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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05660694

Enrollment

Registered

2022-12-21

Start date

2020-01-01

Completion date

2021-09-30

Last updated

2022-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGTriamcinolone

Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy

DRUGPentoxifylline with Vitamin E

Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Intervention model description

Group 1: Triamcinolone Group 2: Pentoxifylline

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026