Bruxism Induced by Obstructive Sleep Apnoea.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWroclaw Medical University
About this trial
The relationship between obstructive sleep apnea (OSA), sleep bruxism, and temporomandibular disorders is becoming clearer, but data on how upper airway volume affects bruxism due to OSA is limited. Recent studies have shown that Cone-Beam Computed Tomography (CBCT) accurately images the upper airway, enabling analysis of its volume and its potential impact on bruxism. CBCT uses low radiation doses, significantly lower than harmful levels, making it a safe method for such assessments. Understanding these relationships can inform clinical practices for managing sleep bruxism, which affects 21% of the global population. The study aims to explore how upper airway volume influences the intensity of sleep bruxism related to OSA.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age equal to/greater than 18 years
moderate or high risk of sleep apnea according to the STOP-Bang questionnaire
presence of bruxism symptoms in the oral cavity according to the current international consensus on bruxism
positive history of bruxism during sleep
Disqualifiers
refusal to participate in the study
pregnancy
breastfeeding
presence of severe mental illness
Trial population
A total of 80 adult volunteers will be recruited for the research project, divided into two groups of 40 each, comprising both sexes, who will give their voluntary and informed consent to participate in the study. The study group will consist of patients with sleep bruxism and obstructive sleep apnoea. The control group will consist of patients with sleep bruxism without obstructive sleep apnoea. Participants are arbitrarily selected from a population.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Upper airway volume assessment using Cone-Beam Computed Tomography (CBCT) and Polysomnography
Diagnostic testPatients in the study group will undergo validated questionnaires assessing psycho-emotional well-being and selected aspects related to the functioning of the stomatognathic system, upper airway volume assessment using CBCT tomography and polysomnography.
Upper airway volume assessment using Cone-Beam Computed Tomography (CBCT)
Diagnostic testPatients in the control group will undergo validated questionnaires assessing psycho-emotional well-being and selected aspects related to the functioning of the stomatognathic system, upper airway volume assessment using CBCT tomography.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Study Group1 intervention
Group B: Control Group1 intervention
Trial outcomes
Primary outcomes
1
The relationship between obstructive sleep apnea and bruxism during sleep.
Relationship between the three-dimensional volume of the upper airways and sleep bruxism induced by sleep apnea, determined by CBCT and polysomnography.
Time frame
01.04.2026-31.11.2026Secondary outcomes
1
Relationship between masticatory muscle pain and depression assessed by Patient Health Questionnaire.
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.
Time frame
01.04.2026-31.12.20262
Relationship between masticatory muscle pain 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.
Time frame
01.04.2026-31.12.20263
Relationship between masticatory muscle pain and perceived stress assessed by Perceived Stress Scale.
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.
Time frame
01.04.2026-31.12.20264
Relationship between masticatory muscle pain and satisfaction with life assessed by Satisfaction With Life Scale.
Each participant will fill in Satisfaction With Life Scale which consist of five questions with 5 possible answers. Total score range is 35. Higher score represents higher life satisfaction. Score ranging from 5-9 as considered as extremly dissatisfied with life, 10-14 dissatisfied, 15-19 slightly dissatisfied, 20-24 slightly satisfied, 25-29 satisfied, 30-35 extremely satisfied.
Time frame
01.04.2026-31.12.2026Sponsors and contacts
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Source ClinicalTrials.gov
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