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Completed

NCT Number: NCT05660694

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

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

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Key information

Conditions

Triamcinolone Neoplasms Oral Submucosa Fibrosis Pentoxifylline Tumor Vitamin E

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Altamash Institute of Dental Medicine

Karachi, Sindh, 75500, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triamcinolone

Drug

Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy

Pentoxifylline with Vitamin E

Drug

Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy

Primary outcomes

  1. Group 1: Triamcinolone measuring mouth opening using calibrated Vernier Caliper

    Time frame: 21 months

    Measuring mouth opening measuring mouth opening using calibrated Vernier Caliper by recording in millimeters the maximum mouth opening

  2. Group 2: Pentoxifylline with Vitamin E measuring mouth opening using calibrated Vernier Caliper

    Time frame: 21 months

    Measuring mouth opening measuring mouth opening using calibrated Vernier Caliper by recording in millimeters the maximum mouth opening

Sponsors and collaborators

Lead sponsor

Altamash Institute of Dental Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 21, 2022
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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