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BruxismNCT07294833

Investigation of Respiratory Functions, Respiratory Muscle Strength, Balance and Sleep Quality in Patients With Bruxism

An observational study of Bruxism and Respiratory Function, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It has been reported that patients with bruxism frequently present with upper respiratory tract symptoms such as rhinitis, sinusitis, and mouth breathing. Upper respiratory tract infections have been shown to reduce lung volumes, and individuals with bruxism commonly exhibit forward head posture, which is known to… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Bruxism, Respiratory Function, Sleep Quality
How many people
34 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2023to 1 Jul 2024
Phase
Observational
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Seventeen individuals with bruxism and 17 healthy controls were compared.

Who may be able to join

  • Aged 18-65 years.
  • Diagnosed with sleep or awake bruxism by a dentomaxillofacial radiologist.
  • Diagnosis was based on subjective reports and clinical assessment according to the Standardised Tool for the Assessment of Bruxism (STAB) framework.
  • Classified as probable bruxism, defined as the presence of:
  • Self-reported behaviors (e.g., grinding, clenching, bracing), and
  • Clinical signs (e.g., tooth wear, linea alba, masseter hypertrophy).
Show all 10Show fewer
  • Aged 18-65 years.
  • Recruited through public campus advertisements.
  • Matched for age and sex with the bruxism group.
  • No history or symptoms of bruxism, confirmed by self-report and clinical examination.

Who cannot join

  • History of smoking.
  • Respiratory conditions affecting pulmonary function (e.g., obstructive sleep apnea, chronic obstructive pulmonary disease, asthma).
  • Difficulty understanding or following instructions.
  • Presence of any dental or temporomandibular disorder other than bruxism.
  • History of masseter botulinum toxin injection or facial/cervical trauma.
  • Current use of sedatives, muscle relaxants, or centrally acting medications.
  • Active orthodontic treatment.
  • History of COVID-19 infection within the last six months.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gazi University Faculty of Health Sciences Department of Cardiopulmonary Physiotherapy and Rehabilitation, Ankara, Çankaya 06490

    Ankara, Çankaya, 06490

Other trials in Turkey (Türkiye)

About this study

It has been reported that patients with bruxism frequently present with upper respiratory tract symptoms such as rhinitis, sinusitis, and mouth breathing. Upper respiratory tract infections have been shown to reduce lung volumes, and individuals with bruxism commonly exhibit forward head posture, which is known to negatively affect postural balance. However, no studies have investigated respiratory function or respiratory muscle strength in patients with bruxism, and the number of studies evaluating balance in this population is limited. The aim of the present study is to assess respiratory function, respiratory muscle strength, balance, and sleep quality in individuals with bruxism and to compare these outcomes with those of healthy controls.

Read the detailed description

Bruxism is defined as an involuntary, irregular, or rhythmic parafunctional oral activity characterized by clenching or grinding of the teeth, without serving any functional chewing purpose. Various central, pathophysiological, psychosocial, morphological, environmental, and biological factors have been proposed in the etiology of sleep bruxism. Three subtypes of bruxism are described: awake (diurnal) bruxism, which occurs during wakefulness; sleep (nocturnal) bruxism, which occurs during sleep; and combined bruxism, in which features of both are present. Common symptoms include temporomandibular joint pain, discomfort in the masticatory and cervical muscles, headaches-particularly in the temporal region-poor sleep quality, fatigue, and recurrent migraine attacks. Increasing evidence suggests that respiration plays a notable role in the pathophysiology of sleep bruxism. Researchers have reported specific alterations in breathing patterns among affected individuals, proposing that sleep is often associated with a mandibular open or retruded position, which may lead to reduced airway patency due to relaxation of the tongue muscles. It has also been suggested that sleep bruxism may be associated with reduced airway flow or increased upper airway resistance, particularly in individuals who tend to sleep in the supine position.

