Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain

NCT ID: NCT03766464

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-01-01

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).

Conditions

Bruxism; Temporomandibular Joint Disorders; Obstructive Sleep Apnea Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

with sleep bruxism, apnea and DTM

Patients who will undergo analysis of:

Evaluation of TMD and pain sensitivity Evaluation of SB Evaluation of AB

Evaluation of TMD and pain sensitivity

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

The presence or absence of SB will be diagnosed by Polysomnography

Evaluation of AB

Intervention Type: 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.

Interventions

Evaluation 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.

Intervention Type: DIAGNOSTIC_TEST

Evaluation of SB

The presence or absence of SB will be diagnosed by Polysomnography

Intervention Type: DIAGNOSTIC_TEST

Evaluation 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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Pelotas

OTHER

Sponsor Role: lead

Responsible Party

Noéli Boscato, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noéli Boscato, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Pelotas

Locations

Noéli Boscato

Pelotas, Rio Grande do Sul, Brazil

Countries

Brazil

References

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Reference Type: RESULT

Other Identifiers

FUPelotas1

Identifier Type: -

Identifier Source: org_study_id