- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06824766
Chewing Muscles in Bruxers
May 11, 2026 updated by: Hazel Çelik Güzel, Bandırma Onyedi Eylül University
Investigation of the Relationship Between Autonomic Nervous System Activity and Biomechanical Characteristics of Chewing Muscles in Bruxers
The aim of this study was to determine the relationship between autonomic nervous system activity and tonus, stiffness and elasticity of temporalis and masseter muscles in individuals with bruxism and to compare them with healthy controls.
Study Overview
Status
Completed
Conditions
Detailed Description
Individuals diagnosed with bruxism and healthy individuals as a control group will be included in the study.
Firstly, the purpose of the research and evaluation methods will be explained to the participants.
Individuals who volunteer to participate in the study and meet the inclusion criteria will be included.
Approval will be obtained from the individuals to be evaluated with the 'Informed Voluntary Consent Form'.
Individuals will then fill in the Descriptive Data Form.
The intensity of pain in the masticatory muscles of all participants at rest and during chewing will be measured by Visual Analogue Scale, Autonomic Nervous System activity (heart rate variables) will be measured by Polar H10 chest strap, and the tonus, stiffness and elasticity of the temporalis and masseter muscles will be measured by Myoton device.
The evaluations are planned to take an average of 20 minutes for each participant.
The evaluations of the participants will be made only once and will not be evaluated again.
Study Type
Observational
Enrollment (Actual)
89
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
-
Balıkesir, Turkey, Turkey (Türkiye), 10200
- Bandırma Onyedi Eylül University
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Bruxers
Description
Inclusion Criteria:
- Diagnosed with bruxism between the ages of 18-65,
- A history of bruxism for at least 6 months,
- Individuals with masseter muscle pain ≥4 at rest and during mastication
- Control group: Healthy individuals aged 18-65 years
Exclusion Criteria:
- Masseter botox application in the last 6 months,
- With regular use of analgesics and anti-inflammatories affecting the OSS,
- Smokes 20 or more cigarettes daily,
- With regular alcohol use of 1-2 glasses per day,
- Daily coffee consumption of 6 cups or more,
- Cardiovascular, respiratory and central nervous system diseases,
- Presence of infection or tumoural structures within intraoral structures,
- Multiple ear piercings,
- With TMJ disc displacement and joint degeneration,
- Cervical or TMJ fracture, systemic disease, musculoskeletal problem with evidence of specific pathological condition,
- Any surgical operation related to cervical or TMJ problem,
- Less than 6 months of cervical or TMJ-related physiotherapy and rehabilitation services,
- The one with facial paralysis,
- Diagnosed psychiatric illness
- Participants who have communication difficulties in speaking and understanding Turkish or who are unable to understand the exercises
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 |
Intervention / Treatment |
|---|---|
|
Control group
Healthy volunteers
|
The pain intensity of the participants will be assessed using the Visual Analogue Scale, which is a simple, reliable and short-term method commonly used to measure pain intensity in the clinic.
The participant is told that the most severe pain he/she experiences is 10 and if there is no pain, the pain intensity is 0. The participant will be asked to tick a number between 0 and 10 corresponding to the intensity of pain felt in the masticatory muscles at rest and during chewing.
All participants included in the study will undergo a 5-minute test with the Polar H10 chest strap device for autonomic nervous system activity assessment (heart rate variability assessment).
The data obtained after the measurement will be analysed with Kubios software.
Stress index (cardiovascular system stress), PNS index (parasympathetic nervous system dominance), SNS index (sympathetic nervous system dominance), LF power (sympathetic activity), HF power (parasympathetic activity) and LF/HF ratio (sympathetic/parasympathetic balance) parameters will be used in the evaluation of HRV in Kubios programme.
The Myoton PRO device will be used to objectively assess the biomechanical properties of the participants' masticatory muscles such as tone, stiffness and elasticity.
The masseter and temporalis muscles will be evaluated bilaterally in the sitting position.
Three measurements will be recorded at one second intervals and the average value will be used for analysis.
|
|
Bruxers
Individuals with bruxism
|
The pain intensity of the participants will be assessed using the Visual Analogue Scale, which is a simple, reliable and short-term method commonly used to measure pain intensity in the clinic.
The participant is told that the most severe pain he/she experiences is 10 and if there is no pain, the pain intensity is 0. The participant will be asked to tick a number between 0 and 10 corresponding to the intensity of pain felt in the masticatory muscles at rest and during chewing.
All participants included in the study will undergo a 5-minute test with the Polar H10 chest strap device for autonomic nervous system activity assessment (heart rate variability assessment).
The data obtained after the measurement will be analysed with Kubios software.
Stress index (cardiovascular system stress), PNS index (parasympathetic nervous system dominance), SNS index (sympathetic nervous system dominance), LF power (sympathetic activity), HF power (parasympathetic activity) and LF/HF ratio (sympathetic/parasympathetic balance) parameters will be used in the evaluation of HRV in Kubios programme.
The Myoton PRO device will be used to objectively assess the biomechanical properties of the participants' masticatory muscles such as tone, stiffness and elasticity.
The masseter and temporalis muscles will be evaluated bilaterally in the sitting position.
Three measurements will be recorded at one second intervals and the average value will be used for analysis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: March 1, 2025- June 1, 2025
|
The pain intensity of the participants will be assessed using the Visual Analogue Scale, which is a simple, reliable and short-term method commonly used to measure pain intensity in the clinic.
The participant is told that the most severe pain he/she experiences is 10 and if there is no pain, the pain intensity is 0. The participant will be asked to tick a number between 0 and 10 corresponding to the intensity of pain felt in the masticatory muscles at rest and during chewing.
|
March 1, 2025- June 1, 2025
|
|
Autonomic nervous system activity assessment
Time Frame: March 1, 2025- June 1, 2025
|
All participants included in the study will undergo a 5-minute test with the Polar H10 chest strap device for autonomic nervous system activity assessment.
The data obtained after the measurement will be analysed with Kubios software.
|
March 1, 2025- June 1, 2025
|
|
Masticatory muscles biomechanical properties assessment
Time Frame: March 1, 2025- June 1, 2025
|
The Myoton PRO device will be used to objectively assess the biomechanical properties of the participants' masticatory muscles.
The masticatory muscles will be evaluated bilaterally in the sitting position.
Three measurements will be recorded at one second intervals and the average value will be used for analysis.
|
March 1, 2025- June 1, 2025
|
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)
March 1, 2025
Primary Completion (Actual)
October 1, 2025
Study Completion (Actual)
October 15, 2025
Study Registration Dates
First Submitted
February 5, 2025
First Submitted That Met QC Criteria
February 8, 2025
First Posted (Actual)
February 13, 2025
Study Record Updates
Last Update Posted (Actual)
May 12, 2026
Last Update Submitted That Met QC Criteria
May 11, 2026
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-248
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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