Temporomandibular Disorders (TMD)NCT06871189
Age and Gender in TMJ Sounds
An observational study of Temporomandibular Disorders (TMD), run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
The temporomandibular joint (TMJ) plays a crucial role in masticatory function, and its proper lubrication is essential for smooth, frictionless movement. Disruptions to the lubricating system, often due to age-related changes or parafunctional activities such as teeth clenching or bruxism, can increase joint… Read more about this study
- Who is it for?
- Ages 10 to 30 years
- Conditions the study is for
- Temporomandibular Disorders (TMD)
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Dec 2024to 5 Mar 2025
- 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 10 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: free of symptoms related to temporomandibular disorder
Who may be able to join
- Participants capable of achieving an inter-incisal opening of 30 to 50 mm without restrictions.
- Free from symptoms indicative of temporomandibular disorder (TMD).
- Possessing fully and/or prosthetically restored dentition.
- Demonstrating adequate mouth opening to facilitate the rotation of the condylar process.
Who cannot join
- Individuals using psychotropic or narcotic medications, regardless of medical oversight.
- Regular consumption of painkillers or anti-inflammatory agents.
- Long-term treatment with cortisone or its derivatives. Individuals who have sustained traumatic injuries to the maxillofacial region.
- Participants who have suffered the loss of organs and/or tissue in the maxillofacial area due to medical or traumatic causes.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Atlas Univercity
Istanbul, Anadolu, 34403
About this study
Official title: Age and Gender on TMJ Sound Frequencies and Mouth-Opening Distances
The temporomandibular joint (TMJ) plays a crucial role in masticatory function, and its proper lubrication is essential for smooth, frictionless movement. Disruptions to the lubricating system, often due to age-related changes or parafunctional activities such as teeth clenching or bruxism, can increase joint friction, leading to vibrations or intra-articular sounds. These sounds have become an essential diagnostic tool for assessing internal derangements of the TMJ. While magnetic resonance imaging (MRI) is considered the gold standard for diagnosing TMJ disorders, its limitations in evaluating intra-articular structures have led to the development of alternative methods, such as Joint Vibration Analysis (JVA). This study explores the relationship between age, gender, and TMJ vibration frequencies using JVA in a cohort of 367 participants. We analyzed four key vibration parameters: Range of Motion (ROM), Total Integral Left (TIL), Total Integral Right (TIR), and frequency distributions in the <300 Hz and >300 Hz segments.
- Conditions
- Temporomandibular Disorders (TMD)
- Keywords
- age, gender, temporomandibular disorders, vibration frequencies
- Medical subject headings
- Temporomandibular Joint Disorders, Coitus
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 |
|---|---|---|
| Female ≤22 years | Participants who identify as female and are 22 years old or younger. | |
| Female ≥23 years | Participants who identify as female and are 23 years old or older. | |
| Male ≤22 years | Participants who identify as male and are 22 years old or younger. | |
| Male ≥23 years | Participants who identify as male and are 23 years old or older. |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion
ROM is measured as the maximum mouth opening (mouth opening distance), which is an indicator of joint mobility and dysfunction in TMD patients. Limited or abnormal ROM in the TMJ, reflected by restricted mouth opening, is often associated with pain, dysfunction, and impaired jaw movement, making it a crucial parameter for assessing the severity of TMD.
Measured: The outcome measure was assessed at baseline.
Total Integral
hese parameters assess the intensity and frequency of the joint's movement on each side (left and right). TIL and TIR represent the overall activity and functional performance of the TMJ during movement, with abnormal values potentially indicating dysfunction or asymmetry between the left and right sides. These parameters are critical for evaluating the joint's response to treatment and the presence of any abnormalities in movement or pressure distribution across the TMJ.
Measured: The outcome measure was assessed at baseline
Frequency Components
The frequency parameters assess the overall movement and condition of the temporomandibular joint (TMJ) by measuring pressure wave activity across different frequency ranges. Integral > 300 Hz (d1/d2) reflects higher frequency components primarily influenced by joint surface roughness and degenerative changes. Integral < 300 Hz (c1/c2) represents lower frequency components associated with disc movements, which can be affected by disc displacement, hypermobility, or joint laxity. The Ratio (e1/e2) indicates the ratio of high to low frequencies, providing insight into joint surface condition and overall TMJ health. These parameters are crucial for evaluating the function and possible degeneration of the TMJ.
