Sleep BruxismWMU1/2019NCT04214561
Relationship Between Selected Parameters and Bruxism
An observational study of Sleep Bruxism and Sleep Disorder, run by Wroclaw Medical University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Bruxism, Sleep Disorder, Psychosomatic Disorder
- What is being tested?
- Polysomnography
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 16 Dec 2019to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- diagnosed sleep bruxism
- age between 18 and 70
Who cannot join
- age under 18
- age over 70
- terminal general diseases
- severe mental disorders
- taking drugs that could falsify polysomnography
- confirmed alcoholism
- drug addiction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Sleep Structure, Selected Blood Parameters, Respiratory Function, Genotype, Phenotype, Pain, Anxiety and Psychosomatization in Patients With Bruxism
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
Read the detailed description
Sleep breathing disorders are a frequent and serious health problem in the Polish population. Obstructive sleep apnea (OSA) is a common disorder. The essence of OSA is repeated episodes of airway obstruction that occur repeatedly during sleep, resulting in a decrease in the level of partial oxygen in the blood. Increased tension in the upper respiratory muscles and throat vibrations often result in very loud snoring. Apnea episodes end with awakenings that cause sleep fragmentation, deep sleep deficiency, and REM phase. Such episodes occur repeatedly, over a dozen or even several dozen times per hour of sleep. The consequence of episodes of obstruction and fragmentation of sleep is ineffective, restless sleep, pathological daytime sleepiness, falling asleep against your own will, awakening with a feeling of stopping breath, shortness of breath or choking. Sleep fragmentation and repetitive episodes of hypoxia result in poor quality of life, chronic fatigue and an increased risk of traffic accidents. The direct consequences of apnea are blood hypoxia, increased heart rate and increased blood pressure. Common complications of OSA are hypertension, stroke, arrhythmias, coronary artery disease, pulmonary hypertension and heart failure. Untreated OSA increases the risk of premature death, especially in men under 50 years of age, contributing to the development of vascular endothelial dysfunction and an increase in cardiovascular risk.
The causal relationship between bruxism and apnea has not been clearly established so far. There is also a lack of research on the contribution of genetic factors to the emergence and severity of both conditions.The project will be implemented at the Sleep Laboratory at the Clinic of Internal, Occupational Diseases and Hypertension of the Medical University of Wrocław, which has a technical room with three computer stations, three polysomnographic devices. About 100 patients will be examined at the Department of Internal Diseases, Occupational and Hypertension and Clinical Oncology because of suspected bruxism during sleep. The full polysomnographic examination with video recording will be directed to patients from the Chewing Organ Dysfunction Clinic operating at the Department of Experimental Dentistry at the Medical University of Wrocław, who will be interviewed and have a comprehensive external and intra-oral examination according to Diagnostic Criteria for Temporomandibular Disorders (DC / TMD) and based on the guidelines of the American Academy of Sleep Medicine International Classification of Sleep Disorders, probable bruxism during sleep will be diagnosed. Polysomnograms will be evaluated in 30-second folds, according to standard sleep criteria. PSG results will include data on sleep latency, total sleep time (TST) and sleep performance (%) as well as assessment of the N1, N2, N3 and REM phases. Respiratory pathological events will be assessed according to the American Sleep Academy standards. Apnea will be defined as no airflow through the airways for more than 10 seconds. Shortness of breath will be defined as a reduction in respiratory amplitude by more than 30% for more than 10 seconds, with subsequent blood desaturation by more than 3%, or with subsequent awakening. The activity of the masticatory muscles during the examination will be assessed on the basis of EMG recording from electrodes placed on the chin and symmetrically in the vicinity of the masseter muscles attachments. As episodes of bruxism, episodes of rhythmic activity of the masseter muscles, often accompanied by grinding or knocking noises and characteristic movements in the orofacial region occurring after a minimum interval of three seconds from the last muscular activity, will be qualified. Bruxism episodes will be assessed quantitatively using the BEI (Bruxism Episodes Index) rating the number of bruxism episodes per hour of patient's sleep, and qualitatively for phase, tonic and mixed episodes. The results will then be analyzed for the incidence of RMMA directly related to bruxism episodes and their relationship to sleep apnea episodes, changes in blood pressure and heart rhythm to determine time and cause-effect relationships.
