<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03766464</url>
  </required_header>
  <id_info>
    <org_study_id>FUPelotas1</org_study_id>
    <nct_id>NCT03766464</nct_id>
  </id_info>
  <brief_title>Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain</brief_title>
  <official_title>Observational Study on Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Pelotas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Pelotas</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluated the influence of the sleep bruxism (SB), awake bruxism (AB) and&#xD;
      obstructive sleep apnea syndrome (OSAS) on the signs and symptoms of temporomandibular&#xD;
      disorders (TMD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obstructive sleep apnea (OSA) is characterized by partial or total obstruction of the upper&#xD;
      airways. Bruxism is defined as a repetitive activity of the mandibular musculature&#xD;
      characterized by the tightening or grinding of the teeth and/or by the retrusion or&#xD;
      propulsion of the mandible, and according to their manifestation circadian is defined as&#xD;
      sleep bruxism (SB) or wake bruxism (AB). This prospective clinical study will be performed&#xD;
      with adults (20 to 60 years) and elderly (&gt; 60 years) (WHO-World Health Organization) who&#xD;
      will be undergone polysomnography (PSG) at a private medical outpatients clinic from January&#xD;
      to December 2019 to evaluate the influence of SB, AB, and OSA on signs and symptoms of TMD.&#xD;
      The individuals will be assessed clinically and diagnosed for TMD using the &quot;Diagnostic&#xD;
      Criteria for Temporomandibular Disorders&quot;, for SB and OSA using PSG, and AB using the&#xD;
      smartphone application. Specific statistical tests will be determined after preliminary&#xD;
      analysis of the data (α= 0.05).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">January 1, 2022</completion_date>
  <primary_completion_date type="Actual">June 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Polisomnography analysis</measure>
    <time_frame>4 months after study start</time_frame>
    <description>Patients included in the study will receive polisomnography exams for diagnosis of SB and OSAS. The data will be obtained from polisomnography records</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TMD assessment</measure>
    <time_frame>6 months after study start</time_frame>
    <description>All patients who had undergone polisomnography will answer the DC / TMD questionaire and clinical exams.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnosis of awake bruxism</measure>
    <time_frame>8 months after study start</time_frame>
    <description>All patients will use a Smartphone application after undergone polisomnography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TMD pain</measure>
    <time_frame>10 months after study start</time_frame>
    <description>All patients who had undergone polisomnography will answer the DC / TMD questionaire and clinical exams with algometer.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Bruxism</condition>
  <condition>Temporomandibular Joint Disorders</condition>
  <condition>Obstructive Sleep Apnea Syndrome</condition>
  <arm_group>
    <arm_group_label>with sleep bruxism, apnea and DTM</arm_group_label>
    <description>Patients who will undergo analysis of:&#xD;
Evaluation of TMD and pain sensitivity Evaluation of SB Evaluation of AB</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Evaluation of TMD and pain sensitivity</intervention_name>
    <description>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.</description>
    <arm_group_label>with sleep bruxism, apnea and DTM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Evaluation of SB</intervention_name>
    <description>The presence or absence of SB will be diagnosed by Polysomnography</description>
    <arm_group_label>with sleep bruxism, apnea and DTM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Evaluation of AB</intervention_name>
    <description>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.</description>
    <arm_group_label>with sleep bruxism, apnea and DTM</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adults (aged 20 to 60 years) and elderly (aged &gt; 60 years) who had undergone PSG at the&#xD;
        Pelotas Sleep Institute (ISP), a private medical outpatients clinic, from January to&#xD;
        December 2019, will be invited to participate in the study. Written consent was given by&#xD;
        all participants who agreed to participate in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (aged 20 to 60 years) and elderly (aged &gt; 60 years) (WHO-World Health&#xD;
             Organization, 2015) who will be undergone PSG at the Pelotas Sleep Institute (ISP);&#xD;
&#xD;
          -  Adequate cognitive capacity to understand and answer the questionnaire.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Those which the participants were unable to answer the questionnaires and who presented a&#xD;
        history of epilepsy that could interfere in the results of PSG.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noéli Boscato, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Pelotas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Noéli Boscato</name>
      <address>
        <city>Pelotas</city>
        <state>RS</state>
        <zip>96015-560</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <results_reference>
    <citation>[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</citation>
  </results_reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>March 14, 2022</last_update_submitted>
  <last_update_submitted_qc>March 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Pelotas</investigator_affiliation>
    <investigator_full_name>Noéli Boscato, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>sleep bruxism</keyword>
  <keyword>polisomnography</keyword>
  <keyword>sleep wake disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Temporomandibular Joint Disorders</mesh_term>
    <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
    <mesh_term>Bruxism</mesh_term>
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Facial Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03766464
org study id: FUPelotas1
nct id: NCT03766464
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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).
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).
observational model: Cohort
time perspective: Prospective
measure: Polisomnography analysis
time frame: 4 months after study start
description: Patients included in the study will receive polisomnography exams for diagnosis of SB and OSAS. The data will be obtained from polisomnography records
measure: TMD assessment
time frame: 6 months after study start
description: All patients who had undergone polisomnography will answer the DC / TMD questionaire and clinical exams.
measure: Diagnosis of awake bruxism
time frame: 8 months after study start
description: All patients will use a Smartphone application after undergone polisomnography
measure: TMD pain
time frame: 10 months after study start
description: All patients who had undergone polisomnography will answer the DC / TMD questionaire and clinical exams with algometer.
arm group label: with sleep bruxism, apnea and DTM
description: Patients who will undergo analysis of:
Evaluation of TMD and pain sensitivity Evaluation of SB Evaluation of AB
intervention type: Diagnostic Test
intervention name: Evaluation of TMD and pain sensitivity
description: 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.
arm group label: with sleep bruxism, apnea and DTM
intervention type: Diagnostic Test
intervention name: Evaluation of SB
description: The presence or absence of SB will be diagnosed by Polysomnography
arm group label: with sleep bruxism, apnea and DTM
intervention type: Diagnostic Test
intervention name: Evaluation of AB
description: 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.
arm group label: with sleep bruxism, apnea and DTM
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Noéli Boscato, PhD
role: Principal Investigator
affiliation: Federal University of Pelotas
facility: 
country: Brazil
citation: [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
responsible party type: Principal Investigator
investigator affiliation: Federal University of Pelotas
investigator full name: Noéli Boscato, PhD
investigator title: Associate Professor
mesh term: Joint Diseases
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
mesh term: Bruxism
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Facial Pain
sharing ipd: No