Measured: The outcome measure was assessed at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start8 Dec 2024
- Primary completion5 Mar 2025
- Study completion5 Mar 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar Gozler, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871189
- Sponsor's protocol ID
- 2024-ATLAS
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age and Gender on TMJ Sound Frequencies and Mouth-Opening Distances
- ClinicalTrials.gov ID
- NCT06871189
- Acronym / sponsor ID
- 2024-ATLAS
- Conditions
- Temporomandibular Disorders (TMD)
- Keywords
- age, gender, temporomandibular disorders, vibration frequencies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 8 Dec 2024 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 11 Mar 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.
The temporomandibular joint (TMJ) plays a crucial role in masticatory function, and its proper lubrication is essential for smooth, frictionless movement. Disruptions to the lubricating system, often due to age-related changes or parafunctional activities such as teeth clenching or bruxism, can increase joint friction, leading to vibrations or intra-articular sounds. These sounds have become an essential diagnostic tool for assessing internal derangements of the TMJ. While magnetic resonance imaging (MRI) is considered the gold standard for diagnosing TMJ disorders, its limitations in evaluating intra-articular structures have led to the development of alternative methods, such as Joint Vibration Analysis (JVA). This study explores the relationship between age, gender, and TMJ vibration frequencies using JVA in a cohort of 367 participants. We analyzed four key vibration parameters: Range of Motion (ROM), Total Integral Left (TIL), Total Integral Right (TIR), and frequency distributions in the <300 Hz and >300 Hz segments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Female ≤22 years | – | –Participants who identify as female and are 22 years old or younger. |
| Female ≥23 years | – | –Participants who identify as female and are 23 years old or older. |
| Male ≤22 years | – | –Participants who identify as male and are 22 years old or younger. |
| Male ≥23 years | – | –Participants who identify as male and are 23 years old or older. |
Who may qualify
- Ages
- 10 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- free of symptoms related to temporomandibular disorder
Key inclusion criteria (4 listed)
- Participants capable of achieving an inter-incisal opening of 30 to 50 mm without restrictions.
- Free from symptoms indicative of temporomandibular disorder (TMD).
- Possessing fully and/or prosthetically restored dentition.
- Demonstrating adequate mouth opening to facilitate the rotation of the condylar process.
Key exclusion criteria (4 listed)
- Individuals using psychotropic or narcotic medications, regardless of medical oversight.
- Regular consumption of painkillers or anti-inflammatory agents.
- Long-term treatment with cortisone or its derivatives. Individuals who have sustained traumatic injuries to the maxillofacial region.
- Participants who have suffered the loss of organs and/or tissue in the maxillofacial area due to medical or traumatic causes.
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
range of motion
Time frame: The outcome measure was assessed at baseline.
ROM is measured as the maximum mouth opening (mouth opening distance), which is an indicator of joint mobility and dysfunction in TMD patients. Limited or abnormal ROM in the TMJ, reflected by restricted mouth opening, is often associated with pain, dysfunction, and impaired jaw movement, making it a crucial parameter for assessing the severity of TMD.
Total Integral
Time frame: The outcome measure was assessed at baseline
hese parameters assess the intensity and frequency of the joint's movement on each side (left and right). TIL and TIR represent the overall activity and functional performance of the TMJ during movement, with abnormal values potentially indicating dysfunction or asymmetry between the left and right sides. These parameters are critical for evaluating the joint's response to treatment and the presence of any abnormalities in movement or pressure distribution across the TMJ.
Frequency Components
Time frame: The outcome measure was assessed at baseline
The frequency parameters assess the overall movement and condition of the temporomandibular joint (TMJ) by measuring pressure wave activity across different frequency ranges. Integral > 300 Hz (d1/d2) reflects higher frequency components primarily influenced by joint surface roughness and degenerative changes. Integral < 300 Hz (c1/c2) represents lower frequency components associated with disc movements, which can be affected by disc displacement, hypermobility, or joint laxity. The Ratio (e1/e2) indicates the ratio of high to low frequencies, providing insight into joint surface condition and overall TMJ health. These parameters are crucial for evaluating the function and possible degeneration of the TMJ.
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 11 Mar 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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), run by Atlas University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 11 Mar 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 Turkey (Türkiye). 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?
range of motion (time frame: The outcome measure was assessed at baseline.). 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 11 Mar 2025.