Clinical trial NCT06758479: Differential Impact of TMJ Disc Displacement and Muscle Disorders on Pain, Function, and Quality of Life in TMD Patients
Official title: Correlations Between Disc Position and the Key Clinical Outcomes in TMD Patients: Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Disorders (TMD)
Disc Displacement
Functional Impairment
Keywords: Temporomandibular Joint Disorders (TMD)
TMJ Disc Displacement
Jaw Pain and Dysfunction
MRI in TMD Assessment
Quality of Life in TMD
Helkimo Index
Oral Health Impact Profile (OHIP-14)
Lead sponsor: King Khalid University
Sponsor class: OTHER
Collaborators: name: Rajiv Gandhi University of Health Sciences
First posted: 2025-01-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of adults aged 18 to 65 years diagnosed with temporomandibular disorders (TMD). Participants are recruited from a multidisciplinary clinic specializing in TMD diagnosis and management. Eligible individuals present with clinical symptoms such as jaw pain, restricted movement, or clicking sounds in the temporomandibular joint (TMJ) and have their diagnosis confirmed through physical examination and MRI imaging. The study excludes individuals with systemic diseases affecting the TMJ, recent jaw trauma, prior TMJ surgeries, and conditions that may interfere with TMD diagnosis or imaging. The population is representative of patients seeking care for TMD, allowing for analysis of clinical and imaging correlations.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Severity
timeFrame: Measured at the time of enrollment.
measure: Pain Severity
timeFrame: Measured at the time of enrollment.
measure: Pain Severity
timeFrame: Measured at the time of enrollment.
Secondary outcomes:
measure: Functional Limitations
timeFrame: Measured at the time of enrollment
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Sri Rajiv Gandhi College of Dental Sciences & Hospital
Study officials:
affiliation: snu@kku.edu.sa
name: Sunil K Vaddamanu, MDS
role: PRINCIPAL_INVESTIGATOR
References: