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临床试验/NCT06960278
NCT06960278已完成1 期

Effect of Alum Stone Containing Mucosal Adhesive Patches on Healing of Recurrent Aphthous Stomatitis: A Randomized Double-blinded Placebo-controlled Clinical Trial

University Of Anbar2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年2月5日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
100
试验地点
2
主要终点
Lesion Size

研究概览

简要总结

The evaluation of recurrent aphthous stomatitis (RAS) was performed by an oral medicine specialist, who relied on the clinical manifestations of the condition. The experimental group was administered 1x1cm mucosal patches containing alum stone at a concentration of 7%, whereas the control group was given placebo patches without any active medication. Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5. Statistical analysis was performed with repeated measures ANOVA using R software.

详细描述

The study's results indicated that the utilization of alum stone in mucosal adhesive patches yielded significant reductions in size of aphthous lesions and degree of pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
22 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • individuals who had a history of RAS, with oral ulceration occurring at least once a month and persistent oral ulceration being present in the majority of patients. Additionally, individuals with mild aphthous ulcer, characterized by ulcer development lasting fewer than three days, were also included.

排除标准

  • Exclusion criteria encompassed the following: Pregnancy or lactation, systemic disorders linked to aphthous ulcers, such as Crohn's disease, Reiter's syndrome, and people who smoke or use cigarettes. Participants who were getting pharmacological therapy for fungal or viral infections, as well as those who were taking non-steroidal anti-inflammatory drugs, subjects with recent oral surgery, and those with fixed orthodontic appliances or retainers near the ulcer were not recruited for the study

结局指标

主要结局

Lesion Size

时间窗: 1, 3, 5 day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwan Mahmood Saleh

Marwan Mahmood Saleh

University Of Anbar

研究点 (2)

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