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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  
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 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  
Status 
Not Applicable 
 
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

 
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