In addition, we will carry out the following surveys: ISI Insomnia Severity Scale, KPS sense of stress questionnaire , TEC Traumatic Experience Checklist. , mini COPE stress management questionnaire, CECS Courtauld Emotional Control Scale, AIS Accteptance of Illness Scale ,BAI Beck Anxiety Index, Short Questionnaire for Measuring the Big Five IPIP-BFM-20, McGill Pain Questionnaire, GCSP Graded Chronic Pain Scale. , PHQ-9 Patient Health Questionnaire, Pittsburgh Sleep Quality Index PSQI, STOP-Bang Apnea Risk Questionnaire, Beck Depression Inventory, PSS-10 Perceived Stress Scale -10, HIT-6 Headache Impact Test,GAD-7 Generalized Anxiety Disorder ,MIDAS scale for assessing functioning disorders in migraine.
Each patient will also be subjected to genetic blood laboratory tests to determine the occurrence of specific genotypes and phenotypes occurring in patients with bruxism.
The tests will be carried out in accordance with the CONSORTated (CONsolidated Standards of Reporting Trials) guidelines for RCT (Randomized Controlled Trial). Expected effects:
- Assessment of the incidence of bruxism during sleep in patients with breathing disorders during sleep
- Determination of changes in sleep structure in patients with bruxism.
- Assessment of possible genetic basis in patients with bruxism
- Assessment of psychosomatization in patients with bruxism.
- Assessment of the level of anxiety and pain felt in patients with bruxism.
- Conditions
- Sleep Bruxism, Sleep Disorder, Psychosomatic Disorder, Pain, Anxiety, Mental Status Change
- Being tested
- Polysomnography
- Medical subject headings
- Sleep Bruxism, Sleep Wake Disorders, Psychophysiologic Disorders, Pain, Anxiety Disorders, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyDiagnostic test
Each of the patients will undergo polysomnography
| Study group | Role | What they receive |
|---|---|---|
| SB group | Patients diagnosed with SB. Receives: Diagnostic Test: Polysomnography | |
| Healthy controls | Patients without diagnosed SB. Receives: Diagnostic Test: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15.10.2019 - 31.12.2020
Secondary outcomes (19)
Relationship between bruxism and insomnia assessed by Insomnia Severity Scale.
Each participant will fill in Insomnia Severity Scale. Questionnaire contains 5 questions, scored from 0 to 4 depending on the severity of ailments. Minimal score is 0, maximal score is 20. A total point value of up to 10 is considered the norm, while a score above 14 points indicates clinically significant insomnia.
Measured: 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.
Each participant will fill in KPS sense of stress questionnaire. The questionnaire consists of 27 statements; the subject determines the extent to which the statement relates to him using a five-point scale. It allows you to calculate the overall score of generalized stress levels, as well as three results related to the following dimensions: emotional tension, external stress and intrapsychic stress. The questionnaire also contains the scale of lies.
Measured: 15.10.2019 - 31.12.2020
Relationship between bruxism and trauma asessed by Traumatic Experience Checklist.
Each participant will fill in Traumatic Experience Checklist comprising 29 different traumatic experiences. It assesses 5 types of trauma and 4 types of problems: emotional neglect, emotional abuse, body threat, sexual harassment, and sexual abuse, serious family problems , death or loss of a family member, body harm, and war experiences. Scoring includes computing two indexes (overall index of number of traumas experienced resulting from the sum of all items, and the total area of traumatic presence which is the sum of the 5 traumatic experiences areas); and three trauma severity indexes (determined by the impact of trauma and age when it occurred, and assembled into emotional, physical, and sexual trauma). The severity of total trauma can range from 0 to 13 (neglect and emotional abuse, physical abuse, and sexual harassment or abuse) or from 0 to 24 (body threat, pain, and bizarre/strange punishment).
Measured: 15.10.2019 - 31.12.2020
Relationship between bruxism and coping with stress assessed by mini COPE- inventory to measure stress management.
Each participant will fill in mini COPE. Questionnaire consists of 28 statements that make up 14 stress coping strategies.Some testing strategies were divided into four categories and corresponding strategies (inventory scales): active coping (including: active coping, planning, positive reevaluation), helplessness (including: taking psychoactive substances, cessation of actions, blaming self), seeking support (including: seeking emotional support, seeking instrumental support), avoidance behaviors (including dealing with something else, denying, discharging). three strategies create independent factors (turning to religion, acceptance, sense of humor). The range of results for each statement ranges from 0 to 3 points. The calculation of the results consists in adding to each other points for the answers regarding two theorems that make up the given scale, and then dividing by 2.
