Skip to main content
Clinical Trials/CTRI/2024/02/063158
CTRI/2024/02/063158Not yet recruitingNot Applicable

Comparative Finite Element Analysis of Temporomandibular Joint (TMJ) in Patients Undergoing Total Joint Replacement (TJR) with and without Concomitant Orthognathic Surgery

All India Institute of Medical Sciences (AIIMS) Raipur1 site in 1 country2 target enrollmentStarted: March 1, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
2
Locations
1
Primary Endpoint
Quantitative assessment of TMJ biomechanics, including stress distribution, strain, and displacement, as determined through Finite Element Analysis (FEA).

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 45.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.
  • 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.

Exclusion Criteria

  • Insufficient Diagnostic Information: Patients with incomplete medical records or insufficient diagnostic information for confirming TMJ ankylosis will not be included.
  • 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.
  • 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.

Outcomes

Primary Outcomes

Quantitative assessment of TMJ biomechanics, including stress distribution, strain, and displacement, as determined through Finite Element Analysis (FEA).

Time Frame: Day 1

Secondary Outcomes

  • 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)

Investigators

Sponsor
All India Institute of Medical Sciences (AIIMS) Raipur
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Santhosh Rao

All India Institute of Medical Sciences, Raipur

Study Sites (1)

Loading locations...

Similar Trials

Understanding Jaw Surgery: Comparing Joint... | Clinical Trial