Comparison of Triamcinolone With Pentoxifylline and Vitamin- E Efficacy in the Treatment of Stage 2 and 3 Oral Submucous Fibrosis

Study Overview
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Brief Summary
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To compare the efficacy of Triamcinolone with Pentoxifylline and Vitamin E in patients with stage two and three oral submucous fibrosis.

Detailed Description
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To compare the efficacy of Triamcinolone with Pentoxifylline and Vitamin E in patients with stage two and three oral submucous fibrosis. It was a randomized control clinical trial to compare efficacy of injection steroids versus pentoxifylline and vitamin E in the treatment of stage 2 and 3 OSF patient. Total 40 patients who presented with signs and symptoms of OSF were enrolled in our study that was evaluated over the period of (January 2020 to September 2021). Parameters taken in the study were age and mouth opening. Descriptive statistics and paired t-test were used for statistical analysis.

Official Title
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Comparison of Triamcinolone With Pentoxifylline and Vitamin- E Efficacy in the Treatment of Stage 2 and 3 Oral Submucous Fibrosis: A Clinical Trial

Conditions
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Triamcinolone, Pentoxifylline, Vitamin E, Oral Submucosa Fibrosis, Tumor

Intervention / Treatment
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* Drug: Triamcinolone
* Drug: Pentoxifylline with Vitamin E


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with clinically diagnosed OSMF who have not undergone any treatment of OSMF in past Patients willing to quit their tobacco chewing habit, gutkha areca nut smoking Patients who are ready to attend regular follow-ups Exclusion Criteria: Patients who have undergone any treatment for OSF in past Patients with any evidence of cardiac, gastrointestinal, kidney, metabolic disorders, pregnant and lactating women's Patients with any co-existing disorder of the orofacial region other than OSF which may interfere with the study protocol
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1: Triamcinolone Group 2: Pentoxifylline
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Triamcinolone<br>Injection steroid Triamcinolone 400mg with lidocaine 1:1 was given twice a week for 4 weeks in bi-lateral buccal mucosa in multiple sites | Drug: Triamcinolone<br>* Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy<br>|
| Experimental: Group 2: Pentoxifylline with Vitamin E<br>Pentoxifylline 40mg twice a day along with vitamin E supplement one tablet per day for 4 weeks | Drug: Pentoxifylline with Vitamin E<br>* Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Group 1: Triamcinolone measuring mouth opening using calibrated Vernier Caliper | Measuring mouth opening measuring mouth opening using calibrated Vernier Caliper by recording in millimeters the maximum mouth opening | 21 months | 
| Group 2: Pentoxifylline with Vitamin E measuring mouth opening using calibrated Vernier Caliper | Measuring mouth opening measuring mouth opening using calibrated Vernier Caliper by recording in millimeters the maximum mouth opening | 21 months |