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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT06332612
Eligibility Criteria:
Inclusion Criteria:
1. Patients with OSF- palpable bands on oral examination
2. Patients with limited mouth opening due to OSF
3. Patients who have not received any treatment for OSF in the previous three months
4. Patients with habits of pan, Chalia, Ghutka
5. Age group between 18 and 45 years
Exclusion Criteria:
1. Patients presenting with both OSCC and OSF
2. Patients with limited mouth opening due to impaction of the third molar (impaction of third molar results in limited mouth opening hence such patients are excluded since limited mouth opening due to third molar impaction can be mistaken for OSF).
3. Patients with limited mouth opening due to temporomandibular joint disorder (temporomandibular joint disorders can limit the ability of patient to open their mouth and hence can be mistaken for OSF)
4. Any history of Metformin intolerance or contraindications.
5. Presence of other severe medical conditions along with drug therapy.
6. Pregnancy or lactation.
7. Participation in other clinical trials concurrently.
8. Inability to provide informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06332612
Study Brief:
Protocol Section:
NCT06332612