +/- standard errors (SE) were -2.37 +/- 0.088 for the strip group, -1.36 +/- 0.091 for the film group, and -0.08 +/- 0.090 for the placebo group. For DeltaL* (brightness), end-of-treatment adjusted means +/- SE were 2.40 +/- 0.121 for the strip group, 1.47 +/- 0.125 for the film group, and 0.06 +/- 0.122 for the placebo group. Groups differed significantly (P< 0.02) at end-of-treatment and throughout post-treatment. All treatments were well-tolerated, both peroxide-containing systems exhibited appreciable color retention throughout the 18-month post-treatment period, and there were no meaningful, persistent adverse events seen with long-term follow-up.

摘要

目的

在一项随机对照试验中比较6%过氧化氢美白牙贴和19%过碳酸钠薄膜的初始和持续临床反应。

方法

获得知情同意后,72名受试者被随机分为三组,分别使用6%过氧化氢美白牙贴(佳洁士美白牙贴)、19%过碳酸钠刷涂凝胶(干燥后形成薄膜,佳洁士夜间美白)或不含过氧化物的安慰剂刷涂凝胶。在治疗2周后评估疗效(数字成像)和安全性(临床检查和访谈),并在治疗后的18个月内,在多达8个治疗后时间点再次评估。

结果

对于Δb*(黄度),治疗结束时调整后的均值±标准误(SE),牙贴组为-2.37±0.088,薄膜组为-1.36±0.091,安慰剂组为-0.08±0.090。对于ΔL*(亮度),治疗结束时调整后的均值±SE,牙贴组为2.40±0.121,薄膜组为1.47±0.125,安慰剂组为0.06±0.122。治疗结束时及整个治疗后各组间差异显著(P<0.02)。所有治疗耐受性良好,两种含过氧化物的系统在整个18个月的治疗后期间均表现出明显的颜色保持,长期随访未发现有意义的持续性不良事件。

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Paediatric dentistry- novel evolvement.儿童牙科学——新进展
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