Evaluation Of Isoxpurine, Pentoxifylline, Colchicine And Lycopene As Therapeutic Agents In The Management Of Oral Submucous Fibrosis: A Randomized, Double-Blind Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Interincisal Opening- measured in millimeters at each visit
Study Overview
Brief Summary
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.
HypothesisWhat is the effect of isoxpurine, pentoxifylline, colchicine, and lycopene on the clinical outcomes of oral submucous fibrosis Grade II patients
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 OSMF diagnosed as Grade II clinically- (More C et al classification of OSMF) 2 Adults aged 18 to 65 years diagnosed with oral submucous fibrosis Gd II.
- •3 Patients who have not received any treatment for oral submucous fibrosis in the last three months.
- •• Patients who willing to quit the usage of areca nut and tobacco.
Exclusion Criteria
- •1 Patients with a history of allergic reactions to the study medications.
- •2 Pregnant or breastfeeding women.
- •3 Patients with severe systemic diseases or malignancies.
- •4 Patients with other white or red lesions of the oral mucosa.
Outcomes
Primary Outcomes
Interincisal Opening- measured in millimeters at each visit
Time Frame: baeline, 1 month, 2 months, 3 months
Pain and burning sensation – Assessed using a visual analong scale (VAS)
Time Frame: baeline, 1 month, 2 months, 3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Preeti Parameswaran Nair
PEOPLES COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTRE BHOPAL