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OpenTrials
Completed

NCT Number: NCT06758479

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sri Rajiv Gandhi College of Dental Sciences & Hospital

Bangalore, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged between 18 and 65 years.
  • Diagnosed with temporomandibular disorders (TMD) based on clinical examination and imaging (MRI).
  • Presence of at least one of the following symptoms:
  • Jaw pain
  • Restricted jaw movement
  • Clicking sounds in the temporomandibular joint (TMJ)
  • No history of recent jaw or facial trauma.
  • No systemic diseases affecting the TMJ or musculoskeletal system (e.g., rheumatoid arthritis).
  • Able to provide informed consent.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Pain Severity

    Time frame: Measured at the time of enrollment.

    Pain severity will be assessed using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst possible pain)

  2. Pain Severity

    Time frame: Measured at the time of enrollment.

    Pain severity will be assessed using the Visual Analog Scale (VAS), but focused on the patient's retrospective assessment of the worst pain experienced within the last week.

  3. Pain Severity

    Time frame: 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 outcomes

  1. Functional Limitations

    Time frame: Measured at the time of enrollment

    Functional limitations will be evaluated using the Helkimo Index, assessing parameters such as jaw movement and mobility.

Sponsors and collaborators

Lead sponsor

King Khalid University

Other

Collaborators

  • Rajiv Gandhi University of Health Sciences

Registry information

Official study title

Correlations Between Disc Position and the Key Clinical Outcomes in TMD Patients: Cross-sectional Study

Acronym: DPTMD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 3, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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