Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)
Phase 2 Study of Efficacy of Adhesive Tablets in Treating Oral Ulcers (Aphthous)
Recurrent Aphthous Stomatitis (RAS) of the oral mucosa is a common and painful condition. Despite advances in therapeutic means there is still necessary to find a way to alleviate the local pain and discomfort induced by the mucosal ulceration.
The hypothesis was to study the effectiveness and acceptance of a herbal adhesive tablets in the treatment of RAS.
Participants in the study will be examined for oral lesions, will be instructed how to apply the oral-tablet, and will be interviewed during the follow-up period up to one week after the application.
研究概览
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Jerusalem、以色列、91120
- Hadassah Medical Organization,
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria (in healthy individuals):
- Age above 18 years old.
- Non-pregnant women.
- Healthy or controlled chronic diseases.
- Examination at the Oral Medicine Clinic
Inclusion Criteria (in RAS patients):
- Age above 18 years old.
- Non-pregnant women.
- Clinical diagnosis of RAS.
- Examination at the Oral Medicine Clinic
Exclusion Criteria:
- Oral lesion suspected to be malignant.
- Ulcerative oral lesion other than RAS.
- Another experimental oral intervention within the last 24 hours.
- Pregnant women.
- Allergy to components of the Pro-pe adhesive tablet
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
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Serial questionnaires within 1 week post treatment to assess patient's perception, patient's pain relief and local adverse events in comparison to his past experience with other local treatments for oral ulcers.
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合作者和调查者
调查人员
- 首席研究员：Rakefet Czerninski, DMD、Hebrew University-Hadassah School of Dental Medicine
- 首席研究员：Sharon Elad, DMD MSc、Hebrew University-Hadassah School of Dental Medicine
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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