Chewing Muscles in Bruxers

NCT06824766 | Recruiting

• 1 other identifier: 2024-248
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Bruxism

Keywords

Autonomic nervous system; bruxism; masseter

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  March 1, 2025- June 1, 2025

Study Arms (2)

Bruxers

Individuals with bruxism

Other: Visual Analogue Scale; Other: Autonomic nervous system activity assessment; Other: Masticatory muscles assessment

Control group

Healthy volunteers

Other: Visual Analogue Scale; Other: Autonomic nervous system activity assessment; Other: Masticatory muscles assessment

Interventions

Visual Analogue Scale OTHER

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.

Bruxers; Control group

Autonomic nervous system activity assessment OTHER

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.

Bruxers; Control group

Masticatory muscles assessment OTHER

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; Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Bruxers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bandırma Onyedi Eylül University: lead

Study Sites (1)

Bandırma Onyedi Eylül University

Balıkesir, Turkey, 10200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 13, 2025
• Study Start: March 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

TU (1)