Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain

Completed

• Conditions: Obstructive Sleep Apnea Syndrome; Bruxism; Temporomandibular Joint Disorders
• Interventions: Diagnostic Test: Evaluation of TMD and pain sensitivity; Diagnostic Test: Evaluation of SB; Diagnostic Test: Evaluation of AB

• Registration Number: NCT03766464
• Lead Sponsor: Federal University of Pelotas

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).

Study Timeline

• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-06
• Study Start: 2019-01-01
• Primary Completion: 2021-06-01
• Study Completion: 2022-01-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
with sleep bruxism, apnea and DTM	Evaluation of TMD and pain sensitivity	Patients who will undergo analysis of: Evaluation of TMD and pain sensitivity Evaluation of SB Evaluation of AB
with sleep bruxism, apnea and DTM	Evaluation of SB	Patients who will undergo analysis of: Evaluation of TMD and pain sensitivity Evaluation of SB Evaluation of AB
with sleep bruxism, apnea and DTM	Evaluation of AB	Patients who will undergo analysis of: Evaluation of TMD and pain sensitivity Evaluation of SB Evaluation of AB

Primary Outcome Measures

Name	Time	Method
Polisomnography analysis	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 Outcome Measures

Name	Time	Method
TMD assessment	6 months after study start	All patients who had undergone polisomnography will answer the DC / TMD questionaire and clinical exams.
Diagnosis of awake bruxism	8 months after study start	All patients will use a Smartphone application after undergone polisomnography
TMD pain	10 months after study start	All patients who had undergone polisomnography will answer the DC / TMD questionaire and clinical exams with algometer.

Trial Locations

Locations (1)

Noéli Boscato; 🇧🇷 Pelotas, RS, Brazil