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Completed

NCT Number: NCT03766464

Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain

This study evaluated the influence of the sleep bruxism (SB), awake bruxism (AB) and obstructive sleep apnea syndrome (OSAS) on the signs and symptoms of temporomandibular disorders (TMD).

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Key information

Conditions

Bruxism Apnea Behavior Craniomandibular Disorders Dyssomnias Habits Jaw Diseases Joint Diseases Mandibular Diseases Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Obstructive Sleep Apnea Syndrome Parasomnias Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Bruxism Sleep Disorders, Intrinsic Sleep Wake Disorders Stomatognathic Diseases Temporomandibular Joint Disorders Tooth Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Noéli Boscato

Pelotas, Rio Grande do Sul, 96015-560, Brazil

About this study

Obstructive sleep apnea (OSA) is characterized by partial or total obstruction of the upper airways. Bruxism is defined as a repetitive activity of the mandibular musculature characterized by the tightening or grinding of the teeth and/or by the retrusion or propulsion of the mandible, and according to their manifestation circadian is defined as sleep bruxism (SB) or wake bruxism (AB). This prospective clinical study will be performed with adults (20 to 60 years) and elderly (> 60 years) (WHO-World Health Organization) who will be undergone polysomnography (PSG) at a private medical outpatients clinic from January to December 2019 to evaluate the influence of SB, AB, and OSA on signs and symptoms of TMD. The individuals will be assessed clinically and diagnosed for TMD using the "Diagnostic Criteria for Temporomandibular Disorders", for SB and OSA using PSG, and AB using the smartphone application. Specific statistical tests will be determined after preliminary analysis of the data (α= 0.05).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults (aged 20 to 60 years) and elderly (aged > 60 years) (WHO-World Health Organization, 2015) who will be undergone PSG at the Pelotas Sleep Institute (ISP);
  • Adequate cognitive capacity to understand and answer the questionnaire.

Exclusion criteria

  • Those which the participants were unable to answer the questionnaires and who presented a history of epilepsy that could interfere in the results of PSG.

Treatment and study plan

Evaluation of TMD and pain sensitivity

Diagnostic Test

Extra and intraoral clinical examination will be performed and the Diagnostic Criteria for Temporomandibular Disorders (DC / TMD) questionnaire will be applied. Measurements shall be bilateral in the masseter, anterior temporal and tenar muscles and the arithmetic mean between three measurements will be considered the value for each side for pain sensitivity analysis with an dynamometer.

Evaluation of SB

Diagnostic Test

The presence or absence of SB will be diagnosed by Polysomnography

Evaluation of AB

Diagnostic Test

A smartphone will be used, which was developed for a momentary evaluation that allows a report of the exact moment of AB and its possible associated symptoms.

Primary outcomes

  1. Polisomnography analysis

    Time frame: 4 months after study start

    Patients included in the study will receive polisomnography exams for diagnosis of SB and OSAS. The data will be obtained from polisomnography records

Secondary outcomes

  1. TMD assessment

    Time frame: 6 months after study start

    All patients who had undergone polisomnography will answer the DC / TMD questionaire and clinical exams.

  2. Diagnosis of awake bruxism

    Time frame: 8 months after study start

    All patients will use a Smartphone application after undergone polisomnography

  3. TMD pain

    Time frame: 10 months after study start

    All patients who had undergone polisomnography will answer the DC / TMD questionaire and clinical exams with algometer.

Sponsors and collaborators

Lead sponsor

Federal University of Pelotas

Other

Registry information

Official study title

Observational Study on Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Dec 6, 2018
Registry last updated
Mar 29, 2022

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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