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/NCT06038812</url>
    </required_header>
    <id_info>
      <org_study_id>REC-FDBSU/03082023-1/AM</org_study_id>
      <nct_id>NCT06038812</nct_id>
    </id_info>
    <brief_title>Galectin Role in Periodontal Disease</brief_title>
    <official_title>Outcome of Non-surgical Periodontal Treatment on Gal-1 &amp; Gal-3 GCF Levels in Periodontitis Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fayoum University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fayoum University</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>
        This study aimed at exploring the effect of nonsurgical periodontal treatment on galectin 1&#xD;
        and 3 GCF levels in patients having gingivitis, periodontitis stage III compared to&#xD;
        periodontally healthy individuals and if galectin-1 and -3 could serve as diagnostic markers&#xD;
        and/or therapeutic targets for periodontitis, in addition to revealing their possible role in&#xD;
        the periodontal disease.&#xD;
  &#xD;
        45 systemically healthy participants were enrolled in this investigation, equally subdivided&#xD;
        into three groups of 15 patients each: gingivitis, periodontitis (stage III) and control&#xD;
        group with healthy gingiva. Probing depth, clinical attachment level, gingival and plaque&#xD;
        index were registered. GCF levels of galectin-1 and -3 were evaluated in all included groups&#xD;
        (before and after non-surgical treatment for periodontitis group) using enzyme linked&#xD;
        immune-sorbent assay (ELISA) kit.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">October 25, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>assessment of gal-1 and gal-3 in GCF samples</measure>
      <time_frame>an average of about 10 months to assess level of gal-1 &amp; -3 after collection of GCF samples at baseline (1st appointment) for all groups and another sample collection after 4 weeks for group II after performing scaling and root planning</time_frame>
      <description>samples are to be sent to biochemistry lab to measure galectin levels</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">45</enrollment>
    <condition>Gingivitis</condition>
    <condition>Periodontitis</condition>
    <arm_group>
      <arm_group_label>Group I</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>patients diagnosed with gingivitis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group II</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>patients diagnosed with periodontitis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group III</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>healthy control</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>GCF sample collection</intervention_name>
      <description>collecting GCF from deepest sites by paper points</description>
      <arm_group_label>Group I</arm_group_label>
      <arm_group_label>Group II</arm_group_label>
      <arm_group_label>Group III</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>non-surgical periodontal treatment</intervention_name>
      <description>performing scaling and root planning using ultrasonic device and manual curettes</description>
      <arm_group_label>Group II</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Non-smokers from both genders.&#xD;
  &#xD;
            2. Not suffering from systemic diseases, pregnancy/lactation.&#xD;
  &#xD;
            3. Not taking contraceptive pills, antibiotics, anti-inflammatory, or immunosuppressive&#xD;
               drugs before inclusion in the study by 6 months.&#xD;
  &#xD;
            4. Patients with only gingivitis or periodontitis stage III.&#xD;
  &#xD;
            5. Periodontitis patients who did not receive any professional periodontal treatment in&#xD;
               the last 6 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. smokers.&#xD;
  &#xD;
            2. having systemic diseases, pregnancy/lactation.&#xD;
  &#xD;
            3. taking contraceptive pills, antibiotics, anti-inflammatory, or immunosuppressive drugs&#xD;
               in the past 6 months.&#xD;
  &#xD;
            4. Patients having periodontitis any other stage than stage III.&#xD;
  &#xD;
            5. Periodontitis patients who receive any professional periodontal treatment in the last&#xD;
               6 months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>faculty of dentistry, Fayoum university</name>
        <address>
          <city>Fayoum</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fayoum University</investigator_affiliation>
      <investigator_full_name>Nayroz Tarrad</investigator_full_name>
      <investigator_title>associate professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gingivitis</mesh_term>
      <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/NCT06038812
  org study id: REC-FDBSU/03082023-1/AM
  nct id: NCT06038812
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed at exploring the effect of nonsurgical periodontal treatment on galectin 1
        and 3 GCF levels in patients having gingivitis, periodontitis stage III compared to
        periodontally healthy individuals and if galectin-1 and -3 could serve as diagnostic markers
        and/or therapeutic targets for periodontitis, in addition to revealing their possible role in
        the periodontal disease.
  
        45 systemically healthy participants were enrolled in this investigation, equally subdivided
        into three groups of 15 patients each: gingivitis, periodontitis (stage III) and control
        group with healthy gingiva. Probing depth, clinical attachment level, gingival and plaque
        index were registered. GCF levels of galectin-1 and -3 were evaluated in all included groups
        (before and after non-surgical treatment for periodontitis group) using enzyme linked
        immune-sorbent assay (ELISA) kit.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: Single (Outcomes Assessor)
  measure: assessment of gal-1 and gal-3 in GCF samples
  time frame: an average of about 10 months to assess level of gal-1 & -3 after collection of GCF samples at baseline (1st appointment) for all groups and another sample collection after 4 weeks for group II after performing scaling and root planning
  description: samples are to be sent to biochemistry lab to measure galectin levels
  arm group label: Group I
  arm group type: Other
  description: patients diagnosed with gingivitis
  arm group label: Group II
  arm group type: Other
  description: patients diagnosed with periodontitis
  arm group label: Group III
  arm group type: Other
  description: healthy control
  intervention type: Diagnostic Test
  intervention name: GCF sample collection
  description: collecting GCF from deepest sites by paper points
  arm group label: Group I
  arm group label: Group II
  arm group label: Group III
  intervention type: Procedure
  intervention name: non-surgical periodontal treatment
  description: performing scaling and root planning using ultrasonic device and manual curettes
  arm group label: Group II
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Fayoum University
  investigator full name: Nayroz Tarrad
  investigator title: associate professor
  mesh term: Gingivitis
  mesh term: Periodontitis
  sharing ipd: No