Measured: 15.10.2019 - 31.12.2020
Relationship between bruxism and emotional controll assessed by Courtauld Emotional Control Scale.
Each participant will fill in Courtauld Emotional Control Scale that consists of three subscales, each of them containing seven statements regarding the way of showing anger, depression, and anxiety. The scale is used to measure subjective control of anger, anxiety, and depression in difficult situations and designed to examine adults (both healthy and ill). CECS is a tool of self-description. Summing up the scores of all three subscales, the overall score of emotion control is established. The examination aims at defining to what degree an individual is convinced subjectively of ability to control his/her reactions in the situation of experiencing given negative emotions. The overall indicator of emotion control is within the range of 21-84 points. The higher the score, the greater the suppression of negative emotions.
Measured: 15.10.2019 - 31.12.2020
Relationship between bruxism and illness accteptance assessed by Accteptance of Illness Scale.
Each participant will fill in Accteptance of Illness Scale. The scale is used to measure the degree of acceptance of the disease. It contains eight statements describing the negative consequences of poor health. Each statement is scored from 1 to 5, where 1 means strongly agree and 5 strongly disagree. The scale has no standards. The obtained result is compared with the average result of one of eight clinical groups. The scale is used to measure the degree of disease acceptance. It can apply to any disease. The greater the acceptance of the disease, the better the adaptation and the less sense of mental discomfort.
Measured: 15.10.2019 - 31.12.2020
Relationship between bruxism and anxiety assessed by Beck Anxiety Index.
Each participant will fill in Beck Anxiety Index. The total score is calculated by finding the sum of the 21 items. Total score for all 21 symptoms that can range between 0 and 63 points. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and; 26 - 63 as "Severe".
Measured: 15.10.2019 - 31.12.2020
Relationship between bruxism and personality assessed by International Personality Item Pool-Big Five Markers-20.
Each participant will fill in IPIP-BFM 20. The questionnaire measures five traits (Extraversion, Agreeableness, Conscientiousness, Emotional Stability, Intellect), and consists of 20 items.
Measured: 15.10.2019 - 31.12.2020
Relationship between bruxism and pain assessed by McGill questionnaire.
Each participant will fill in McGill questionnaire that is composed of 78 words. Respondents choose those that best describe their experience of pain. Scores are tabulated by summing values associated with each word; scores range from 0 (no pain) to 78 (severe pain).
Measured: 15.10.2019 - 31.12.2020
Relationship between bruxism and pain assessed by Graded Chronic Pain Scale.
Each participant will fill in Graded Chronic Pain Scale. Scoring Criteria for Grading Chronic Pain Severity: Characteristic Pain Intensity is a 0 to 100 score derived from Questions 1 through 3:Mean (Pain Right Now, Worst Pain, Average Pain) X 10. Disability Score is 0 to 100score derived from Questions 4 through 6:Mean (Daily Activities, Social Activities, Work Activities) X 10. Disability Points: Add the indicated points for Disability Days (Question 7)and for Disability Score. Classification: GRADE 0- No TMD pain in prior 6 months. GRADE I-Low Intensity Characteristic Pain Intensity<50, Low Disability<3 Disability Point. GRADE II -High Intensity Characteristic Pain Intensity >50, LowDisability<3 Disability Points. GRADE III- High Disability3 to 4 Disability Points, Moderately Limiting (Regardless of Characteristic Pain Intensity). GRADE IV- High Disability 5 to 6 Disability Points, Severely Limiting (Regardless of Characteristic Pain Intensity).
Measured: 15.10.2019 - 31.12.2020
Relationship between bruxism and depression assessed by Patient Health Questionnaire - 9.
Each participant will fill in Patient Health Questionnaire - 9. PHQ-9 total score for the nine items ranges from 0 to 27.Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
Measured: 15.10.2019 - 31.12.2020
Relationship between bruxism and sleep quality assessed by Pittsburgh Sleep Quality Index - a self-report questionnaire that assesses sleep quality over a 1-month time interval.
Each participant will fill in Pittsburgh Sleep Quality Index. The measure consists of 19 individual items, creating 7 components that produce one global score ranging from 0 to 21, where lower scores mean better sleep quality.
Measured: 15.10.2019 - 31.12.2020
Relationship between bruxism and apnea risk assessed by STOP-Bang.
Each participant will fill in STOP-Bang questionnaire. The total score ranges from 0 to 8. The lower the score is, the lower the risk of occurrence Obstructive Sleep Apnea (OSA).
Measured: 15.10.2019 - 31.12.2020
Relationship between bruxism and depression assessed by Beck Depression Inventory.
Each participant will fill in Beck Depression Inventory. The questionnaire is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The minimum total score is 0, the maximum total score is 63. Enables scoring: 0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, 29-63: severe depression.
Measured: 15.10.2019 - 31.12.2020
Relationship between bruxism and perceived stress assessed by Perceived Stress Scale - 10.
Each participant will fill in Perceived Stress Scale -10. Scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items. It can range from 0 to 40. Scores ranging from 0-13 would be considered low stress,14-26 would be considered moderate stress, 27-40 would be considered high perceived stress.
Measured: 15.10.2019 - 31.12.2020
Relationship between bruxism and headache assessed by Headache Impact Test - 6.
Each participant will fill in Headache Impact Test - 6 . These responses are summed to produce a total score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent.
Measured: 15.10.2019 - 31.12.2020
Relationship between bruxism and anxiety assessed by Generalized Anxiety Disorder -7.
Each participant will fill in Generalized Anxiety Disorder -7 that consists of 7 items. Total score ranges 0-21 points. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Measured: 15.10.2019 - 31.12.2020
Relationship between bruxism and headache impact assessed by Migraine Disability Assessment questionnaire.
Each participant will fill in Migraine Disability Assessment questionnaire. Scoring includes adding the total number of days from questions 1-5. Grading includes: grade I (little or no disability) 0-5 days, grade II (mild disability) 6-10 days, grade III (moderate disability) 11-20 days, grade IV (severe disability) more than 21 days.
Measured: 15.10.2019 - 31.12.2020
Relationship between bruxism and genotype and fenotype assessed in blood test.
Each participant will undergo genetical blood test.
Measured: 15.10.2019 - 31.12.2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start16 Dec 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sleep BruxismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Smardz, Wroclaw Medical University
- Investigators
- Mieszko Wieckiewicz, DMD, PhD, Study chair, Wroclaw Medical UniversityHelena Martynowicz, MD, PhD, Principal investigator, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214561
- Sponsor's protocol ID
- WMU1/2019
- Acronym
- WMU1/2019
- Status last verified
- Jul 2026
- First submitted
- 27 Dec 2019
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Orzeszek S, Martynowicz H, Smardz J, Wojakowska A, Bombala W, Wieckiewicz M. Trauma, Emotional Control, Stress Coping Mechanisms, and Illness Acceptance in Individuals With Orofacial Pain, Headache, and Sleep Bruxism. J Oral Rehabil. 2026 Sep;53(9):1626-1636. doi: 10.1111/joor.70219. Epub 2026 May 23.
PubMed 42175672Martynowicz 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.
PubMed 41914053Orzeszek 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.
PubMed 40640286Orzeszek 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.
PubMed 38832763Wieckiewicz 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.
PubMed 37479853
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sleep Structure, Selected Blood Parameters, Respiratory Function, Genotype, Phenotype, Pain, Anxiety and Psychosomatization in Patients With Bruxism
- ClinicalTrials.gov ID
- NCT04214561
- Acronym / sponsor ID
- WMU1/2019 / WMU1/2019
- Conditions
- Sleep Bruxism, Sleep Disorder, Psychosomatic Disorder, Pain, Anxiety, Mental Status Change
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Sleep breathing disorders are a frequent and serious health problem in the Polish population. Obstructive sleep apnea (OSA) is a common disorder. The essence of OSA is repeated episodes of airway obstruction that occur repeatedly during sleep, resulting in a decrease in the level of partial oxygen in the blood. Increased tension in the upper respiratory muscles and throat vibrations often result in very loud snoring. Apnea episodes end with awakenings that cause sleep fragmentation, deep sleep deficiency, and REM phase. Such episodes occur repeatedly, over a dozen or even several dozen times per hour of sleep. The consequence of episodes of obstruction and fragmentation of sleep is ineffective, restless sleep, pathological daytime sleepiness, falling asleep against your own will, awakening with a feeling of stopping breath, shortness of breath or choking. Sleep fragmentation and repetitive episodes of hypoxia result in poor quality of life, chronic fatigue and an increased risk of traffic accidents. The direct consequences of apnea are blood hypoxia, increased heart rate and increased blood pressure. Common complications of OSA are hypertension, stroke, arrhythmias, coronary artery disease, pulmonary hypertension and heart failure. Untreated OSA increases the risk of premature death, especially in men under 50 years of age, contributing to the development of vascular endothelial dysfunction and an increase in cardiovascular risk.
