临床试验/NCT01501409

NCT01501409已完成不适用

Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis : a Randomised Clinical Trial

Yonsei University0 个研究点目标入组 90 人开始时间: 2010年1月最近更新: 2011年12月29日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Yonsei University
入组人数: 90
主要终点: Number of episodes

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Sodium lauryl sulfate (SLS) is an anionic detergent that has been used as the major or sole surfactant in most dentifrices. But it is known to local irritating factor to oral mucosa and skin and results in many side effects. This study was to compare the effects of SLS-free dentifrice and SLS-containing dentifrice in patients with recurrent aphthous stomatitis (RAS).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
盲法: Double (Participant, Investigator)

入排标准

性别: All
接受健康志愿者: 否

入选标准

•The volunteers had a history of regularly recurring oral ulcerations of at least 6 months duration, with more than one episode per month

排除标准

•already using an SLS-free dentifrice
•taking medications affecting oral ulcers (e.g., corticosteroids)
•having chronic oral mucosal disease (ex, lichen planus, pemphigus vulgaris, pemphigoid, and etc.)
•having allergies to food or medications
•being pregnant

结局指标

主要结局

Number of episodes

时间窗: after 18 weeks

Sum of the number of episodes experienced by the subject over an 8-week period

次要结局

Mean pain score(after 18 weeks)
Number of ulcers(after 18 weeks)
duration of ulcers(after 18 weeks)

研究者

发起方

Yonsei University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Shim Young Joo

research fellow

Yonsei University

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