| 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
|
|
|
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
|
|
|
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. |