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/NCT05994885</url>
    </required_header>
    <id_info>
      <org_study_id>747622</org_study_id>
      <nct_id>NCT05994885</nct_id>
    </id_info>
    <brief_title>Evaluation of Prognostic Potentials of Gingival Crevicular Fluid E-cadherin and Total Antioxidant Capacity</brief_title>
    <official_title>Prognostic Potentials of E-cadherin and Total Antioxidant Capacity in Gingival Crevicular Fluid of Moderately Deep Periodontal Pockets Treated With Nonsurgical Periodontal Therapy</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Ability to anticipate the outcomes of periodontal therapy at baseline visit is crucial to&#xD;
        outline and customize a treatment plan with predictable outcomes and cost-effectiveness.&#xD;
        Presence of diverse range of health/disease-associated molecules in oral environment that&#xD;
        reflect health and disease, together with clinical parameters, is an appealing approach to&#xD;
        use them as biomarkers to diagnose, predict, and monitor periodontal disease. Among these&#xD;
        proteins are E-cad and TAC which available evidence indicate that their concentrations in&#xD;
        oral biofluids increase remarkably during periodontitis as compared to healthy periodontium.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Loss of attachment and formation of periodontal pockets are hallmarks of periodontitis. The&#xD;
        treatment approach is either by nonsurgical or surgical periodontal therapy or a combination&#xD;
        of both depending on the severity of the case. In general, sites with moderately deep pockets&#xD;
        (4 to 6 mm) are responding favorably to nonsurgical periodontal therapy (NSPT). Nevertheless,&#xD;
        some sites exhibit persistent pockets even with multiple treatment sessions which could be&#xD;
        attributed to the presence of tissue invaders or aberrant immune response that impede healing&#xD;
        process.&#xD;
  &#xD;
        Prediction of treatment outcomes based on clinical data is limited and sometimes lacking&#xD;
        accuracy. Use of biomarkers that can be non-invasively collected from oral fluids e.g.,&#xD;
        gingival crevicular fluid (GCF) as diagnostic/predictive tools has gained attention in the&#xD;
        last decade. For instance, E-Cadherin (E-cad) and total antioxidant capacity (TAC) are&#xD;
        associated with periodontitis. E-cad is a transmembrane glycoprotein that is a key mediator&#xD;
        of stable cell-cell adhesion of epithelial cells. E-cadherin-based adherens junctions&#xD;
        specialized cell structures that mediate cell-cell adhesion and regulate cytoskeleton&#xD;
        reorganization forming a continuous, linear circumferential belt (zonula adherens) around the&#xD;
        apical part of the cell. While TAC, defined as the moles of oxidants neutralized by one liter&#xD;
        of solution, is a biomarker measuring the antioxidant potential of body fluids.&#xD;
  &#xD;
        Available evidence indicates that the concentration of both molecules are substantially&#xD;
        increased with increasing severity of periodontitis and vice versa in periodontal health.&#xD;
        This suggests the potential of GCF-E-cad and TAC to predict the prognosis following NSPT.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 15, 2023</start_date>
    <completion_date type="Anticipated">December 25, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 15, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Patients with periodontitis, of any stage, having periodontal pockets of a moderate depth (4 to 6 mm) treated with nonsurgical periodontal therapy.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>The care provider is not aware about clinical parameters and biochemical analysis of GCF (E-cadherin and total antioxidant capacity).</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Probing pocket depth</measure>
      <time_frame>Baseline, 1 week, then 1 month and 3 months after treatment</time_frame>
      <description>Linear distance, in mm, measured from the gingival margin to the base of periodontal pocket or sulcus.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinical attachment loss</measure>
      <time_frame>Baseline, 1 week, then 1 month and 3 months after treatment</time_frame>
      <description>Linear distance, in mm, measured from the cementoenamel junction to the base of periodontal pocket or sulcus.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bleeding on probing</measure>
