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

NCT06758479 | Completed DMC

• 1 other identifier: ECC#2024-14
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (3)

• Pain Severity

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

  Measured at the time of enrollment.

• Pain Severity

  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.

  Measured at the time of enrollment.

• Pain Severity

  Pain severity will be assessed using the Visual Analog Scale (VAS), considering the patient's average pain experienced over the past month.

  Measured at the time of enrollment.

Secondary Outcomes (1)

• Functional Limitations

  Measured at the time of enrollment

Study Arms (3)

Normal Disc Position

Participants with an anatomically correct TMJ disc position as observed on MRI.

Disc Displacement with Reduction (DDwR)

Participants whose TMJ disc is displaced anteriorly at rest but returns to its normal position during mouth opening.

Disc Displacement without Reduction (DDwoR)

Participants whose TMJ disc remains displaced and does not return to its normal position during mouth opening

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Khalid University: lead
• Rajiv Gandhi University of Health Sciences: collaborator

Study Sites (1)

Sri Rajiv Gandhi College of Dental Sciences & Hospital

Bangalore, India

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Sunil K Vaddamanu, MDS

  snu@kku.edu.sa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 3, 2025
• Study Start: December 26, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 22, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)