Wound Healing Effect of Chitosan Nanoparticles and Low Molecular Weight Chitosan: Animal and Clinical Studies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Change in clinical ulcer diameter
研究概览
简要总结
The purpose of this study is to evaluate the therapeutic clinical efficacy of a synthesized 5 wt.% chitosan nanoparticle paste compared to a standard topical corticosteroid (triamcinolone acetonide 0.1% oral paste) in patients suffering from minor recurrent aphthous stomatitis. The study specifically monitors changes in clinical ulcer diameter and pain reduction.
详细描述
Recurrent aphthous stomatitis (RAS) is a common oral mucosal disease causing significant pain and discomfort. This randomized, active-controlled, single-blind clinical trial investigates a novel mucoadhesive 5 wt.% chitosan nanoparticle paste formulation synthesized via the ionic gelation technique. Eligible patients diagnosed with minor RAS are randomly allocated in a 1:1 ratio to either Group A (active control: triamcinolone acetonide 0.1% oral paste) or Group B (experimental: 5 wt.% chitosan nanoparticle paste). Both groups apply their designated medication topically four times a day using a sterile swab after rinsing and drying the affected area. Treatment is continued until complete healing of the ulcer occurs. Clinical follow-up examinations are performed periodically at days 0, 1, 6, and 10 to measure the clinical ulcer diameter using a Hu-Friedy periodontal probe and to record subjective pain scores via a Visual Analogue Scale (VAS).
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
- Single (Outcomes Assessor)
盲法说明
To ensure rigorous single-blinding, medications were dispensed in masked, identical containers by an independent coordinator. The clinical investigator performing all follow-up measurements and scoring was completely blinded to the treatment assignments.
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
- •Patients complaining of oral recurrent ulcers with signs of minor recurrent aphthous stomatitis.
- •History of oral recurrent ulcers with a recurrence rate of 2 to 3 times per year.
- •Ulcer diameter less than 1 cm at baseline.
- •Maximum of 4 days passed since the emergence of the current ulcer.
- •No use of any prior medications or treatment for the current ulcer.
- •Signed written informed consent.
排除标准
- •Background of systemic diseases, including diabetes mellitus.
- •Connective tissue diseases such as Lupus.
- •Syndromes or diseases related to aphthous ulcers, such as cyclic neutropenia and Behcet's disease.
研究组 & 干预措施
Experimental: Chitosan Nanoparticle Group
Patients received mucoadhesive 5 wt.% chitosan nanoparticle paste applied topically 4 times a day until complete healing.
干预措施: 5 wt.% Chitosan Nanoparticle Paste (Drug)
Active Comparator: Triamcinolone Group
Patients received triamcinolone acetonide 0.1% oral paste (Adcortyl) applied topically 4 times a day until complete healing.
干预措施: Triamcinolone Acetonide 0.1% Oral Paste (Drug)
结局指标
主要结局
Change in clinical ulcer diameter
时间窗: Days 0, 1, 6, and 10
Measured in millimeters using a Hu-Friedy periodontal probe to evaluate clinical wound contraction and reduction in lesion size.
次要结局
- Change in pain severity score(Days 0, 1, 6, and 10)
研究者
zahra atai
Professor of Oral Medicine
Kerman University of Medical Sciences