Selected Disorders and Sleep Bruxism

NCT03083405 | Enrolling By Invitation FDA Drug

• 1 other identifier: WMU1/2017
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep apnea is a common and serious health problem in the Polish population. According to epidemiological data problem concerns about 7% of the adult population. The most common sleep disorder is obstructive sleep apnea (OSA). The consequence of episodes of airway obstruction and sleep fragmentation is an inefficient sleep, pathological daytime sleepiness, falling asleep involuntarily, awakening with feelings of shortness of breath or throttling. The direct consequences of sleep apnea are hypoxia, increased heart rate and increased blood pressure. Frequent complications of OSA are hypertension, stroke, cardiac arrhythmia, coronary artery disease and pulmonary hypertension. An additional problem in patients with sleep apnea is an increased incidence of bruxism. Bruxism is a common problem; reports of prevalence range from 8-31% in the general population. The most common symptoms of bruxism include: hypersensitive teeth, tooth wear, damage to dental restorations (e.g. crowns and fillings), damage to periodontal and oral mucosa, masticatory muscle pain and headaches. The etiology of bruxism is multifactorial and not fully understood. It can be caused by biologic, psychologic and exogenous factors. Arousals during the apnea episodes are considered to be a major cause of sleep bruxism in OSA patients. The relationship between OSA and sleep bruxism is still not clearly defined. Further research is needed to help explain the relationship between these two phenomena, which will enable further therapy in patients with coexisting OSA and sleep bruxism (SB).

Conditions

Sleep Bruxism; Hypertension; Thyroid Dysfunction; Mental Status Change; Sleep Apnea; Sleep Disorders; Cardiovascular Risk Factor; Cardiovascular Diseases; Temporomandibular Disorder

Outcome Measures

Primary Outcomes (1)

• Relationship between bruxism and quality of sleep assessed 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.

  01.03.2017 - 01.03.2018

Secondary Outcomes (22)

• Relationship between bruxism and quality of sleep assessed by Epworth scale.

  01.03.2017 - 01.03.2018

• Relationship between bruxism and quality of sleep assessed by Athens scale.

  01.03.2017 - 01.03.2018

• Relationship between bruxism and quality of sleep assessed by STOP-bang questionnaire.

  01.03.2017 - 01.03.2018

• Relationship between bruxism and quality of sleep assessed by Pittsburgh Sleep Quality Index.

  01.03.2017 - 01.03.2018

• Relationship between bruxism and sleep apnea assessed by polysomnography and genetical tests.

  01.03.2017 - 01.03.2018

Study Arms (3)

Opipramol group

Patients diagnosed with SB and opipramol intervention.

Drug: Opipramol

SB group

Patients diagnosed with SB and no drug intervention.

Healthy controls

Patients without diagnosed SB.

Interventions

Opipramol DRUG

The study group will get a drug to decrease bruxism activity. Group will be evaluated using polysomnography included rhythmic masticatory muscle activity registration before and after intervention.

Opipramol 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 from the Clinic of Prosthodontics operating at the Department of Prosthodontics, Medical University in Wroclaw and other dental institutions diagnosed with sleep bruxism using Diagnostic Criteria for temporomandibular Disorders (DC / TMD). Patients referred to the Department of Internal Medicine, Occupational Diseases and Hypertension and Clinical Oncology for suspected sleep apnea and bruxism. Healthy controls.

You may qualify if:

• diagnosed sleep bruxism
• full dentition
• single tooth loss
• age between 18 and 70

You may not qualify if:

• age under 18
• age over 70
• terminal general diseases
• severe mental disorders
• edentulism
• 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 (5)

• 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

• Wieczorek T, Wieckiewicz M, Smardz J, Wojakowska A, Michalek-Zrabkowska M, Mazur G, Martynowicz H. Sleep structure in sleep bruxism: A polysomnographic study including bruxism activity phenotypes across sleep stages. J Sleep Res. 2020 Dec;29(6):e13028. doi: 10.1111/jsr.13028. Epub 2020 Mar 11.

  PMID: 32160378 DERIVED

• Smardz J, Martynowicz H, Wojakowska A, Michalek-Zrabkowska M, Mazur G, Wieczorek T, Wieckiewicz M. The meaning of the masticatory muscle tonic-type electromyographic pathway correlated with sleep bruxism and sleep-related breathing disorders - A polysomnographic study. Sleep Med. 2020 Apr;68:131-137. doi: 10.1016/j.sleep.2019.08.025. Epub 2019 Oct 2.

  PMID: 32035303 DERIVED

• Martynowicz H, Smardz J, Michalek-Zrabkowska M, Gac P, Poreba R, Wojakowska A, Mazur G, Wieckiewicz M. Evaluation of Relationship Between Sleep Bruxism and Headache Impact Test-6 (HIT-6) Scores: A Polysomnographic Study. Front Neurol. 2019 May 14;10:487. doi: 10.3389/fneur.2019.00487. eCollection 2019.

  PMID: 31139138 DERIVED

• Smardz J, Martynowicz H, Michalek-Zrabkowska M, Wojakowska A, Mazur G, Winocur E, Wieckiewicz M. Sleep Bruxism and Occurrence of Temporomandibular Disorders-Related Pain: A Polysomnographic Study. Front Neurol. 2019 Mar 11;10:168. doi: 10.3389/fneur.2019.00168. eCollection 2019.

  PMID: 30915015 DERIVED

MeSH Terms

Conditions

Sleep Bruxism; Hypertension; Sleep Apnea Syndromes; Sleep Wake Disorders; Cardiovascular Diseases; Temporomandibular Joint Disorders

Interventions

Opipramol

Condition Hierarchy (Ancestors)

Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Nervous System Diseases; Mental Disorders; Vascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; 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)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Helena Martynowicz, M.D., Ph.D.

  Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

• Mieszko Wieckiewicz, D.M.D., Ph.D.

  Wroclaw Medical University

  STUDY CHAIR

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: February 19, 2017
• First Posted: March 20, 2017
• Study Start: April 20, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

PL (1)