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/NCT06016933</url>
    </required_header>
    <id_info>
      <org_study_id>5</org_study_id>
      <nct_id>NCT06016933</nct_id>
    </id_info>
    <brief_title>Effect of Spirulina on Periodontitis</brief_title>
    <official_title>Effect of Locally Delivered Spirulina Gel on Treatment of Stage II, Grade B Periodontitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kafrelsheikh University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kafrelsheikh 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>
        The purpose of this study is to assess the clinical and immunological effect of spirulina in&#xD;
        treatment of stage II periodontitis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, the investigators tested the effect of spirulina gel as adjunctive of scaling&#xD;
        and root planing in treatment of stage II, grade B periodontitis in term of probing pocket&#xD;
        depth reduction, mean gain in clinical attachment level, and level of interleukin 6.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 1, 2022</start_date>
    <completion_date type="Actual">July 22, 2023</completion_date>
    <primary_completion_date type="Actual">March 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Clinical attachment level</measure>
      <time_frame>3 months</time_frame>
      <description>Clinical attachment level was measured at baseline, 1 and 3 months after gel application.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Probing pocket depth</measure>
      <time_frame>3 months</time_frame>
      <description>Probing pocket depth was measured at baseline, 1 and 3 months after gel application.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Interleukin 6.</measure>
      <time_frame>3 months</time_frame>
      <description>Enzyme linked immune-assay for the quantitative measurement of interleukin 6 concentration in gingival cervicular fluid at baseline, 1 and 3 months after gel application.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Plaque Index</measure>
      <time_frame>3 months</time_frame>
      <description>Plaque index was measured at baseline and at 1, and 3-months post treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gingival index</measure>
      <time_frame>3 months</time_frame>
      <description>Gingival index was measured at baseline and at 1, and 3-months post treatment.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Periodontitis</condition>
    <arm_group>
      <arm_group_label>oral hygiene instructions and SRP of all teeth plus placebo gel.</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel.</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>spirulina gel</intervention_name>
      <description>Patient were received spirulina gel in diseased sites. The process will be repeated at 7, 14, 21 days.</description>
      <arm_group_label>oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel.</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>SRP of all teeth</intervention_name>
      <description>Patients received oral hygiene instructions and SRP of all teeth.</description>
      <arm_group_label>oral hygiene instructions and SRP of all teeth plus placebo gel.</arm_group_label>
      <arm_group_label>oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel.</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All the patients suffer from stage II, grade B periodonitis with attachment loss 3-4&#xD;
               mm and probing pocket depth ≤ 5mm.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any systemic disease that affects the periodontium. ·&#xD;
  &#xD;
            -  Pregnant, postmenopausal women. ·&#xD;
  &#xD;
            -  People who take anti-inflammatory drugs, antibiotics, or vitamins within the previous&#xD;
               3 month.&#xD;
  &#xD;
            -  People who use mouth washes regularly ·&#xD;
  &#xD;
            -  Participation in other clinical trials.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Kafrelsheikh University</name>
        <address>
          <city>Tanta</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kafrelsheikh University</investigator_affiliation>
      <investigator_full_name>Enas Elgendy</investigator_full_name>
      <investigator_title>Prof. of Oral Medicine and Periodontology</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>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/NCT06016933
  org study id: 5
  nct id: NCT06016933
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to assess the clinical and immunological effect of spirulina in
        treatment of stage II periodontitis.
  In this study, the investigators tested the effect of spirulina gel as adjunctive of scaling
        and root planing in treatment of stage II, grade B periodontitis in term of probing pocket
        depth reduction, mean gain in clinical attachment level, and level of interleukin 6.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Clinical attachment level
  time frame: 3 months
  description: Clinical attachment level was measured at baseline, 1 and 3 months after gel application.
  measure: Probing pocket depth
  time frame: 3 months
  description: Probing pocket depth was measured at baseline, 1 and 3 months after gel application.
  measure: Interleukin 6.
  time frame: 3 months
  description: Enzyme linked immune-assay for the quantitative measurement of interleukin 6 concentration in gingival cervicular fluid at baseline, 1 and 3 months after gel application.
  measure: Plaque Index
  time frame: 3 months
  description: Plaque index was measured at baseline and at 1, and 3-months post treatment.
  measure: Gingival index
  time frame: 3 months
  description: Gingival index was measured at baseline and at 1, and 3-months post treatment.
  arm group label: oral hygiene instructions and SRP of all teeth plus placebo gel.
  arm group type: Placebo Comparator
  arm group label: oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel.
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: spirulina gel
  description: Patient were received spirulina gel in diseased sites. The process will be repeated at 7, 14, 21 days.
  arm group label: oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel.
  intervention type: Procedure
  intervention name: SRP of all teeth
  description: Patients received oral hygiene instructions and SRP of all teeth.
  arm group label: oral hygiene instructions and SRP of all teeth plus placebo gel.
  arm group label: oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel.
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: 50 Years
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Kafrelsheikh University
  investigator full name: Enas Elgendy
  investigator title: Prof. of Oral Medicine and Periodontology
  mesh term: Periodontitis
  sharing ipd: Undecided