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Clinical Trials in Poland / NCT03083405
Enrolling by invitation Observational

Selected Disorders and Sleep Bruxism

NCT03083405 · tracked via the Priya Life Science Poland tracker
Phase
Observational
Started
2017-04-20
Last updated
2026-03-06

Condition(s) studied

Sleep BruxismHypertensionThyroid DysfunctionMental Status ChangeSleep ApneaSleep DisordersCardiovascular Risk FactorCardiovascular DiseasesTemporomandibular Disorder

Investigational drug(s) / intervention(s)

Opipramol

Opipramol: 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.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria: * diagnosed sleep bruxism * full dentition * single tooth loss * age between 18 and 70 Exclusion Criteria: * age under 18 * age over 70 * terminal general diseases * severe mental disorders * edentulism * taking drugs that could falsify polysomnography * confirmed alcoholism * drug addiction

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Wroclaw Medical University Wroclaw Poland

More Wroclaw Medical University trials in Poland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03083405 on ClinicalTrials.gov ↗ ← All trials in Poland