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

Phase 4

Completed

• Conditions: Oral Submucosa Fibrosis; Triamcinolone; Vitamin E; Pentoxifylline; Tumor
• Interventions: Drug: Pentoxifylline with Vitamin E; Drug: Triamcinolone

• Registration Number: NCT05660694
• Lead Sponsor: Altamash Institute of Dental Medicine

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2022-12
• Study First Submitted: 2022-12-04
• Study First Submitted QC: 2022-12-13
• Last Update Submitted: 2022-12-13
• Study First Posted: 2022-12-21
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Pentoxifylline with Vitamin E	Pentoxifylline with Vitamin E	Pentoxifylline 40mg twice a day along with vitamin E supplement one tablet per day for 4 weeks
Group 1: Triamcinolone	Triamcinolone	Injection steroid Triamcinolone 400mg with lidocaine 1:1 was given twice a week for 4 weeks in bi-lateral buccal mucosa in multiple sites

Primary Outcome Measures

Name	Time	Method
Group 1: Triamcinolone measuring mouth opening using calibrated Vernier Caliper	21 months	Measuring mouth opening measuring mouth opening using calibrated Vernier Caliper by recording in millimeters the maximum mouth opening
Group 2: Pentoxifylline with Vitamin E measuring mouth opening using calibrated Vernier Caliper	21 months	Measuring mouth opening measuring mouth opening using calibrated Vernier Caliper by recording in millimeters the maximum mouth opening

Trial Locations

Locations (1)

Altamash Institute of Dental Medicine; 🇵🇰 Karachi, Sindh, Pakistan