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

NCT ID: NCT06758479

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-26

Study Completion Date

2025-02-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Temporomandibular Disorders (TMD) Disc Displacement Functional Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normal Disc Position

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

No interventions assigned to this group

Disc Displacement with Reduction (DDwR)

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

No interventions assigned to this group

Disc Displacement without Reduction (DDwoR)

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rajiv Gandhi University of Health Sciences

OTHER

Sponsor Role collaborator

King Khalid University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sunil Kumar Vaddamanu

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sunil K Vaddamanu, MDS

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sri Rajiv Gandhi College of Dental Sciences & Hospital

Bangalore, , India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ECC#2024-14

Identifier Type: OTHER

Identifier Source: secondary_id

ECC#2024-14

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.