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/NCT06034769</url>
    </required_header>
    <id_info>
      <org_study_id>2023-44</org_study_id>
      <nct_id>NCT06034769</nct_id>
    </id_info>
    <brief_title>Oral and Jaw Health in Bipolar Patients</brief_title>
    <official_title>Oral Health, Temporomandibular Dysfunction and Oropharyngeal Dysphagia in Bipolar Patients</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>
        The assessment of oral health, jaw health and related problems in bipolar patients is&#xD;
        important to provide a holistic approach to patients in terms of physical, mental and&#xD;
        psychosocial aspects and to improve quality of life. In this study, oral health,&#xD;
        temporomandibular dysfunction (TMD) and oropharyngeal dysphagia (OD) were investigated in&#xD;
        patients with Bipolar Disorder (BD).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        During the remission period, 70 individuals aged 20-60 years with BD were divided into two&#xD;
        groups according to the duration of diagnosis as under ten years (Group 1=33) and over ten&#xD;
        years (Group 2=37). Oral and dental health-related quality of life was assessed with the Oral&#xD;
        Health Impact Profile-14 (OHIP-14), TMJ pain was assessed with the Numeric Pain Scale (NPS),&#xD;
        the presence of TMJ discomfort was assessed with the Fonseca Anamnestic Questionnaire (FAQ),&#xD;
        chewing functionality was assessed with the Jaw Function Limitation Scale-8 (JFLS-8), and&#xD;
        oropharyngeal dysphagia was assessed with the Eating Assessment Tool (EAT-10).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Actual">July 20, 2023</completion_date>
    <primary_completion_date type="Actual">July 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>Oral Health Impact Profile-14 (OHIP-14)</measure>
      <time_frame>February 2023- July 2023</time_frame>
      <description>This scale, which has been shown to be valid and reliable in measuring oral and dental health-related quality of life, consists of 14 questions in 7 dimensions. Each question is scored from 0 (never) to 4 (always). The scale ranges from 0 to 56, with high scores indicating poor quality of life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Numerical Pain Scale (NPS)</measure>
      <time_frame>February 2023- July 2023</time_frame>
      <description>This simple, valid and reliable method, often used to measure pain intensity in the clinic, asks the participant to mark a number on a 10 cm scale with numbers ranging from '0' (no pain) to '10' (unbearable pain) for the pain felt in the TMJ region</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fonseca Anamnestic Questionnaire (FAQ)</measure>
      <time_frame>February 2023- July 2023</time_frame>
      <description>This scale, which has been shown to be valid and reliable as a TMD assessment tool, consists of 10 questions. A score of 25 or more on the scale indicates the presence of TMD.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Jaw Functional Limitation Scale-8 (JFLS-8)</measure>
      <time_frame>February 2023- July 2023</time_frame>
      <description>This scale, which has demonstrated validity and reliability, provides an assessment of chewing functionality during various activities of the jaw and consists of 8 questions. On this scale, which ranges from 0-80, a high score indicates limited chewing functionality.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Eating Assessment Tool (EAT-10)</measure>
      <time_frame>February 2023- July 2023</time_frame>
      <description>This scale, which assesses the symptoms and severity of oropharyngeal swallowing disorder and has been shown to be valid and reliable, consists of 10 questions. A total score of 3 and above on the scale, indicates the presence of a swallowing problem.</description>
    </primary_outcome>
    <enrollment type="Actual">70</enrollment>
    <condition>Bipolar Disorders</condition>
    <condition>Oral Health</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with bipolar disorder in remission&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients between 20 and 60 years of age who volunteered to participate in the study&#xD;
               and signed the informed consent form,&#xD;
  &#xD;
            -  diagnosed with BD at the outpatient department of Bakırkoy Prof. Dr. Mazhar Osman&#xD;
               Mental Health and Neurological Diseases Training and Research Hospital,&#xD;
  &#xD;
            -  in remission for at least 3 months,&#xD;
  &#xD;
            -  had a history of regular lithium use for at least 1 year in any phase of the disease&#xD;
               were included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  being in a manic or depressive episode (Young Mania Rating Scale score greater than 7,&#xD;
               Hamilton Depression Rating Scale score greater than 7)&#xD;
  &#xD;
            -  history of comorbid psychiatric illness,&#xD;
  &#xD;
            -  alcohol and substance use disorder,&#xD;
  &#xD;
            -  cancer, neurological problems, congenital anomalies, musculoskeletal problems,&#xD;
               systemic illness,&#xD;
  &#xD;
            -  facial paralysis,&#xD;
  &#xD;
            -  spinal, abdominal and/or TMJ surgery,&#xD;
  &#xD;
            -  and having received any spinal or TMJ treatment in less than 6 months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Bakırkoy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital</name>
        <address>
          <city>Istanbul</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 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 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>Bipolar disorders</keyword>
    <keyword>Oral health</keyword>
    <keyword>Temporomandibular disorders</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bipolar Disorder</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/NCT06034769
  org study id: 2023-44
  nct id: NCT06034769
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The assessment of oral health, jaw health and related problems in bipolar patients is
        important to provide a holistic approach to patients in terms of physical, mental and
        psychosocial aspects and to improve quality of life. In this study, oral health,
        temporomandibular dysfunction (TMD) and oropharyngeal dysphagia (OD) were investigated in
        patients with Bipolar Disorder (BD).
  During the remission period, 70 individuals aged 20-60 years with BD were divided into two
        groups according to the duration of diagnosis as under ten years (Group 1=33) and over ten
        years (Group 2=37). Oral and dental health-related quality of life was assessed with the Oral
        Health Impact Profile-14 (OHIP-14), TMJ pain was assessed with the Numeric Pain Scale (NPS),
        the presence of TMJ discomfort was assessed with the Fonseca Anamnestic Questionnaire (FAQ),
        chewing functionality was assessed with the Jaw Function Limitation Scale-8 (JFLS-8), and
        oropharyngeal dysphagia was assessed with the Eating Assessment Tool (EAT-10).
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: Oral Health Impact Profile-14 (OHIP-14)
  time frame: February 2023- July 2023
  description: This scale, which has been shown to be valid and reliable in measuring oral and dental health-related quality of life, consists of 14 questions in 7 dimensions. Each question is scored from 0 (never) to 4 (always). The scale ranges from 0 to 56, with high scores indicating poor quality of life.
  measure: Numerical Pain Scale (NPS)
  time frame: February 2023- July 2023
  description: This simple, valid and reliable method, often used to measure pain intensity in the clinic, asks the participant to mark a number on a 10 cm scale with numbers ranging from '0' (no pain) to '10' (unbearable pain) for the pain felt in the TMJ region
  measure: Fonseca Anamnestic Questionnaire (FAQ)
  time frame: February 2023- July 2023
  description: This scale, which has been shown to be valid and reliable as a TMD assessment tool, consists of 10 questions. A score of 25 or more on the scale indicates the presence of TMD.
  measure: Jaw Functional Limitation Scale-8 (JFLS-8)
  time frame: February 2023- July 2023
  description: This scale, which has demonstrated validity and reliability, provides an assessment of chewing functionality during various activities of the jaw and consists of 8 questions. On this scale, which ranges from 0-80, a high score indicates limited chewing functionality.
  measure: Eating Assessment Tool (EAT-10)
  time frame: February 2023- July 2023
  description: This scale, which assesses the symptoms and severity of oropharyngeal swallowing disorder and has been shown to be valid and reliable, consists of 10 questions. A total score of 3 and above on the scale, indicates the presence of a swallowing problem.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 60 Years
  healthy volunteers: No
  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: Bipolar Disorder
  sharing ipd: Undecided