Clinicians are encouraged to consider the coexistence of sleep-related breathing disturbances-such as snoring, upper airway resistance, or apnea-hypopnea-in patients presenting with sleep bruxism. Snoring, the most common initial respiratory disturbance during sleep, is defined as an oropharyngeal sound resulting from turbulent airflow that causes vibration of soft tissues. In addition, patients with bruxism frequently experience symptoms associated with upper respiratory tract involvement, including rhinitis, sinusitis, and mouth breathing. Upper respiratory tract infections have been shown to reduce lung volumes, and mouth breathing is thought to influence cerebral oxygenation and provoke involuntary contractions of the facial musculature, potentially triggering sleep bruxism. Despite these associations, no studies to date have investigated pulmonary function or respiratory muscle strength in individuals with bruxism.

Bruxism is also associated with dental damage, temporomandibular joint dysfunction, headaches, and postural alterations. These findings indicate that bruxism affects not only the masticatory muscles but also the craniofacial complex and the musculature of the neck and shoulders. Previous studies have demonstrated that individuals with bruxism, particularly children, exhibit a more pronounced forward head posture compared with non-bruxism controls. A forward shift of the head increases the mechanical load on the cervical region and can alter the body's center of gravity, potentially contributing to muscular imbalance and impairments in postural stability. Thus, head posture should be considered in the clinical evaluation of bruxism. Although balance has been examined in individuals with temporomandibular joint dysfunction, studies focusing specifically on balance in patients with bruxism are lacking, and research including bruxism populations within broader temporomandibular dysfunction cohorts remains limited.

Sleep is a vital physiological process during which sensory perception and neuromuscular function are restored and hormonal rhythms are regulated. It consists of multiple stages that differ physiologically and interact with circadian mechanisms to regulate the sleep-wake cycle. When sleep is disrupted-by sleep bruxism, chronic insomnia, narcolepsy, sleep apnea, or other disorders-functional alterations in sleep architecture may occur, negatively affecting quality of life and contributing to public health concerns. Despite the known associations between bruxism, respiratory disturbances, postural alterations, and sleep disruption, no studies have investigated respiratory muscle strength or pulmonary function specifically in individuals with bruxism, and only a few studies have evaluated balance in this population.

The aim of the present study is to assess respiratory muscle strength, respiratory function, balance, and sleep quality in individuals with bruxism using valid, reliable, and objective measurement methods, and to compare these findings with those of healthy controls. This work seeks to address important gaps in the literature and contribute novel insights into the multisystem effects of bruxism.

Keywords
bruxism, respiratory functions, respiratory muscle strength, balance, sleep quality
Medical subject headings
Bruxism, Respiratory Aspiration, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07294833
Study groupRoleWhat they receive
Individuals with bruxismInformation about the diagnostic required for the study, type of bruxism, duration of symptoms, duration of diagnosis were recorded from the patient's files. All assessments were performed once, in a temperature-controlled, quiet laboratory setting, by experienced physiotherapists. The evaluated parameters included pulmonary function, respiratory muscle strength, balance performance, and sleep quality.
Health ControlsAll assessments were performed once, in a temperature-controlled, quiet laboratory setting, by experienced physiotherapists. The evaluated parameters included pulmonary function, respiratory muscle strength, balance performance, and sleep quality.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pulmonary function (Forced expiratory volume in the first second (FEV1))

    Pulmonary function was assessed with the spirometry. Dynamic lung volume measurements were made according to ATS and ERS criteria. With the device, forced expiratory volume in the first second (FEV1) was assessed.

    Measured: First day

  2. Pulmonary function (Forced vital capacity (FVC))

    Pulmonary function was assesed with the spirometry. Dynamic lung volume measurements were made according to ATS and ERS criteria. With the device, forced vital capacity (FVC) was assessed

    Measured: First Day

  3. Pulmonary function (FEV1 / FVC)

    Pulmonary function was assessed with the spirometry. Dynamic lung volume measurements were made according to ATS and ERS criteria. With the device, FEV1 / FVC was assessed.

