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

Sponsor

Altamash Institute of Dental Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT05660694

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Triamcinolone Pentoxifylline Vitamin E Oral Submucosa Fibrosis Tumor	Drug: Triamcinolone Drug: Pentoxifylline with Vitamin E	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Group 1: Triamcinolone Group 2: PentoxifyllineGroup 1: Triamcinolone Group 2: Pentoxifylline

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: Triamcinolone 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 Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy
Experimental: Group 2: Pentoxifylline with Vitamin E Pentoxifylline 40mg twice a day along with vitamin E supplement one tablet per day for 4 weeks	Drug: Pentoxifylline with Vitamin E Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy

Arm

Intervention/Treatment

Experimental: Group 1: Triamcinolone

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

Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy

Experimental: Group 2: Pentoxifylline with Vitamin E

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

Drug: Pentoxifylline with Vitamin E

Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Altamash Institute of Dental Medicine	Karachi	Sindh	Pakistan	75500

Sponsors and Collaborators

Altamash Institute of Dental Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abhishek Lal, Dr. Abhishek Lal, Altamash Institute of Dental Medicine

ClinicalTrials.gov Identifier:

NCT05660694

Other Study ID Numbers:

Treatment of OSF stage 2 and 3

First Posted:

Dec 21, 2022

Last Update Posted:

Dec 21, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Oral Submucous Fibrosis

Study Results

No Results Posted as of Dec 21, 2022