| CTRI Number |
CTRI/2025/11/097772 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Platelet-Rich Plasma and Placentrex with Hyaluronidase Injections for Better Healing After Surgery in Oral Submucous Fibrosis : A Clinical Study |
|
Scientific Title of Study
|
A Comparative Evaluation of the Efficacy of Submucosal Injections of Autologous Platelet-Rich Plasma Versus Placentrex® Combined with Hyaluronidase in the Management of Oral Submucous Fibrosis Following Immediate Surgical Release of Fibrous Bands: 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 |
Dr Deepali Surti |
| Designation |
Junior Resident |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
| Address |
Room No. 101,Department of Oral and Maxillofacial Surgery, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongari Road, Hingna, Nagpur
Nagpur MAHARASHTRA 441110 India |
| Phone |
8928095077 |
| Fax |
|
| Email |
surtideepali13@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mayur Gawande |
| Designation |
Associate Professor |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
| Address |
Room no. 101, Department of Oral and Maxillofacial Surgery, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongari Road, Hingna, Nagpur
Nagpur MAHARASHTRA 441110 India |
| Phone |
8793851956 |
| Fax |
|
| Email |
mayur.gawande@sdk-dentalcollege.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Deepali Surti |
| Designation |
Junior Resident |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
| Address |
Room No. 101, Department of Oral and Maxillofacial Surgery, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur
Nagpur MAHARASHTRA 441110 India |
| Phone |
8928095077 |
| Fax |
|
| Email |
surtideepali13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongari Road, Hingna, Nagpur-441110 |
|
|
Primary Sponsor
|
| Name |
Dr Deepali Surti |
| Address |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital Wanadongari Road Hingna Nagpur 441110 |
| Type of Sponsor |
Other [self] |
|
|
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 Deepali Surti |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
Room No. 101, Department of Oral and Maxillofacial Surgery, Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Wanadongari Road Hingna Nagpur Nagpur MAHARASHTRA |
8928095077
surtideepali13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z128||Encounter for screening for malignant neoplasm of other sites, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autologous Platelet Rich Plasma |
Autologous platelet Rich plasma is derived from patients own blood. 2ml of platelet rich plasma will be injected intraoperatively and follow up will be done till 8 weeks |
| Comparator Agent |
Placentrex |
Placentrex is a placental extract derived from human placenta used for its regenerative and healing properties 2ml of Placentrex will be injected intraoperatively and follow up will be done for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Stage IV OSMF according to Khanna and Andrade classification (1995)30.
Patients in age group 20-50 years.
Patient willing for cessation of habit
|
|
| ExclusionCriteria |
| Details |
Temporomandibular joint disorder or trauma to it.
Patient giving history of allergy to placentrex injection .
Clinical signs and symptoms or proven report of malignancy and red and white lesion.
|
|
|
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 and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the efficacy of autologous platelet-rich plasma and Placentrex in combination with hyaluronidase for improving mouth opening in oral submucous fibrosis following immediate surgical release of fibrous bands for 3 months. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the efficacy of autologous platelet-rich plasma and Placentrex in combination with hyaluronidase for reducing burning sensation and increasing cheek flexibility in oral submucous fibrosis following immediate surgical release of fibrous bands for 3 months. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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 |
|
Date of First Enrollment (India)
|
12/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/12/2025 |
| 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
|
| Oral Submucous Fibrosis is an insidious chronic disease affecting any part of the oral cavity and sometimes the pharynx Although occasionally preceded by and or associated with vesicle formation it is always associated with juxtaepithelial inflammatory reaction followed by a fibroelastic change of the lamina propria with epithelial atrophy leading to stiffness of the oral mucosa and causing trismus and inability to eat This potentially malignant condition was first reported by Schwartz in 1952 in five Indian females from Kenya when he coined the term atropica idiopathica mucosae oris . OSMF shows multifactorial pathogenesis. Factors such as areca nut chewing, excessive ingestion of chilies hereditary factors can trigger the juxtaepithelial inflammatory response of oral mucosa That is followed by a fibro elastic change of lamina propria and epithelial atrophy leading to stiffness of oral mucosa leading to trismus and difficulty in eating Due to its stubborn nature the management of OSMF is difficult The lack of complete response to treatment aim is to reduce morbidity and risk of malignant transformation Most patients are treated with Pharmacological methods and oral physiotherapy The main aim of treatment is to relieve symptoms, prevent malignant transformation, and improve mouth opening Surgical intervention is typically indicated in the late and irreversible stages of the condition It involves the release of fibrous bands followed by the placement of various grafts to restore function and prevent recurrence Placental extract Placentrex is an aqueous extract of human placenta that contains nucleotides enzymes like alkaline phosphatase acid phosphatase vitamins like Vit E B1 B2 B4 B6 pantothenic acid nicotinic acid P amino benzoic acid folic acid essential and non essential amino acids and certain trace elements Main effects of placental extract are anti-inflammatory and analgesic action that increases blood circulation tissue vascularity, arrest tissue growth stagnation and lower immune response factor Platelet rich plasma is a simple efficient and minimally invasive method of obtaining a natural concentration of autologous growth factors Formation of PRP involves centrifugation of autologous blood to separate and extract the plasma and buffy coat layer that contains high concentration of platelets PRP has seven fundamental proteins that are platelet derived growth factors PDGF transforming growth factor TGF B vascular endothelial growth factor VEGF epidermal growth factor EGF and adhesive proteins fibrin fibronectin and vitronectin PDGF is a glycoprotein which emerges from degranulation of platelets at the site of injury It activates cell membrane receptors on target cell which in turn develop high energy phosphate bonds which activates the signal proteins to initiate specific activity of target cells These specific activities include mitogenesis angiogenesis and macrophage activation TGFb is secreted by platelets and also by macrophages and acts as an anti proliferative factor in normal epithelial cells It acts as paracrine and autocrine in nature The target cells for TGF b are fibroblasts marrow stem cells and preosteoblasts They represent long term healing bone regeneration and bone modelling TGF b also inhibits osteoclast formation VEGF originally known as vascular permeability factor is a signal protein produced by cells that stimulates vasculogenesis and angiogenesis EGF is a growth factor that stimulates cell growth proliferation and differentiation by binding to its receptor EGFR Hyaluronidase is an enzyme that breaks down hyaluronic acid a key component of tissue cement thereby decreasing tissue density and enhancing permeability This enables injectables to disperse more easily facilitating localized absorption and promoting effective treatment outcomes The aim of the present study is to comparatively evaluate the efficacy of submucosal injections of autologous platelet rich plasma PRP versus Placentrex combined with hyaluronidase in the management of oral submucous fibrosis OSMF following immediate surgical release of fibrous bands | |