<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/NCT04410679</url>
  </required_header>
  <id_info>
    <org_study_id>FayoumU</org_study_id>
    <nct_id>NCT04410679</nct_id>
  </id_info>
  <brief_title>Treatment of Internal Inflammatory Root Resorption Using Injectable PRF Revascularization Technque</brief_title>
  <official_title>Treatment of Internal Inflammatory Root Resorption Using Injectable PRF Revascularization Technique: A Clinical Study With Cone Beam Computed Tomography Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fayoum University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fayoum University</source>
  <oversight_info>
    <has_dmc>No</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>
      Currently Endodontics looks forward for regeneration rather than repair. Regenerative&#xD;
      endodontic therapy was limited to pulp revascularization of necrotic pulp in immature teeth ,&#xD;
      followed by mature teeth. Recently pulp revascularization technique by induction of blood&#xD;
      clot was applied in the treatment of inflammatory root resorption. So far, no clinical study&#xD;
      for management of teeth with inflammatory internal root resorption by using injectable PRF&#xD;
      revascularization has been described in the literature. Thus, this is the first clinical&#xD;
      attempt to manage inflammatory root resorption in necrotic incisor teeth using injectable PRF&#xD;
      regenerative approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      13 teeth in a total of 10 patients with inflammatory root resorption will be treated using&#xD;
      revascualrization technique, iPRF will be prepared and unjected in the canal after previous&#xD;
      canal disinfection with calcium hydroxide for 2-4 weeks. cBCT will be taken preoperative and&#xD;
      12 month follow up period, also clinical and radiographic follow uo will be considered every&#xD;
      3 months for 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 3, 2018</start_date>
  <completion_date type="Actual">May 2, 2020</completion_date>
  <primary_completion_date type="Actual">June 6, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in volumetric size of internal root resorption lesions</measure>
    <time_frame>12 months</time_frame>
    <description>Measuring volumetric dimensions of resorption lesion pre and postoperatively using CBCT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in volumetric size of periapical lesions</measure>
    <time_frame>12 months</time_frame>
    <description>Measuring volumetric dimensions of periapical lesion pre and postoperatively using CBCT</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Root Resorption</condition>
  <arm_group>
    <arm_group_label>injectabl PRF for treatment of internal root resorption</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>injectable PRF</intervention_name>
    <description>blood sample and centrifuged to obtain i-PRF</description>
    <arm_group_label>injectabl PRF for treatment of internal root resorption</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients 13-30 years old&#xD;
&#xD;
          -  no sex predilection&#xD;
&#xD;
          -  medically free&#xD;
&#xD;
          -  Suffering from internal inflammatory root resorption in permanent anterior mature&#xD;
             teeth&#xD;
&#xD;
          -  associated with or without periapical radiolucency&#xD;
&#xD;
          -  no or grade I tooth mobility, and a pocket depth &lt;3 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  old age&#xD;
&#xD;
          -  Medically medically compromised patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Nageh, Lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of dentistry, Fayoum University</affiliation>
  </overall_official>
  <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>October 2021</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>October 1, 2021</last_update_submitted>
  <last_update_submitted_qc>October 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fayoum University</investigator_affiliation>
    <investigator_full_name>Mohamed Nageh</investigator_full_name>
    <investigator_title>Lecturer of Endodontics</investigator_title>
  </responsible_party>
  <keyword>Pulp revascularization</keyword>
  <keyword>injectable Platelet rich fibrin</keyword>
  <keyword>i-PRF</keyword>
  <keyword>root resorption</keyword>
  <keyword>CBCT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Root Resorption</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/NCT04410679
org study id: FayoumU
nct id: NCT04410679
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Currently Endodontics looks forward for regeneration rather than repair. Regenerative
      endodontic therapy was limited to pulp revascularization of necrotic pulp in immature teeth ,
      followed by mature teeth. Recently pulp revascularization technique by induction of blood
      clot was applied in the treatment of inflammatory root resorption. So far, no clinical study
      for management of teeth with inflammatory internal root resorption by using injectable PRF
      revascularization has been described in the literature. Thus, this is the first clinical
      attempt to manage inflammatory root resorption in necrotic incisor teeth using injectable PRF
      regenerative approach.
13 teeth in a total of 10 patients with inflammatory root resorption will be treated using
      revascualrization technique, iPRF will be prepared and unjected in the canal after previous
      canal disinfection with calcium hydroxide for 2-4 weeks. cBCT will be taken preoperative and
      12 month follow up period, also clinical and radiographic follow uo will be considered every
      3 months for 1 year.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change in volumetric size of internal root resorption lesions
time frame: 12 months
description: Measuring volumetric dimensions of resorption lesion pre and postoperatively using CBCT
measure: change in volumetric size of periapical lesions
time frame: 12 months
description: Measuring volumetric dimensions of periapical lesion pre and postoperatively using CBCT
arm group label: injectabl PRF for treatment of internal root resorption
arm group type: Experimental
intervention type: Biological
intervention name: injectable PRF
description: blood sample and centrifuged to obtain i-PRF
arm group label: injectabl PRF for treatment of internal root resorption
criteria: 
gender: All
minimum age: 13 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mohamed Nageh, Lecturer
role: Principal Investigator
affiliation: Faculty of dentistry, Fayoum University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Fayoum University
investigator full name: Mohamed Nageh
investigator title: Lecturer of Endodontics
mesh term: Root Resorption