Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07331935
Eligibility Criteria:
Inclusion Criteria:
* Clinically and histologically diagnosed with homogeneous oral leukoplakia not indicated for surgical excision .
* Lesions accessible for topical application.
* Willing to sign informed consent and comply with study instructions and return to follow up
Exclusion Criteria:
* Moderate-to-severe dysplasia, carcinoma in situ, or invasive oral cancer.
* Presence of any visible oral lesions except for oral leukoplakia.
* Active periodontal diseases as this can confound salivary biomarkers.
* Significant systemic illness or immunosuppression.
* Patients who have taken systemic or topical antioxidant supplements within the last four weeks will be excluded to avoid confounding effects on salivary biomarkers.
* Pregnant and lactating women will be excluded due to hormonal changes that may alter oxidative stress and ethical considerations.
* Patients unwilling or unable to comply with study requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT07331935
Study Brief:
Protocol Section:
NCT07331935