<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/NCT03804450</url>
  </required_header>
  <id_info>
    <org_study_id>15012017</org_study_id>
    <nct_id>NCT03804450</nct_id>
  </id_info>
  <brief_title>Magnetic Resonance Imaging (MRI) of Pulp Regeneration</brief_title>
  <official_title>Magnetic Resonance Imaging Assessment of Pulp Regeneration Following Regenerative Endodontic Procedures in Mature Teeth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria 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 present study was conducted to test whether pulp-like tissue can be regenerated in mature&#xD;
      teeth with closed apex? And whether the size of the apical diameter affects the success of&#xD;
      REPs? And whether Magnetic resonance imaging (MRI) can be used to quantitatively assess the&#xD;
      vitality of the regenerated pulp-like tissue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Regenerative endodontic procedures via blood clot were done on 18 mature anterior necrotic&#xD;
      teeth with periapical lesions. The teeth were randomly assigned into two groups according to&#xD;
      the size of the apical diameter of the rotary files used for instrumentation.&#xD;
&#xD;
      In the test group, rotary instrumentation was done using Pro-taper Next till size X3, while&#xD;
      in the control group, instrumentation was done till size X5.&#xD;
&#xD;
      Calcium hydroxide was used as an intracanal medication for 1-2 weeks. Calcium hydroxide was&#xD;
      then washed away using 1.5%NaOCl, followed by induction of blood using pre-curved K-fi;e #25&#xD;
      2mm past the radiographic apex. Biodentine was then used as a cervical plug over the blood&#xD;
      clot followed by resin-modified glass ionomer cement and composite resin as coronal&#xD;
      restoration.&#xD;
&#xD;
      MRI was used to assess the vitality of the regenerated pulp-like tissue, where the signal&#xD;
      intensity of the regenerated pulp-like tissue was measured after 3,6 and 12 months follow up&#xD;
      and compared to the normal contralateral teeth. In addition, sensibility tests using cold&#xD;
      test and electric pulp testing were used to assess vitality of regenerated pulp-like tissue&#xD;
      after 3,6,9 and 12 months. Cone beam computed tomography (CBCT) was also used to assess the&#xD;
      healing of the periapical lesion after 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">December 28, 2018</completion_date>
  <primary_completion_date type="Actual">September 3, 2018</primary_completion_date>
  <phase>Phase 2</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>MRI assessment of pulp-like tissue regeneration</measure>
    <time_frame>12 months</time_frame>
    <description>Signal intensity of the regenerated pulp-like tissue was quantitatively measured in both test and control groups after 3,6 and 12 months follow up and compared to the contralateral normal teeth.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Healing of the periapical lesion</measure>
    <time_frame>12 months</time_frame>
    <description>Cone beam computed tomography (CBCT) was used to assess the healing of the periapical lesion after 12 months follow up period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive pulpal response</measure>
    <time_frame>12 months</time_frame>
    <description>The positive response to sensibility tests using cold test and electric pulp tester was done after 3,6,9 and 12 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Pulp Necroses</condition>
  <condition>Periapical Lesion</condition>
  <condition>Regeneration</condition>
  <arm_group>
    <arm_group_label>Test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The root canals were instrumented using Pro-taper next rotary files till size X3. REPs via blood clot using calcium hydroxide were then applied</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The root canals were instrumented using Pro-taper next rotary files till size X5. REPs via blood clot using calcium hydroxide were then applied.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Regenerative endodontic procedures (REPs)</intervention_name>
    <description>Instrumentation using rotary Pro-Taper Next, disinfection using sodium hypochlorite and calcium hydroxide as intracanal medication followed by induction of blood and application of Biodentine as a cervical plug.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Test group</arm_group_label>
    <other_name>Pulp Regeneration</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Upper anterior mature teeth with single canals.&#xD;
&#xD;
          -  Necrotic teeth&#xD;
&#xD;
          -  Presence of periapical lesion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of systemic diseases.&#xD;
&#xD;
          -  Presence of stainless steel wires o brackets&#xD;
&#xD;
          -  Vital immature teeth with open apex&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Alexandria University</name>
      <address>
        <city>Alexandria</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>Noha Mohamed El Kateb</investigator_full_name>
    <investigator_title>Assistant lecturer, Faculty of dentistry</investigator_title>
  </responsible_party>
  <keyword>Mature teeth</keyword>
  <keyword>Necrotic teeth</keyword>
  <keyword>REPs</keyword>
  <keyword>Biodentine</keyword>
  <keyword>MRI</keyword>
  <keyword>CBCT</keyword>
  <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/NCT03804450
org study id: 15012017
nct id: NCT03804450
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The present study was conducted to test whether pulp-like tissue can be regenerated in mature
      teeth with closed apex? And whether the size of the apical diameter affects the success of
      REPs? And whether Magnetic resonance imaging (MRI) can be used to quantitatively assess the
      vitality of the regenerated pulp-like tissue.
Regenerative endodontic procedures via blood clot were done on 18 mature anterior necrotic
      teeth with periapical lesions. The teeth were randomly assigned into two groups according to
      the size of the apical diameter of the rotary files used for instrumentation.

      In the test group, rotary instrumentation was done using Pro-taper Next till size X3, while
      in the control group, instrumentation was done till size X5.

      Calcium hydroxide was used as an intracanal medication for 1-2 weeks. Calcium hydroxide was
      then washed away using 1.5%NaOCl, followed by induction of blood using pre-curved K-fi;e #25
      2mm past the radiographic apex. Biodentine was then used as a cervical plug over the blood
      clot followed by resin-modified glass ionomer cement and composite resin as coronal
      restoration.

      MRI was used to assess the vitality of the regenerated pulp-like tissue, where the signal
      intensity of the regenerated pulp-like tissue was measured after 3,6 and 12 months follow up
      and compared to the normal contralateral teeth. In addition, sensibility tests using cold
      test and electric pulp testing were used to assess vitality of regenerated pulp-like tissue
      after 3,6,9 and 12 months. Cone beam computed tomography (CBCT) was also used to assess the
      healing of the periapical lesion after 12 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: MRI assessment of pulp-like tissue regeneration
time frame: 12 months
description: Signal intensity of the regenerated pulp-like tissue was quantitatively measured in both test and control groups after 3,6 and 12 months follow up and compared to the contralateral normal teeth.
measure: Healing of the periapical lesion
time frame: 12 months
description: Cone beam computed tomography (CBCT) was used to assess the healing of the periapical lesion after 12 months follow up period.
measure: Positive pulpal response
time frame: 12 months
description: The positive response to sensibility tests using cold test and electric pulp tester was done after 3,6,9 and 12 months
arm group label: Test group
arm group type: Experimental
description: The root canals were instrumented using Pro-taper next rotary files till size X3. REPs via blood clot using calcium hydroxide were then applied
arm group label: Control group
arm group type: Experimental
description: The root canals were instrumented using Pro-taper next rotary files till size X5. REPs via blood clot using calcium hydroxide were then applied.
intervention type: Procedure
intervention name: Regenerative endodontic procedures (REPs)
description: Instrumentation using rotary Pro-Taper Next, disinfection using sodium hypochlorite and calcium hydroxide as intracanal medication followed by induction of blood and application of Biodentine as a cervical plug.
arm group label: Control group
arm group label: Test group
other name: Pulp Regeneration
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: Noha Mohamed El Kateb
investigator title: Assistant lecturer, Faculty of dentistry
mesh term: Dental Pulp Necrosis
mesh term: Necrosis