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Search / Trial NCT03083405

Selected Disorders and Sleep Bruxism

Launched by WROCLAW MEDICAL UNIVERSITY · Mar 13, 2017

Trial Information

Current as of November 12, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

This study in Poland looks at sleep bruxism (teeth grinding during sleep) and how it relates to sleep quality, heart and blood vessel health, thyroid function, and mental well-being. It will also explore whether a medication called opipramol can reduce bruxism episodes. The researchers will compare three groups: people with sleep bruxism who receive opipramol, people with sleep bruxism who do not receive the drug, and healthy controls without bruxism. About 100 participants are planned, and the study is being followed over time to see how things change.

If you’re eligible, you’d be an adult between 18 and 70 with diagnosed sleep bruxism (full set of teeth is preferred, with limited tooth loss allowed). Exclusion criteria include being under 18 or over 70, serious illnesses or major mental health disorders, complete tooth loss, and factors that could interfere with sleep testing (like alcohol or drug problems). What to expect if you join: an overnight sleep study (polysomnography) that records sleep stages, breathing, heart rate, and movement; ultrasound tests of the heart and blood vessels; blood tests for thyroid function; and several questionnaires about sleep quality, stress, mood, fatigue, and quality of life. Jaw muscle activity will be measured with small sensors, and doctors will assess headaches and temporomandibular disorders. The study is ongoing, and results have not yet been published.

Gender

ALL

Eligibility criteria

  • 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

About Wroclaw Medical University

Wrocław Medical University is a prestigious academic institution located in Wrocław, Poland, renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, the university leverages its extensive expertise in healthcare and biomedical sciences to facilitate innovative research initiatives aimed at improving patient outcomes. With a strong emphasis on ethical practices and regulatory compliance, Wrocław Medical University collaborates with a diverse network of healthcare professionals and researchers to conduct rigorous clinical trials that contribute to the development of new therapies and enhance the understanding of various medical conditions. Its dedication to scientific excellence and patient safety positions the university as a key player in the global clinical research landscape.

Locations

Wrocław, Poland

Patients applied

0 patients applied

Trial Officials

Helena Martynowicz, M.D., Ph.D.

Principal Investigator

Wroclaw Medical University

Mieszko Wieckiewicz, D.M.D., Ph.D.

Study Chair

Wroclaw Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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