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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Minor Recurrent Aphthous Ulcer Size (mm) Measured Using Periodontal Probe
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Group1: Probiotic gel Group 2: Triamcinolone acetonide
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Probiotic gel (Drug)
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.
干预措施: Triamcinelone acetonide (Drug)
结局指标
主要结局
Minor Recurrent Aphthous Ulcer Size (mm) Measured Using Periodontal Probe
时间窗: 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.
Pain Severity Measured Using Visual Analogue Scale (VAS 0-10)
时间窗: 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.
次要结局
- Salivary microRNA-146a Expression Measured by qRT-PCR (ΔΔCt Method)(Baseline, 1 week and 2 weeks after treatment initiation)
研究者
Ahmed Adel Mohamed Abdelazim
Lecturer
Cairo University