An observational study in Temporomandibular Disorders (TMD), Disc Displacement and Functional Impairment, sponsored by King Khalid University. Completed at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by King Khalid University · Observational
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.
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.
591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.
This study's enrollment of 100 is close to the median of 91 across 165 observational studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →King Khalid University is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presence of at least one of the following symptoms:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with an anatomically correct TMJ disc position as observed on MRI.
Participants whose TMJ disc is displaced anteriorly at rest but returns to its normal position during mouth opening.
Participants whose TMJ disc remains displaced and does not return to its normal position during mouth opening
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)
Time frame: 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.
Time frame: 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.
Time frame: Measured at the time of enrollment.
Functional Limitations
Functional limitations will be evaluated using the Helkimo Index, assessing parameters such as jaw movement and mobility.
Time frame: Measured at the time of enrollment
Plan to share: No — Individual Participant Data (IPD) will not be shared because the study involves sensitive patient information, including clinical and imaging data, which are subject to strict privacy and confidentiality regulations. Additionally, the scope of the study does not include provisions for external data sharing, as the data is intended solely for the purposes of this research and its analysis. Access to the data is restricted to the research team to ensure compliance with ethical standards and institutional review board (IRB) requirements.
No publications or documents are linked to this record.
Ran from Dec 2024 to primary completion in Feb 2025, 1 month.
Of 57 non-industry observational studies under Temporomandibular Joint Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 30. This study's 1 month is below that.
Counting every sponsor, half of 59 studies reached it within 12 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Temporomandibular Joint Disorders →
King Khalid University