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/NCT05995067</url>
    </required_header>
    <id_info>
      <org_study_id>lncRNA in periodontal disease</org_study_id>
      <nct_id>NCT05995067</nct_id>
    </id_info>
    <brief_title>The Potential Association of Long Non-coding RNA (NEAT1 and MALAT1) in the Process of Epithelial-mesenchymal Transition in Periodontitis</brief_title>
    <official_title>The Potential Association of Long Non-coding RNA (NEAT1 and MALAT1) in the Process of Epithelial-mesenchymal Transition in Periodontitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ali A Abdulkareem</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Baghdad</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Periodontitis is a polymicrobial, inflammatory condition affecting tooth-supporting tissues.&#xD;
        It is characterized by a progressive loss of epithelial attachment and resorption of alveolar&#xD;
        bone, which can lead to tooth loss. Epithelial-mesenchymal transition (EMT) has been proposed&#xD;
        as a reversible process that shifts the cell phenotype from epithelial to mesenchymal-like&#xD;
        and may be involved in the process of periodontal inflammation either completely or&#xD;
        partially. Long non-coding RNAs (lncRNAs) are a large class of regulatory transcripts longer&#xD;
        than 200 nucleotides lacking evident protein-coding potential. Studies have shown that lncRNA&#xD;
        dysregulation plays key roles in human diseases, including cancer, by modulating the&#xD;
        epithelial-mesenchymal transition (EMT). The involvement of lncRNAs markers in the&#xD;
        pathogenesis of periodontal disease induced EMT has not been studied thoroughly and have&#xD;
        created a gap in the knowledge.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">February 14, 2022</start_date>
    <completion_date type="Anticipated">September 2023</completion_date>
    <primary_completion_date type="Anticipated">August 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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>determining the relative expression of lncRNAs (NEAT1 and MALAT1) in healthy and diseased periodontal tissue.</measure>
      <time_frame>one year</time_frame>
      <description>reverse transcription real time polymerase chain reaction</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>determine the expression of EMT-related genes (E-cadherin, Vimentin, β-catenin, and Snail1), in healthy and diseased tissues, and their correlation with lncRNAs and clinical parameters.</measure>
      <time_frame>one year</time_frame>
      <description>reverse transcription real time polymerase chain reaction</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">48</enrollment>
    <condition>Periodontal Disease, AVDC Stage 3and 4</condition>
    <condition>Epithelial Mesenchymal Transition</condition>
    <condition>Long Noncoding RNA</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <description>-healthy groups/without the condition</description>
    </arm_group>
    <arm_group>
      <arm_group_label>study group</arm_group_label>
      <description>-diseased group-/with the condition (periodontitis)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>periodontitis challenge</intervention_name>
      <description>control will be compared to diseased group suffering from periodontal disease.</description>
      <arm_group_label>study group</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        gingival tissue byproduct of resective periodontal surgery&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients diagnosed with periodontitis, and healthy periodontal tissues will be recruited at&#xD;
          the College of Dentistry/University of Baghdad and Al Sadir specialized dental&#xD;
          center/Al-Risafa directorate/ Ministry of Health. No age or gender restriction.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with no history of systemic disease e.g., diabetes.&#xD;
  &#xD;
            -  Both males and females will be included in the study.&#xD;
  &#xD;
            -  Control group: patients fit the case definition of gingival health2, and confirmed by&#xD;
               Histopathological inflammatory cell infiltration analysis.&#xD;
  &#xD;
            -  Periodontitis group: patients fit the case definition of periodontal disease referred&#xD;
               for periodontal flap surgery (modified Widman's flap).&#xD;
  &#xD;
            -  Patients radiographically confirmed with infrabony pocket eligible for periodontal&#xD;
               flap surgery.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients not willing to participate or consent.&#xD;
  &#xD;
            -  Patient taking medications that affect or modify immunity (e.g., corticosteroid), for&#xD;
               the last 3 months.&#xD;
  &#xD;
            -  Patient taking NSAIDs for the last 3 months.&#xD;
  &#xD;
            -  Active smoker.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>saif mohammed T AL Mufti</name>
        <address>
          <city>Baghdad</city>
          <zip>964</zip>
          <country>Iraq</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Iraq</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Baghdad</investigator_affiliation>
      <investigator_full_name>Ali A Abdulkareem</investigator_full_name>
      <investigator_title>assistant professor- department of periodontics-college of dentistry- Baghdad university</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Periodontitis</mesh_term>
      <mesh_term>Periodontal Diseases</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/NCT05995067
  org study id: lncRNA in periodontal disease
  nct id: NCT05995067
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Periodontitis is a polymicrobial, inflammatory condition affecting tooth-supporting tissues.
        It is characterized by a progressive loss of epithelial attachment and resorption of alveolar
        bone, which can lead to tooth loss. Epithelial-mesenchymal transition (EMT) has been proposed
        as a reversible process that shifts the cell phenotype from epithelial to mesenchymal-like
        and may be involved in the process of periodontal inflammation either completely or
        partially. Long non-coding RNAs (lncRNAs) are a large class of regulatory transcripts longer
        than 200 nucleotides lacking evident protein-coding potential. Studies have shown that lncRNA
        dysregulation plays key roles in human diseases, including cancer, by modulating the
        epithelial-mesenchymal transition (EMT). The involvement of lncRNAs markers in the
        pathogenesis of periodontal disease induced EMT has not been studied thoroughly and have
        created a gap in the knowledge.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: determining the relative expression of lncRNAs (NEAT1 and MALAT1) in healthy and diseased periodontal tissue.
  time frame: one year
  description: reverse transcription real time polymerase chain reaction
  measure: determine the expression of EMT-related genes (E-cadherin, Vimentin, β-catenin, and Snail1), in healthy and diseased tissues, and their correlation with lncRNAs and clinical parameters.
  time frame: one year
  description: reverse transcription real time polymerase chain reaction
  arm group label: control group
  description: -healthy groups/without the condition
  arm group label: study group
  description: -diseased group-/with the condition (periodontitis)
  intervention type: Other
  intervention name: periodontitis challenge
  description: control will be compared to diseased group suffering from periodontal disease.
  arm group label: study group
  gingival tissue byproduct of resective periodontal surgery
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Iraq
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Baghdad
  investigator full name: Ali A Abdulkareem
  investigator title: assistant professor- department of periodontics-college of dentistry- Baghdad university
  mesh term: Periodontitis
  mesh term: Periodontal Diseases
  sharing ipd: Undecided