xml: <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/NCT06041633</url>
    </required_header>
    <id_info>
      <org_study_id>1072.6120.312.2021-15.12.2</org_study_id>
      <nct_id>NCT06041633</nct_id>
    </id_info>
    <brief_title>Preliminary Assessment of the Psycho-emotional State of Patients With TMD</brief_title>
    <official_title>Preliminary Assessment of the Psycho-emotional State of Patients With TMD</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jagiellonian University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jagiellonian University</source>
    <oversight_info>
      <has_dmc>No</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>
        TMD (temporomandibular disorders) is the name for a collective syndrome of disorders that&#xD;
        includes abnormal function of the muscles of mastication, the temporomandibular joints and&#xD;
        surrounding structures. It is one of the most significant causes of orofacial pain, along&#xD;
        with dental pain. In TMD syndrome, the cause of pain is often due to overloading of the&#xD;
        masticatory muscles rather than primary changes in the joints themselves.&#xD;
  &#xD;
        Nowadays, doctors who treat patients with TMD have no doubt that one of the very important&#xD;
        etiological factors of this condition is psycho-emotional disorders (excessive nervous&#xD;
        excitability, anxiety, depression), which has been confirmed by numerous authors of studies&#xD;
        on this subject [4-11].&#xD;
  &#xD;
        The etiology of TMD is complex and multifactorial. Numerous factors may also contribute to&#xD;
        the development of the disorder. An important factor affecting the state of masticatory&#xD;
        function is an increase in stress levels (psycho-emotional tension). Structures such as the&#xD;
        hypothalamus, reticular formation and limbic system have a decisive influence on the&#xD;
        emotional state of each patient The activity of the limbic system, which governs the emotions&#xD;
        of adults, and the additional connections of the gamma loops to the masticatory muscles,&#xD;
        determine that increased emotional tension translates into a significant increase in the&#xD;
        &quot;contractile&quot; activity of the masticatory muscles.&#xD;
  &#xD;
        TMD and functional disorder of the masticatory muscles are the most common complaint of the&#xD;
        patients, seeking treatment in dental office. The two main symptoms of TMD problems are pain&#xD;
        and dysfunction. Myalgia -the most common cause is an increased level of muscle use. It is&#xD;
        related to vasocontraction of relevant arteries and accumulation of metabolic waste product&#xD;
        in the muscles. Activities such as daytime clenching of the teeth and bruxism, habits of&#xD;
        chewing gum, biting lips, finger nails or cheeks are factors that cause significant strain on&#xD;
        the masticatory muscles and temporomandibular joints.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 1, 2021</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</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>Questionanire</measure>
      <time_frame>2021-2023</time_frame>
      <description>The questionnaire survey includes a total of 30 questions, regarding the emotional state of the of the respondents over the past 4 weeks such as lowered mood, states of emotional irritability, feelings of sadness, lack of desire for daily activities, lack of concentration, or desire for self-isolation and critical thoughts toward one's own person person, or nervousness, fearfulness. Responses in each question included: * no, * a few times in the past 4 weeks, *a few times during the week, and *continuously/continually. The scores for each question were: 0 points for most favorable response and 4 points for the most unfavorable patient response. The result of the questionnaire was divided into four sections; A, B, C,D.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">260</enrollment>
    <condition>C05.500.607.221.897</condition>
    <condition>C05.550.905</condition>
    <arm_group>
      <arm_group_label>Clinical</arm_group_label>
      <description>One hundred and thirty patients diagnosed with TMD constituted the study group (group I)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <description>One hundred and thirty patients were excluded from having TMD based on the RDC/ TMD questionnaire, and these patients constituted the control group (group II).</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Clinical</intervention_name>
      <description>Questionnaire</description>
      <arm_group_label>Clinical</arm_group_label>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Population of Patients of University Clinic&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          (i) good general health, with no craniofacial trauma in the last 5 years and without severe&#xD;
          mental conditions (ii) the presence of TMD symptoms (pain in the masticatory muscles,&#xD;
          limitation of mouth opening range, clicking or popping in the temporomandibular joints. For&#xD;
          control group there was absences of these symptoms.&#xD;
  &#xD;
          (iii) consent of the patient to participate in the research project&#xD;
  &#xD;
          The exclusion criteria for the study were:&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          (i). willingness to resign out of the study.&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Andrzej Gala, Dr</last_name>
      <phone>48124245555</phone>
      <phone_ext>230</phone_ext>
      <email>andrzej.gala@uj.edu.pl</email>
    </overall_contact>
    <location>
      <facility>
        <name>Uniwersytecka Klinika Stomatologiczna</name>
        <address>
          <city>Kraków</city>
          <zip>31-155</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Andrzej Gala, Dr</last_name>
        <phone>+48124245555</phone>
        <phone_ext>230</phone_ext>
        <email>andrzej.gala@uj.edu.pl</email>
      </contact>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Jagiellonian University</investigator_affiliation>
      <investigator_full_name>Malgorzata Pihut</investigator_full_name>
      <investigator_title>Prof. Małgorzata Pihut</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06041633
  org study id: 1072.6120.312.2021-15.12.2
  nct id: NCT06041633
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  TMD (temporomandibular disorders) is the name for a collective syndrome of disorders that
        includes abnormal function of the muscles of mastication, the temporomandibular joints and
        surrounding structures. It is one of the most significant causes of orofacial pain, along
        with dental pain. In TMD syndrome, the cause of pain is often due to overloading of the
        masticatory muscles rather than primary changes in the joints themselves.
  
