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CTRI Number  CTRI/2025/11/097172 [Registered on: 11/11/2025] Trial Registered Prospectively
Last Modified On: 07/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Buccal Fat Pad Reconstruction With or Without PRF in Oral Submucous Fibrosis 
Scientific Title of Study   COMPARATIVE STUDY OF ORAL SUBMUCOUS FIBROSIS PATIENTS UNDERGOING RECONSTRUCTION WITH BUCCAL FAT PAD WITH AND WITHOUT PLATELET RICH FIBRIN 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AUTADE ROSHANI RAVINDRA 
Designation  PG STUDENT 
Affiliation  GOVERNMENT DENTAL COLLEGE AND HOSPITAL, JAMNAGAR 
Address  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, ROOM NO-4, GOVERNMENT DENTAL COLLEGE AND HOSPITAL, JAMNAGAR, PATHIKASHRAM ROAD, NAVAGAM, GHED

Jamnagar
GUJARAT
361008
India 
Phone  9324808625  
Fax    
Email  rautade15@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR. NISHIT KUMAR 
Designation  TUTOR 
Affiliation  GOVERNMENT DENTAL COLLEGE AND HOSPITAL, JAMNAGAR 
Address  GOVERNMENT DENTAL COLLEGE AND HOSPITAL, JAMNAGAR, PATHIKASHRAM ROAD, NAVAGAM, GHED

Jamnagar
GUJARAT
361008
India 
Phone  9824282509  
Fax    
Email  drnishitomfs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  AUTADE ROSHANI RAVINDRA 
Designation  PG STUDENT 
Affiliation  GOVERNMENT DENTAL COLLEGE AND HOSPITAL, JAMNAGAR 
Address  GOVERNMENT DENTAL COLLEGE AND HOSPITAL, JAMNAGAR, PATHIKASHRAM ROAD, NAVAGAM, GHED

Jamnagar
GUJARAT
361008
India 
Phone  9324808625  
Fax    
Email  rautade15@gmail.com  
 
Source of Monetary or Material Support  
DR. ROSHANI R. AUTADE DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, GOVERNMENT DENTAL COLLEGE AND HOSPITAL, JAMNAGAR 
 
Primary Sponsor  
Name  DR ROSHANI R AUTADE 
Address  GOVERNMENT DENTAL COLLEGE AND HOSPITAL, JAMNAGAR, NAVAGAM, GHED 
Type of Sponsor  Other [DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, GOVERNMENT DENTAL COLLEGE AND HOSPITAL, JAMNAGAR] 
 
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 
AUTADE ROSHANI RAVINDRA  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, GOVERNMENT DENTAL COLLEGE AND HOSPITAL, JAMNAGAR
Jamnagar
GUJARAT 
09324808625

rautade15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, M.P. SHAH GOVT. MEDICAL COLLEGE AND GURU GOBIND SINGH HOSPITAL JAMNAGAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K135||Oral submucous fibrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  reconstruction of fibrotomy defect with buccal fat pad and prf in osmf patients  prf helps in soft tissue regeneration and can be used in osmf along with buccal fat pad as an adjuvant aiding in soft tissue healing 
Intervention  reconstruction of fibrotomy defect with buccal fat pad in osmf patients  Buccal fat pad (BFP) is a supple lobulated mass and has been steadily gaining acceptance amongst surgeons as it is accessible and can be easily mobilized and used for reconstruction in osmf 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients with an interincisal mouth opening less than 20 mm.
2.Biopsy proven OSMF.
3.No systemic disorders.
4.Patients who have quit tobacco use more than 6 months ago. 
 
ExclusionCriteria 
Details  1. Patients with an interincisal mouth opening greater than 20 mm.
2. Currently chewing tobacco or less than 6 months of quitting of habit.
3. Smokers.
4. Patients who have undergone any kind of treatment for OSMF previously.
• Patients with an uncontrolled systemic illness.
• Patients with altered hemodynamic values.
• Patients who have undergone treatment for malignancy (any radiotherapy or chemotherapy).
• Women who are pregnant, lactating or taking oral contraceptives.
• Patients who have reduced mouth opening due to reasons other than OSMF.
 
 
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 Blinded 
Primary Outcome  
Outcome  TimePoints 
• Mouth opening in mm.
• Post reconstruction healing (epithelialization) of the defect created by resection of the fibrous bands at the surgical site.
 
UPTO 6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
• Reduction in the burning sensation post surgery will be assessed on subjective basis after 3 months.  3 MONTHS 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/11/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Numerous treatment modalities have evolved over time for treatment of OSMF. These include simple release of fibrosis, skin grafting, use of bilateral tongue flap, nasolabial flap, palatal island flap, bilateral radial artery forearm free flap, superficial temporal fascia flap, buccal fat pad. But each has its own drawback.

Buccal fat pad (BFP) is a supple lobulated mass and has been steadily gaining acceptance amongst surgeons as it is accessible and can be easily mobilized. 

Platelet-rich fibrin (PRF) is a second generation platelet concentrate, developed in 2001 by Choukroun et al, now defined as ‘‘an immune and platelet concentrate collected on a single fibrin membrane containing all the constituents of a blood sample favorable to healing and immunity.’’ It has been revealed by clinical studies that this biomaterial promotes wound healing, wound sealing and hemostasis. PRF has certain clear advantages over other platelet concentrates which include simple, quick, single staged fabrication, cost effectiveness, reduced risk of antigenicity. 

It has been shown that conversion of fibrinogen to fibrin in PRF is slow, with physiologically available thrombin of blood, creating a fibrin network similar to a natural one leading to more efficient cell migration and cell proliferation. It was hence proposed that grafting of autologous PRF membrane after excision of nondysplastic, potentially malignant, oral lesions could help in wound coverage and might also have a positive effect on wound healing and epithelialization. 

We intend to apply the wound healing properties of PRF in treatment of the defects created by surgical excision of fibrous bands in OSMF patients by comparing it with the commonly used BFP flap and also compare the post operative mouth opening of the patients in both the groups.

 
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