Investigation of Respiratory Function in Bruxism

August 19, 2025 updated by: Seval Yilmaz, Atılım University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Gölbaşı
      • Ankara, Gölbaşı, Turkey, 06830
        • Atılım University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Male and female individuals between the ages of 18-45

Description

Inclusion Criteria:

  • Being between 18-45 years old

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Bruxism
Individuals diagnosed with bruxism
Diagnostic test: Pulmonary function 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.
Diagnostic test: Fonseca Anamnestic Index
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.
Other: Jenkins Sleep Scale
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.
Other: Berlin Questionnaire
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.
Other: Headache Impact Test-6
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.
Control
healthy individuals
Diagnostic test: Pulmonary function 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.
Diagnostic test: Fonseca Anamnestic Index
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.
Other: Jenkins Sleep Scale
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.
Other: Berlin Questionnaire
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.
Other: Headache Impact Test-6
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of the assessment period at 2 hours
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.
From enrollment to the end of the assessment period at 2 hours
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.
From enrollment to the end of the assessment period at 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Atılım University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seval Yılmaz, PhD., Atılım University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6040102284-Bruxism

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are currently no plans to share the data and it is collected for internal use only

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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