    Measured: First Day

  4. Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))

    Pulmonary function was assessed with the spirometry. Dynamic lung volume measurements were made according to ATS and ERS criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) was assessed

    Measured: First Day

  5. Pulmonary function (Peak flow rate (PEF))

    Pulmonary function was assessed with the spirometry. Dynamic lung volume measurements were made according to ATS and ERS criteria. With the device, peak flow rate (PEF) was assessed.

    Measured: First Day

  6. Respiratory Muscle Strength

    Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength were measured using a portable mouth pressure measuring device according to American Thoracic Society and European Respiratory Society criteria

    Measured: First day

Secondary outcomes (3)
  1. Posture assessment

    Posture assessment form of Corbin et al. was used for posture assessment. The form provides scoring according to the severity of postural disorders observed from lateral and posterior (0=absent, 1=mild, 2=moderate, 3=severe).

    Measured: First Day

  2. Balance

    Balance was assessed with the Y balance test. Participants were asked to stand on the central junction point of 3 tape measures; each fixed to the ground at 120-degree angles.

    Measured: First Day

  3. Sleep quality

    Sleep quality was assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 24 questions, and these questions are also evaluated as 7 components. Each question is scored according to the values of the numbers from 0 to 3, and the total score is obtained by adding the scores of the 7 components.

    Measured: First Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2025
  2. Study start1 Jun 2023
  3. Primary completion1 Jun 2024
  4. Study completion1 Jul 2024

Resources

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
Retrospective
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07294833
Sponsor's protocol ID
Gazi2710
Status last verified
Dec 2025
First submitted
8 Dec 2025
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Castroflorio T, Bargellini A, Rossini G, Cugliari G, Deregibus A. Sleep bruxism in adolescents: a systematic literature review of related risk factors. Eur J Orthod. 2017 Feb;39(1):61-68. doi: 10.1093/ejo/cjw012. Epub 2016 Feb 15.

    PubMed 26884421
  • Manfredini D, Bucci MB, Sabattini VB, Lobbezoo F. Bruxism: overview of current knowledge and suggestions for dental implants planning. Cranio. 2011 Oct;29(4):304-12. doi: 10.1179/crn.2011.045.

    PubMed 22128671
  • Cuccia A, Caradonna C. The relationship between the stomatognathic system and body posture. Clinics (Sao Paulo). 2009;64(1):61-6. doi: 10.1590/s1807-59322009000100011.

    PubMed 19142553
  • Fabozzi A, Steffanina A, Nicolai A, Olmati F, Bonini M, Palange P. The Impact of Lung Function on Sleep Monitoring in Obstructive Sleep Apnea Associated with Obstructive Lung Diseases: Insights from a Clinical Study. J Clin Med. 2024 Oct 17;13(20):6189. doi: 10.3390/jcm13206189.

    PubMed 39458139
  • Shaffer SW, Teyhen DS, Lorenson CL, Warren RL, Koreerat CM, Straseske CA, Childs JD. Y-balance test: a reliability study involving multiple raters. Mil Med. 2013 Nov;178(11):1264-70. doi: 10.7205/MILMED-D-13-00222.

    PubMed 24183777
  • Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.

    PubMed 30956204
  • Johnson JD, Theurer WM. A stepwise approach to the interpretation of pulmonary function tests. Am Fam Physician. 2014 Mar 1;89(5):359-66.

    PubMed 24695507

Questions about this trial

What is this clinical trial studying?

An observational study of Bruxism and Respiratory Function, run by Gazi 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 10 inclusion and 8 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: finished, as of the sponsor's last update on 19 Dec 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Pulmonary function (Forced expiratory volume in the first second (FEV1)) (time frame: First day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07294833, which also lists 7 linked publications.

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 19 Dec 2025.

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