Primary Purpose of the protocol
Oral submucous fibrosis is a debilitating potentially malignant disorder of the oral cavity characterized by progressive fibrosis of the submucosal tissues. The pathophysiology of OSMF involves chronic inflammation, fibrosis, and changes in the oral mucosa due to factors like areca nut chewing. Current treatments, which largely focus on symptom management rather than reversing the condition, are often inadequate and offer temporary relief. Given the pharmacological actions of isoxpurine, pentoxifylline, colchicine, and lycopene ranging from anti-inflammatory and antioxidant properties to anti-fibrotic effects there is a strong rationale to investigate their individual efficacy in modulating the disease process in OSMF. These agents target the underlying mechanisms such as collagen synthesis, fibroblast activity, and oxidative stress, which are crucial in OSMF pathogenesis.

Hypothesis  What is the effect of isoxpurine, pentoxifylline, colchicine, and lycopene on the clinical outcomes of oral submucous fibrosis Grade II patients