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/NCT06034756</url>
    </required_header>
    <id_info>
      <org_study_id>2022-18</org_study_id>
      <nct_id>NCT06034756</nct_id>
    </id_info>
    <brief_title>Temporomandibular Joint Problems and Core Stabilization</brief_title>
    <official_title>Temporomandibular Joint Problems, Head Posture, Tongue Strength and Endurance and Core Stabilization With University Students</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bandırma Onyedi Eylül University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bandırma Onyedi Eylül 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>
        This study aimed to investigate the relationship between temporomandibular joint problems,&#xD;
        head posture, tongue strength, and endurance with core stabilization.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This cross-sectional study was conducted on university students aged 18-31 between September&#xD;
        2022 and February 2023. In the evaluation of the students were used that the Fonseca's&#xD;
        Anamnestic Questionnaire for temporomandibular joint dysfunction, Research Diagnostic&#xD;
        Criteria for Temporomandibular Disorders Examination Form for maximum pain-free mouth&#xD;
        opening, presence of sound in temporomandibular joint movements, and palpation parameters of&#xD;
        temporomandibular joint and surrounding muscles, Craniovertebral Angle for forward head&#xD;
        posture, and Iowa Oral Performance Instrument for tongue strength and endurance. In addition,&#xD;
        the Trunk Flexor Endurance Test and Biering Sorenson Test were used for static endurance of&#xD;
        the core muscles, and Sit-ups Test and Modified Push-ups Test were used for dynamic endurance&#xD;
        of the core muscles.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 1, 2022</start_date>
    <completion_date type="Actual">February 15, 2023</completion_date>
    <primary_completion_date type="Actual">February 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>TMJ dysfunction</measure>
      <time_frame>September 2022- February 2023</time_frame>
      <description>Fonseca's Anamnestic Questionnaire (FAQ) was used for TMJ dysfunction. The FAQ has a multi-factor evaluation structure. The questionnaire consists of ten questions about pain in TMJ, head, and joints, with answer options of &quot;No, Sometimes and Yes.&quot; A score of 25 and above was accepted as the presence of TMD.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum pain-free mouth opening (MMO)</measure>
      <time_frame>September 2022- February 2023</time_frame>
      <description>The maximum pain-free mouth opening was recorded using a 15 cm ruler</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Forward head posture</measure>
      <time_frame>September 2022- February 2023</time_frame>
      <description>Forward head posture was evaluated by CVA using a goniometer.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tongue strength and endurance</measure>
      <time_frame>September 2022- February 2023</time_frame>
      <description>Tongue strength and endurance were evaluated with IOPI (Medical LLC, Redmond, WA), which has been clinically validated and reliable</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Static endurance evaluation of the trunk muscles</measure>
      <time_frame>September 2022- February 2023</time_frame>
      <description>The Trunk Flexors Endurance Test and the Biering Sorenson Test were used. These static tests are measurements targeting the local core muscles. The time the individuals maintained their position was recorded in seconds (sec) using a stopwatch.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dynamic endurance evaluation of the core muscles:</measure>
      <time_frame>September 2022- February 2023</time_frame>
      <description>The Sit-ups and the Modified Push-ups Tests were used. These dynamic tests are measurements targeting the global core muscles. The number of times the individuals could perform the movement for 30 sec was recorded.</description>
    </primary_outcome>
    <enrollment type="Actual">70</enrollment>
    <condition>Temporomandibular Joint Disorders</condition>
    <condition>Core Stability</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>TMJ dysfunction</intervention_name>
      <description>Fonseca's Anamnestic Questionnaire (FAQ) was used for TMJ dysfunction. The diagnostic accuracy of the FAQ was found to be high in identifying pain-related and intra-articular TMDs, and the cut-off point was set as 25 points. A score of 25 and above was accepted as the presence of TMD.</description>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Maximum pain-free mouth opening (MMO)</intervention_name>
      <description>The maximum pain-free mouth opening was recorded using a 15 cm ruler</description>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Forward head posture</intervention_name>
      <description>Forward head posture was evaluated by CVA using a goniometer. CVA was measured in degrees as the angle between the horizontal plane, the seventh cervical vertebra and the ear hole</description>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Tongue strength and endurance</intervention_name>
      <description>Tongue strength and endurance were evaluated with IOPI (Medical LLC, Redmond, WA), which has been clinically validated and reliable</description>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Static endurance evaluation of the trunk muscles</intervention_name>
      <description>The Trunk Flexors Endurance Test and the Biering Sorenson Test were used. These static tests are measurements targeting the local core muscles.</description>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Dynamic endurance evaluation of the core muscles</intervention_name>
      <description>The Sit-ups and the Modified Push-ups Tests were used. These dynamic tests are measurements targeting the global core muscles.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          University students&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  University students aged 18 and 31 who agreed to participate in the study and signed&#xD;
               the Informed Consent Form were included.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Exclusion criteria included having a non-reducible disc problem, having surgery&#xD;
               related to spine, abdomen and/or TMJ problem, history of trauma, history of cancer,&#xD;
               presence of neurological problems, presence of congenital anomaly, presence of&#xD;
               musculoskeletal problems, presence of systemic disease, presence of facial paralysis,&#xD;
               and receiving any treatment related to the spine and TMJ in less than six months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>31 Years</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Bandırma Onyedi Eylül University</name>
        <address>
          <city>Balıkesir</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bandırma Onyedi Eylül University</investigator_affiliation>
      <investigator_full_name>Hazel Çelik Güzel</investigator_full_name>
      <investigator_title>Assist. Prof. Dr</investigator_title>
    </responsible_party>
    <keyword>temporomandibular disorders</keyword>
    <keyword>core stability</keyword>
    <keyword>head posture</keyword>
    <keyword>tongue strength</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>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06034756
  org study id: 2022-18
  nct id: NCT06034756
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to investigate the relationship between temporomandibular joint problems,
        head posture, tongue strength, and endurance with core stabilization.
