| CTRI Number |
CTRI/2024/11/077090 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Innovative jaw reconstruction system in jaw-joint disorders. |
|
Scientific Title of Study
|
Development and design of novel prosthetic total temporomandibular joint (TMJ) reconstruction system in patients with temporomandibular joint disorder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sujata Mohanty |
| Designation |
Professor (SAG) and Head of Department |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Room No 112, Division of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery,Maulana Azad Institute of Dental Sciences, Bahadur Shah Zafar Marg, Delhi-110002
Central
DELHI
110002
India |
| Phone |
9654700960 |
| Fax |
|
| Email |
drsm28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjali Verma |
| Designation |
Senior Research Associate |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Room No 106, Division of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery,Maulana Azad Institute of Dental Sciences, Bahadur Shah Zafar Marg, Delhi-110002
Central
DELHI
110002
India |
| Phone |
8447801126 |
| Fax |
|
| Email |
anjalidevchugh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjali Verma |
| Designation |
Senior Research Associate |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Room No 106, Division of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery,Maulana Azad Institute of Dental Sciences, Bahadur Shah Zafar Marg, Delhi-110002
Central
DELHI
110002
India |
| Phone |
8447801126 |
| Fax |
|
| Email |
anjalidevchugh@gmail.com |
|
|
Source of Monetary or Material Support
|
| INDIAN COUNCIL OF MEDICAL RESEARCH, V. RAMALINGASWAMI BHAWAN, P.O.BOX NO.911, ANSARI NAGAR, NEW DELHI-110029, INDIA |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramslingaswami Bhawan, P.O box no. 4911, Ansari Nagar, New Delhi-110029, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Naresh Kumar Sharma |
Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University |
Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University,Bhagwanpur, Varanasi, Uttar Pradesh 221005
Varanasi
UTTAR PRADESH |
9358708432
drnaresh@bhu.ac.in |
| Dr Sujata Mohanty |
Maulana Azad Institute of Dental Sciences |
Department of Oral and Maxillofacial Surgery,Maulana Azad Institute of Dental Sciences, Bahadur Shah Zafar Marg, Delhi-110002
Central
DELHI |
9654700960
drsm28@gmail.com |
| Dr Virender Singh |
Post Graduate Institute of Dental Sciences |
Pt BD Sharma Post Graduate Institute of Dental Sciences
Medical Road, Rohtak, Haryana 124001
Rohtak
HARYANA |
989626781
drvirendrasingh1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Biomedical and health research Ethics Committee, PGIDS, Rohtak |
Approved |
| Institutional Ethics Committee Institute of Medical Sciences Banaras Hindu University |
Approved |
| Institutional Ethics Committee,Maulana Azad Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M278||Other specified diseases of jaws, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
NOVEL PROSTHETIC TOTAL TEMPOROMANDIBULAR JOINT (TMJ) RECONSTRUCTION SYSTEM |
All of the patients would be fully informed of the nature of their problem and the fact that the surgical treatment recommended is total custom-made patient specific TMJ reconstruction system. The pre- and postoperative data will be collected using a standardized format by the same observer. Orthopantomography and CT /MRI imaging will be performed within 1 week and 1 year postoperatively in order to visualize the position of the ramus and fossa components and the relationships between retention screws and the inferior alveolar nerve for the ramus components. The patient will be examined on a scheduled basis (at 1,3, 6, 12 months postoperatively). Subjective data regarding TMJ pain, function of the lower jaw, and diet, will be collected. Objective evaluation will include mandibular range of motion, measurable as interincisal opening and lateral excursion, deviation on mouth opening measured in millimetres and occlusal discrepancy. These measures will be compared using mean values. In case of any post-operative complications, these radiographic investigations may be repeated |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) End-Stage Temporomandibular disorders including Internal disc derangement and osteoarthritis
b) Late-stage degenerative joint disease (osteoarthritis, rheumatoid arthritis, traumatic arthritis, etc.)
c) Ankylosis irrespective of site and duration of ankylosis
d) Revision procedures for failed alloplastic or autogenous reconstruction
f) Neoplasia/cyst requiring resection of TMJ
|
|
| ExclusionCriteria |
| Details |
a) Allergy to any of the prosthetic materials
b) Systemic disease with increased susceptibility to infection
c) Known neurologic/psychiatric disorders,
d) Uncontrolled systemic disorder or immunocompromised state,
e) Patient not willing to participate in study
f) Skeletally immature patients
g) Bilateral ankylosis cases / bilateral temporomandibular joint disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
A. Subjective Outcomes
1)Improvement in pain levels
2. Improvement in diet and jaw function
B. Objective Outcomes
1. Changes in range of motion of mandible
2. Changes in Occlusion
3. Changes in Mandibular deviation
4. Electromyography
5. Bite force
6. Total Time of surgical procedure
7. Facial nerve function
8. Other complications of surgical procedure
C. Quality of life
D. Changes in Joint morphology
|
The outcomes will be assessed/estimated Preoperatively(baseline), at 1-month, 3-months and 6-months follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Develop and design a novel total temporomandibular joint (TMJ) reconstruction system in a cohort of patients treated for Temporomandibular joint disorders (TMJ) suitable for Indian population. |
3 years |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Work
on Temporomandibular Joint (TMJ) at tertiary care centers like Maulana Azad
Institute of Dental Sciences, Delhi, is being carried out for multiple decades. However, these institutes
still rely on autogenous grafts for the reconstruction of temporomandibular
joint. This not only creates a second surgical site but also carries the risk
of patient morbidity and graft resorption. Thus, an optimal treatment alternative
is not available for these patients. Out of multiple options for reconstruction
of the temporomandibular joint, prosthetic joint replacement is associated with
a single surgery which causes less donor site morbidity. Commercially available
pre-fabricated TMJ prosthesis does not fit the Indian population as they have
been designed according to the Caucasian population, it cannot fit the patient
population in India. The alternative to this is custom -made patient specific
TMJ prosthesis which is designed according to the patient anatomy. Patient
specific TMJ prosthesis is not available commercially in India, and it is not
cost effective around the world (average price around 20,000 USD). Due to absence
of complete range of motion with stock prosthetic TMJ, the mouth opening
remains less. Inability to open the mouth is an impediment to patient to eat,
speak.
Prosthetic joints available
in the market also do not have any arrangement to incorporate lateral pterygoid
muscle which is required for proper mouth opening without jaw deviation and
performing lateral movements of the TMJ. In view of the above problems an
innovative design was created by the investigators that would facilitate
translation as well as rotational movements with a slot to incorporate the
lateral pterygoid muscles. To achieve these objectives, the investigators
comprehensively planned the reconstruction of glenoid fossa and reattachment of
the lateral pterygoid muscle to the prosthetic TMJ to support normal functional
occlusion and mandibular motion. The innovative design of prosthesis is based
on the biomechanics of the natural temporomandibular joint and is focused on 4
main outcomes: Maximum mouth opening and lateral movements, pain reduction,
dietary restitution, and quality-of-life improvement. As a result, the results
from this project would help to outline that re-establishing functional and
structural mechanics is a critical goal and influences total TMJ replacement
surgical success. The modification in the design of the prosthesis aims to
improve the clinical success of total joint prosthesis in restoring mouth
opening and complete range of mandibular movements. During total joint
replacement, the proper reattachment of the lateral pterygoid on condylar neck
of the mandibular component is necessary for the proper grinding of food.
Similarly, the change in glenoid fossa design will influence the range of
mandibular movements which may directly influence the vital functions of
speech, mastication and overall quality of life. |