Association of Candida and Antifungal Therapy With Pro-inflammatory Cytokines in Oral Leukoplakia- A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Oral burning sensation
Study Overview
Brief Summary
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%.
Detailed Description
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Oral burning sensation
Time Frame: Before and after antifungal treatment (2 weeks)
VAS score (0-10)
Clinical size of lesion
Time Frame: 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
Time Frame: Before and after antifungal treatment (2 weeks)
il6,il8,il17,TNF-alpha by ELISA before and after antifungal treatment
Erythema of oral lesion
Time Frame: 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
Time Frame: 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
Time Frame: before antifungal treatment
Swabs for smear or culture positive for Candida
Phospholipase Activity of Candida in Oral leukoplakia
Time Frame: 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
Time Frame: 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
Time Frame: Before antifungal therapy
Absorbance values of test wells at 490nm of XTT reduction assay- absorbance values of control
Histopathology
Time Frame: Before antifungal therapy
Mild Dysplasia Moderate Dysplasia Severe Dysplasia PAS stain positive/ negative
Antifungal sensitivity
Time Frame: 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
Secondary Outcomes
- Malignant transformation(after 2,5,7,10 years)
Investigators
Dr. Shalini Gupta
Associate Professor
All India Institute of Medical Sciences, New Delhi