        Nowadays, doctors who treat patients with TMD have no doubt that one of the very important
        etiological factors of this condition is psycho-emotional disorders (excessive nervous
        excitability, anxiety, depression), which has been confirmed by numerous authors of studies
        on this subject [4-11].
  
        The etiology of TMD is complex and multifactorial. Numerous factors may also contribute to
        the development of the disorder. An important factor affecting the state of masticatory
        function is an increase in stress levels (psycho-emotional tension). Structures such as the
        hypothalamus, reticular formation and limbic system have a decisive influence on the
        emotional state of each patient The activity of the limbic system, which governs the emotions
        of adults, and the additional connections of the gamma loops to the masticatory muscles,
        determine that increased emotional tension translates into a significant increase in the
        "contractile" activity of the masticatory muscles.
  
        TMD and functional disorder of the masticatory muscles are the most common complaint of the
        patients, seeking treatment in dental office. The two main symptoms of TMD problems are pain
        and dysfunction. Myalgia -the most common cause is an increased level of muscle use. It is
        related to vasocontraction of relevant arteries and accumulation of metabolic waste product
        in the muscles. Activities such as daytime clenching of the teeth and bruxism, habits of
        chewing gum, biting lips, finger nails or cheeks are factors that cause significant strain on
        the masticatory muscles and temporomandibular joints.
  observational model: Case-Control
  time perspective: Retrospective
  measure: Questionanire
  time frame: 2021-2023
  description: The questionnaire survey includes a total of 30 questions, regarding the emotional state of the of the respondents over the past 4 weeks such as lowered mood, states of emotional irritability, feelings of sadness, lack of desire for daily activities, lack of concentration, or desire for self-isolation and critical thoughts toward one's own person person, or nervousness, fearfulness. Responses in each question included: * no, * a few times in the past 4 weeks, *a few times during the week, and *continuously/continually. The scores for each question were: 0 points for most favorable response and 4 points for the most unfavorable patient response. The result of the questionnaire was divided into four sections; A, B, C,D.
  arm group label: Clinical
  description: One hundred and thirty patients diagnosed with TMD constituted the study group (group I)
  arm group label: Control
  description: One hundred and thirty patients were excluded from having TMD based on the RDC/ TMD questionnaire, and these patients constituted the control group (group II).
  intervention type: Diagnostic Test
  intervention name: Clinical
  description: Questionnaire
  arm group label: Clinical
  arm group label: Control
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  last name: Andrzej Gala, Dr
  phone: 48124245555
  phone ext: 230
  email: andrzej.gala@uj.edu.pl
  facility: 
  status: Recruiting
  contact: 
  country: Poland
  responsible party type: Principal Investigator
  investigator affiliation: Jagiellonian University
  investigator full name: Malgorzata Pihut
  investigator title: Prof. Małgorzata Pihut
  sharing ipd: No