Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain
Observational Study on Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain
Observational Study on Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain
Sponsor study identifier
observational
80
1 country
1
Study Start
January 1, 2019
Actual (reported)Primary Completion
June 1, 2021
Actual (reported)Study Completion
January 1, 2022
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 6, 2018
Actual (reported)December 6, 2018
Actual (reported)January 1, 2019
Actual (reported)June 1, 2021
Actual (reported)January 1, 2022
Actual (reported)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
TMD assessment
6 months after study start
Diagnosis of awake bruxism
8 months after study start
TMD pain
10 months after study start
Patients who will undergo analysis of: Evaluation of TMD and pain sensitivity Evaluation of SB Evaluation of AB
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.
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.
Noéli Boscato
Pelotas, Rio Grande do Sul, 96015-560, Brazil
[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
Noéli Boscato, PhD
Federal University of Pelotas
80 participants (actual enrollment reported by the registry).
First Submitted
November 6, 2018
First Posted
December 6, 2018
Study Start
January 1, 2019
Actual (reported)Botulinum Toxin Administration on Masticatory Performance
The presence or absence of SB will be diagnosed by Polysomnography
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 1, 2021
Actual (reported)Study Completion
January 1, 2022
Actual (reported)Last Updated
March 29, 2022
Record last verified: 2022-03
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Source: ClinicalTrials.gov.
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