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CTRI Number  CTRI/2026/01/100477 [Registered on: 07/01/2026] Trial Registered Prospectively
Last Modified On: 07/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing two types of fat tissue in jaw opening surgery in patients with jaw joint stiffness and their results in improving chewing 
Scientific Title of Study   Comparative assessment of masticatory efficiency surgical outcomes in temporomandibular joint ankylosis patients treated with pedicled buccal fat pad & free abdominal fat graft interpositional arthroplasty: An ambispective-cum-prospective study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aparna Mahajan 
Designation  Junior Resident 
Affiliation  AIIMS Rishikesh 
Address  Division of Oral & Maxillofacial Surgery, Department of Dentistry, Level 2C, AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9814976829  
Fax    
Email  aparnamahajan34@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ashi Chug 
Designation  Professor and Head (Guide) 
Affiliation  AIIMS Rishikesh 
Address  Division of Oral & Maxillofacial Surgery, Department of Dentistry, Level2C, AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8475000290  
Fax    
Email  ashichug@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Aparna Mahajan 
Designation  Junior Resident 
Affiliation  AIIMS Rishikesh 
Address  Division of Oral & Maxillofacial Surgery, Department of Dentistry, Level 2C, AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9814976829  
Fax    
Email  aparnamahajan34@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Aparna Mahajan 
Address  Division of Oral & Maxillofacial Surgery, Department of Dentistry, Level 2C, AIIMS Rishikesh, Uttarakhand, 249203, India. 
Type of Sponsor  Government medical college 
 
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 Aparna Mahajan  AIIMS Rishikesh  Division of Oral & Maxillofacial Surgery, Department of Dentistry, Level 2C
Dehradun
UTTARANCHAL 
9814976829

aparnamahajan34@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Rishikesh, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M279||Disease of jaws, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Abdominal fat graft  free abdominal fat graft via periumblical insicision which is asite distant from the primary surgucal site but has less volumetric shrinkage over the span of 1 year 
Comparator Agent  Buccal fat pad  Pedicled buccal fat pad from the same primary surgical site which has more volumetric shrinakge over the span of 1 year 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1] Presence of Temporomandibular joint ankylosis (Sawhney type I-IV).
2] ASA I, II category patients.
3] Patients who are willing to come for the follow up visit.
 
 
ExclusionCriteria 
Details  1] Patients with uncontrolled systemic diseases.
2] Pregnant patients.
3] Patients with metabolic fat disorders or other fat degeneration disorders or with local abdominal or buccal mucosa pathology.
4] Patients who do not provide written informed consent.
5] Patients who refuse to attend all scheduled visits.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Maximum Voluntary Bite force
Chewing efficiency 
Maximum Voluntary Bite force at 1 year
Chewing efficiency at 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Maximal Incisal Opening (MIO)
Re-ankylosis 
1. To assess MIO postoperatively after 1 year.
2. To evaluate the incidence of recurrence of ankylosis postoperatively after 1 year.
 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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)   02/02/2026 
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="2"
Months="0"
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  

Interpositional arthroplasty has emerged as the preferred treatment for TMJA due to its ability to prevent re-ankylosis by inhibiting osteoblastic growth between the bone surfaces Studies by Wolford and Karras  have shown that autologous transplantation of abdominal fat around the TMJ reduces fibrosis and heterotopic bone formation, leading to improved range of motion Dimitroulis utilized a dermis fat graft from the groin for interposition in the TMJ however harvesting fat grafts from distant sites poses risks of morbidity and complications The BFP situated nearby the TMJ offers an alternative with ample volume and a dependable blood supply making it a logical choice for grafting without the need for distant site harvesting  Additionally  minimal changes in facial contour have been reported after the removal of the superior extension of the buccal fat pad which can be advantageous in cases of unilateral TMJA by addressing facial asymmetry

Roy et al compared the volumetric shrinkage of grafts and surgical outcomes favoring abdominal fat graft over pedicled buccal fat pad in treating TMJA Another study by Ejaz et al in 2022 evaluated masticatory function including bite force and chewing efficiency in patients with unilateral TMJ ankylosis treated with pedicled BFP interpositional arthroplasty alone Despite numerous studies on TMJA and graft materials individually there is limited direct comparison between pedicled BFP and free abdominal fat as interpositional grafts in terms of surgical outcome and  masticatory efficiency Therefore a prospective interventional study is warranted to compare the efficacy of these two methods This study is based on the hypothesis that there is no significant difference in surgical outcomes and masticatory efficiency in both free abdominal fat and pedicled BFP as an interpositional graft in TMJA patients


 
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