Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain

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

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).

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea Syndrome; Bruxism; Temporomandibular Joint Disorders
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Pelotas, RS, Brazil, 96015-560
      • Noéli Boscato

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All adults (aged 20 to 60 years) and elderly (aged > 60 years) who had undergone PSG at the Pelotas Sleep Institute (ISP), a private medical outpatients clinic, from January to December 2019, will be invited to participate in the study. Written consent was given by all participants who agreed to participate in the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal University of Pelotas

Publications and helpful links

General Publications

• [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, not peripherally. J Oral Rehabil. 2001;28:1085-1091. [3] Lavigne GJ, Khoury S, Abe S, Yamaguchi T, Raphael K. Bruxism physiology and pathology: an overview for clinicians. J Oral Rehabi. 2008;35:476-494. [4] Svensson P, Arima T, Lavigne G, Castrillon E. Sleep Bruxism: Definition, Prevalence, Classification, Etiology, and Consequences, In: Kryger M, Roth T, Dement WC (eds), Principles and Practice of Sleep Medicine, 7th edition, 2020, chapter 171. [5] Lobbezoo F, Ahlberg J, Raphael KG, Wetselaar P, Glaros AG, Kato T, et al. International consensus on the assessment of bruxism: Report of a work in progress. J Oral Rehabil. 2018;45:837-44. [6] American Academy of Sleep Medicine (AASM). International Classification of Sleep Disorders. 3rd ed. ed. Darien, IL: American Academy of Sleep Medicine; 2014. [7] Louca M, Short MA. The effect of one night's sleep deprivation on adolescent neurobehavioral performance. Sleep. 2014;37:1799-1807.. [8] Casett E, Réus JC, Stuginski-Barbosa J, Porporatti AL, Carra MC, Peres MA, De Luca Canto D, Manfredini, D. Validity of different tools to assess sleep bruxism: a meta-analysis. J Oral Rehabil. 2017;44:722-734. [9] Schroeder K, Gurenlian JR. Recognizing poor sleep quality factors during oral health evaluations. Clin Med Res. 2019;17: 20-28. [10] Ramzy JA, Rengan R, Mandal M, Rani S, Sanchez MV, Jaffe F, Krachman S. Hypoxic Burden and Apnea-Hypopnea Duration in Patients with Positional Obstructive Sleep Apnea. Sleep. 2020;43:A217-A218. [11] Baad-Hansen L, Thymi M, Lobbezoo F, Svensson P. To what extent is bruxism associated with musculoskeletal signs and symptoms? A systematic review. J Oral Rehabil. 2019;46:845-861. [12] Ferreira MC, Porto de Toledo I, Dutra KL, Stefani FM, Porporatti AL, Flores-Mir C, De Luca Canto G. Association between chewing dysfunctions and temporomandibular disorders: A systematic review. J Oral Rehabil. 2018;45:819-835. [13] Amorim CSM, Vieira GF, Firsoff EFO, Frutuoso JRC, Puliti E, Marques AP. Symptoms in different severity degrees of bruxism: a cross-sectional study. Fisio Pesq, 2016;23:423-430. [14] Sessle BJ, Adachi K, Yao D, Suzuki Y, Lavigne GJ. Orofacial pain and sleep. Contemp Oral Med. 2017;1-27. [15] Manfredini D, Ahlberg J, Castroflorio T, Poggio CE, Guarda-Nardini L, Lobbezoo F. Diagnostic accuracy of portable instrumental devices to measure sleep bruxism: a systematic literature review of polysomnographic studies. J Oral Rehabil. 2014;41:836-842. [16] Wetselaar P, Vermaire E, Lobbezoo F, Schuller AA. The prevalence of awake bruxism and sleep bruxism in the Dutch adult population. J Oral Rehabi. 2019;46:617-623. [17] von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014;12:1495-9. [18] World Health Organization (WHO). Obesity and overweight. Fact sheet 2016

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): June 1, 2021
• Study Completion (ACTUAL): January 1, 2022

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (ACTUAL): December 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: sleep bruxism; polisomnography; sleep wake disorders
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Signs and Symptoms, Respiratory; Tooth Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Joint Diseases; Bruxism; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Facial Pain
• Other Study ID Numbers: FUPelotas1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No