<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/NCT03813433</url>
  </required_header>
  <id_info>
    <org_study_id>pedodontic department cairo</org_study_id>
    <nct_id>NCT03813433</nct_id>
  </id_info>
  <brief_title>Discoloration of Endosequence and Mineral Trioxde Aggregate in Revascularization of Necrotic Immature Permanent Teeth</brief_title>
  <official_title>Discoloration After Revascularization Using Calcium Phosphosilicate Based Bioceramic vs Mineral Trioxide Aggregate in Necrotic Immature Permanent Anterior Teeth: 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>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      the objective of this study is to evaluate post operative pain after using Endosequence&#xD;
      versus Mineral Trioxide Aggregate as coronal plug material in revascularization of non vital&#xD;
      immature anterior teeth&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The treatment of immature young permanent anterior teeth is challenging because in addition&#xD;
      of the need of elimination of bacterial infection; the lack of natural apical constriction&#xD;
      against which a suitable filling material can be placed is considered the main problem.&#xD;
&#xD;
      In the past many different treatments have been proposed for immature permanent teeth with&#xD;
      necrotic pulps such as:Custom fitting of filling materials like gutta percha, Periapical&#xD;
      surgeries, apexification. The disadvantages of these treatments are: the compromised&#xD;
      Crown/root ratio, possibility of vertical fracture.&#xD;
&#xD;
      Pulp revascularization is dependent on the ability of residual pulp and apical and&#xD;
      periodontal stem cells to differentiate. These cells have the ability to generate a highly&#xD;
      vascularized and rich living tissue.&#xD;
&#xD;
      MTA was chosen as coronal seal to be placed over the blood clot due its a biocompatibility,&#xD;
      bio-inductivity. However, the disadvantages of MTA are: discoloration of the coronal dentine&#xD;
      when placed in the canal and the difficult handling properties.&#xD;
&#xD;
      Recently, a new bioceramic material has been introduced to the market, namely, EndoSequence&#xD;
      which is bioactive, has antibacterial activity, less cytotoxic effect and similar&#xD;
      antimicrobial properties, maintain color stability of the tooth when compared to MTA&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 2023</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Anticipated">November 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>discoloration</measure>
    <time_frame>1 month</time_frame>
    <description>Asking patient question (Binary:present or absent)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>discoloration</measure>
    <time_frame>3 months</time_frame>
    <description>Asking patient question (Binary:present or absent)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>dicoloration</measure>
    <time_frame>6 months</time_frame>
    <description>Asking patient question (Binary:present or absent)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>discoloration</measure>
    <time_frame>9 months</time_frame>
    <description>Asking patient question (Binary:present or absent)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>discoloration</measure>
    <time_frame>12months</time_frame>
    <description>Asking patient question (Binary:present or absent)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>post operative pain</measure>
    <time_frame>1,3, 6, 9 and 12 months</time_frame>
    <description>asking the patient (Binary: present or Absent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>color stability</measure>
    <time_frame>1,3, 6, 9 and 12 months</time_frame>
    <description>Operator and supervisor evaluation (Using shade guide)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain on percussion</measure>
    <time_frame>1,3, 6, 9 and 12 months</time_frame>
    <description>Assessed by back of the mirror (Binary: present or absent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swelling</measure>
    <time_frame>1,3, 6, 9 and 12 months</time_frame>
    <description>assessed by visual examination (Binary:present or absent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sinus or fistula</measure>
    <time_frame>1,3, 6, 9 and 12 months</time_frame>
    <description>assessed by visual examination (Binary:present or absent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Root lengthening</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>assessed radiographically (DIGORA® for Windows software)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Pulp Necrosis</condition>
  <arm_group>
    <arm_group_label>Enosequence</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3-4 mm of Endosequence will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mineral Trioxide Aggregate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3-4 mm of Mineral Trioxide Aggregate will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Revascularization</intervention_name>
    <description>a procedure used to regenerate pulp dentin complex that restores the functional properties of this immature anterior teeth, prevent and resolves apical periodontitis</description>
    <arm_group_label>Enosequence</arm_group_label>
    <arm_group_label>Mineral Trioxide Aggregate</arm_group_label>
    <other_name>pulp regeneration</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of patient range from 8-14 y.&#xD;
&#xD;
          -  Patients are free from any systemic diseases that may hinder the normal healing&#xD;
             process.&#xD;
&#xD;
          -  Non vital permanent anterior teeth with open apex.&#xD;
&#xD;
          -  Pulp space not needed for post and core for final restoration.&#xD;
&#xD;
          -  Compliant patient/parent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients having allergy to medicaments and antibiotics necessary to complete the&#xD;
             procedure.&#xD;
&#xD;
          -  Tooth with vital pulp or complete root formation.&#xD;
&#xD;
          -  Teeth with internal or external root resorption.&#xD;
&#xD;
          -  Un-cooperative patients&#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>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 19, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Rana Tarek Bartaw</investigator_full_name>
    <investigator_title>Assisstant lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Pulp Necrosis</mesh_term>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03813433
org study id: pedodontic department cairo
nct id: NCT03813433
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
the objective of this study is to evaluate post operative pain after using Endosequence
      versus Mineral Trioxide Aggregate as coronal plug material in revascularization of non vital
      immature anterior teeth
The treatment of immature young permanent anterior teeth is challenging because in addition
      of the need of elimination of bacterial infection; the lack of natural apical constriction
      against which a suitable filling material can be placed is considered the main problem.

