Correlations Between Disc Position and Clinical Outcomes in Temporomandibular Disorder Patients

Not yet recruiting

• Conditions: Temporomandibular Disorders (TMD); Disc Displacement; Functional Impairment

• Registration Number: NCT06758479
• Lead Sponsor: King Khalid University

Brief Summary

This study aims to explore the relationship between the position of the temporomandibular joint (TMJ) disc and key clinical outcomes in patients with temporomandibular disorders (TMD). TMD is a condition that can cause pain, difficulty in jaw movement, and reduced quality of life. The research examines how disc displacement, as seen on MRI scans, correlates with pain levels, jaw function, and overall well-being. By better understanding these connections, the study seeks to provide insights that could improve the diagnosis and management of TMD, enhancing patient care and outcomes. This observational study involves non-invasive clinical and imaging assessments of TMD patients.

Detailed Description

This observational, cross-sectional study investigates the correlation between temporomandibular joint (TMJ) disc position and clinical outcomes in patients diagnosed with temporomandibular disorders (TMD). TMD encompasses conditions causing pain, jaw dysfunction, and diminished quality of life. The study evaluates disc displacement using magnetic resonance imaging (MRI) and measures clinical outcomes such as pain severity (Visual Analog Scale), functional limitations (Helkimo Index), and quality of life (Oral Health Impact Profile-14).

Participants include 100 individuals aged 18-65 with clinically confirmed TMD. Data collection involves clinical evaluations and MRI imaging to classify disc displacement into categories such as normal, with reduction, and without reduction. Statistical analyses, including correlation and regression, identify relationships between disc position and outcomes while accounting for confounding factors.

The findings aim to improve understanding of the pathophysiology of TMD and guide diagnostic and therapeutic strategies for better patient outcomes. The study adheres to ethical guidelines, ensuring informed consent and patient confidentiality.

Study Timeline

• Study Start: 2024-12-26
• Study First Submitted: 2024-12-26
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-02
• Last Update Submitted: 2025-01-02
• Study First Posted: 2025-01-03
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-02-20
• Study Completion: 2025-02-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Adults aged between 18 and 65 years.

2. Diagnosed with temporomandibular disorders (TMD) based on clinical examination and imaging (MRI).

3. Presence of at least one of the following symptoms:

   • Jaw pain
   • Restricted jaw movement
   • Clicking sounds in the temporomandibular joint (TMJ)

4. No history of recent jaw or facial trauma.

5. No systemic diseases affecting the TMJ or musculoskeletal system (e.g., rheumatoid arthritis).

6. Able to provide informed consent.

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Exclusion Criteria

1. History of major jaw or facial trauma within the last six months.
2. Systemic conditions that might affect TMJ function, such as autoimmune diseases or bone disorders.
3. Previous TMJ surgery or other major interventions.
4. Pregnant or lactating women.
5. Inability to undergo MRI due to contraindications (e.g., metal implants, pacemakers).
6. Severe malocclusion or other dental/medical conditions interfering with TMD diagnosis.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Severity	Measured at the time of enrollment.	Pain severity will be assessed using the Visual Analog Scale (VAS), considering the patient's average pain experienced over the past month.

Secondary Outcome Measures

Name	Time	Method
Functional Limitations	Measured at the time of enrollment	Functional limitations will be evaluated using the Helkimo Index, assessing parameters such as jaw movement and mobility.

Trial Locations

Locations (1)

Sri Rajiv Gandhi College of Dental Sciences & Hospital; 🇮🇳 Bangalore, India