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

Primary Purpose

Triamcinolone, Pentoxifylline, Vitamin E

Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Triamcinolone
Pentoxifylline with Vitamin E
Sponsored by
Altamash Institute of Dental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triamcinolone

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Altamash Institute of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1: Triamcinolone

Group 2: Pentoxifylline with Vitamin E

Arm 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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
December 4, 2022
Last Updated
December 13, 2022
Sponsor
Altamash Institute of Dental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05660694
Brief Title
Comparison of Triamcinolone With Pentoxifylline and Vitamin- E Efficacy in the Treatment of Stage 2 and 3 Oral Submucous Fibrosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Altamash Institute of Dental Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triamcinolone, Pentoxifylline, Vitamin E, Oral Submucosa Fibrosis, Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Group 1: Triamcinolone Group 2: Pentoxifylline
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Triamcinolone
Arm Type
Experimental
Arm 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
Arm Title
Group 2: Pentoxifylline with Vitamin E
Arm Type
Experimental
Arm Description
Pentoxifylline 40mg twice a day along with vitamin E supplement one tablet per day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Intervention Description
Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline with Vitamin E
Intervention Description
Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy
Primary Outcome Measure Information:
Title
Group 1: Triamcinolone measuring mouth opening using calibrated Vernier Caliper
Description
Measuring mouth opening measuring mouth opening using calibrated Vernier Caliper by recording in millimeters the maximum mouth opening
Time Frame
21 months
Title
Group 2: Pentoxifylline with Vitamin E measuring mouth opening using calibrated Vernier Caliper
Description
Measuring mouth opening measuring mouth opening using calibrated Vernier Caliper by recording in millimeters the maximum mouth opening
Time Frame
21 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Altamash Institute of Dental Medicine
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75500
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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