Evaluation of the Efficacy of 1% Nanochitosan Solution Compared to Nystatin Oral Suspension in the Treatment of Newton's Type II Denture Stomatitis: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in erythematous palatal mucosa lesion area
研究概览
简要总结
The purpose of this study is to evaluate and compare the clinical efficacy of a 1% nanochitosan solution versus a standard Nystatin oral suspension in patients diagnosed with Newton's type II denture stomatitis (chronic atrophic candidiasis). Chitosan nanoparticles are investigated as a potential biocompatible, mucoadhesive alternative to traditional antifungal treatments to accelerate mucosal healing and reduce the erythema of the palatal mucosa.
详细描述
Denture stomatitis is a common oral mucosal lesion, primarily caused by Candida species under dental prostheses. This randomized single-blind clinical trial investigates the therapeutic properties of a novel 1% nanochitosan formulation synthesized via ionic gelation technique. Eligible participants with Newton's type II denture stomatitis are randomly allocated into two parallel groups. The intervention group receives the 1% nanochitosan solution, and the active control group receives a standard Nystatin oral suspension (100,000 U/mL). Both groups apply 2 mL of their respective medications topically as an oral rinse four times a day for a total duration of 2 weeks. Prior to each application, patients are instructed to remove their dentures to maximize mucosal contact. Clinical outcomes, specifically the change in the erythematous lesion area of the palatal mucosa (measured in square millimeters), are assessed at baseline, at the end of the first week, and at the completion of the second week.
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
Commercial labels were removed from the medication bottles before delivery to maintain participant blinding.
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
- •Complete denture wearers diagnosed with Newton's type II denture stomatitis.
- •Diagnosis verified by an oral medicine specialist.
- •No use of antifungal agents, antibiotics, corticosteroids, or medications that reduce salivary flow in the month prior to the study.
- •Willing to provide written informed consent.
排除标准
- •Patients with Alzheimer's disease.
- •Patients with diabetes mellitus.
- •Patients with masticatory muscle disorders.
- •Patients with immunocompromising diseases.
- •Patients with psychiatric disorders.
研究组 & 干预措施
Experimental: Nanochitosan Group
Participants in this group received a 1% nanochitosan solution prepared via the ionic gelation technique. They rinsed with 2 mL of the solution four times a day for 2 minutes over a 2-week period. Patients were instructed to remove their dentures prior to each rinse.
干预措施: 1% Nanochitosan Solution (Drug)
Active Comparator: Nystatin Group
Participants in this group received a standard Nystatin oral suspension (100,000 U/mL). They rinsed with 2 mL of the suspension four times a day for 2 minutes over a 2-week period. Patients were instructed to remove their dentures prior to each rinse.
干预措施: Nystatin Oral Suspension (Drug)
结局指标
主要结局
Change in erythematous palatal mucosa lesion area
时间窗: Baseline, 1 week, and 2 weeks
The total surface area of the erythematous lesion on the palatal mucosa is measured and calculated in square millimeters (mm²) to determine the reduction in denture stomatitis inflammation and evaluate clinical efficacy.
次要结局
- Microbiological findings from palatal smears(Baseline and 2 weeks)
- Overall clinical response rate(2 weeks)
- Change in burning sensation(Baseline, 1 week, and 2 weeks)
研究者
zahra atai
Professor of Oral Medicine
Kerman University of Medical Sciences