Clinical Trials Directory

Trials / Completed

CompletedNCT03766464

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
Phase
Study type
Observational
Enrollment
80 (actual)
Sponsor
Federal University of Pelotas · Academic / Other
Sex
All
Age
20 Years – 80 Years
Healthy volunteers
Accepted

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).

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTEvaluation of TMD and pain sensitivityExtra 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 SBThe presence or absence of SB will be diagnosed by Polysomnography
DIAGNOSTIC_TESTEvaluation of ABA 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.

Timeline

Start date
2019-01-01
Primary completion
2021-06-01
Completion
2022-01-01
First posted
2018-12-06
Last updated
2022-03-29

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT03766464. Inclusion in this directory is not an endorsement.

Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain (NCT03766464) · Clinical Trials Directory