      <time_frame>Baseline, 1 week, then 1 month and 3 months after treatment</time_frame>
      <description>Presence or absence of bleeding is detected after 30 seconds of inserting periodontal probe to the depth of periodontal pocket/sulcus</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gingival crevicular fluid E-cadherin</measure>
      <time_frame>Baseline, 1 month and 3 months after treatment</time_frame>
      <description>Level of E-cadherin in GCF collected from periodontal pockets is determined by biochemical analysis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total antioxidant capacity</measure>
      <time_frame>Baseline, 1 month and 3 months after treatment</time_frame>
      <description>Level of TAC in GCF collected from periodontal pockets is determined by biochemical analysis</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Periodontitis</condition>
    <arm_group>
      <arm_group_label>Root surface debridement</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Periodontal pockets with PPD of 4 to 6mm are treated with root surface debridement only and assessed after 3 months for success/failure of treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Root surface debridement</intervention_name>
      <description>the included patients will undergo full-mouth supra- and subgingival debridement by using ultrasonic device and manual instrumentation at baseline. This is followed, after 1 week, by performing root surface debridement for all pockets with PPD = 4-6 mm for each patient. All patients will be instructed to brush their teeth twice daily and will be supplied with the same type of tooth paste and toothbrush, with suitable interdental aids.</description>
      <arm_group_label>Root surface debridement</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Systemically healthy adult patients (&gt; 18 years).&#xD;
  &#xD;
            -  Periodontitis (interdental clinical attachment loss (CAL) detectable at ≥2&#xD;
               non-adjacent teeth, or buccal/oral CAL of ≥3mm with pocketing of &gt;3mm is detectable at&#xD;
               ≥2 teeth). All patients should exhibit generalized periodontitis with pockets of PPD =&#xD;
               4 to 6 mm of any stage, unstable, and grade A to C. Only maxillary teeth with single&#xD;
               root will be included.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Consumption of antibiotics or periodontal treatment 3-months prior to the study.&#xD;
  &#xD;
            -  Pregnancy and lactation.&#xD;
  &#xD;
            -  Smoker.&#xD;
  &#xD;
            -  History of systemic disease e.g., diabetes mellitus.&#xD;
  &#xD;
            -  Patients currently recruited in other trials.&#xD;
  &#xD;
            -  Patients not willing to consent.&#xD;
  &#xD;
            -  Periodontal pockets ≥ 7mm, active caries, endodontic problem.&#xD;
  &#xD;
            -  Multi-rooted teeth will be also considered as exclusion reasons.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ali A Abdulkareem, PhD</last_name>
      <phone>07806866717</phone>
      <email>ali.abbas@codental.uobaghdad.edu.iq</email>
    </overall_contact>
    <location>
      <facility>
        <name>College of Dentistry/ University of Baghdad</name>
        <address>
          <city>Baghdad</city>
          <country>Iraq</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ali A Abdulkareem, PhD</last_name>
        <phone>009647806866717</phone>
        <email>ali.abbas@codental.uobaghdad.edu.iq</email>
      </contact>
    </location>
    <location_countries>
      <country>Iraq</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 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</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Periodontitis</mesh_term>
    </condition_browse>
    <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/NCT05994885
  org study id: 747622
  nct id: NCT05994885
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Ability to anticipate the outcomes of periodontal therapy at baseline visit is crucial to
        outline and customize a treatment plan with predictable outcomes and cost-effectiveness.
        Presence of diverse range of health/disease-associated molecules in oral environment that
        reflect health and disease, together with clinical parameters, is an appealing approach to
        use them as biomarkers to diagnose, predict, and monitor periodontal disease. Among these
        proteins are E-cad and TAC which available evidence indicate that their concentrations in
        oral biofluids increase remarkably during periodontitis as compared to healthy periodontium.
  Loss of attachment and formation of periodontal pockets are hallmarks of periodontitis. The
        treatment approach is either by nonsurgical or surgical periodontal therapy or a combination
        of both depending on the severity of the case. In general, sites with moderately deep pockets
        (4 to 6 mm) are responding favorably to nonsurgical periodontal therapy (NSPT). Nevertheless,
        some sites exhibit persistent pockets even with multiple treatment sessions which could be
        attributed to the presence of tissue invaders or aberrant immune response that impede healing
        process.
  
        Prediction of treatment outcomes based on clinical data is limited and sometimes lacking
        accuracy. Use of biomarkers that can be non-invasively collected from oral fluids e.g.,
        gingival crevicular fluid (GCF) as diagnostic/predictive tools has gained attention in the
        last decade. For instance, E-Cadherin (E-cad) and total antioxidant capacity (TAC) are
        associated with periodontitis. E-cad is a transmembrane glycoprotein that is a key mediator
        of stable cell-cell adhesion of epithelial cells. E-cadherin-based adherens junctions
        specialized cell structures that mediate cell-cell adhesion and regulate cytoskeleton
        reorganization forming a continuous, linear circumferential belt (zonula adherens) around the
        apical part of the cell. While TAC, defined as the moles of oxidants neutralized by one liter
        of solution, is a biomarker measuring the antioxidant potential of body fluids.
  
        Available evidence indicates that the concentration of both molecules are substantially
        increased with increasing severity of periodontitis and vice versa in periodontal health.
        This suggests the potential of GCF-E-cad and TAC to predict the prognosis following NSPT.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Patients with periodontitis, of any stage, having periodontal pockets of a moderate depth (4 to 6 mm) treated with nonsurgical periodontal therapy.
  primary purpose: Other
  masking: None (Open Label)
  masking description: The care provider is not aware about clinical parameters and biochemical analysis of GCF (E-cadherin and total antioxidant capacity).
  measure: Probing pocket depth
  time frame: Baseline, 1 week, then 1 month and 3 months after treatment
  description: Linear distance, in mm, measured from the gingival margin to the base of periodontal pocket or sulcus.
  measure: Clinical attachment loss
  time frame: Baseline, 1 week, then 1 month and 3 months after treatment
  description: Linear distance, in mm, measured from the cementoenamel junction to the base of periodontal pocket or sulcus.
  measure: Bleeding on probing
  time frame: Baseline, 1 week, then 1 month and 3 months after treatment
  description: Presence or absence of bleeding is detected after 30 seconds of inserting periodontal probe to the depth of periodontal pocket/sulcus
  measure: Gingival crevicular fluid E-cadherin
  time frame: Baseline, 1 month and 3 months after treatment
  description: Level of E-cadherin in GCF collected from periodontal pockets is determined by biochemical analysis
  measure: Total antioxidant capacity
  time frame: Baseline, 1 month and 3 months after treatment
  description: Level of TAC in GCF collected from periodontal pockets is determined by biochemical analysis
  arm group label: Root surface debridement
  arm group type: Other
  description: Periodontal pockets with PPD of 4 to 6mm are treated with root surface debridement only and assessed after 3 months for success/failure of treatment.
  intervention type: Procedure
  intervention name: Root surface debridement
  description: the included patients will undergo full-mouth supra- and subgingival debridement by using ultrasonic device and manual instrumentation at baseline. This is followed, after 1 week, by performing root surface debridement for all pockets with PPD = 4-6 mm for each patient. All patients will be instructed to brush their teeth twice daily and will be supplied with the same type of tooth paste and toothbrush, with suitable interdental aids.
  arm group label: Root surface debridement
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ali A Abdulkareem, PhD
  phone: 07806866717
  email: ali.abbas@codental.uobaghdad.edu.iq
  facility: 
  status: Recruiting
  contact: 
  country: Iraq
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Baghdad
  investigator full name: Ali A Abdulkareem
  investigator title: Assistant Professor
  mesh term: Periodontitis
  sharing ipd: No