Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Selected Disorders and Sleep Bruxism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03083405
Recruitment Status : Enrolling by invitation
First Posted : March 20, 2017
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Joanna Smardz, Wroclaw Medical University

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).

Condition or disease Intervention/treatment
Sleep Bruxism Hypertension Thyroid Dysfunction Mental Status Change Sleep Apnea Sleep Disorders Cardiovascular Risk Factor Cardiovascular Diseases Temporomandibular Disorder Drug: Buspirone

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Quality of Sleep, Endothelial Function, Cardiovascular Risk, Thyroid Function, a Function of Masticatory Muscles and Psycho-emotional State of Patients With Sleep Bruxism
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Buspirone group
Patients diagnosed with SB and buspirone intervention.
Drug: Buspirone
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.

SB group
Patients diagnosed with SB and no drug intervention.
Healthy controls
Patients without diagnosed SB.



Primary Outcome Measures :
  1. Relationship between bruxism and quality of sleep assessed by polysomnography. [ Time Frame: 01.03.2017 - 01.03.2018 ]
    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.


Secondary Outcome Measures :
  1. Relationship between bruxism and quality of sleep assessed by Epworth scale. [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Each participant will fill in Epworth scale.

  2. Relationship between bruxism and quality of sleep assessed by Athens scale. [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Each participant will fill in Athens scale.

  3. Relationship between bruxism and quality of sleep assessed by STOP-bang questionnaire. [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Each participant will fill in STOP-bang questionnaire.

  4. Relationship between bruxism and quality of sleep assessed by Pittsburgh Sleep Quality Index. [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Each participant will fill in Pittsburgh Sleep Quality Index.

  5. Relationship between bruxism and sleep apnea assessed by polysomnography and genetical tests. [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Each participant will fill undergo polysomnography and genetical blood tests.

  6. Relationship between bruxism and sleep apnea assessed by Berlin questionaire. [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Each participant will fill in Berlin questionaire.

  7. Relationship between bruxism and cardiovascular risk assessed by ABPM. [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Cardiovascular risk will be assessed in each participant using ABPM.

  8. Relationship between bruxism and cardiovascular risk assessed by ECG Holter. [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Cardiovascular risk will be assessed in each participant using ECG Holter.

  9. Relationship between bruxism and cardiovascular risk assessed by heart ultrasonography. [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Cardiovascular risk will be assessed in each participant using heart ultrasonography.

  10. Relationship between bruxism and the function of vascular endothelium assessed by expansion of the brachial artery using ultrasonography. [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Expansion of the brachial artery will be evaluated using ultrasonography Aloka Prosound Alpha 6.

  11. Relationship between bruxism and thyroid function assessed by clinical tests of blood. [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Blood test determining levels of FT3, FT4, TSH and Anti-TPO will be conducted for each participant to evaluate the function of thyroid.

  12. Relationship between bruxism and masticatory muscle activity assessed by electromyography. [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Masticatory muscle activity during the study will be assessed on the basis of the record coming from EMG electrodes placed on the beard and symmetrically around the masseter muscle attachments.

  13. Relationship between bruxism, quality of life and mental status assessed by the scale of perceived stress - questionnaire PSS 10. [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Each participant will fill in the scale of perceived stress - questionnaire PSS 10.

  14. Relationship between bruxism, quality of life and mental status assessed by the questionnaire assessing quality of life. [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Each participant will fill in a questionnaire assessing quality of life.

  15. Relationship between bruxism quality of life and mental status assessed by the severity level of fatigue scale. [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Each participant will fill in severity level of fatigue scale.

  16. Relationship between bruxism quality of life and mental status assessed by the severity level of tiredness scale. [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Each participant will fill in severity level of tiredness scale.

  17. Relationship between bruxism and mental status assessed by Beck Depression Inventory [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Each participant will fill in Beck Depression Inventory.

  18. Relationship between bruxism and temporomandibular disorders (TMD). [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Each participant will fill in TMD pain screener, Oral Behavior Checklist. All of the participants will also undergo diagnostics in accordance to DC/TMD.

  19. Relationship between bruxism and headaches assessed by Headache Impact Test - 6 (HIT-6). [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Each participant will fill in HIT-6 questionnaire.

  20. Relationship between bruxism and headaches assessed by HUNT questionnaire. [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Each participant will fill in HUNT questionnaire.

  21. Effect of treatment with buspirone on bruxism episodes. [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Buspirone treatment will be implemented in patients with bruxism.

  22. Is bruxism genetically determined? [ Time Frame: 01.03.2017 - 01.03.2018 ]
    Each patient will undergo genetical blood test.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083405


Locations
Layout table for location information
Poland
Wroclaw Medical University
Wrocław, Poland
Sponsors and Collaborators
Wroclaw Medical University
Investigators
Layout table for investigator information
Principal Investigator: Helena Martynowicz, M.D., Ph.D. Wroclaw Medical University
Study Chair: Mieszko Wieckiewicz, D.M.D., Ph.D. Wroclaw Medical University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Joanna Smardz, Principal Investigator, Wroclaw Medical University
ClinicalTrials.gov Identifier: NCT03083405     History of Changes
Other Study ID Numbers: WMU1/2017
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Bruxism
Sleep Bruxism
Sleep Wake Disorders
Thyroid Diseases
Disease
Cardiovascular Diseases
Pathologic Processes
Nervous System Diseases
Endocrine System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Parasomnias
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Tooth Diseases
Buspirone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs