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Clinical Trials/NCT03766464
NCT03766464
Completed
Not Applicable

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

Federal University of Pelotas1 site in 1 country80 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bruxism
Sponsor
Federal University of Pelotas
Enrollment
80
Locations
1
Primary Endpoint
Polisomnography analysis
Status
Completed
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
January 1, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Federal University of Pelotas
Responsible Party
Principal Investigator
Principal Investigator

Noéli Boscato, PhD

Associate Professor

Federal University of Pelotas

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • TMD assessment(6 months after study start)
  • Diagnosis of awake bruxism(8 months after study start)
  • TMD pain(10 months after study start)

Study Sites (1)

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