<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/NCT04409067</url>
  </required_header>
  <id_info>
    <org_study_id>0012/08/15</org_study_id>
    <nct_id>NCT04409067</nct_id>
  </id_info>
  <brief_title>Masticatory Muscle Activity in Patients With Pain-related Temporomandibular Disorders</brief_title>
  <official_title>The Use of Electromyography in the Assessment of Masticatory Muscle Activity in Patients With Pain-related Temporomandibular Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pomeranian Medical University Szczecin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pomeranian Medical University Szczecin</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to evaluate masticatory muscle electrical activity in patients with&#xD;
      pain-related and pain-free temporomandibular disorders (TMD) as well as in subjects with no&#xD;
      TMD. Ninety children with mixed dentition were recruited to the study. Of this total, 30&#xD;
      subjects were diagnosed with pain-related TMD, 30 with pain-free TMD, and 30 without TMD. We&#xD;
      used Axis I of the Research Diagnostic Criteria for TMD (RDC/TMD) to assess the presence of&#xD;
      TMD in the examined children. The electromyographical (EMG) potentials of the temporalis and&#xD;
      masseter muscles were measured with a DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany)&#xD;
      at rest and during maximum voluntary clenching (MVC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2, 2019</start_date>
  <completion_date type="Actual">February 3, 2020</completion_date>
  <primary_completion_date type="Actual">February 3, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Electromyographic analysis of the masticatory muscles in patients with pain-related temporomandibular disorders</measure>
    <time_frame>For a single subject the whole EMG examination was taken 40 minutes.</time_frame>
    <description>A DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany) was used to take electromyographical (EMG) recordings of the temporalis and masseter muscles at rest and during maximum voluntary contraction (MVC).Disposable, self-adhesive Ag/AgCl bipolar surface electrodes were placed at a fixed inter-electrode distance of 20 mm on the anterior temporal muscles and on the superficial masseter muscles parallel to the muscular fibres. The EMG signals were amplified, digitized and digitally filtered. The EMG results were analysed using the Student t-test, analysis of variance (ANOVA) and a Student-Newman-Keuls post-hoc test.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>TMD</condition>
  <arm_group>
    <arm_group_label>TMD-pain group</arm_group_label>
    <description>The TMD-pain group consisted of 30 children aged between 7.1 and 12.3 with a pain-related TMD diagnosis. All the patients in the TMD-pain group had myogenous or arthrogenous TMD according to the RDC/TMD protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pain-free TMD group</arm_group_label>
    <description>The pain-free TMD group consisted of 30 children between 7.3 and 12.6 years of age. To be included in the pain-free TMD group the participants had to meet Axis I of the RDC/TMD criteria for a pain-free diagnosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-TMD group</arm_group_label>
    <description>The non-TMD group comprised 30 children aged between 7.2 and 12.5 without any recognised TMD based on RDC/TMD, Axis I.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>electromyography</intervention_name>
    <description>Surface electromyography (sEMG) was used as an additional non-invasive tool for assessing patients with TMD.The electromyographical (EMG) potentials of the temporalis and masseter muscles were measured with a DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany) at rest and during maximum voluntary clenching (MVC).</description>
    <arm_group_label>TMD-pain group</arm_group_label>
    <arm_group_label>non-TMD group</arm_group_label>
    <arm_group_label>pain-free TMD group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The subjects were selected from patients who had been referred to the Orthodontic Clinic in&#xD;
        Szczecin, Poland for orthodontic treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  mixed dentition (the subjects should be aged between 7 and 12 years)&#xD;
&#xD;
          -  consent to participate voluntarily in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects who had undergone orthodontic or masticatory motor system dysfunction&#xD;
             treatment, had systemic or rheumatologic diseases, a history of mouth breathing,&#xD;
             surgery, traumas or malformations in the head and neck region&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pomeranian Medical University, Department of Orthodontics</name>
      <address>
        <city>Szczecin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pomeranian Medical University Szczecin</investigator_affiliation>
    <investigator_full_name>Liliana Szyszka-Sommerfeld</investigator_full_name>
    <investigator_title>DDS, PhD</investigator_title>
  </responsible_party>
  <keyword>masticatory muscles</keyword>
  <keyword>surface electromyography</keyword>
  <keyword>muscle activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Temporomandibular Joint Disorders</mesh_term>
    <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04409067
org study id: 0012/08/15
nct id: NCT04409067
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to evaluate masticatory muscle electrical activity in patients with
      pain-related and pain-free temporomandibular disorders (TMD) as well as in subjects with no
      TMD. Ninety children with mixed dentition were recruited to the study. Of this total, 30
      subjects were diagnosed with pain-related TMD, 30 with pain-free TMD, and 30 without TMD. We
      used Axis I of the Research Diagnostic Criteria for TMD (RDC/TMD) to assess the presence of
      TMD in the examined children. The electromyographical (EMG) potentials of the temporalis and
      masseter muscles were measured with a DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany)
      at rest and during maximum voluntary clenching (MVC).
observational model: Case-Control
time perspective: Retrospective
measure: Electromyographic analysis of the masticatory muscles in patients with pain-related temporomandibular disorders
time frame: For a single subject the whole EMG examination was taken 40 minutes.
description: A DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany) was used to take electromyographical (EMG) recordings of the temporalis and masseter muscles at rest and during maximum voluntary contraction (MVC).Disposable, self-adhesive Ag/AgCl bipolar surface electrodes were placed at a fixed inter-electrode distance of 20 mm on the anterior temporal muscles and on the superficial masseter muscles parallel to the muscular fibres. The EMG signals were amplified, digitized and digitally filtered. The EMG results were analysed using the Student t-test, analysis of variance (ANOVA) and a Student-Newman-Keuls post-hoc test.
arm group label: TMD-pain group
description: The TMD-pain group consisted of 30 children aged between 7.1 and 12.3 with a pain-related TMD diagnosis. All the patients in the TMD-pain group had myogenous or arthrogenous TMD according to the RDC/TMD protocol.
arm group label: pain-free TMD group
description: The pain-free TMD group consisted of 30 children between 7.3 and 12.6 years of age. To be included in the pain-free TMD group the participants had to meet Axis I of the RDC/TMD criteria for a pain-free diagnosis.
arm group label: non-TMD group
description: The non-TMD group comprised 30 children aged between 7.2 and 12.5 without any recognised TMD based on RDC/TMD, Axis I.
intervention type: Diagnostic Test
intervention name: electromyography
description: Surface electromyography (sEMG) was used as an additional non-invasive tool for assessing patients with TMD.The electromyographical (EMG) potentials of the temporalis and masseter muscles were measured with a DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany) at rest and during maximum voluntary clenching (MVC).
arm group label: TMD-pain group
arm group label: non-TMD group
arm group label: pain-free TMD group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Pomeranian Medical University Szczecin
investigator full name: Liliana Szyszka-Sommerfeld
investigator title: DDS, PhD
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
sharing ipd: Undecided