| CTRI Number |
CTRI/2025/12/099212 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of efficacy of Intralesional Platelet Rich Plasma(PRP) with Intralesional Dexamethasone and Hyaluronidase in the treatment of Oral Submucous Fibrosis |
|
Scientific Title of Study
|
Comparison of efficacy of Intralesional Platelet Rich Plasma(PRP) with Intralesional Dexamethasone and Hyaluronidase in the treatment of Oral Submucous Fibrosis: A Randomized Controlled Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Haritha S |
| Designation |
MDS PG Student |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL, VIJAYAWADA |
| Address |
Room No 1,Department of Oral Medicine and Radiology, Government Dental College and Hospital, Vijayawada
Krishna
ANDHRA PRADESH
520004
India |
| Phone |
7397435507 |
| Fax |
|
| Email |
harithaselvaraj99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gautam Srivastava |
| Designation |
Associate Professor |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL, VIJAYAWADA |
| Address |
Room No 1,Department of Oral Medicine and Radiology, Government Dental College and Hospital, Vijayawada
Krishna
ANDHRA PRADESH
520004
India |
| Phone |
7893009911 |
| Fax |
|
| Email |
srivastava15@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Haritha S |
| Designation |
MDS PG Student |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL, VIJAYAWADA |
| Address |
Room no 1,Department of Oral Medicine and Radiology, Government Dental College and Hospital, Vijayawada
Krishna
ANDHRA PRADESH
520004
India |
| Phone |
7397435507 |
| Fax |
|
| Email |
harithaselvaraj99@gmail.com |
|
|
Source of Monetary or Material Support
|
| SELF FUNDED(Materials)Trial conducted at Government Dental College and Hospital,Vijayawada(Infrastructural support-GDCH Vijayawada) |
|
|
Primary Sponsor
|
| Name |
HARITHA S |
| Address |
Room No 1,Department of Oral Medicine and Radiology, Government Dental College and Hospital, Vijayawada, Andhra Pradesh-520004 |
| Type of Sponsor |
Other [self funded] |
|
|
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 HARITHA S |
Government Dental College and Hospital, Vijayawada |
Room No 1,Department of Oral Medicine and Radiology, Government Dental College and Hospital, Vijayawada
Krishna
ANDHRA PRADESH |
7397435507
harithaselvaraj99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVERNMENT DENTAL COLLEGE AND HOSPITAL ,VIJAYAWADA,INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K135||Oral submucous fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intralesional injection of Dexamethasone 4mg/ml (1.5ml)+ Intralesional injection of Hyaluronidase 1500 IU + with 0.5ml Lignocaine HCL |
Patients will be administered Intralesional injection of Dexamethasone 4mg/ml (1.5ml)+ Intralesional injection of Hyaluronidase 1500 IU + with 0.5ml Lignocaine HCL two times per week combined with oral antioxidant tablets containing Spirulina 500mg once daily for a period of 8 weeks |
| Intervention |
Platelet Rich Plasma 1ml |
Patients will be administered intralesional injection of PRP 1 ml once a week with oral antioxidant tablets containing Spirulina 500mg once daily for a period of 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients of age 21-60 years clinically diagnosed with OSMF.
2. Patients who are willing to quit the habit of chewing tobacco and areca nut.
3. Patients who will agree to come for regular follow-up visits will be included.
|
|
| ExclusionCriteria |
| Details |
1. Patients who are currently under treatment for OSMF.
2. Patients under treatment for chronic systemic diseases and blood disorders.
3. OSMF patients with severe restricted mouth opening where there is no adequate access to administer intralesional injections.
4. Patients under treatment for other OPMDs.
5. Pregnant and lactating patients. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mouth Opening |
18 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Burning Sensation |
18 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to compare the efficacy of intralesional Platelet Rich Plasma (PRP) with intralesional Dexamethasone and Hyaluronidase in the treatment of Oral Submucous Fibrosis with Spirulina as an adjuvant .Out patients reporting to the Department of Oral Medicine and Radiology, Government Dental College and Hospital ,Vijayawada who are diagnosed clinically with Oral Submucous Fibrosis and requires treatment will be enrolled in the study. Detailed history of health and habit will be taken and patient will be motivated to quit the habit. The intended procedure will be explained to every patient and an informed consent will be obtained thereafter. Selected patients will be allocated into group A and B randomly. Group A:Consists of 15 OSMF patients who will be administered intralesional injection of PRP 1 ml once a week with oral antioxidant tablets containing Spirulina 500mg once daily for a period of 8 weeks. Group B:Consists of 15 OSMF patients who will be administered Intralesional injection of Dexamethasone 4mg/ml (1.5ml)+ Intralesional injection of Hyaluronidase 1500 IU + with 0.5ml Lignocaine HCL two times per week combined with oral antioxidant tablets containing Spirulina 500mg once daily for a period of 8 weeks. |