| CTRI Number |
CTRI/2025/02/081216 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the role of temporalis fascia and buccal fat pad in treating TMJ ankylosis |
|
Scientific Title of Study
|
Role of temporalis fascia and buccal fat pad in the management of temporomandibular joint ankylosis: A clinico-radiographic comparative 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 |
Dr Aakriti Kumari |
| Designation |
PG Resident |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
02, Department of Oral & Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Chaudhary Vihar Utrathia Raebareily Road Lucknow
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
7023433109 |
| Fax |
|
| Email |
kaakriti1546@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhinav Srivastava |
| Designation |
Reader |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
02, Department of Oral & Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Chaudhary Vihar Utrathia Raebareily Road Lucknow
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
9151657779 |
| Fax |
|
| Email |
drabhinav27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhinav Srivastava |
| Designation |
Reader |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
| Address |
02, Department of Oral & Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Chaudhary Vihar Utrathia Raebareily Road Lucknow
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
9151657779 |
| Fax |
|
| Email |
drabhinav27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral and Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences,Lucknow, Uttar Pradesh-226025, India |
|
|
Primary Sponsor
|
| Name |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences,Lucknow |
| Address |
Raebareilly road Lucknow-226025 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Aakriti Kumari |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
Dept- 02, Department of Oral and Maxillofacial Surgery Sardar Patel Post Graduate Institute of Dental and Medical Sciences,Lucknow
Lucknow
UTTAR PRADESH |
7023433109
kaakriti1546@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buccal Fat Pad |
Using Al-Kayat and Bramley incision, ankylotic mass is exposed and removed to create gap of 1.5cm. The buccal fat pad is exposed through same incision intraoral used for coronoidectomy and the buccal fat pad is transposed to the extraoral gap arthroplasty site through created tunnel and then secured using sutures.
The follow up will be done on 1st, 3rd, 7th, 14th day, 1 month, 3 month, 6 month and 1 year. the total duration of intervention is 1 year |
| Comparator Agent |
Temporalis Fascia |
Using Al-Kayat and Bramley incision, exposure of ankylotic mass and its removal is done to create a gap of 1.5cm. A 1.5 cm width of temporalis fascia is dissected and rotated beneath the zygomatic arch to fill the gap resulting from gap arthroplasty. The follow up will be done on 1st, 3rd, 7th, 14th day, 1 month, 3 month, 6 month and 1 year. The total duration of study is 1 year. |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) Group I & II patients
Unilateral TMJ ankylosis
Sawhneys type 3 and type 4
Patient ready to give informed consent
Patients willing to perform postoperative mouth opening exercises as per instruction |
|
| ExclusionCriteria |
| Details |
Medically compromised patient
Patients not willing for surgery
Patients deemed medically unfit to undergo procedure under general anaesthesia
|
|
|
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
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is to evaluate the efficacy of buccal fat pad and temporalis fascia for managing TMJ ankylosis and to assess the maximum interincisal mouth opening |
The estimated time may range from 6th month to 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is to evaluate the efficacy of buccal fat pad and temporalis fascia for managing TMJ ankylosis and to assess the pain, transient facial paresis, infection, maintenance of intra-articular space. |
The estimated time may range from 6th month to 1 year |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
05/03/2025 |
| Date of Study Completion (India) |
26/03/2026 |
| Date of First Enrollment (Global) |
05/03/2025 |
| Date of Study Completion (Global) |
26/03/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
The objective of our re-search is to access the efficaciousness of temporal fascia and buccal pad of fat in the TMJ ankylosis management and evaluate, compare, and analyze various clinical and radiographic parameters at different intervals. Primary objective- Clinical assessment 1. Maximum interincisal mouth opening (in mm) Secondary objectives- Clinical assessment 2. Pain (according to Visual Analog Scale) 3. Transient Facial paresis (House Brackmann scale) 4. Infection (pus discharge and wound dehiscence at operated site) Radiographic assessment 5. Maintenance of the intra-articular space (OPG and CT scan)
The data for this study will be collected from patients who visit the Out Patient Department (OPD) of Oral and Maxillofacial Surgery at Sardar Patel Post Graduate Institute of Dental and Medical Sciences. Prior to participating in the study, each patient will be provided with a detailed explanation of the procedure, its possible outcomes, consequences, and complications. Written informed consent will be secured from every patient, regardless of their caste, creed, sex, religion, or socio-economic status.Patients will be randomly assigned into two groups i.e., Group A and Group B utilizing Lottery Method. All patients will undergo surgery under general anaesthesia. Pre-operative antibiotics and Tetanus prophylaxis will be administered. Nasotracheal intubation will be done using fiber-optic bronchoscope followed by surgical part preparation and draping. General anaesthesia will be induced using propofol and will then be maintained by isoflurane and O2 and N2O. Local anaesthetic infiltration with 2% lignocaine with 1:80,000 adrenaline will be given at the planned incision site. |