<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/NCT03308266</url>
  </required_header>
  <id_info>
    <org_study_id>KB-0012/08/15</org_study_id>
    <nct_id>NCT03308266</nct_id>
  </id_info>
  <brief_title>Electromyographic Analysis of the Masticatory Muscles in Cleft Lip and Palate Children With Temporomandibular Disorders</brief_title>
  <official_title>Electromyographic Analysis of the Masticatory Muscles in Cleft Lip and Palate Children 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 assess the electrical activity of the temporal and masseter&#xD;
      muscles in cleft lip and palate (CLP) children with pain-related temporomandibular disorders&#xD;
      (TMD) and in CLP individuals with no TMD by means of surface electromyography (sEMG). Another&#xD;
      objective was to determine the diagnostic value of electromyography in identifying CLP&#xD;
      patients with temporomandibular disorders. The sample comprised 87 children with CLP and&#xD;
      mixed dentition. The children were assessed for the presence of TMD using of the Research&#xD;
      Diagnostic Criteria for TMD (RDC/TMD) by a single examiner. A DAB-Bluetooth Instrument&#xD;
      (Zebris Medical GmbH, Germany) was used to take electromyographical (EMG) recordings of the&#xD;
      temporal and masseter muscles both in the mandibular rest position and during maximum&#xD;
      voluntary contraction (MVC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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 cleft lip and palate children 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 temporal and masseter muscles both in the mandibular rest position 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's t test and Mann-Whitney U test to determine differences between the mean values of the independent variables.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The diagnostic value of electromyography in identifying cleft lip and palate patients with 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 temporal and masseter muscles both in the mandibular rest position 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. A mathematical analysis of the ROC curve was used to assess the diagnostic efficiency of electromyography in identifying patients withTMD. The results were described by the area under the curve (AUC), the P value and the ROC coordinate curves, i.e. sensitivity and specificity.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">87</enrollment>
  <condition>Cleft Lip and Palate</condition>
  <condition>Temporomandibular Disorder</condition>
  <arm_group>
    <arm_group_label>CLP children with pain-related TMD</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>CLP children with no TMD</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>CLP children with painfree TMD</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>electromyography</intervention_name>
    <arm_group_label>CLP children with no TMD</arm_group_label>
    <arm_group_label>CLP children with pain-related TMD</arm_group_label>
    <arm_group_label>CLP children with painfree TMD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The subjects were selected from patients who had been referred to three Cleft Care Centres&#xD;
        in Szczecin, Poznań and Wrocław, Poland.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  presence of a cleft without a syndrome, a sequence, or karyotype abnormalities&#xD;
&#xD;
          -  presence of mixed dentition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the presence of systemic or rheumatologic diseases&#xD;
&#xD;
          -  a history of cervical spine or temporomandibular joint (TMJ) surgery, trauma or&#xD;
             malformations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
  </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>October 2017</verification_date>
  <study_first_submitted>October 7, 2017</study_first_submitted>
  <study_first_submitted_qc>October 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>October 7, 2017</last_update_submitted>
  <last_update_submitted_qc>October 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</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>
  <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>
    <mesh_term>Cleft Lip</mesh_term>
  </condition_browse>
  <!-- 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/NCT03308266
org study id: KB-0012/08/15
nct id: NCT03308266
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to assess the electrical activity of the temporal and masseter
      muscles in cleft lip and palate (CLP) children with pain-related temporomandibular disorders
      (TMD) and in CLP individuals with no TMD by means of surface electromyography (sEMG). Another
      objective was to determine the diagnostic value of electromyography in identifying CLP
      patients with temporomandibular disorders. The sample comprised 87 children with CLP and
      mixed dentition. The children were assessed for the presence of TMD using of the Research
      Diagnostic Criteria for TMD (RDC/TMD) by a single examiner. A DAB-Bluetooth Instrument
      (Zebris Medical GmbH, Germany) was used to take electromyographical (EMG) recordings of the
      temporal and masseter muscles both in the mandibular rest position and during maximum
      voluntary contraction (MVC).
observational model: Case-Control
time perspective: Retrospective
measure: Electromyographic analysis of the masticatory muscles in cleft lip and palate children 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 temporal and masseter muscles both in the mandibular rest position 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's t test and Mann-Whitney U test to determine differences between the mean values of the independent variables.
measure: The diagnostic value of electromyography in identifying cleft lip and palate patients with 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 temporal and masseter muscles both in the mandibular rest position 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. A mathematical analysis of the ROC curve was used to assess the diagnostic efficiency of electromyography in identifying patients withTMD. The results were described by the area under the curve (AUC), the P value and the ROC coordinate curves, i.e. sensitivity and specificity.
arm group label: CLP children with pain-related TMD
arm group label: CLP children with no TMD
arm group label: CLP children with painfree TMD
intervention type: Diagnostic Test
intervention name: electromyography
arm group label: CLP children with no TMD
arm group label: CLP children with pain-related TMD
arm group label: CLP children with painfree TMD
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 13 Years
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
mesh term: Cleft Lip