Fibrosis-Modulating Effects of Metformin and Pirfenidone in Oral Submucous Fibrosis

Launched by ZIAUDDIN UNIVERSITY · Mar 11, 2025

Keywords

ClinConnect Summary

Oral submucous fibrosis stands as a persistent inflammatory and potentially malignant condition affecting the oral cavity, marked by progressive fibrosis of the oral mucosa. Existing therapies, such as corticosteroids, are costly and merely treat the symptoms without addressing the molecular pathways that cause fibrosis, which results in limited efficacy, relapse, and side effects. Given the financial constraints of affected communities, there is a desperate need for affordable and accessible treatments. This research project aims to investigate the effects of metformin and antifibrotic dru...

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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.