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CTRI Number  CTRI/2024/02/063202 [Registered on: 27/02/2024] Trial Registered Prospectively
Last Modified On: 26/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Abdominal Dermal Fat Graft versus Nasolabial Flap as Graft in Surgical Management of Advanced Oral Submucous Fibrosis 
Scientific Title of Study   Comparison of Abdominal Dermal Fat Graft with Nasolabial Flap as Graft in Surgical Management of Advanced Oral Submucous Fibrosis- A Randomized Controlled 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 Mehak Kataria 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  8800557124  
Fax    
Email  mehak.kataria1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Varsha Manekar 
Designation  Associate Professor 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Nagpur
Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Nagpur
Nagpur
MAHARASHTRA
440003
India 
Phone  9823077626  
Fax    
Email  varshamanekar67@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mehak Kataria 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Nagpur
Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Nagpur
Nagpur
MAHARASHTRA
440003
India 
Phone  8800557124  
Fax    
Email  mehak.kataria1997@gmail.com  
 
Source of Monetary or Material Support  
Government Dental College and Hospital, Nagpur 
 
Primary Sponsor  
Name  Dr Mehak Kataria 
Address  Department of Oral and Maxillofacial Surgery, Government Dental College and Hospital, Nagpur 
Type of Sponsor  Other [Self Funded] 
 
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 Mehak Kataria  Government Dental College and Hospital, Nagpur  Room no. 106, Department of ORal and Maxillofacial Surgery, Govenrmebt Dental College and Hospital Nagpur, Medical Chowk, Nagpur
Nagpur
MAHARASHTRA 		 8800557124

mehak.kataria1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Dental College and Hospital, Nagpur  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, (2) ICD-10 Condition: K135||Oral submucous fibrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Abdominal dermal fat graft  Reconstruction of fibrotomy defect with abdominal dermal fat graft in a single surgery under general anesthesia (3-4 hours) and then patient will be followed up for 6 months 
Comparator Agent  Nasolabial flap  Reconstruction of fibrotomy defect with nasolabial flap as graft in a single surgery under general anesthesia (3-4 hours) and then patient will be followed up for 6 months 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients with OSMF Grade 3 and 4A
2. Patients in whom diagnosis is confirmed clinically
3. Patient with mouth opening equal to or less than 15mm.
4. Good general health status.
5. Patient with good oral hygiene and motivation. 
 
ExclusionCriteria 
Details  1. Patients with OSMF Grade 1, 2 and 4B
2. Patients with presentation of any other cause of trismus.
3. Medically compromised patients (ASA class III and IV)
4. Unable to come for follow up visits
5. Not willing to quit deleterious habits. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Interincisal mouth opening  preoperatively, and
postoperatively and at 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Graft uptake
 		 post operatively at 6 months 
Lower facial height  preoperatively and post operatively at 6 months 
Donor site morbidity
 		 post operatively at 6 months 
Surgical time of the procedure  from first incision till the placement of last suture 
Quality of life  preoperatively and
postoperatively at 6 months 
Ease of surgery  postoperatively 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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 4 
Date of First Enrollment (India)   10/03/2024 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mehak.kataria1997@gmail.com].

  6. For how long will this data be available start date provided 12-03-2025 and end date provided 12-03-2026?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Oral Submucous fibrosis is a debilitating but preventable oral disease, which affects mouth opening and general health condition of the patient. The various treatment modalities are mainly medical, surgical, or a combination of both. The goal of this study is to find a promising graft material in the form of abdominal dermal fat graft and compare it with conventional nasolabial flap being used as graft in the management of advanced oral submucous fibrosis, in terms of -  Interincisal mouth opening, Graft uptake,   Lower facial height,  Donor site morbidity, Surgical time of the procedure,  Quality of life and Ease of surgery.

 
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