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CompletedNCT07070141BRUX-TMJUpdated Jul 17, 2025

Bruxism and Temporomandibular Joint Vibrational Analysis Study

An observational study in Bruxism and Temporomandibular Disorder (TMD), sponsored by Atlas University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-17.

Sponsored by Atlas University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
195
Ages
18 Years to 45 Years
Sex
All
01

Study 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). 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.

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.

02

Conditions studied

  • Bruxism
  • Temporomandibular Disorder (TMD)

Keywords

  • Bruxism
  • Joint Vibration analysis
  • Sound frequencies
  • Temporomandibular,
  • Temporomandibular joint
03

In context

Bruxism

166 studies on the registry are indexed under Bruxism; 38 are open to participants now.

This study's enrollment of 195 is above the median of 90 across 59 observational studies indexed under Bruxism.

Browse Bruxism studies →

Lead sponsor

Atlas University is the lead sponsor of 91 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Bruxism

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
195 participants (actual)
Patient registry
No

Groups and cohorts

  • control

    healthy

    Diagnostic Test: Diagnostic work up

  • bruxism

    self-reported bruxism

    Diagnostic Test: Diagnostic work up

Interventions

  • Diagnostic testDiagnostic work up

    None intervention

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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)

    Time frame: Baseline

07

Study locations

1 site
  • Istanbul Atlas University
    Kâğıthane, Istanbul 34408, Turkey (Türkiye)
08

References and documents

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 Mar 12. doi: 10.1111/joor.70188. Online ahead of print. PubMed 41821230 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07070141
Lead sponsor
Atlas University
Responsible party
Serdar Gozler (ass. prof, Atlas University) — Principal investigator
First posted
Jul 17, 2025
Start date
Feb 1, 2025
Primary completion
Feb 1, 2025
Completion
Jun 1, 2025
Last update
Jul 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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