Temporomandibular Disorders (TMD)DPTMDNCT06758479
Differential Impact of TMJ Disc Displacement and Muscle Disorders on Pain, Function, and Quality of Life in TMD Patients
An observational study of Temporomandibular Disorders (TMD) and Disc Displacement, run by King Khalid University at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Disorders (TMD), Disc Displacement, Functional Impairment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 26 Dec 2024to 22 Feb 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlations Between Disc Position and the Key Clinical Outcomes in TMD Patients: Cross-sectional Study
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.
Read the 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.
- 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)
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: Measured at the time of enrollment.
Secondary outcomes (1)
Functional Limitations
Functional limitations will be evaluated using the Helkimo Index, assessing parameters such as jaw movement and mobility.
Measured: Measured at the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start26 Dec 2024
- Primary completion20 Feb 2025
- Study completion22 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- King Khalid University
- Sponsor type
- University, hospital or other
- Collaborators
- Rajiv Gandhi University of Health Sciences
- Responsible party
- Principal investigator, Sunil Kumar Vaddamanu, King Khalid University
- Investigators
- Sunil K Vaddamanu, MDS, Principal investigator, snu@kku.edu.sa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758479
- Sponsor's protocol ID
- ECC#2024-14
- Other IDs
- ECC#2024-14
- Acronym
- DPTMD
- Status last verified
- Apr 2025
- First submitted
- 26 Dec 2024
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlations Between Disc Position and the Key Clinical Outcomes in TMD Patients: Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06758479
- Acronym / sponsor ID
- DPTMD / ECC#2024-14
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- King Khalid UniversityUniversity, hospital or other
- Collaborators
- Rajiv Gandhi University of Health Sciences
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 22 Feb 2025 (actual)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Severity
Time frame: Measured at the time of enrollment.
Pain severity will be assessed using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst possible pain)
Pain Severity
Time frame: Measured at the time of enrollment.
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.
Pain Severity
Time frame: Measured at the time of enrollment.
Pain severity will be assessed using the Visual Analog Scale (VAS), considering the patient's average pain experienced over the past month.
1 secondary outcome
Functional Limitations
Time frame: Measured at the time of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunil K Vaddamanu, MDS principal investigator
snu@kku.edu.sa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorders (TMD) and Disc Displacement, run by King Khalid University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity (time frame: Measured at the time of enrollment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.