Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain

Sponsor
Federal University of Pelotas (Other)
Overall Status
Completed
CT.gov ID
NCT03766464
Collaborator
(none)
80
1
36
2.2

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Evaluation of TMD and pain sensitivity
  • Diagnostic Test: Evaluation of SB
  • Diagnostic Test: Evaluation of AB

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 Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observational Study on Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Jun 1, 2021
Actual Study Completion Date :
Jan 1, 2022

Arms and Interventions

Arm Intervention/Treatment
with sleep bruxism, apnea and DTM

Patients who will undergo analysis of: Evaluation of TMD and pain sensitivity Evaluation of SB Evaluation of AB

Diagnostic Test: 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.

Diagnostic Test: Evaluation of SB
The presence or absence of SB will be diagnosed by Polysomnography

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. TMD assessment [6 months after study start]

    All patients who had undergone polisomnography will answer the DC / TMD questionaire and clinical exams.

  2. Diagnosis of awake bruxism [8 months after study start]

    All patients will use a Smartphone application after undergone polisomnography

  3. TMD pain [10 months after study start]

    All patients who had undergone polisomnography will answer the DC / TMD questionaire and clinical exams with algometer.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Noéli Boscato Pelotas RS Brazil 96015-560

Sponsors and Collaborators

  • Federal University of Pelotas

Investigators

  • Principal Investigator: Noéli Boscato, PhD, Federal University of Pelotas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Noéli Boscato, PhD, Associate Professor, Federal University of Pelotas
ClinicalTrials.gov Identifier:
NCT03766464
Other Study ID Numbers:
  • FUPelotas1
First Posted:
Dec 6, 2018
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Noéli Boscato, PhD, Associate Professor, Federal University of Pelotas
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2022