Status:
COMPLETED
Candida Associated Cytokines in Oral Leukoplakia
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Oral Leukoplakia
Eligibility:
All Genders
18-100 years
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 com...
Detailed Description
Objectives 1. To determine the association of candida phenotypes, virulence attributes ( Secreted aspartyl proteinases, biofilm formation, Phospholipase) and antifungal sensitivity with clinicopathol...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 60 clinically and histologically confirmed cases of Oral Leukoplakia would be prospectively recruited for this study who have not been under treatment for the same for past 6 months.
- 30 healthy controls ( age and sex matched) would also be recruited from patients who are reporting for other routine dental problems.
- Also these patients would be those who have good oral hygiene (simplified oral hygiene index score 0-3, periodontal screening and recording PSR code 0-2) and do not have any potentially malignant disorder of the oral mucosa or oral squamous cell carcinoma and have no systemic diseases or any other malignancy.
- Exclusion criteria:
- Patients with history of significant and serious uncontrolled systemic disease allergy to antifungals or history of antifungal therapy in past 6 months.
- Patients with history of any other malignant disease.
- Children ( age \< 18 years) and pregnant women.
- Patients with history of major/ minor surgery and predisposing factors for oral candidal infection like diabetes/ endocrine disorders, xerostomia, poor oral hygiene, removable prosthesis, prolonged corticosteroid/ antibiotic/ immunosuppressant/ antibacterial mouthwash therapy, radiation/ chemotherapy, auto immune disorders and primary / secondary immune deficiencies, nutritional deficiencies and hospitalized debilitated patients.
Exclusion
Key Trial Info
Start Date :
November 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 30 2020
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04712929
Start Date
November 1 2018
End Date
March 30 2020
Last Update
January 20 2021
Active Locations (1)
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1
All india Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029