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Differential Impact of TMJ Disc Displacement and Muscle Disorders on Pain, Function, and Quality of Life in TMD Patients (DPTMD)

K

King Khalid University

Status

Completed

Conditions

Temporomandibular Disorders (TMD)
Disc Displacement
Functional Impairment

Study type

Observational

Funder types

Other

Identifiers

NCT06758479
ECC#2024-14 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

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.

Trial design

100 participants in 3 patient groups

Normal Disc Position
Description:
Participants with an anatomically correct TMJ disc position as observed on MRI.
Disc Displacement with Reduction (DDwR)
Description:
Participants whose TMJ disc is displaced anteriorly at rest but returns to its normal position during mouth opening.
Disc Displacement without Reduction (DDwoR)
Description:
Participants whose TMJ disc remains displaced and does not return to its normal position during mouth opening

Trial contacts and locations

1

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Central trial contact

Sunil K Vaddamanu, MDS

Data sourced from clinicaltrials.gov

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