NCT07070141

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

Same day

First QC Date

June 25, 2025

Last Update Submit

July 15, 2025

Conditions

Keywords

BruxismJoint Vibration analysisSound frequenciesTemporomandibular,Temporomandibular joint

Outcome Measures

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

    Baseline (single assessment at initial visit)

Secondary Outcomes (1)

  • Presence and severity of bruxism symptoms based on clinical assessment

    Baseline

Study Arms (2)

control

healthy

Diagnostic Test: Diagnostic work up

bruxism

self-reported bruxism

Diagnostic Test: Diagnostic work up

Interventions

Diagnostic work upDIAGNOSTIC_TEST

None intervention

bruxismcontrol

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Bruxism

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Atlas University

Kâğıthane, Istanbul, 34408, Turkey (Türkiye)

Location

MeSH Terms

Conditions

BruxismTemporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehaviorCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ass. prof

Study Record Dates

First Submitted

June 25, 2025

First Posted

July 17, 2025

Study Start

February 1, 2025

Primary Completion

February 1, 2025

Study Completion

June 1, 2025

Last Updated

July 17, 2025

Record last verified: 2025-07

Locations