Investigation of Respiratory Function in Bruxism

NCT07133035 | Active Not Recruiting

• 1 other identifier: 6040102284-Bruxism
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bruxism; Sleep

Keywords

bruxism; sleep; respiratory function; headache

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From enrollment to the end of the assessment period at 2 hours

Study Arms (2)

Bruxism

Individuals diagnosed with bruxism

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

Diagnostic Test: Pulmonary function test; Diagnostic Test: Fonseca Anamnestic Index; Other: Jenkins Sleep Scale; Other: Berlin Questionnaire; Other: Headache Impact Test-6

Interventions

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.

Bruxism; Control

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.

Bruxism; Control

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.

Bruxism; Control

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.

Bruxism; Control

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.

Bruxism; Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Male and female individuals between the ages of 18-45

You may qualify if:

• Being between 18-45 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Atılım University: lead

Study Sites (1)

Atılım University

Ankara, Gölbaşı, 06830, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bruxism; Respiratory Aspiration; Headache

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Seval Yılmaz, PhD.

  Atılım University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 20, 2025
• Study Start: October 15, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)