Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain

Temporomandibular Joint Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03766464
• Other study ID #: FUPelotas1
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: March 2022
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 1, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Bruxism
• Facial Pain
• Joint Diseases
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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.
• Evaluation of SB
The presence or absence of SB will be diagnosed by Polysomnography
• 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.

Locations

Country	Name	City	State
Brazil	Noéli Boscato	Pelotas	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

[1] Lobbezoo F, Ahlberg J, Glaros AG, Kato T, Koyano K, Lavigne GJ, Leeuw LR, Manfredini D, Winocur, E. Bruxism defined and graded: an international consensus. J Oral Rehabil. 2013;40:2-4. [2] Lobezzo F, Naeije M. Bruxism is mainly regulated centrally, no

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polisomnography analysis	Patients included in the study will receive polisomnography exams for diagnosis of SB and OSAS. The data will be obtained from polisomnography records	4 months after study start
Secondary	TMD assessment	All patients who had undergone polisomnography will answer the DC / TMD questionaire and clinical exams.	6 months after study start
Secondary	Diagnosis of awake bruxism	All patients will use a Smartphone application after undergone polisomnography	8 months after study start
Secondary	TMD pain	All patients who had undergone polisomnography will answer the DC / TMD questionaire and clinical exams with algometer.	10 months after study start