BruxismNCT06824766
Chewing Muscles in Bruxers
An observational study of Bruxism, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism
- What is being tested?
- Visual Analogue Scale, Autonomic nervous system activity assessment and Masticatory muscles assessment
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 15 Oct 2025
- How long will I take part?
- 1 Day
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Bruxers
Who may be able to join
- 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
Who cannot join
- 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,
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bandırma Onyedi Eylül University
Balıkesir, Turkey, 10200
About this study
Official title: 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.
Read the 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.
- Conditions
- Bruxism
- Being tested
- Visual Analogue Scale, Autonomic nervous system activity assessment, Masticatory muscles assessment
- Keywords
- Autonomic nervous system, bruxism, masseter
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Analogue ScaleOther
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.
Autonomic nervous system activity assessmentOther
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.
Masticatory muscles assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Bruxers | Individuals with bruxism Receives: Other: Visual Analogue Scale; Other: Autonomic nervous system activity assessment; Other: Masticatory muscles assessment | |
| Control group | Healthy volunteers Receives: Other: Visual Analogue Scale; Other: Autonomic nervous system activity assessment; Other: Masticatory muscles assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
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.
Measured: March 1, 2025- June 1, 2025
Autonomic nervous system activity assessment
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.
Measured: March 1, 2025- June 1, 2025
Masticatory muscles biomechanical properties assessment
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.
Measured: March 1, 2025- June 1, 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Mar 2025
- Primary completion1 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazel Çelik Güzel, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824766
- Sponsor's protocol ID
- 2024-248
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Autonomic Nervous System Activity and Biomechanical Characteristics of Chewing Muscles in Bruxers
- ClinicalTrials.gov ID
- NCT06824766
- Acronym / sponsor ID
- 2024-248
- Conditions
- Bruxism
- Keywords
- Autonomic nervous system, bruxism, masseter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 13 Feb 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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bruxers | – | Other: Visual Analogue Scale, Other: Autonomic nervous system activity assessment, Other: Masticatory muscles assessmentIndividuals with bruxism |
| Control group | – | Other: Visual Analogue Scale, Other: Autonomic nervous system activity assessment, Other: Masticatory muscles assessmentHealthy volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Bruxers
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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,
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 |
|---|---|---|
| Visual Analogue ScaleThe 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. | Other | Bruxers, Control group |
| Autonomic nervous system activity assessmentAll 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. | Other | Bruxers, Control group |
| Masticatory muscles assessmentThe 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. | Other | Bruxers, Control group |
Primary outcome
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.
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.
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.
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 12 May 2026.
- Individual participant dataSharing planned: Undecided
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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, run by Bandırma Onyedi Eylül 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 4 inclusion and 15 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 12 May 2026. 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?
Visual Analogue Scale (time frame: March 1, 2025- June 1, 2025). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.