FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090284 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 06/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Stem Cell Therapy
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Finding Relief from Oral Submucous Fibrosis: using Injection of either Dexamethasone or Platelet Rich Plasma  
Scientific Title of Study   Comparison of Dexamethasone Versus Platelet Rich Plasma Injection for Improving Trismus in Oral Submucous Fibrosis – A Prospective Randomized 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 Tejashree R 
Designation   
Affiliation   
Address  Shri Atal Bihari Vajpayee Medical College and Research Institute 1, Lady Curzon Rd, Shivaji Nagar, Bengaluru, Karnataka 560001

Bangalore
KARNATAKA
560001
India 
Phone  9844386210  
Fax    
Email  tejashree.darshu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tejashree R 
Designation   
Affiliation  Shri Atal Bihari Vajpayee Medical College and Research Institute 
Address  Shri Atal Bihari Vajpayee Medical College and Research Institute 1, Lady Curzon Rd, Shivaji Nagar, Bengaluru, Karnataka 560001

Bangalore
KARNATAKA
560001
India 
Phone  9844386210  
Fax    
Email  tejashree.darshu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tejashree R 
Designation   
Affiliation  Shri Atal Bihari Vajpayee Medical College and Research Institute 
Address  Shri Atal Bihari Vajpayee Medical College and Research Institute 1, Lady Curzon Rd, Shivaji Nagar, Bengaluru, Karnataka 560001

Bangalore
KARNATAKA
560001
India 
Phone  9844386210  
Fax    
Email  tejashree.darshu@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Tejashree R 
Address  Shri Atal Bihari Vajpayee Medical College and Research Institute 1, Lady Curzon Rd, Shivaji Nagar, Bengaluru, Karnataka 560001 
Type of Sponsor  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 TEJASHREE R  Department of Dentistry, BOWRING & LADY CURZON HOSPITALS  Shri Atal Bihari Vajpayee Medical College and Research Institute 1, Lady Curzon Rd, Shivaji Nagar, Bengaluru, Karnataka 560001
Bangalore
KARNATAKA 
9844386210

tejashree.darshu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
www.sabvmcri.karnataka.gov.in  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L948||Other specified localized connective tissue disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DEXAMETHASONE  1ML 
Comparator Agent  PRP  1ML 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.The patients of either gender will be included
2.with a clinical diagnosis of OSMF,
3.having burning sensation on eating spicy food
4.presence of palpable fibrous bands on the buccal mucosa and having restricted mouth opening.
 
 
ExclusionCriteria 
Details  1.who had undergone any other treatment for OSMF
2.patients with diabetes mellitus
3.patients on antiplatelet drugs
4.those with temporo-mandibular joint disorders
5.those who were allergic to local drugs
6.pregnant and lactating women
• those with trismus due to other causes and those with other pre-malignant lesions like leukoplakia.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of Dexamethasone versus Platelet Rich Plasma (PRP) injection intraorally for improving trismus with regard to mouth opening in Oral Submucous Fibrosis (OSMF)  DAY-1
WEEK 1
EVERY WEEK TILL WEEK -8 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of Dexamethasone versus Platelet Rich Plasma (PRP) injection intraorally for improving colour of the mucosa, and burning sensation in Oral Submucous Fibrosis (OSMF)  DAY-1
WEEK 1
EVERY WEEK TILL WEEK -8 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   20/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/07/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [tejashree.darshu@gmail.com].

  6. For how long will this data be available start date provided 05-07-2025 and end date provided 01-07-2026?
    Response - Immediately following publication. No end date.

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

Oral sub mucous fibrosis (OSMF) is a chronic, premalignant condition of the oral mucosa its insidious, chronic disease affecting any part of the oral cavity and sometimes the pharynx. OSMF is also characterized by reduced movement and depapillation of the tongue, blanching and leathery texture of the oral mucosa, progressive reduction of mouth opening, and shrunken uvula. Dysphonia and hearing impairment is also observed in advanced cases . Quality of life (QoL) is severely affected, worsening with increasing stage of the disease.  The malignant transformation rate of OSMF has been reported to be in the range of 7–13%, studies with smaller follow up periods report malignant transformation rates ranging from 1.9–9%. 

 

Conventional medical management includes avoidance of irritating substance like betel chewing, tobacco ingestion or smoking etc. and involves regular administration of corticosteroids, either via submucosal injections or topical application . Steroids suppress or prevent inflammatory reactions, also act as immunosuppressive agents. They can prevent fibrosis by decreasing deposition of collagen and fibroblastic proliferation. Steroids such as dexamethasone, triamcinolone, betamethasone, and hydrocortisone have been used in the treatment of OSMF. 

 

Recently platelet rich plasma (PRP) treatment is gaining popularity in oral

and dental surgery. Platelet rich plasma acts by inducing the platelets to secrete proinflammatory mediators and growth factors. These, in turn, initiate the cascade of wound healing and bring about tissue remodeling. 

 

This study is designed to evaluate the effect of Dexamethasone versus platelet rich plasma in improving trismus due to oral submucous fibrosis.

 
Close