The causal relationship between bruxism and apnea has not been clearly established so far. There is also a lack of research on the contribution of genetic factors to the emergence and severity of both conditions.The project will be implemented at the Sleep Laboratory at the Clinic of Internal, Occupational Diseases and Hypertension of the Medical University of Wrocław, which has a technical room with three computer stations, three polysomnographic devices. About 100 patients will be examined at the Department of Internal Diseases, Occupational and Hypertension and Clinical Oncology because of suspected bruxism during sleep. The full polysomnographic examination with video recording will be directed to patients from the Chewing Organ Dysfunction Clinic operating at the Department of Experimental Dentistry at the Medical University of Wrocław, who will be interviewed and have a comprehensive external and intra-oral examination according to Diagnostic Criteria for Temporomandibular Disorders (DC / TMD) and based on the guidelines of the American Academy of Sleep Medicine International Classification of Sleep Disorders, probable bruxism during sleep will be diagnosed. Polysomnograms will be evaluated in 30-second folds, according to standard sleep criteria. PSG results will include data on sleep latency, total sleep time (TST) and sleep performance (%) as well as assessment of the N1, N2, N3 and REM phases. Respiratory pathological events will be assessed according to the American Sleep Academy standards. Apnea will be defined as no airflow through the airways for more than 10 seconds. Shortness of breath will be defined as a reduction in respiratory amplitude by more than 30% for more than 10 seconds, with subsequent blood desaturation by more than 3%, or with subsequent awakening. The activity of the masticatory muscles during the examination will be assessed on the basis of EMG recording from electrodes placed on the chin and symmetrically in the vicinity of the masseter muscles attachments. As episodes of bruxism, episodes of rhythmic activity of the masseter muscles, often accompanied by grinding or knocking noises and characteristic movements in the orofacial region occurring after a minimum interval of three seconds from the last muscular activity, will be qualified. Bruxism episodes will be assessed quantitatively using the BEI (Bruxism Episodes Index) rating the number of bruxism episodes per hour of patient's sleep, and qualitatively for phase, tonic and mixed episodes. The results will then be analyzed for the incidence of RMMA directly related to bruxism episodes and their relationship to sleep apnea episodes, changes in blood pressure and heart rhythm to determine time and cause-effect relationships.
In addition, we will carry out the following surveys: ISI Insomnia Severity Scale, KPS sense of stress questionnaire , TEC Traumatic Experience Checklist. , mini COPE stress management questionnaire, CECS Courtauld Emotional Control Scale, AIS Accteptance of Illness Scale ,BAI Beck Anxiety Index, Short Questionnaire for Measuring the Big Five IPIP-BFM-20, McGill Pain Questionnaire, GCSP Graded Chronic Pain Scale. , PHQ-9 Patient Health Questionnaire, Pittsburgh Sleep Quality Index PSQI, STOP-Bang Apnea Risk Questionnaire, Beck Depression Inventory, PSS-10 Perceived Stress Scale -10, HIT-6 Headache Impact Test,GAD-7 Generalized Anxiety Disorder ,MIDAS scale for assessing functioning disorders in migraine.
Each patient will also be subjected to genetic blood laboratory tests to determine the occurrence of specific genotypes and phenotypes occurring in patients with bruxism.
The tests will be carried out in accordance with the CONSORTated (CONsolidated Standards of Reporting Trials) guidelines for RCT (Randomized Controlled Trial). Expected effects:
- Assessment of the incidence of bruxism during sleep in patients with breathing disorders during sleep
- Determination of changes in sleep structure in patients with bruxism.
- Assessment of possible genetic basis in patients with bruxism
- Assessment of psychosomatization in patients with bruxism.
