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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

Altamash Institute of Dental Medicine

Status and phase

Completed
Phase 4

Conditions

Triamcinolone
Pentoxifylline
Vitamin E
Tumor
Oral Submucosa Fibrosis

Treatments

Drug: Triamcinolone
Drug: Pentoxifylline with Vitamin E

Study type

Interventional

Funder types

Other

Identifiers

NCT05660694
Treatment of OSF stage 2 and 3

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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