| 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
|
|
|
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
|
|
|
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
|
|
|
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
- 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).
- 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
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [tejashree.darshu@gmail.com].
- 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.
- 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. |