| CTRI Number |
CTRI/2024/02/063158 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
01/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Jaw Surgery: Comparing Joint Replacement with and without Corrective Jaw Surgery |
|
Scientific Title of Study
|
Comparative Finite Element Analysis of Temporomandibular Joint (TMJ) in Patients
Undergoing Total Joint Replacement (TJR) with and without Concomitant Orthognathic Surgery
|
| 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 Santhosh Rao |
| Designation |
Additional proffesor,Oral and maxillofacial surgery,Department of DentistryAIIMS,Raipur |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Dentistry,C block,Ground floor,AIIMS,Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9981525599 |
| Fax |
|
| Email |
santhosh@aiimsraipur.edu.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santhosh Rao |
| Designation |
Additional proffesor,Oral and maxillofacial surgery,Department of DentistryAIIMS,Raipur |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Dentistry,C block,Ground floor,AIIMS,Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9981525599 |
| Fax |
|
| Email |
santhosh@aiimsraipur.edu.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santhosh Rao |
| Designation |
Additional proffesor,Oral and maxillofacial surgery,Department of DentistryAIIMS,Raipur |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Dentistry,C block,Ground floor,AIIMS,Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9981525599 |
| Fax |
|
| Email |
santhosh@aiimsraipur.edu.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS) Raipur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences (AIIMS) Raipur |
| Address |
All India Institute of Medical Sciences Raipur Chattisgarh - 492099 |
| 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 Santhosh Rao |
All India Institute of Medical Sciences , Raipur |
Department of Dentistry C Block, Ground Floor All India Institute of Medical Sciences Raipur CHHATTISGARH 492099
Raipur
CHHATTISGARH |
9981525599
santhosh@aiimsraipur.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee,AIIMS,Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M266||Temporomandibular joint disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIl |
NIl |
| Comparator Agent |
NIl |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
. Diagnosis of Unilateral or Bilateral TMJ Ankylosis: Patient must have a
confirmed diagnosis of either unilateral or bilateral TMJ ankylosis based on
clinical evaluation and diagnostic imaging, including CT scans.
2. Availability of DICOM Images: Patient must have high-quality DICOM
images of their TMJ anatomy, which will be used for creating patient
specific TMJ designs and conducting FEA |
|
| ExclusionCriteria |
| Details |
1. Insufficient Diagnostic Information: Patients with incomplete medical
records or insufficient diagnostic information for confirming TMJ ankylosis
will not be included.
2. Previous TMJ Surgical Interventions: Patients who have undergone prior
TMJ surgical procedures, including joint replacement or other surgical
treatments, will be excluded to maintain homogeneity in the study.
3. Other Severe Medical Conditions: Patients with severe medical conditions or
comorbidities that could influence the study outcomes or introduce confounding
variables will not be included |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quantitative assessment of TMJ biomechanics, including stress distribution, strain, and displacement, as determined through Finite Element Analysis (FEA). |
Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparative analysis of TMJ biomechanics between patients undergoing Total Joint Replacement (TJR) with Concomitant Orthognathic Surgery and those undergoing TJR without orthognathic surgery. |
Day 1 |
|
|
Target Sample Size
|
Total Sample Size="2"
Sample Size from India="2"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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="0"
Months="8"
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
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [santhosh@aiimsraipur.edu.in].
- For how long will this data be available start date provided 30-10-2024 and end date provided 30-04-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The primary focus of this study is to investigate the biomechanical behavior of the TMJ and assess the performance of novel patient-specific TMJ prostheses. The TMJ is a crucial joint for oral function and overall quality of life. However, it can be afflicted by various conditions, necessitating interventions such as total joint replacement (TJR) using custom-made implants.
The study of TMJ disorders and associated surgical interventions is a complex yet essential pursuit in the realm of oral and maxillofacial surgery. By merging innovation through patented surgical designs, a groundbreaking application of FEA, and patient-specific CT imaging, this research seeks to advance our knowledge of TMJ surgeries and improve treatment outcomes for individuals suffering from TMJ ankylosis and related conditions. Ultimately, this study aims to contribute significantly to the field of maxillofacial surgery, benefiting patients by enhancing the safety and efficacy of treatments for these challenging conditions. Through these innovations, this research aspires to pave the way for more effective and personalized interventions, ultimately improving the quality of life for individuals affected by TMJ disorders and associated dentofacial deformities.
This study’s justification lies in its pioneering approach to combine patented TMJ prostheses and finite element analysis, addressing TMJ pathology and dentofacial deformities simultaneously. With limited literature on FEA in TMJ biomechanics, this research fills a critical knowledge gap, promising insights to optimize surgical techniques and patient outcomes. The interdisciplinary nature of this study enhances evidence-based practice, benefiting individuals suffering from TMJ ankylosis and related conditions. By advancing knowledge and improving interventions, this study ultimately aims to enhance patient wellbeing and contribute to the field of maxillofacial surgery. |