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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
    • Anadolu
      • Istanbul, Anadolu, Turkey, 34403
        • Istanbul Atlas Univercity

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Atlas University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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