  This cross-sectional study was conducted on university students aged 18-31 between September
        2022 and February 2023. In the evaluation of the students were used that the Fonseca's
        Anamnestic Questionnaire for temporomandibular joint dysfunction, Research Diagnostic
        Criteria for Temporomandibular Disorders Examination Form for maximum pain-free mouth
        opening, presence of sound in temporomandibular joint movements, and palpation parameters of
        temporomandibular joint and surrounding muscles, Craniovertebral Angle for forward head
        posture, and Iowa Oral Performance Instrument for tongue strength and endurance. In addition,
        the Trunk Flexor Endurance Test and Biering Sorenson Test were used for static endurance of
        the core muscles, and Sit-ups Test and Modified Push-ups Test were used for dynamic endurance
        of the core muscles.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: TMJ dysfunction
  time frame: September 2022- February 2023
  description: Fonseca's Anamnestic Questionnaire (FAQ) was used for TMJ dysfunction. The FAQ has a multi-factor evaluation structure. The questionnaire consists of ten questions about pain in TMJ, head, and joints, with answer options of "No, Sometimes and Yes." A score of 25 and above was accepted as the presence of TMD.
  measure: Maximum pain-free mouth opening (MMO)
  time frame: September 2022- February 2023
  description: The maximum pain-free mouth opening was recorded using a 15 cm ruler
  measure: Forward head posture
  time frame: September 2022- February 2023
  description: Forward head posture was evaluated by CVA using a goniometer.
  measure: Tongue strength and endurance
  time frame: September 2022- February 2023
  description: Tongue strength and endurance were evaluated with IOPI (Medical LLC, Redmond, WA), which has been clinically validated and reliable
  measure: Static endurance evaluation of the trunk muscles
  time frame: September 2022- February 2023
  description: The Trunk Flexors Endurance Test and the Biering Sorenson Test were used. These static tests are measurements targeting the local core muscles. The time the individuals maintained their position was recorded in seconds (sec) using a stopwatch.
  measure: Dynamic endurance evaluation of the core muscles:
  time frame: September 2022- February 2023
  description: The Sit-ups and the Modified Push-ups Tests were used. These dynamic tests are measurements targeting the global core muscles. The number of times the individuals could perform the movement for 30 sec was recorded.
  intervention type: Other
  intervention name: TMJ dysfunction
  description: Fonseca's Anamnestic Questionnaire (FAQ) was used for TMJ dysfunction. The diagnostic accuracy of the FAQ was found to be high in identifying pain-related and intra-articular TMDs, and the cut-off point was set as 25 points. A score of 25 and above was accepted as the presence of TMD.
  intervention type: Other
  intervention name: Maximum pain-free mouth opening (MMO)
  description: The maximum pain-free mouth opening was recorded using a 15 cm ruler
  intervention type: Other
  intervention name: Forward head posture
  description: Forward head posture was evaluated by CVA using a goniometer. CVA was measured in degrees as the angle between the horizontal plane, the seventh cervical vertebra and the ear hole
  intervention type: Other
  intervention name: Tongue strength and endurance
  description: Tongue strength and endurance were evaluated with IOPI (Medical LLC, Redmond, WA), which has been clinically validated and reliable
  intervention type: Other
  intervention name: Static endurance evaluation of the trunk muscles
  description: The Trunk Flexors Endurance Test and the Biering Sorenson Test were used. These static tests are measurements targeting the local core muscles.
  intervention type: Other
  intervention name: Dynamic endurance evaluation of the core muscles
  description: The Sit-ups and the Modified Push-ups Tests were used. These dynamic tests are measurements targeting the global core muscles.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 31 Years
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Bandırma Onyedi Eylül University
  investigator full name: Hazel Çelik Güzel
  investigator title: Assist. Prof. Dr
  mesh term: Joint Diseases
  mesh term: Temporomandibular Joint Disorders
  mesh term: Temporomandibular Joint Dysfunction Syndrome
  sharing ipd: Undecided