Clinical trial NCT06824766: Chewing Muscles in Bruxers
Official title: Investigation of the Relationship Between Autonomic Nervous System Activity and Biomechanical Characteristics of Chewing Muscles in Bruxers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bruxism
Keywords: Autonomic nervous system
bruxism
masseter
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bruxers

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: March 1, 2025- June 1, 2025
measure: Autonomic nervous system activity assessment
timeFrame: March 1, 2025- June 1, 2025
measure: Masticatory muscles biomechanical properties assessment
timeFrame: March 1, 2025- June 1, 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Balikesir
country: Turkey
facility: Bandırma Onyedi Eylül University
Study officials:
References: