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:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT06871904
Eligibility Criteria:
Inclusion Criteria:
1. Patients with OSF having fibrous bands
2. Patients with limited mouth opening due to OSF in Stage 2 and Stage 3
3. Patients who have not received any treatment for OSF in the previous three months
4. Patients with habits of pan, Chalia, Gutkha
5. The age group between 18 and 45 years
Exclusion Criteria:
1. Patients presenting with OSCC
2. Patients with limited mouth opening due to impaction of the third molar
3. Patients with limited mouth opening due to temporomandibular joint disorder
4. Any history of Metformin intolerance or contraindications to its use.
5. Medical conditions (e.g., cardiovascular disease, renal/hepatic impairment) or drug therapy (\>6 months) with immunosuppressants, corticosteroids, or antifibrotics.
6. Pregnancy or lactation.
7. Participation in other clinical trials concurrently.
8. Inability / unwilling to provide informed written consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06871904
Study Brief:
Protocol Section:
NCT06871904