Skip to content

Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03766464
Enrollment
80
Registered
2018-12-06
Start date
2019-01-01
Completion date
2022-01-01
Last updated
2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bruxism, Obstructive Sleep Apnea Syndrome, Temporomandibular Joint Disorders

Keywords

sleep bruxism, polisomnography, sleep wake disorders

Brief summary

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).

Detailed description

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).

Interventions

DIAGNOSTIC_TESTEvaluation of TMD and pain sensitivity

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.

DIAGNOSTIC_TESTEvaluation of SB

The presence or absence of SB will be diagnosed by Polysomnography

DIAGNOSTIC_TESTEvaluation of AB

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.

Sponsors

Federal University of Pelotas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Polisomnography analysis4 months after study startPatients included in the study will receive polisomnography exams for diagnosis of SB and OSAS. The data will be obtained from polisomnography records

Secondary

MeasureTime frameDescription
TMD assessment6 months after study startAll patients who had undergone polisomnography will answer the DC / TMD questionaire and clinical exams.
Diagnosis of awake bruxism8 months after study startAll patients will use a Smartphone application after undergone polisomnography
TMD pain10 months after study startAll patients who had undergone polisomnography will answer the DC / TMD questionaire and clinical exams with algometer.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026