- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06871189
Age and Gender in TMJ Sounds
March 5, 2025 updated by: Serdar Gozler, Atlas University
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Anadolu
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Istanbul, Anadolu, Turkey, 34403
- Istanbul Atlas Univercity
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
free of symptoms related to temporomandibular disorder
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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.
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Male ≤22 years
Participants who identify as male and are 22 years old or younger.
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Male ≥23 years
Participants who identify as male and are 23 years old or older.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
The outcome measure was assessed at baseline.
|
|
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.
|
The outcome measure was assessed at baseline
|
|
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.
|
The outcome measure was assessed at baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 8, 2024
Primary Completion (Actual)
March 5, 2025
Study Completion (Actual)
March 5, 2025
Study Registration Dates
First Submitted
February 28, 2025
First Submitted That Met QC Criteria
March 5, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 5, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-ATLAS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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