Association of Candida and Antifungal Therapy With Pro-inflammatory Cytokines in Oral Leukoplakia- A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Oral burning sensation
研究概览
简要总结
This study aims to determine the correlation between candida and pro- inflammatory cytokines response in Oral Leukoplakia(OL) with antifungal therapy. Ethical clearance from the Institutes ethical committee and Informed written consent from the patient will be obtained. The study group would comprise of clinically and histopathologically confirmed cases of OL (60 patients). The control group would be 30 dental patients ( age & sex matched) who do not any malignancy, OL or any other potentially malignant disorder of oral mucosa. Patients who have any predisposing factor for oral candidiasis will be excluded from the study. Swabs will be taken from the oral lesion and cultured for candida to determine phenotypes, virulence attributes and antifungal sensitivity. Sterile PVA opthalmic sponges will be used to collect sample from the surface of oral epithelium and then processed to determine levels of pro- inflammatory cytokines (IL-6, IL-8. IL-17, TNFα). This procedure will be repeated in study group 2 weeks after a course of antifungal therapy. The results will be tested statistically at a confidence level of 95%.
详细描述
Objectives
- To determine the association of candida phenotypes, virulence attributes ( Secreted aspartyl proteinases, biofilm formation, Phospholipase) and antifungal sensitivity with clinicopathologic characteristics in oral leukoplakia
- To determine the secretion and levels of pro-inflammatory cytokines ( IL-6, IL-8. IL-17, TNFα ) in oral leukoplakia before and after antifungal therapy.
- To study the correlation between candida and pro-inflammatory cytokines in oral leukoplakia with antifungal therapy
Detailed methodology including study design, outcome measures, sample size and statistical analysis.
Study design:
Prospective case- control observational study
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Oral burning sensation
时间窗: Before and after antifungal treatment (2 weeks)
VAS score (0-10)
Clinical size of lesion
时间窗: Before and after antifungal treatment (2 weeks)
maximum Length( L) and width (W) L1: L/W ≤ 2 cm L2: L /W 2-4 cm L3: L/W ≥ 4cm
Pro- inflammatory cytokines
时间窗: Before and after antifungal treatment (2 weeks)
il6,il8,il17,TNF-alpha by ELISA before and after antifungal treatment
Erythema of oral lesion
时间窗: Before and after antifungal treatment (2 weeks)
Scores as \[ 0- no change, 1- minimal change ( Reduction in erythema \< 1cm of oral lesion, and 2- significant change( Reduction in erythema ≥ 1cm of oral lesion)
Thickness of oral lesion
时间窗: Before and after antifungal treatment (2 weeks)
Scores as \[ 0- no change, 1- minimal change ( Reduction in thickness \< 1cm of oral lesion, and 2- significant change( Reduction in thickness ≥ 1cm of oral lesion)
candida positivity
时间窗: before antifungal treatment
Swabs for smear or culture positive for Candida
Phospholipase Activity of Candida in Oral leukoplakia
时间窗: Before antifungal therapy
Phospholipase activity (Pz) was measured by dividing colony diameter by the diameter of the precipitation zone (Pz) around the colony formed on the plate. A Precipitation zone (in mm) around colony 1.0 : 0 negative (-), 0.99-0.9 : 1 weak (+), 0.89-0.8: 2 poor (++), 0.79-0.7: 3 moderate (+++), \< 0.69: 4 Strong positive(++++),
Secreted aspartyl proteinase activity of Candidain Oral leukoplakia
时间窗: Before antifungal therapy
Secreted aspartyl proteinase activity was measured by dividing colony diameter by the diameter of the precipitation zone (Pz) around the colony formed on the plate. A Precipitation zone (in mm) around colony 1.0 : 0 negative (-), 0.99-0.9 : 1 weak (+), 0.89-0.8: 2 poor (++), 0.79-0.7: 3 moderate (+++), \< 0.69: 4 Strong positive(++++),
Biofilm formation
时间窗: Before antifungal therapy
Absorbance values of test wells at 490nm of XTT reduction assay- absorbance values of control
Histopathology
时间窗: Before antifungal therapy
Mild Dysplasia Moderate Dysplasia Severe Dysplasia PAS stain positive/ negative
Antifungal sensitivity
时间窗: Before antifungal therapy
Using CLSI document M44-A for disk diffusion method for Fluconazole (25 μg), Voriconazole (1 μg) and Clotrimazole (50 μg) S: Sensitive R: Resistant I: Intermediate
次要结局
- Malignant transformation(after 2,5,7,10 years)
研究者
Dr. Shalini Gupta
Associate Professor
All India Institute of Medical Sciences, New Delhi