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/NCT05988788</url>
    </required_header>
    <id_info>
      <org_study_id>Epigallocatechin-3-Gallate</org_study_id>
      <nct_id>NCT05988788</nct_id>
    </id_info>
    <brief_title>Effect of Epigallocatechin-3-Gallate Solution as a Root Canal Irrigant on Post-Operative Pain Intensity and Bacterial Load Reduction in Necrotic Tooth</brief_title>
    <official_title>Effect of Epigallocatechin-3-Gallate Solution Versus Sodium Hypochlorite as a Root Canal Irrigant on Post-Operative Pain Intensity and Bacterial Load Reduction in Asymptomatic Necrotic Mandibular Premolars: A Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        clinically compare the intensity of post-operative pain and the amount of bacterial load&#xD;
        reduction after using 20% Epigallocatechin-3-gallate solution during chemomechanical&#xD;
        preparation, versus 2.5% NaOCl, in asymptomatic necrotic mandibular premolars treated in a&#xD;
        single visit.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The patients will be randomly divided into 2 groups. Intervention group (20%&#xD;
        epigallocatechin-3-gallate solution root canal irrigant) and control group (2.5% sodium&#xD;
        hypochlorite root canal irrigant).&#xD;
  &#xD;
        Post-operative pain will be measured at 6, 12, 24 and 48 hours post-operatively. The pain&#xD;
        will be recorded using the Numerical Rating Scale (NRS).&#xD;
  &#xD;
        Amount of bacterial load reduction The intracanal bacterial load reduction will be determined&#xD;
        using agar culture technique by counting the colony forming units per milliliter (CFUs/mL)&#xD;
        before and after root canal preparation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2024</completion_date>
    <primary_completion_date type="Anticipated">May 2024</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Postoperative pain</measure>
      <time_frame>Postoperative pain measured at 6, 12, 24, 48 hours after single visit treatment.</time_frame>
      <description>Categorical None 0 Mild 1-3 Moderate 4-6 Severe 7-10</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Amount of intracanal bacterial load reduction</measure>
      <time_frame>T0: preintervention, preinstrumentation after access cavity. T1: postinstrumentation up to 10 min</time_frame>
      <description>The intracanal bacterial load reduction will be determined using agar culture technique by counting the colony forming units per milliliter (CFUs/mL) before and after root canal preparation</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">42</enrollment>
    <condition>Necrotic Pulp</condition>
    <arm_group>
      <arm_group_label>Epigallocatechin-3-Gallate</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>20% Epigallocatechin-3-Gallate solution</description>
    </arm_group>
    <arm_group>
      <arm_group_label>sodium hypochlorite</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>2.5% sodium hypochlorite</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Epigallocatechin-3-gallate</intervention_name>
      <description>to be used as a root canal irrigant</description>
      <arm_group_label>Epigallocatechin-3-Gallate</arm_group_label>
      <other_name>green tea catechin</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>sodium hypochlorite</intervention_name>
      <description>to be used as a root canal irrigant</description>
      <arm_group_label>sodium hypochlorite</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          The inclusion criteria:&#xD;
  &#xD;
            1. Systematically healthy patient (ASA I, II).&#xD;
  &#xD;
            2. Age between 18 and 45 years&#xD;
  &#xD;
            3. Male or female.&#xD;
  &#xD;
            4. Asymptomatic mandibular premolar teeth diagnosed with pulp necrosis.&#xD;
  &#xD;
          The exclusion criteria:&#xD;
  &#xD;
            1. Medically compromised patients having significant systemic disorders. (ASA III or IV).&#xD;
  &#xD;
            2. Teeth with:&#xD;
  &#xD;
                 -  Immature roots&#xD;
  &#xD;
                 -  Association with swelling or sinus tract.&#xD;
  &#xD;
                 -  Acute peri-apical abscess or acute exacerbation of a chronic abscess.&#xD;
  &#xD;
                 -  Mobility Grade II or III&#xD;
  &#xD;
                 -  Previously accessed or endodontically treated&#xD;
  &#xD;
                 -  Deep periodontal pockets more than 4 mm&#xD;
  &#xD;
                 -  Vertical root fractures, coronal perforation, calcification, and external or&#xD;
                    internal root resorptions.&#xD;
  &#xD;
            3. Patients who could not interpret the NRS.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>rayan adlan</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>rayan adlan, BDS</last_name>
      <phone>+201117801699</phone>
      <email>rayan.elsadig@dentistry.cu.edu.eg</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 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 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Rayan Elsadig Izzeldin</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <keyword>Asymptomatic</keyword>
    <keyword>Necrotic Mandibular premolar</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dental Pulp Necrosis</mesh_term>
      <mesh_term>Pain, Postoperative</mesh_term>
      <mesh_term>Pain</mesh_term>
      <mesh_term>Necrosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sodium Hypochlorite</mesh_term>
      <mesh_term>Eusol</mesh_term>
      <mesh_term>Epigallocatechin gallate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    </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/NCT05988788
  org study id: Epigallocatechin-3-Gallate
  nct id: NCT05988788
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: Yes
  clinically compare the intensity of post-operative pain and the amount of bacterial load
        reduction after using 20% Epigallocatechin-3-gallate solution during chemomechanical
        preparation, versus 2.5% NaOCl, in asymptomatic necrotic mandibular premolars treated in a
        single visit.
  The patients will be randomly divided into 2 groups. Intervention group (20%
        epigallocatechin-3-gallate solution root canal irrigant) and control group (2.5% sodium
        hypochlorite root canal irrigant).
  
        Post-operative pain will be measured at 6, 12, 24 and 48 hours post-operatively. The pain
        will be recorded using the Numerical Rating Scale (NRS).
  
        Amount of bacterial load reduction The intracanal bacterial load reduction will be determined
        using agar culture technique by counting the colony forming units per milliliter (CFUs/mL)
        before and after root canal preparation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Postoperative pain
  time frame: Postoperative pain measured at 6, 12, 24, 48 hours after single visit treatment.
  description: Categorical None 0 Mild 1-3 Moderate 4-6 Severe 7-10
  measure: Amount of intracanal bacterial load reduction
  time frame: T0: preintervention, preinstrumentation after access cavity. T1: postinstrumentation up to 10 min
  description: The intracanal bacterial load reduction will be determined using agar culture technique by counting the colony forming units per milliliter (CFUs/mL) before and after root canal preparation
  arm group label: Epigallocatechin-3-Gallate
  arm group type: Experimental
  description: 20% Epigallocatechin-3-Gallate solution
  arm group label: sodium hypochlorite
  arm group type: Active Comparator
  description: 2.5% sodium hypochlorite
  intervention type: Other
  intervention name: Epigallocatechin-3-gallate
  description: to be used as a root canal irrigant
  arm group label: Epigallocatechin-3-Gallate
  other name: green tea catechin
  intervention type: Other
  intervention name: sodium hypochlorite
  description: to be used as a root canal irrigant
  arm group label: sodium hypochlorite
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: rayan adlan
  role: Principal Investigator
  affiliation: Cairo University
  last name: rayan adlan, BDS
  phone: +201117801699
  email: rayan.elsadig@dentistry.cu.edu.eg
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Rayan Elsadig Izzeldin
  investigator title: Principal investigator
  mesh term: Dental Pulp Necrosis
  mesh term: Pain, Postoperative
  mesh term: Pain
  mesh term: Necrosis
  mesh term: Sodium Hypochlorite
  mesh term: Eusol
  mesh term: Epigallocatechin gallate
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)