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/NCT06012331</url>
    </required_header>
    <id_info>
      <org_study_id>dental pulp revascularization</org_study_id>
      <nct_id>NCT06012331</nct_id>
    </id_info>
    <brief_title>Clinical and Radiographic Evaluation of Revascularization of Immature Anterior Permanent Teeth Using Concentrated Growth Factor (CGF) Versus Blood Clot (BC)</brief_title>
    <official_title>Clinical and Radiographic Evaluation of Revascularization of Immature Anterior Permanent Teeth Using (CGF) Versus (BC)</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to compare clinical and radiographic evaluation treatment of&#xD;
        necrotic immature permanent teeth using:&#xD;
  &#xD;
          1. Concentrated Growth Factor&#xD;
  &#xD;
          2. Blood Clot&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Rationale for conducting the research:&#xD;
  &#xD;
        Concentrated growth factor (CGF) is relatively a new generation of platelet concentrate&#xD;
        product, it contains more cytokines and growth factors compared with PRP and PRF also&#xD;
        promotes the proliferation, migration, and differentiation of stem cells.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">January 2025</completion_date>
    <primary_completion_date type="Anticipated">December 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>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>clinically successful treatment</measure>
      <time_frame>3,6,9,12 months</time_frame>
      <description>The treatment will be considered to be clinically successful when. Absence of pain will record it by verbal question to patient/ parent. Absence of tenderness to percussion) will record it by percussion test (by the back of the dental mirror) Absence of swelling and fistula or sinus tract -- will record it by visual clinical examination</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Radiographic Success treatment</measure>
      <time_frame>6, 12 months</time_frame>
      <description>The treatment will be considered to be Radiographic Success when.&#xD;
  Root elongation (increased root length): will be assessed in mm through a radiographic x-ray system measure from cementoenamel junction to the apex.&#xD;
  Root maturation: increased root dentin thickness will be assessed in mm through a radiographic x-ray system for each case and will be calculated as the difference between the outer root area and the pulp space area.&#xD;
  Absence or reduce in the size of periapical radiolucency: will be assessed in mm through a radiographic x-ray system.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Revascularization</condition>
    <arm_group>
      <arm_group_label>Concentrated Growth Factor (CGF)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Concentrated growth factor (CGF) is relatively a new generation of platelet concentrate product, it contains more cytokines and growth factors compared with PRP and PRF also promotes the proliferation, migration, and differentiation of stem cells</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Blood Clot (BC)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Inducing bleeding to facilitate healing is a common surgical procedure. The blood clot formed after hemorrhage, acts as a scaffold and rich source of growth factors, and could play an important role in tissue repair in the canal. The growth factors could stimulate differentiation, growth, and maturation of fibroblasts, odontoblasts and cementoblasts, from the immature undifferentiated mesenchymal cells in the newly formed tissue matrix</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>concentrated growth factors in open apex</intervention_name>
      <description>Dry canals with paper points. A 10 ml of venous blood will be collected and transferred to sterile tubes without anticoagulant solutions by a trained nurse. The tubes will be centrifuged machine using a one-step centrifugation protocol at variable rpm, after centrifugation, four layers will be obtained: the first layer at the top is serum, second layer is the fibrin buffy coat, the third layer is the liquid phase containing growth factors, The concentrated growth factor was separated from the red blood cells and serum using sterile scissors.&#xD;
  CGF will be packed into canal to the full working length using sterile pluggers.&#xD;
  The coronal level of the CGF gel is near the cervical area above cementoenamel junction and white MTA placed as capping material after CGF, then GIC and composite restoration</description>
      <arm_group_label>Blood Clot (BC)</arm_group_label>
      <arm_group_label>Concentrated Growth Factor (CGF)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Blood Clot (BC)</intervention_name>
      <description>Create bleeding into the canal by over-instrumenting (induce by rotating a pre-curved K-file at 2 mm past the apical foramen with the goal of having the entire canal filled with blood to CEJ level)&#xD;
  Stop bleeding at a level that allows for 3-4 mm of restorative material.&#xD;
  Then white MTA as a coronal plug material be followed by GIC, then composite restoration.</description>
      <arm_group_label>Blood Clot (BC)</arm_group_label>
      <arm_group_label>Concentrated Growth Factor (CGF)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Children aged between 8_14 years.&#xD;
  &#xD;
            2. Anterior tooth diagnosed with necrotic pulp (due to trauma, caries, or anomaly)&#xD;
               responded negatively to sensibility tests.&#xD;
  &#xD;
            3. Teeth not indicated for post and core.&#xD;
  &#xD;
            4. A cooperative and compliant patient/parent.&#xD;
  &#xD;
            5. Patients not allergic to medicaments necessary to complete the procedure.&#xD;
  &#xD;
            6. Patients with no history of chronic systemic diseases.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Medically compromised patient.&#xD;
  &#xD;
            2. Teeth with vertical fractures.&#xD;
  &#xD;
            3. Non-restorable teeth.&#xD;
  &#xD;
            4. Teeth when bleeding could not be induced.&#xD;
  &#xD;
            5. Unable to attend follow-up visits.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>14 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hana A Omer, master</last_name>
      <phone>+201144587858</phone>
      <email>hana.omer@dentistry.cu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Reem M Wahby, PhD</last_name>
      <phone>+201122788078</phone>
      <email>reem.wahby@dentistry.cu.edu.eg</email>
    </overall_contact_backup>
    <reference>
      <citation>Kasprisin DO, Heiss R, Rausen AR. Cholelithiasis during remission of acute lymphocytic leukemia in a child. Clin Pediatr (Phila). 1981 Oct;20(10):678. No abstract available.</citation>
      <PMID>6944166</PMID>
    </reference>
    <reference>
      <citation>Ruskin KJ, Tissot M. A new method of communication between anesthesiologists. Anesthesiology. 1993 Oct;79(4):867. doi: 10.1097/00000542-199310000-00037. No abstract available.</citation>
      <PMID>8214771</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Hana Ahmed Omer</investigator_full_name>
      <investigator_title>PhD researcher in pediatric dentistry and public health department</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mitogens</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06012331
  org study id: dental pulp revascularization
  nct id: NCT06012331
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to compare clinical and radiographic evaluation treatment of
        necrotic immature permanent teeth using:
  
