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Evaluation of Topical Probiotic Gel Versus Triamcinolone in Minor Recurrent Aphthous Ulcers

2026年6月22日更新者：Ahmed Adel Mohamed Abdelazim、Cairo University

Evaluation of Topical Probiotic Gel Versus Triamcinolone in Minor Recurrent Aphthous Ulcers: A Randomized Controlled Trial Incorporating Salivary microRNA-146a as a Novel Biomarker of Healing

This study looks at a new way to treat minor recurrent aphthous ulcers. These ulcers are painful, round or oval sores that show up on the soft, non-chewing surfaces of the mouth (like the inside of the cheeks or lips). While they are not dangerous, they cause severe pain and make eating, talking, and swallowing difficult.

The current standard treatment is usually a topical steroid gel called triamcinolone acetonide, which helps reduce pain and swelling but can have limitations. This clinical trial is testing whether a novel topical probiotic gel can work just as well as the steroid gel to speed up healing, lower pain, and reduce local inflammation.

Additionally, the study will measure a molecule found in saliva called microRNA-146a. This molecule acts as a natural biological marker that tracks how well the mouth tissue is healing from inflammation

研究概览

地位

完全的

条件

Treatment of Minor Aphthous Ulcers

干预/治疗

研究类型

介入性

注册 (实际的)

阶段

第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

埃及
- - Cairo、埃及
    - Faculty of Dentistry (Menoufia University and Modern University for Technology and Information (MTI), Egypt).

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

描述

Inclusion Criteria:

Both genders
Adults ≥18 years diagnosed with minor recurrent aphthous ulcer based on clinical examination (Parra-Moreno et al., 2023).
The definitive diagnostic criteria for Minor Recurrent Aphthous Ulcers (Minor RAU/RAS) rely heavily on distinct clinical features and standard medical histories. Because there is no single definitive lab test or histopathological standard, diagnosis is made primarily by clinical evaluation (Baccaglini et al., 2013; Akintoye and Greenberg, 2014)

Exclusion Criteria:

Patients with major aphthous ulcer or traumatic ulcers, patients took steroids in last 6 months, vulnerable groups as prisoners, mentally disabled, pregnant orlactating women (El-Haddad et al., 2014).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：双倍的

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Group (1): Probiotic Gel Investigational Patient Group A topical probiotic gel formulation designed for direct oral mucosal application. Participants will apply a thin layer of the experimental probiotic gel directly onto their minor recurrent aphthous ulcer lesion(s) four times daily. The therapeutic regimen will be maintained continuously for a duration of 1 to 2 weeks. Clinical assessments (lesion size; pain intensity via Visual Analogue Scale; and Thongprasom scoring) and salivary microRNA-146a biomarker collections will be systematically performed at baseline, 1 week, and 2 weeks.	药品：Probiotic gel Topical probiotic gel formulation designed for oral mucosal application. Participants applied a thin layer of the probiotic gel directly onto the active minor aphthous ulcer lesion four times daily. The treatment was maintained for a duration of 1 to 2 weeks depending on individual healing timelines, with clinical assessments scheduled at baseline, 1 week, and 2 weeks.
有源比较器：Group (2): Triamcinolone Active Control Patient Group Active control topical corticosteroid paste/gel (Triamcinolone acetonide). Participants will apply a thin layer of the triamcinolone gel directly onto the active minor aphthous ulcer lesion four times daily. The treatment will be maintained for a duration of 1 to 2 weeks, matching the experimental arm timeline, with clinical and salivary biomarker assessments scheduled at baseline, 1 week, and 2 weeks.	药品：Triamcinelone acetonide Active control topical corticosteroid paste/gel (Triamcinolone acetonide). Participants will apply a thin layer of the triamcinolone gel directly onto the active minor aphthous ulcer lesion four times daily. The treatment will be maintained for a duration of 1 to 2 weeks, matching the experimental arm timeline, with clinical and salivary biomarker assessments scheduled at baseline, 1 week, and 2 weeks.

参与者组/臂

干预/治疗

实验性的：Group (1): Probiotic Gel Investigational Patient Group

A topical probiotic gel formulation designed for direct oral mucosal application. Participants will apply a thin layer of the experimental probiotic gel directly onto their minor recurrent aphthous ulcer lesion(s) four times daily. The therapeutic regimen will be maintained continuously for a duration of 1 to 2 weeks. Clinical assessments (lesion size; pain intensity via Visual Analogue Scale; and Thongprasom scoring) and salivary microRNA-146a biomarker collections will be systematically performed at baseline, 1 week, and 2 weeks.

药品：Probiotic gel

Topical probiotic gel formulation designed for oral mucosal application. Participants applied a thin layer of the probiotic gel directly onto the active minor aphthous ulcer lesion four times daily. The treatment was maintained for a duration of 1 to 2 weeks depending on individual healing timelines, with clinical assessments scheduled at baseline, 1 week, and 2 weeks.

有源比较器：Group (2): Triamcinolone Active Control Patient Group

Active control topical corticosteroid paste/gel (Triamcinolone acetonide). Participants will apply a thin layer of the triamcinolone gel directly onto the active minor aphthous ulcer lesion four times daily. The treatment will be maintained for a duration of 1 to 2 weeks, matching the experimental arm timeline, with clinical and salivary biomarker assessments scheduled at baseline, 1 week, and 2 weeks.

药品：Triamcinelone acetonide

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Minor Recurrent Aphthous Ulcer Size (mm) Measured Using Periodontal Probe 大体时间：Baseline, 1 week, and 2 weeks after treatment initiation	The size of the target minor recurrent aphthous ulcer will be measured clinically in millimeters using a calibrated periodontal probe. The maximum ulcer diameter will be recorded at baseline, 1 week, and 2 weeks after treatment initiation. Change in ulcer size from baseline will be calculated. A reduction in size indicates clinical improvement and healing.	Baseline, 1 week, and 2 weeks after treatment initiation
Pain Severity Measured Using Visual Analogue Scale (VAS 0-10) 大体时间：Baseline, 1 week, and 2 weeks after treatment initiation	Pain severity related to the target aphthous ulcer will be assessed using a 0-10 Visual Analogue Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded at baseline, 1 week, and 2 weeks after treatment initiation. Change from baseline will be compared between the probiotic gel group and the triamcinolone group. A lower score indicates improvement.	Baseline, 1 week, and 2 weeks after treatment initiation

次要结果测量

结果测量	措施说明	大体时间
Salivary microRNA-146a Expression Measured by qRT-PCR (ΔΔCt Method) 大体时间：Baseline, 1 week and 2 weeks after treatment initiation	Salivary microRNA-146a expression will be assessed from saliva samples using RNA extraction, reverse transcription, and real-time quantitative PCR. Relative expression will be calculated using the ΔCt and 2-ΔΔCt methods. Expression levels will be compared between baseline and post-treatment values to assess molecular changes related to inflammation and healing.	Baseline, 1 week and 2 weeks after treatment initiation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Cairo University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月20日

初级完成 (实际的)

2026年4月20日

研究完成 (实际的)

2026年4月20日

研究注册日期

首次提交

2026年6月17日

首先提交符合 QC 标准的

2026年6月22日

首次发布 (实际的)

2026年6月29日

研究记录更新

最后更新发布 (实际的)

2026年6月29日

上次提交的符合 QC 标准的更新

2026年6月22日

最后验证

2026年2月1日

Evaluation of Topical Probiotic Gel Versus Triamcinolone in Minor Recurrent Aphthous Ulcers