Antifungal Effect of Chitosan Nanoparticles Paste Against Oral Candidosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Change in erythematous surface area
研究概览
简要总结
This study is designed to survey the therapeutic effect of a low molecular weight 5% nanochitosan paste against oral candidosis (denture stomatitis) and compare its efficacy with a standard Nystatin ointment.
详细描述
Denture stomatitis, also called chronic atrophic candidosis, is a common chronic disease in people who use full dentures, primarily caused by Candida albicans. This randomized single-blind clinical trial evaluates the antifungal effect of nanochitosan particles prepared by the ionic gelation method in a 5% paste formulation. Thirty patients using full dentures and suffering from type 2 denture stomatitis are randomly divided into two groups of fifteen. One group receives the 5% nanochitosan paste and the other receives Nystatin ointment. Both groups apply their respective medications to the palatal areas four times a day for two weeks. Patients are instructed to remove their dentures during application. Clinical and microbiological assessments are performed before treatment and after two weeks to evaluate changes in erythematous plaque surface area, palatal cell culture colony counts, and burning sensation.
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 (Participant)
盲法说明
This is a single-blind clinical trial where the drug label was covered in the Nystatin group to ensure participant blinding to the treatment allocation.
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 using full dentures.
- •Suffering from type 2 denture stomatitis.
- •Diagnosis and infection confirmed by an oral medicine specialist.
- •Signed written informed consent.
排除标准
- •History of using antifungal drugs, antibiotics, corticosteroids, and saliva-reducing drugs in the previous month.
- •Patients with Alzheimer's disease.
- •Patients with diabetes mellitus.
- •Patients with masticatory muscle disorders.
- •Patients with an immune suppressive situation.
- •Patients with psychological diseases.
研究组 & 干预措施
Experimental: Nanochitosan Paste Group
Patients received 5% nanochitosan paste applied on the palatal areas four times a day for two weeks.
干预措施: 5% Nanochitosan Paste (Drug)
Active Comparator: Nystatin Ointment Group
Patients received Nystatin ointment applied on the palatal areas four times a day for two weeks.
干预措施: Nystatin Ointment (Drug)
结局指标
主要结局
Change in erythematous surface area
时间窗: Baseline, 1 week, and 2 weeks
The size of the erythematous plaques under the denture-bearing surface is measured in square millimeters (mm2) to evaluate clinical healing.
次要结局
- Microbiological palatal cell culture findings(Baseline and 2 weeks)
- Change in burning sensation(Baseline, 1 week, and 2 weeks)
研究者
zahra atai
Clinical Professor
Kerman University of Medical Sciences