Relationship Between Selected Parameters and Bruxism

NCT04214561 | Enrolling By Invitation

• 1 other identifier: WMU1/2019
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Bruxism is a common phenomenon. It is estimated that its prevalence in the adult population is 8-31%. Bruxism occurring during sleep is the activity of the masticatory muscles that appear during sleep, which can be rhythmic or phased and is not a movement disorder or sleep disorder in healthy people. It is currently believed that bruxism should not be considered a disorder. In healthy people, it is treated rather as behavior, which may be a risk factor for pathological clinical implications or a protective factor in the presence of other disease entities. The most common symptoms of bruxism include: pathological wear and tooth sensitivity, periodontal and oral mucosa damage, myalgia in the stomatognathic system, headache and prosthetic restoration damage. However, due to nocturnal occurrence, bruxism symptoms may go unnoticed for a long time, which means that patients are often unaware of this behavior. The etiology of bruxism is multifactorial and not fully understood. It is currently believed that it can be caused by genetic, psychological and exogenous factors. Due to the unclear etiology of bruxism, it is so important to conduct research that allows making a certain diagnosis and finding the causes of this phenomenon

Conditions

Pain; Sleep Bruxism; Sleep Disorder; Psychosomatic Disorder; Anxiety; Mental Status Change; Temporomandibular Disorder

Outcome Measures

Primary Outcomes (1)

• Relationship between bruxism and sleep structure by polysomnography.

  Polysomnograms will be evaluated in a 30-second contributions, according to standard sleep criteria. PSG results will contain data on the latency of sleep, total sleep time (TST), sleep efficiency (%) and an evaluation of phases N1, N2, N3 and REM.

  15.10.2019 - 31.12.2020

Secondary Outcomes (19)

• Relationship between bruxism and insomnia assessed by Insomnia Severity Scale.

  15.10.2019 - 31.12.2020

• Relationship between bruxism and sense of stress assessed by Sense of stress questionnaire - KPS questionnaire measuring the structure of stress sensations. sense of stress questionnaire.

  15.10.2019 - 31.12.2020

• Relationship between bruxism and trauma asessed by Traumatic Experience Checklist.

  15.10.2019 - 31.12.2020

• Relationship between bruxism and coping with stress assessed by mini COPE- inventory to measure stress management.

  15.10.2019 - 31.12.2020

• Relationship between bruxism and emotional controll assessed by Courtauld Emotional Control Scale.

  15.10.2019 - 31.12.2020

Study Arms (2)

SB group

Patients diagnosed with SB.

Diagnostic Test: Polysomnography

Healthy controls

Patients without diagnosed SB.

Diagnostic Test: Polysomnography

Interventions

Polysomnography DIAGNOSTIC_TEST

Each of the patients will undergo polysomnography

Healthy controls; SB group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with probable sleep bruxism referred to the Department of Internal Medicine, Occupational Diseases and Hypertension and Clinical Oncology for polysomnography. Healthy controls.

You may qualify if:

• diagnosed sleep bruxism
• age between 18 and 70

You may not qualify if:

• age under 18
• age over 70
• terminal general diseases
• severe mental disorders
• taking drugs that could falsify polysomnography
• confirmed alcoholism
• drug addiction

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Wroclaw Medical University

Wroclaw, Poland

Location

Related Publications (4)

• Martynowicz H, Bort M, Nowacki D, Frosztega W, Przegralek J, Nowak J, Madziarska K, Wieckiewicz M. Association of simple snoring and myogenous temporomandibular disorders based on polysomnographic examination. J Oral Facial Pain Headache. 2026 Mar;40(2):1-13. doi: 10.22514/jofph.2026.017. Epub 2026 Mar 12.

  PMID: 41914053 DERIVED

• Orzeszek S, Martynowicz H, Smardz J, Wojakowska A, Bombala W, Jenca A Jr, Wieckiewicz M. Relationship between pain, quality of sleep, sleep bruxism and patients' personality among individuals with reported orofacial pain. Sci Rep. 2025 Jul 11;15(1):25009. doi: 10.1038/s41598-025-09978-w.

  PMID: 40640286 DERIVED

• Orzeszek S, Martynowicz H, Smardz J, Wojakowska A, Bombala W, Mazur G, Wieckiewicz M. Assessment of sleep quality in patients with orofacial pain and headache complaints: A polysomnographic study. Dent Med Probl. 2024 Jul-Aug;61(4):549-562. doi: 10.17219/dmp/177008.

  PMID: 38832763 DERIVED

• Wieckiewicz M, Martynowicz H, Lavigne G, Lobbezoo F, Kato T, Winocur E, Wezgowiec J, Danel D, Wojakowska A, Mazur G, Smardz J. An exploratory study on the association between serotonin and sleep breathing disorders. Sci Rep. 2023 Jul 21;13(1):11800. doi: 10.1038/s41598-023-38842-y.

  PMID: 37479853 DERIVED

MeSH Terms

Conditions

Sleep Bruxism; Sleep Wake Disorders; Psychophysiologic Disorders; Pain; Anxiety Disorders; Temporomandibular Joint Disorders

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mieszko Wieckiewicz, DMD, PhD

  Wroclaw Medical University

  STUDY CHAIR

• Helena Martynowicz, MD, PhD

  Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: January 2, 2020
• Study Start: December 16, 2019
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

PL (1)