- Assessment of the level of anxiety and pain felt in patients with bruxism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SB group | – | Diagnostic Test: PolysomnographyPatients diagnosed with SB. |
| Healthy controls | – | Diagnostic Test: PolysomnographyPatients without diagnosed SB. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- diagnosed sleep bruxism
- age between 18 and 70
Key exclusion criteria (7 listed)
- age under 18
- age over 70
- terminal general diseases
- severe mental disorders
- taking drugs that could falsify polysomnography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolysomnographyEach of the patients will undergo polysomnography | Diagnostic test | Healthy controls, SB group |
Primary outcome
Relationship between bruxism and sleep structure by polysomnography.
Time frame: 15.10.2019 - 31.12.2020
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.
19 secondary outcomes
Relationship between bruxism and insomnia assessed by Insomnia Severity Scale.
Time frame: 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.
Time frame: 15.10.2019 - 31.12.2020
Relationship between bruxism and trauma asessed by Traumatic Experience Checklist.
Time frame: 15.10.2019 - 31.12.2020
Relationship between bruxism and coping with stress assessed by mini COPE- inventory to measure stress management.
Time frame: 15.10.2019 - 31.12.2020
Relationship between bruxism and emotional controll assessed by Courtauld Emotional Control Scale.
Time frame: 15.10.2019 - 31.12.2020
Relationship between bruxism and illness accteptance assessed by Accteptance of Illness Scale.
Time frame: 15.10.2019 - 31.12.2020
Relationship between bruxism and anxiety assessed by Beck Anxiety Index.
Time frame: 15.10.2019 - 31.12.2020
Relationship between bruxism and personality assessed by International Personality Item Pool-Big Five Markers-20.
Time frame: 15.10.2019 - 31.12.2020
Relationship between bruxism and pain assessed by McGill questionnaire.
Time frame: 15.10.2019 - 31.12.2020
Relationship between bruxism and pain assessed by Graded Chronic Pain Scale.
Time frame: 15.10.2019 - 31.12.2020
Relationship between bruxism and depression assessed by Patient Health Questionnaire - 9.
Time frame: 15.10.2019 - 31.12.2020
Relationship between bruxism and sleep quality assessed by Pittsburgh Sleep Quality Index - a self-report questionnaire that assesses sleep quality over a 1-month time interval.
Time frame: 15.10.2019 - 31.12.2020
Relationship between bruxism and apnea risk assessed by STOP-Bang.
Time frame: 15.10.2019 - 31.12.2020
Relationship between bruxism and depression assessed by Beck Depression Inventory.
Time frame: 15.10.2019 - 31.12.2020
Relationship between bruxism and perceived stress assessed by Perceived Stress Scale - 10.
Time frame: 15.10.2019 - 31.12.2020
Relationship between bruxism and headache assessed by Headache Impact Test - 6.
Time frame: 15.10.2019 - 31.12.2020
Relationship between bruxism and anxiety assessed by Generalized Anxiety Disorder -7.
Time frame: 15.10.2019 - 31.12.2020
Relationship between bruxism and headache impact assessed by Migraine Disability Assessment questionnaire.
Time frame: 15.10.2019 - 31.12.2020
Relationship between bruxism and genotype and fenotype assessed in blood test.
Time frame: 15.10.2019 - 31.12.2020
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Derived from this study: PubMed 42175672Orzeszek S, Martynowicz H, Smardz J, Wojakowska A, Bombala W, Wieckiewicz M. Trauma, Emotional Control, Stress Coping Mechanisms, and Illness Acceptance in Individuals With Orofacial Pain, Headache, and Sleep Bruxism. J Oral Rehabil. 2026 Sep;53(9):1626-1636. doi: 10.1111/joor.70219. Epub 2026 May 23.
- Derived from this study: PubMed 41914053Martynowicz 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.
- Derived from this study: PubMed 40640286Orzeszek 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.
- Derived from this study: PubMed 38832763Orzeszek 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.
- Derived from this study: PubMed 37479853Wieckiewicz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mieszko Wieckiewicz, DMD, PhD study chair
Wroclaw Medical University
Helena Martynowicz, MD, PhD principal investigator
Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Bruxism and Sleep Disorder, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between bruxism and sleep structure by polysomnography. (time frame: 15.10.2019 - 31.12.2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04214561, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.