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

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

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

Study Overview

• Status: Completed
• Conditions: Tumor; Pentoxifylline; Triamcinolone; Vitamin E; Oral Submucosa Fibrosis
• Intervention / Treatment: Drug: Triamcinolone; Drug: Pentoxifylline with Vitamin E

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75500
      • Altamash Institute of dental medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: 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	Drug: Triamcinolone; Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy
Experimental: Group 2: Pentoxifylline with Vitamin E; Pentoxifylline 40mg twice a day along with vitamin E supplement one tablet per day for 4 weeks	Drug: Pentoxifylline with Vitamin E; Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Altamash Institute of Dental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: December 4, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Estimate): December 21, 2022

Study Record Updates

• Last Update Posted (Estimate): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Mouth Diseases; Fibrosis; Oral Submucous Fibrosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Platelet Aggregation Inhibitors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Micronutrients; Vitamins; Antioxidants; Phosphodiesterase Inhibitors; Free Radical Scavengers; Radiation-Protective Agents; Triamcinolone; Vitamin E; Pentoxifylline
• Other Study ID Numbers: Treatment of OSF stage 2 and 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No