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

NCT05660694 | Completed Phase 4

• 1 other identifier: Treatment of OSF stage 2 and 3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Triamcinolone; Pentoxifylline; Vitamin E; Oral Submucosa Fibrosis; Tumor

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group 1: Triamcinolone

EXPERIMENTAL

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

Group 2: Pentoxifylline with Vitamin E

EXPERIMENTAL

Pentoxifylline 40mg twice a day along with vitamin E supplement one tablet per day for 4 weeks

Drug: Pentoxifylline with Vitamin E

Interventions

Triamcinolone DRUG

Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy

Group 1: Triamcinolone

Pentoxifylline with Vitamin E DRUG

Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy

Group 2: Pentoxifylline with Vitamin E

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Altamash Institute of Dental Medicine: lead

Study Sites (1)

Altamash Institute of Dental Medicine

Karachi, Sindh, 75500, Pakistan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Triamcinolone; Pentoxifylline; Vitamin E

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Abhishek Lal

Model Details: Group 1: Triamcinolone Group 2: Pentoxifylline

Study Record Dates

• First Submitted: December 4, 2022
• First Posted: December 21, 2022
• Study Start: January 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

PA (1)