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NCT05660694 Clinical Trial

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

Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05660694
Other study ID # Treatment of OSF stage 2 and 3
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 1, 2020
Est. completion date September 30, 2021

Study information
Verified date December 2022
Source Altamash Institute of Dental Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Triamcinolone
Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy
• Pentoxifylline with Vitamin E
Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy

Locations
Country Name City State
Pakistan Altamash Institute of Dental Medicine Karachi Sindh

Sponsors (1)
Lead Sponsor Collaborator
Altamash Institute of Dental Medicine

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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