BruxismNCT07133035
Investigation of Respiratory Function in Bruxism
An observational study of Bruxism and Sleep, run by Atılım University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to evaluate the respiratory functions, sleep quality and headache severity of individuals with bruxism and to compare them with the control group without bruxism. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- What is being tested?
- Pulmonary function test, Fonseca Anamnestic Index and Jenkins Sleep Scale
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 31 Aug 2025
- How long will I take part?
- 1 Day
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Male and female individuals between the ages of 18-45
Who may be able to join
- Being between 18-45 years old
Who cannot join
- Receiving orthodontic or splint treatment
- Having more than two missing teeth
- Having undergone jaw, thoracic, or abdominal surgery within the last 6 months
- Having a history of cervical and/or thoracic trauma
- Having a neurological, systemic, and/or cardiopulmonary disease
- Using sleeping pills
- Having a diagnosis of psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Respiratory Function, Biomechanical Properties of Neck and Jaw Muscles and Pain Sensitivity in Individuals With Bruxism
The aim of the study was to evaluate the respiratory functions, sleep quality and headache severity of individuals with bruxism and to compare them with the control group without bruxism.
Read the detailed description
Bruxism is defined as a repetitive jaw muscle activity characterized by teeth grinding or clenching accompanied by tooth wear and jaw muscle discomfort in the absence of a medical condition. Bruxism can occur during the day or during sleep and is defined as awake bruxism or sleep bruxism, respectively. According to the diagnostic criteria of the American Sleep Disorders Association (AASM), the New Classification of Sleep Disorders (ICSD-3), sleep bruxism requires the presence of a regular or frequent teeth grinding sound during sleep, accompanied by at least one of the following symptoms: signs of tooth wear, morning jaw fatigue or pain, and/or temporal headache and/or jaw locking. The etiology of bruxism is not fully understood but is influenced by psychosocial factors such as personality traits and stress. Sleep bruxism has been defined as a sleep-related movement disorder and has been reported to be associated with other sleep disorders. One sleep disorder reported to accompany bruxism is obstructive sleep apnea syndrome. Obstructive sleep apnea syndrome (OSAS) is characterized by upper airway obstruction that disrupts normal sleep patterns and ventilation despite respiratory efforts. OSAS is considered a risk factor for triggering bruxism. It has been suggested that rhythmic masticatory muscle activity during sleep bruxism plays a role in lubricating the upper gastrointestinal tract and increasing airway patency. This is assumed to facilitate better breathing. The possible relationship between sleep bruxism and sleep apnea suggests that the respiratory functions of individuals with bruxism may differ from those of individuals without bruxism. This difference is anticipated to be particularly pronounced in the supine sleep position. A review of the literature revealed no studies evaluating the respiratory functions of individuals with sleep bruxism. The study will also investigate sleep quality and headache severity in individuals with bruxism.
- Being tested
- Pulmonary function test, Fonseca Anamnestic Index, Jenkins Sleep Scale, Berlin Questionnaire, Headache Impact Test-6
- Keywords
- bruxism, sleep, respiratory function, headache
- Medical subject headings
- Bruxism, Respiratory Aspiration, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary function testDiagnostic test
Participants' respiratory functions will be assessed in different positions with the Cosmed Pony Fx Digital Spirometer (11). Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), the ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC), and peak expiratory flow rate (PEF) will be determined during the pulmonary function test.
Fonseca Anamnestic IndexDiagnostic test
The questionnaire consists of 10 questions covering headaches, neck pain, temporomandibular joint pain, pain during chewing, parafunctional habits, malocclusion, and stress, and is scored as 10 (yes), 5 (sometimes), and 0 (no). The total score ranges from 0 to 100. A higher total score indicates an increased risk of temporomandibular joint problems.
Jenkins Sleep ScaleOther
The Jennkis Sleep Scale consists of four questions that assess sleep problems over a 4-week period. Each question is scored from 0 to 5. The total score ranges from 0 to 20 and indicates increasing sleep disturbance.
Berlin QuestionnaireOther
Berlin Questionnaire: The Berlin Questionnaire is a three-part assessment tool that assesses individuals' predisposition to sleep apnea. The first part contains five questions investigating snoring, the second part contains four questions investigating daytime sleepiness, and the third part contains two questions investigating hypertension and obesity. Each section is evaluated independently. Individuals who score 2 or higher in the first and second sections, and those who score 1 in the third section, are considered predisposed to sleep apnea. If two or more categories are positive, the participant is considered high risk for obstructive sleep apnea. If the participant scores two or more in the first and second categories, they are considered high risk. If blood pressure is high or BMI is above 30 kg/m2, the participant is considered high risk.
