<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/NCT02201498</url>
  </required_header>
  <id_info>
    <org_study_id>BIODENT1</org_study_id>
    <nct_id>NCT02201498</nct_id>
  </id_info>
  <brief_title>Randomized Clinical Trial for Primary Molar Pulpotomy, Biodentine Vs Formocresol-ZOE</brief_title>
  <official_title>A New Technique for Primary Molar Pulpotomy : A Randomized Clinical Trial Comparing the Radiographic and Clinical Success of the Formocresol-zinc Oxide Eugenol Technique and the Biodentine Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Septodont</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Justine's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Université de Montréal</source>
  <brief_summary>
    <textblock>
      This is a RCT that will compare the clinical and radiographic success of pulpotomies on&#xD;
      primary molars between the traditional technique (Formocresol/ZOE) and the new technique with&#xD;
      Biodentine. 180 pulpotomies (90 in each group) will be followed for a period of 12 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical success</measure>
    <time_frame>12 months post treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>radiographic success</measure>
    <time_frame>12 months post treatment</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Deep Dental Caries</condition>
  <arm_group>
    <arm_group_label>Formocresol/OZE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional pulpotomy technique, with formocresol and zinc oxide eugenol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biodentine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>New technique, with biodentine</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pulpotomies with Formocresol/OZE and Biodentine</intervention_name>
    <arm_group_label>Biodentine</arm_group_label>
    <arm_group_label>Formocresol/OZE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I and II&#xD;
&#xD;
          -  less than 1/3 of physiologic root resorption&#xD;
&#xD;
          -  asymptomatic tooth (with no history of symptoms)&#xD;
&#xD;
          -  no clinical or radiological sign of pathology&#xD;
&#xD;
          -  vital tooth, with carious pulpal exposure&#xD;
&#xD;
          -  hemostasis must be obtained simply with pressure in less than 5 min&#xD;
&#xD;
          -  teeth restored with stainless steel crowns&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  more than 10 y.o.&#xD;
&#xD;
          -  symptomatic tooth (presently or history of symptoms)&#xD;
&#xD;
          -  previous pulpal treatment on the tooth&#xD;
&#xD;
          -  necrotic pulp&#xD;
&#xD;
          -  hyperemic pulp&#xD;
&#xD;
          -  inadequate operative technique, defective restauration&#xD;
&#xD;
          -  non diagnostic x-ray (pre or post treatment)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Sainte-Justine</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>h3t1c5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>January 10, 2018</last_update_submitted>
  <last_update_submitted_qc>January 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</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/NCT02201498
org study id: BIODENT1
nct id: NCT02201498
lead sponsor: 
collaborator: 
collaborator: 
This is a RCT that will compare the clinical and radiographic success of pulpotomies on
      primary molars between the traditional technique (Formocresol/ZOE) and the new technique with
      Biodentine. 180 pulpotomies (90 in each group) will be followed for a period of 12 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: clinical success
time frame: 12 months post treatment
measure: radiographic success
time frame: 12 months post treatment
arm group label: Formocresol/OZE
arm group type: Active Comparator
description: Conventional pulpotomy technique, with formocresol and zinc oxide eugenol
arm group label: Biodentine
arm group type: Active Comparator
description: New technique, with biodentine
intervention type: Procedure
intervention name: Pulpotomies with Formocresol/OZE and Biodentine
arm group label: Biodentine
arm group label: Formocresol/OZE
criteria: 
gender: All
minimum age: N/A
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Dental Caries