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| ID | Type | Description | Link |
|---|---|---|---|
| ECC#2024-14 | Other Identifier | Sri Rajiv Gandhi College of Dental Sciences & Hospital |
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| Name | Class |
|---|---|
| Rajiv Gandhi University of Health Sciences | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Limitations | Functional limitations will be evaluated using the Helkimo Index, assessing parameters such as jaw movement and mobility. | Measured at the time of enrollment |
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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:
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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Sunil K Vaddamanu, MDS | snu@kku.edu.sa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sri Rajiv Gandhi College of Dental Sciences & Hospital | Bangalore | India |
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.
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |