BruxismBRUX-TMJNCT07070141
Bruxism and Temporomandibular Joint Vibrational Analysis Study
An observational study of Bruxism and Temporomandibular Disorder (TMD), run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
Background and Rationale Bruxism is a repetitive jaw-muscle activity involving clenching or grinding of the teeth. Although its pathophysiology remains unclear, it is hypothesized that bruxism may contribute to biomechanical alterations in the temporomandibular joint (TMJ). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Temporomandibular Disorder (TMD)
- What is being tested?
- Diagnostic work up
- How many people
- 195 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 1 Jun 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Bruxism
Who may be able to join
- Adults aged 18 to 45 years
- Patients treated at the specialized TMD Clinic of Istanbul Atlas University
- Presence of at least one diagnostic criterion (e.g., orofacial pain, joint clicking, limited mandibular movement)
Who cannot join
- Patients with incomplete clinical documentation
- Individuals with systemic diseases affecting joint or muscle function
- Patients with a history of maxillofacial trauma or surgery
- Patients outside the specified age range
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Atlas University
Kâğıthane, Istanbul, 34408
About this study
Official title: Bruxism and Temporomandibular Joint Vibrational Patterns: Insights From Joint Vibration Analysis
Background and Rationale
Bruxism is a repetitive jaw-muscle activity involving clenching or grinding of the teeth. Although its pathophysiology remains unclear, it is hypothesized that bruxism may contribute to biomechanical alterations in the temporomandibular joint (TMJ). Joint Vibration Analysis (JVA) is a non-invasive method capable of detecting vibrational patterns associated with TMJ function. This study protocol aims to assess the potential association between bruxism and TMJ vibrational characteristics in adults.
Read more
Objectives
The primary objective is to determine whether there is a difference in TMJ vibrational parameters between individuals with clinically diagnosed bruxism and individuals without signs or symptoms of bruxism. The secondary objective is to explore the relationship between bruxism severity and specific vibrational parameters measured by JVA.
Study Design
This is a retrospective observational study of patient records collected between January 2020 and May 2025 at the Istanbul Atlas University TMD Clinic.
Study Population
- Inclusion Criteria:
- Adults aged 18-45 years
- Documented bruxism evaluation
- Complete Joint Vibration Analysis (JVA) recordings
- Exclusion Criteria:
- History of orthodontic treatment within the past year
- TMJ surgery or major facial trauma
- Neurological or systemic inflammatory conditions
- Pregnancy at time of evaluation
- Use of medications affecting neuromuscular activity
Sample Size
Approximately 195 patient records meeting eligibility criteria will be analyzed. The bruxism group is expected to include ~175 participants, and the control group ~20 participants.
Methodology
Clinical data include patient-reported bruxism history, maximum mouth opening measurements, and TMJ clinical assessments. JVA recordings will be used to obtain vibrational parameters such as peak frequency, median frequency, amplitude, and total vibrational energy. Standardized protocols for JVA will be applied to all included patients.
Statistical Analysis
Data normality will be assessed. For normally distributed variables, independent t-tests will be used to compare groups; for non-normally distributed variables, Mann-Whitney U tests will be applied. Correlation between bruxism severity and vibrational parameters will be evaluated using Spearman's rank correlation. Multiple linear regression may be used to analyze the predictive value of bruxism indicators.
Ethics
The study protocol has been approved by the Istanbul Atlas University Clinical Research Ethics Committee (Approval No: E-22686390-050.99-66516). Informed consent for use of anonymized data was obtained at the time of clinical examination.
Read the detailed description
Bruxism involves repetitive jaw-muscle activity, including clenching and grinding, which may generate excessive and chronic mechanical loading on the temporomandibular joint (TMJ). Although its causal link to TMJ disorders is still debated, it is hypothesized that bruxism-induced stress may lead to internal joint changes, detectable as vibrational anomalies.
Joint Vibration Analysis (JVA) is a non-invasive, real-time diagnostic modality that records vibrational events within the TMJ during mandibular movements. By analyzing parameters such as peak frequency (Hz), median frequency (Hz), amplitude (µV), and total energy (Pa·s), JVA enables objective assessment of intra-articular mechanical behavior. These metrics help differentiate between normal joint function and pathological conditions such as disc displacement or degenerative changes.
This retrospective observational study will assess whether individuals with clinically identified bruxism exhibit distinct vibrational profiles compared to asymptomatic controls. Patient records collected at the Istanbul Atlas University TMD Clinic between January 2020 and May 2025 will be included. Bruxism classification will be based on a standardized clinical scale, incorporating both self-reported symptoms (e.g., morning jaw fatigue, tooth wear, headache) and clinical signs (e.g., hypertrophic masseter muscles, linea alba, occlusal facets).
JVA recordings will be obtained using the BioJVA™ system (BioResearch Associates, Inc.), following a uniform protocol: bilateral sensor placement over the TMJs, seated posture with back support, and execution of five maximal open-close mandibular cycles. Calibration procedures will ensure data consistency across sessions. Demographic data (age, gender), maximum mouth opening (MMO), presence of joint sounds (clicks, crepitus), and JVA output parameters will be recorded.
Statistical analysis will include comparative tests (e.g., t-test, Mann-Whitney U) between bruxism and control groups, and correlation analyses (e.g., Pearson or Spearman coefficients) between vibrational variables and bruxism severity scores. Multivariate models may be used to control for age and gender effects.
This study protocol is ethically approved by the Istanbul Atlas University Clinical Research Ethics Committee. Anonymized data from consenting patients will be used in compliance with institutional and international research standards.
Findings from this research are expected to clarify the biomechanical effects of bruxism on TMJ structures and support the utility of JVA as an objective adjunct tool in the functional evaluation of temporomandibular disorders.
- Conditions
- Bruxism, Temporomandibular Disorder (TMD)
- Being tested
- Diagnostic work up
- Keywords
- Bruxism, Joint Vibration analysis, Sound frequencies, Temporomandibular,, Temporomandibular joint
- Medical subject headings
- Bruxism, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic work upDiagnostic test
None intervention
| Study group | Role | What they receive |
|---|---|---|
| control | healthy Receives: Diagnostic Test: Diagnostic work up | |
| bruxism | self-reported bruxism Receives: Diagnostic Test: Diagnostic work up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak frequency of TMJ sounds
Peak frequency refers to the dominant frequency component in the TMJ sound spectrum, measured during jaw opening. Unit of Measure: Hz
Measured: Baseline (single assessment at initial visit)
Secondary outcomes (1)
Presence and severity of bruxism symptoms based on clinical assessment
Bruxism symptoms (such as tooth wear, muscle pain, or jaw fatigue) are assessed during clinical examination and rated using a standard severity scale. Unit of Measure: Binary (Yes/No) and clinical scale (e.g., 0-3 severity index)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Feb 2025
- Primary completion1 Feb 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BruxismStudies 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
- Retrospective
- Enrolment
- 195 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
- NCT07070141
- Sponsor's protocol ID
- 2024-ATLAS-MSEHF-002
- Acronym
- BRUX-TMJ
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gozler S, Durmaz N, Bayraktar B, Eyuboglu TF, Ozcan M. Bruxism-Related Vibrational Patterns Assessed by Joint Vibration Analysis: A Cross-Sectional Study in Patients With Temporomandibular Joint Disorder Features. J Oral Rehabil. 2026 Jul;53(7):1319-1326. doi: 10.1111/joor.70188. Epub 2026 Mar 12.
PubMed 41821230
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bruxism and Temporomandibular Joint Vibrational Patterns: Insights From Joint Vibration Analysis
- ClinicalTrials.gov ID
- NCT07070141
- Acronym / sponsor ID
- BRUX-TMJ / 2024-ATLAS-MSEHF-002
- Conditions
- Bruxism, Temporomandibular Disorder (TMD)
- Keywords
- Bruxism, Joint Vibration analysis, Sound frequencies, Temporomandibular,, Temporomandibular joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 17 Jul 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.
Background and Rationale
Bruxism is a repetitive jaw-muscle activity involving clenching or grinding of the teeth. Although its pathophysiology remains unclear, it is hypothesized that bruxism may contribute to biomechanical alterations in the temporomandibular joint (TMJ). Joint Vibration Analysis (JVA) is a non-invasive method capable of detecting vibrational patterns associated with TMJ function. This study protocol aims to assess the potential association between bruxism and TMJ vibrational characteristics in adults.
Objectives
The primary objective is to determine whether there is a difference in TMJ vibrational parameters between individuals with clinically diagnosed bruxism and individuals without signs or symptoms of bruxism. The secondary objective is to explore the relationship between bruxism severity and specific vibrational parameters measured by JVA.
Study Design
This is a retrospective observational study of patient records collected between January 2020 and May 2025 at the Istanbul Atlas University TMD Clinic.
Study Population
- Inclusion Criteria:
- Adults aged 18-45 years
- Documented bruxism evaluation
- Complete Joint Vibration Analysis (JVA) recordings
- Exclusion Criteria:
- History of orthodontic treatment within the past year
- TMJ surgery or major facial trauma
- Neurological or systemic inflammatory conditions
- Pregnancy at time of evaluation
- Use of medications affecting neuromuscular activity
Sample Size
Approximately 195 patient records meeting eligibility criteria will be analyzed. The bruxism group is expected to include ~175 participants, and the control group ~20 participants.
Methodology
Clinical data include patient-reported bruxism history, maximum mouth opening measurements, and TMJ clinical assessments. JVA recordings will be used to obtain vibrational parameters such as peak frequency, median frequency, amplitude, and total vibrational energy. Standardized protocols for JVA will be applied to all included patients.
Statistical Analysis
Data normality will be assessed. For normally distributed variables, independent t-tests will be used to compare groups; for non-normally distributed variables, Mann-Whitney U tests will be applied. Correlation between bruxism severity and vibrational parameters will be evaluated using Spearman's rank correlation. Multiple linear regression may be used to analyze the predictive value of bruxism indicators.
Ethics
The study protocol has been approved by the Istanbul Atlas University Clinical Research Ethics Committee (Approval No: E-22686390-050.99-66516). Informed consent for use of anonymized data was obtained at the time of clinical examination.
Detailed description
Bruxism involves repetitive jaw-muscle activity, including clenching and grinding, which may generate excessive and chronic mechanical loading on the temporomandibular joint (TMJ). Although its causal link to TMJ disorders is still debated, it is hypothesized that bruxism-induced stress may lead to internal joint changes, detectable as vibrational anomalies.
Joint Vibration Analysis (JVA) is a non-invasive, real-time diagnostic modality that records vibrational events within the TMJ during mandibular movements. By analyzing parameters such as peak frequency (Hz), median frequency (Hz), amplitude (µV), and total energy (Pa·s), JVA enables objective assessment of intra-articular mechanical behavior. These metrics help differentiate between normal joint function and pathological conditions such as disc displacement or degenerative changes.
This retrospective observational study will assess whether individuals with clinically identified bruxism exhibit distinct vibrational profiles compared to asymptomatic controls. Patient records collected at the Istanbul Atlas University TMD Clinic between January 2020 and May 2025 will be included. Bruxism classification will be based on a standardized clinical scale, incorporating both self-reported symptoms (e.g., morning jaw fatigue, tooth wear, headache) and clinical signs (e.g., hypertrophic masseter muscles, linea alba, occlusal facets).
JVA recordings will be obtained using the BioJVA™ system (BioResearch Associates, Inc.), following a uniform protocol: bilateral sensor placement over the TMJs, seated posture with back support, and execution of five maximal open-close mandibular cycles. Calibration procedures will ensure data consistency across sessions. Demographic data (age, gender), maximum mouth opening (MMO), presence of joint sounds (clicks, crepitus), and JVA output parameters will be recorded.
Statistical analysis will include comparative tests (e.g., t-test, Mann-Whitney U) between bruxism and control groups, and correlation analyses (e.g., Pearson or Spearman coefficients) between vibrational variables and bruxism severity scores. Multivariate models may be used to control for age and gender effects.
This study protocol is ethically approved by the Istanbul Atlas University Clinical Research Ethics Committee. Anonymized data from consenting patients will be used in compliance with institutional and international research standards.
Findings from this research are expected to clarify the biomechanical effects of bruxism on TMJ structures and support the utility of JVA as an objective adjunct tool in the functional evaluation of temporomandibular disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | Diagnostic Test: Diagnostic work uphealthy |
| bruxism | – | Diagnostic Test: Diagnostic work upself-reported bruxism |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Bruxism
Key inclusion criteria (3 listed)
- Adults aged 18 to 45 years
- Patients treated at the specialized TMD Clinic of Istanbul Atlas University
- Presence of at least one diagnostic criterion (e.g., orofacial pain, joint clicking, limited mandibular movement)
Key exclusion criteria (4 listed)
- Patients with incomplete clinical documentation
- Individuals with systemic diseases affecting joint or muscle function
- Patients with a history of maxillofacial trauma or surgery
- Patients outside the specified age range
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic work upNone intervention | Diagnostic test | bruxism, control |
Primary outcome
Peak frequency of TMJ sounds
Time frame: Baseline (single assessment at initial visit)
Peak frequency refers to the dominant frequency component in the TMJ sound spectrum, measured during jaw opening. Unit of Measure: Hz
1 secondary outcome
Presence and severity of bruxism symptoms based on clinical assessment
Time frame: Baseline
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 17 Jul 2025.
- Derived from this study: PubMed 41821230Gozler S, Durmaz N, Bayraktar B, Eyuboglu TF, Ozcan M. Bruxism-Related Vibrational Patterns Assessed by Joint Vibration Analysis: A Cross-Sectional Study in Patients With Temporomandibular Joint Disorder Features. J Oral Rehabil. 2026 Jul;53(7):1319-1326. doi: 10.1111/joor.70188. Epub 2026 Mar 12.
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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 Bruxism and Temporomandibular Disorder (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 3 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 17 Jul 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?
Peak frequency of TMJ sounds (time frame: Baseline (single assessment at initial visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07070141, which also lists 1 linked publication.
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 17 Jul 2025.