          1. Concentrated Growth Factor
  
          2. Blood Clot
  Rationale for conducting the research:
  
        Concentrated growth factor (CGF) is relatively a new generation of platelet concentrate
        product, it contains more cytokines and growth factors compared with PRP and PRF also
        promotes the proliferation, migration, and differentiation of stem cells.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: clinically successful treatment
  time frame: 3,6,9,12 months
  description: The treatment will be considered to be clinically successful when. Absence of pain will record it by verbal question to patient/ parent. Absence of tenderness to percussion) will record it by percussion test (by the back of the dental mirror) Absence of swelling and fistula or sinus tract -- will record it by visual clinical examination
  measure: Radiographic Success treatment
  time frame: 6, 12 months
  description: The treatment will be considered to be Radiographic Success when.
  Root elongation (increased root length): will be assessed in mm through a radiographic x-ray system measure from cementoenamel junction to the apex.
  Root maturation: increased root dentin thickness will be assessed in mm through a radiographic x-ray system for each case and will be calculated as the difference between the outer root area and the pulp space area.
  Absence or reduce in the size of periapical radiolucency: will be assessed in mm through a radiographic x-ray system.
  arm group label: Concentrated Growth Factor (CGF)
  arm group type: Experimental
  description: Concentrated growth factor (CGF) is relatively a new generation of platelet concentrate product, it contains more cytokines and growth factors compared with PRP and PRF also promotes the proliferation, migration, and differentiation of stem cells
  arm group label: Blood Clot (BC)
  arm group type: Active Comparator
  description: Inducing bleeding to facilitate healing is a common surgical procedure. The blood clot formed after hemorrhage, acts as a scaffold and rich source of growth factors, and could play an important role in tissue repair in the canal. The growth factors could stimulate differentiation, growth, and maturation of fibroblasts, odontoblasts and cementoblasts, from the immature undifferentiated mesenchymal cells in the newly formed tissue matrix
  intervention type: Procedure
  intervention name: concentrated growth factors in open apex
  description: Dry canals with paper points. A 10 ml of venous blood will be collected and transferred to sterile tubes without anticoagulant solutions by a trained nurse. The tubes will be centrifuged machine using a one-step centrifugation protocol at variable rpm, after centrifugation, four layers will be obtained: the first layer at the top is serum, second layer is the fibrin buffy coat, the third layer is the liquid phase containing growth factors, The concentrated growth factor was separated from the red blood cells and serum using sterile scissors.
  CGF will be packed into canal to the full working length using sterile pluggers.
  The coronal level of the CGF gel is near the cervical area above cementoenamel junction and white MTA placed as capping material after CGF, then GIC and composite restoration
  arm group label: Blood Clot (BC)
  arm group label: Concentrated Growth Factor (CGF)
  intervention type: Procedure
  intervention name: Blood Clot (BC)
  description: Create bleeding into the canal by over-instrumenting (induce by rotating a pre-curved K-file at 2 mm past the apical foramen with the goal of having the entire canal filled with blood to CEJ level)
  Stop bleeding at a level that allows for 3-4 mm of restorative material.
  Then white MTA as a coronal plug material be followed by GIC, then composite restoration.
  arm group label: Blood Clot (BC)
  arm group label: Concentrated Growth Factor (CGF)
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 14 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hana A Omer, master
  phone: +201144587858
  email: hana.omer@dentistry.cu.edu.eg
  last name: Reem M Wahby, PhD
  phone: +201122788078
  email: reem.wahby@dentistry.cu.edu.eg
  citation: Kasprisin DO, Heiss R, Rausen AR. Cholelithiasis during remission of acute lymphocytic leukemia in a child. Clin Pediatr (Phila). 1981 Oct;20(10):678. No abstract available.
  PMID: 6944166
  citation: Ruskin KJ, Tissot M. A new method of communication between anesthesiologists. Anesthesiology. 1993 Oct;79(4):867. doi: 10.1097/00000542-199310000-00037. No abstract available.
  PMID: 8214771
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Hana Ahmed Omer
  investigator title: PhD researcher in pediatric dentistry and public health department
  mesh term: Mitogens