Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain

NCT03766464 | Completed DMC

• 1 other identifier: FUPelotas1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Bruxism; Temporomandibular Joint Disorders; Obstructive Sleep Apnea Syndrome

Keywords

sleep bruxism; polisomnography; sleep wake disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• TMD assessment

  6 months after study start

• Diagnosis of awake bruxism

  8 months after study start

• TMD pain

  10 months after study start

Study Arms (1)

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; Diagnostic Test: Evaluation of SB; Diagnostic Test: Evaluation of AB

Interventions

Evaluation of TMD and pain sensitivity 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.

with sleep bruxism, apnea and DTM

Evaluation of SB DIAGNOSTIC_TEST

The presence or absence of SB will be diagnosed by Polysomnography

with sleep bruxism, apnea and DTM

Evaluation of AB 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.

with sleep bruxism, apnea and DTM

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (1)

Noéli Boscato

Pelotas, Rio Grande do Sul, 96015-560, Brazil

Location

Related 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, 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

  RESULT

MeSH Terms

Conditions

Bruxism; Temporomandibular Joint Disorders; Sleep Apnea, Obstructive; Sleep Bruxism; Sleep Wake Disorders

Interventions

Pain Threshold

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Parasomnias; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pain; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Noéli Boscato, PhD

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: December 6, 2018
• Study Start: January 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: January 1, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)