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NCT Number: NCT07133035

Investigation of Respiratory Function in 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bruxism Behavior Habits Headache Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Signs and Symptoms Sleep Stomatognathic Diseases Tooth Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Atılım University

Ankara, Gölbaşı, 06830, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmonary Function Test

Diagnostic 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 Index

Diagnostic 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 Scale

Other

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 Questionnaire

Other

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-6

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Atılım University

Other

Registry information

Official study title

Investigation of Respiratory Function, Biomechanical Properties of Neck and Jaw Muscles and Pain Sensitivity in Individuals With Bruxism

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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