      In the past many different treatments have been proposed for immature permanent teeth with
      necrotic pulps such as:Custom fitting of filling materials like gutta percha, Periapical
      surgeries, apexification. The disadvantages of these treatments are: the compromised
      Crown/root ratio, possibility of vertical fracture.

      Pulp revascularization is dependent on the ability of residual pulp and apical and
      periodontal stem cells to differentiate. These cells have the ability to generate a highly
      vascularized and rich living tissue.

      MTA was chosen as coronal seal to be placed over the blood clot due its a biocompatibility,
      bio-inductivity. However, the disadvantages of MTA are: discoloration of the coronal dentine
      when placed in the canal and the difficult handling properties.

      Recently, a new bioceramic material has been introduced to the market, namely, EndoSequence
      which is bioactive, has antibacterial activity, less cytotoxic effect and similar
      antimicrobial properties, maintain color stability of the tooth when compared to MTA
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: discoloration
time frame: 1 month
description: Asking patient question (Binary:present or absent)
measure: discoloration
time frame: 3 months
description: Asking patient question (Binary:present or absent)
measure: dicoloration
time frame: 6 months
description: Asking patient question (Binary:present or absent)
measure: discoloration
time frame: 9 months
description: Asking patient question (Binary:present or absent)
measure: discoloration
time frame: 12months
description: Asking patient question (Binary:present or absent)
measure: post operative pain
time frame: 1,3, 6, 9 and 12 months
description: asking the patient (Binary: present or Absent)
measure: color stability
time frame: 1,3, 6, 9 and 12 months
description: Operator and supervisor evaluation (Using shade guide)
measure: Pain on percussion
time frame: 1,3, 6, 9 and 12 months
description: Assessed by back of the mirror (Binary: present or absent)
measure: Swelling
time frame: 1,3, 6, 9 and 12 months
description: assessed by visual examination (Binary:present or absent)
measure: Sinus or fistula
time frame: 1,3, 6, 9 and 12 months
description: assessed by visual examination (Binary:present or absent)
measure: Root lengthening
time frame: 6 and 12 months
description: assessed radiographically (DIGORA® for Windows software)
arm group label: Enosequence
arm group type: Experimental
description: 3-4 mm of Endosequence will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization
arm group label: Mineral Trioxide Aggregate
arm group type: Active Comparator
description: 3-4 mm of Mineral Trioxide Aggregate will be applied over the blood clot in group I. Material will be packed using condenser with light pressure. Periapical radiograph will be taken to ensure coronal seal in the second visit of revascularization
intervention type: Other
intervention name: Revascularization
description: a procedure used to regenerate pulp dentin complex that restores the functional properties of this immature anterior teeth, prevent and resolves apical periodontitis
arm group label: Enosequence
arm group label: Mineral Trioxide Aggregate
other name: pulp regeneration
criteria: 
gender: All
minimum age: 8 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Rana Tarek Bartaw
investigator title: Assisstant lecturer
mesh term: Dental Pulp Necrosis
mesh term: Necrosis