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CTRI Number  CTRI/2024/04/066118 [Registered on: 23/04/2024] Trial Registered Prospectively
Last Modified On: 23/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Assessing the Impact of Oral Pentoxifylline and Vitamin E on Oral Submucous Fibrosis 
Scientific Title of Study   DETERMINING EFFICACY OF ORAL PENTOXIFYLLINE AND VITAMIN E IN ORAL SUBMUCOUS FIBROSIS PATIENTS A PROSPECTIVE STUDY 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Yashika Kewalramani 
Designation  PG STUDENT 
Affiliation  Government College of Dentistry Indore 
Address  Room No. 1, Department of Oral Medicine and Radiology, 1 Sardar Patel Marg , opposite M.Y Hospital , Indore.

Indore
MADHYA PRADESH
452001
India 
Phone  9860520075  
Fax    
Email  kewalramanidryashika@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR AJAY PARIHAR  
Designation  HEAD & PROFESSOR  
Affiliation  Government College of Dentistry Indore 
Address  Room No. 1, Department of Oral Medicine and Radiology, 1 Sardar Patel Marg , opposite M.Y Hospital , Indore.

Indore
MADHYA PRADESH
452001
India 
Phone  9860520075  
Fax    
Email  ajaycbct@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Yashika Kewalramani 
Designation  PG STUDENT 
Affiliation  Government College of Dentistry Indore 
Address  Room No. 1, Department of Oral Medicine and Radiology, 1 Sardar Patel Marg , opposite M.Y Hospital , Indore.

Indore
MADHYA PRADESH
452001
India 
Phone  9860520075  
Fax    
Email  kewalramanidryashika@gmail.com  
 
Source of Monetary or Material Support  
Room No. 1, Department of Oral Medicine and Radiology, 1 Sardar Patel Marg , opposite M.Y Hospital , Indore -452001 Madhya Pradesh 
 
Primary Sponsor  
Name  Government College of Dentistry 
Address  Room No. 1, Department of Oral Medicine and Radiology, 1 Sardar Patel Marg , opposite M.Y Hospital , Indore. 
Type of Sponsor  Other [GOVERNMENT MEDICAL COLLEGE] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yashika Kewalramani  Government College of Dentistry  Room No. 1, Department of Oral Medicine and Radiology, 1 Sardar Patel Marg , opposite M.Y Hospital , Indore.
Indore
MADHYA PRADESH 		 9860520075

kewalramanidryashika@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government College of Dentistry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 3||Administration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral submucous fibrosis   30 oral submucous fibrosis patients meeting the inclusion and exclusion criteria will be given Oral pentoxifylline 400mg T.D.S for 3months.  
Comparator Agent  oral submucous fibrosis  30 oral submucous fibrosis patients meeting the inclusion and exclusion exteria will be given Vitamin E 400 IU O.D for 3months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1)All new clinically diagnosed cases of OSMF between age group 18-55 years.
2)Patients who were willing to quit gutkha, areca nut and/or with tobacco chewing habit.
3)Patients who were ready to give their consent for the treatment.
 
 
ExclusionCriteria 
Details  1)Patients who have disclosed medical history for major diseases.
2)Patients with coexisting disease or disorder of the orofacial region other than OSMF which may interfere with the study protocol.
3)Patients with or having a history of oral cancer.
4)Patients with the inadequate reference point (i.e. incisal edges of the central incisors) for measuring interincisal distance.
5)Patients with limited mouth opening reasons other than OSMF.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To eliminate the signs & symptoms, halt disease progression & reduce the predisposition for malignant transformation.
 		 baseline
1month
2month
3month
6months
 
 
Secondary Outcome  
Outcome  TimePoints 
1) To assess improvement in mouth opening.
2) To assess relief from intolerance to spicy food.
3) To evaluate difference in pain on opening mouth wide in control & study group.
4) To evaluate difference in cheek flexibility, tongue protrusion, blanching & depapillation of tongue and the extent of fibrous bands.
 		 baseline
1month
2month
3month
6months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   05/05/2024 
Date of Study Completion (India) 13/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  -

  6. For how long will this data be available start date provided 08-02-2024 and end date provided 08-02-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

"In this prospective study, patients with Oral Submucous Fibrosis will undergo screening and clinical diagnosis at the Department of Oral Medicine and Radiology. Following inclusion and exclusion criteria, consenting patients will be randomly assigned to either a study group receiving oral pentoxifylline 400 mg thrice daily for 3 months or an active control group receiving Vitamin E 400 IU once daily for the same duration. Various parameters including burning sensation, mouth opening, cheek flexibility, pain on wide mouth opening, blanching, and tongue protrusion will be assessed and compared between the two groups."

 
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