Headache Impact Test-6Other
Headache Impact Test-6: The Headache Impact Test-6 (HIT-6) is administered to identify activities individuals are unable to perform due to headaches and to determine the extent to which headaches impact daily life. This six-question questionnaire includes columns with increasing scores, from "never" to "always." Participants are asked to mark the box closest to their response. A high total score indicates that headaches negatively impact daily life.
| Study group | Role | What they receive |
|---|---|---|
| Bruxism | Individuals diagnosed with bruxism Receives: Diagnostic Test: Pulmonary function test; Diagnostic Test: Fonseca Anamnestic Index; Other: Jenkins Sleep Scale; Other: Berlin Questionnaire; Other: Headache Impact Test-6 | |
| Control | healthy individuals Receives: Diagnostic Test: Pulmonary function test; Diagnostic Test: Fonseca Anamnestic Index; Other: Jenkins Sleep Scale; Other: Berlin Questionnaire; Other: Headache Impact Test-6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced vital capacity (FVC)
Participant's forced vital capacity (FVC) will be assessed in different positions with the Cosmed Pony Fx Digital Spirometer. Forced vital capacity (FVC) is a subparameter of pulmonary function tests.
Measured: From enrollment to the end of the assessment period at 2 hours
Forced expiratory volume in one second (FEV1)
Participants' forced expiratory volume in one second (FEV1) will be assessed in different positions with the Cosmed Pony Fx Digital Spirometer. Forced forced expiratory volume in one second (FEV1) is a subparameter of pulmonary function tests.
Measured: From enrollment to the end of the assessment period at 2 hours
Peak expiratory flow rate (PEF)
Peak expiratory flow rate (PEF) will be assessed in different positions with the Cosmed Pony Fx Digital Spirometer. Peak expiratory flow rate (PEF) a subparameter of pulmonary function tests.
Measured: From enrollment to the end of the assessment period at 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start15 Oct 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Atılım University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seval Yilmaz, Atılım University
- Investigators
- Seval Yılmaz, PhD., Principal investigator, Atılım University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133035
- Sponsor's protocol ID
- 6040102284-Bruxism
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are currently no plans to share the data and it is collected for internal use only
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Respiratory Function, Biomechanical Properties of Neck and Jaw Muscles and Pain Sensitivity in Individuals With Bruxism
- ClinicalTrials.gov ID
- NCT07133035
- Acronym / sponsor ID
- 6040102284-Bruxism
- Keywords
- bruxism, sleep, respiratory function, headache
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Atılım UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 20 Aug 2025 (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.
The aim of the study was to evaluate the respiratory functions, sleep quality and headache severity of individuals with bruxism and to compare them with the control group without bruxism.
Detailed description
Bruxism is defined as a repetitive jaw muscle activity characterized by teeth grinding or clenching accompanied by tooth wear and jaw muscle discomfort in the absence of a medical condition. Bruxism can occur during the day or during sleep and is defined as awake bruxism or sleep bruxism, respectively. According to the diagnostic criteria of the American Sleep Disorders Association (AASM), the New Classification of Sleep Disorders (ICSD-3), sleep bruxism requires the presence of a regular or frequent teeth grinding sound during sleep, accompanied by at least one of the following symptoms: signs of tooth wear, morning jaw fatigue or pain, and/or temporal headache and/or jaw locking. The etiology of bruxism is not fully understood but is influenced by psychosocial factors such as personality traits and stress. Sleep bruxism has been defined as a sleep-related movement disorder and has been reported to be associated with other sleep disorders. One sleep disorder reported to accompany bruxism is obstructive sleep apnea syndrome. Obstructive sleep apnea syndrome (OSAS) is characterized by upper airway obstruction that disrupts normal sleep patterns and ventilation despite respiratory efforts. OSAS is considered a risk factor for triggering bruxism. It has been suggested that rhythmic masticatory muscle activity during sleep bruxism plays a role in lubricating the upper gastrointestinal tract and increasing airway patency. This is assumed to facilitate better breathing. The possible relationship between sleep bruxism and sleep apnea suggests that the respiratory functions of individuals with bruxism may differ from those of individuals without bruxism. This difference is anticipated to be particularly pronounced in the supine sleep position. A review of the literature revealed no studies evaluating the respiratory functions of individuals with sleep bruxism. The study will also investigate sleep quality and headache severity in individuals with bruxism.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bruxism | – | Diagnostic Test: Pulmonary function test, Diagnostic Test: Fonseca Anamnestic Index, Other: Jenkins Sleep Scale, Other: Berlin Questionnaire, Other: Headache Impact Test-6Individuals diagnosed with bruxism |
