Clinical trial · Observational
Candida Associated Cytokines in Oral Leukoplakia
Association of Candida and Antifungal Therapy With Pro-inflammatory Cytokines in Oral Leukoplakia- A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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%.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Leukoplakia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluconazole | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Homogenous oral leukoplakia
- description
- uniform, flat, thin, smooth/ wrinkled/corrugated surface throughout the white lesion. Tab Fluconazole 100 mg as a mouthwash ( tablet dissolved in 10 ml of drinking water and used as a mouth rinse for 2 minute and swallowed) once a day for 14 days
- interventionNames
- Other: Fluconazole
- label
- Non-Homogenous oral leukoplakia
- description
- mixture of red and white lesions with a irregularly speckled/ nodular/ verrucous surface Tab Fluconazole 100 mg as a mouthwash ( tablet dissolved in 10 ml of drinking water and used as a mouth rinse for 2 minute and swallowed) once a day for 14 days
- interventionNames
- Other: Fluconazole
- label
- Control group
- description
- 30 healthy controls ( age and sex matched) would also be recruited from patients who are reporting for other routine dental problems.
Primary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGupta SR, Gupta N, Sharma A, Xess I, Singh G, Mani K. The association of Candida and antifungal therapy with pro-inflammatory cytokines in oral leukoplakia. Clin Oral Investig. 2021 Nov;25(11):6287-6296. doi: 10.1007/s00784-021-03927-3. Epub 2021 Apr 4. PMID 33813637