| 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
|
|
|
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
|
|
|
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
|
|
|
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 |