| Control | – | Diagnostic Test: Pulmonary function test, Diagnostic Test: Fonseca Anamnestic Index, Other: Jenkins Sleep Scale, Other: Berlin Questionnaire, Other: Headache Impact Test-6healthy individuals |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male and female individuals between the ages of 18-45
Key inclusion criteria (1 listed)
- Being between 18-45 years old
Key exclusion criteria (7 listed)
- Receiving orthodontic or splint treatment
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 |
|---|---|---|
| Pulmonary function testParticipants' respiratory functions will be assessed in different positions with the Cosmed Pony Fx Digital Spirometer (11). Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), the ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC), and peak expiratory flow rate (PEF) will be determined during the pulmonary function test. | Diagnostic test | Bruxism, Control |
| Fonseca Anamnestic IndexThe questionnaire consists of 10 questions covering headaches, neck pain, temporomandibular joint pain, pain during chewing, parafunctional habits, malocclusion, and stress, and is scored as 10 (yes), 5 (sometimes), and 0 (no). The total score ranges from 0 to 100. A higher total score indicates an increased risk of temporomandibular joint problems. | Diagnostic test | Bruxism, Control |
| Jenkins Sleep ScaleThe Jennkis Sleep Scale consists of four questions that assess sleep problems over a 4-week period. Each question is scored from 0 to 5. The total score ranges from 0 to 20 and indicates increasing sleep disturbance. | Other | Bruxism, Control |
| Berlin QuestionnaireBerlin Questionnaire: The Berlin Questionnaire is a three-part assessment tool that assesses individuals' predisposition to sleep apnea. The first part contains five questions investigating snoring, the second part contains four questions investigating daytime sleepiness, and the third part contains two questions investigating hypertension and obesity. Each section is evaluated independently. Individuals who score 2 or higher in the first and second sections, and those who score 1 in the third section, are considered predisposed to sleep apnea. If two or more categories are positive, the participant is considered high risk for obstructive sleep apnea. If the participant scores two or more in the first and second categories, they are considered high risk. If blood pressure is high or BMI is above 30 kg/m2, the participant is considered high risk. | Other | Bruxism, Control |
| Headache Impact Test-6Headache Impact Test-6: The Headache Impact Test-6 (HIT-6) is administered to identify activities individuals are unable to perform due to headaches and to determine the extent to which headaches impact daily life. This six-question questionnaire includes columns with increasing scores, from "never" to "always." Participants are asked to mark the box closest to their response. A high total score indicates that headaches negatively impact daily life. | Other | Bruxism, Control |
Primary outcome
Forced vital capacity (FVC)
Time frame: From enrollment to the end of the assessment period at 2 hours
Participant's forced vital capacity (FVC) will be assessed in different positions with the Cosmed Pony Fx Digital Spirometer. Forced vital capacity (FVC) is a subparameter of pulmonary function tests.
Forced expiratory volume in one second (FEV1)
Time frame: From enrollment to the end of the assessment period at 2 hours
Participants' forced expiratory volume in one second (FEV1) will be assessed in different positions with the Cosmed Pony Fx Digital Spirometer. Forced forced expiratory volume in one second (FEV1) is a subparameter of pulmonary function tests.
Peak expiratory flow rate (PEF)
Time frame: From enrollment to the end of the assessment period at 2 hours
Peak expiratory flow rate (PEF) will be assessed in different positions with the Cosmed Pony Fx Digital Spirometer. Peak expiratory flow rate (PEF) a subparameter of pulmonary function tests.
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 20 Aug 2025.
- Individual participant dataSharing planned: No. There are currently no plans to share the data and it is collected for internal use only
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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. This study is not recruiting at the moment.
Seval Yılmaz, PhD. principal investigator
Atılım 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 Bruxism and Sleep, run by Atılım University at 1 site in Turkey (Türkiye).
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 1 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2025. 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 Turkey (Türkiye). 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?
Forced vital capacity (FVC) (time frame: From enrollment to the end of the assessment period at 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2025.