NCT07294833

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 8, 2025

Last Update Submit

December 8, 2025

Conditions

Keywords

bruxismrespiratory functionsrespiratory muscle strengthbalancesleep quality

Outcome Measures

Primary Outcomes (6)

  • 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.

    First day

  • 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

    First Day

  • 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.

    First Day

  • 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

    First Day

  • 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.

    First Day

  • 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

    First day

Secondary Outcomes (3)

  • Posture assessment

    First Day

  • Balance

    First Day

  • Sleep quality

    First Day

Study Arms (2)

Individuals with bruxism

Information 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 Controls

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Seventeen individuals with bruxism and 17 healthy controls were compared.

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Health Sciences Department of Cardiopulmonary Physiotherapy and Rehabilitation, Ankara, Çankaya 06490

Ankara, Çankaya, 06490, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

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

MeSH Terms

Conditions

BruxismRespiratory AspirationSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehaviorRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Betül Yoleri, MSc

    Gazi University

    STUDY CHAIR
  • Meral Boşnak Güçlü, Prof

    Gazi University

    STUDY DIRECTOR
  • Musa Güneş, PhD

    Karabük University

    PRINCIPAL INVESTIGATOR
  • Nebiha Gözde İspir, MD

    Gazi University

    PRINCIPAL INVESTIGATOR
  • Okan Karaoğlu, Pt

    Gazi University

    PRINCIPAL INVESTIGATOR
  • Dilek Kaya, Pt

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

December 8, 2025

First Posted

December 19, 2025

Study Start

June 1, 2023

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations