<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/NCT01733420</url>
  </required_header>
  <id_info>
    <org_study_id>2011/538</org_study_id>
    <nct_id>NCT01733420</nct_id>
  </id_info>
  <brief_title>Biodentine Versus White MTA Pulpotomy</brief_title>
  <official_title>The Clinical and Radiographic Efficacy of Biodentine™ and White Mineral Trioxide Aggregate in Deciduous Molar Pulpotomy - a Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Ghent</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A clinical trial to evaluate and compare three different products used for endodontic&#xD;
      treatment (taking the infected nerve out of the teeth) of primary teeth.&#xD;
&#xD;
      Null Hypothesis: The new biological products (WMTA and Biodentine) behave as good as the&#xD;
      former iodoform product.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 4, 2011</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Phase 3</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>Clinical successes after pulpotomy.</measure>
    <time_frame>at baseline visit</time_frame>
    <description>clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical success after pulpotomy.</measure>
    <time_frame>3 months after pulpotomy.</time_frame>
    <description>clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical successes after pulpotomy.</measure>
    <time_frame>6 months after pulpotomy.</time_frame>
    <description>Clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical successes after pulpotomy.</measure>
    <time_frame>12 months after pulpotomy.</time_frame>
    <description>Clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiographic successes after pulpotomy.</measure>
    <time_frame>at baseline visit</time_frame>
    <description>Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiographic successes after pulpotomy.</measure>
    <time_frame>6 months after pulpotomy.</time_frame>
    <description>Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiographic successes after pulpotomy.</measure>
    <time_frame>12 months after pulpotomy.</time_frame>
    <description>Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Extensive Decay in Primary Molars</condition>
  <arm_group>
    <arm_group_label>Biodentine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pulpotomy using Biodentine as pulpotomy medicine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>White Mineral trioxide Aggregate (MTA)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pulpotomy using white MTA as pulpotomy medicine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tempophore</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pulpotomy using Tempophore as pulpotomy medicine in a control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Biodentine pulpotomy</intervention_name>
    <arm_group_label>Biodentine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>White MTA pulpotomy</intervention_name>
    <arm_group_label>White Mineral trioxide Aggregate (MTA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tempophore pulpotomy</intervention_name>
    <arm_group_label>Tempophore</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients (Children with carious deciduous molars indicated for pulpotomy) belonging to&#xD;
             the category of ASA I according to the 'American Society of Anaesthesiologists'.&#xD;
&#xD;
          -  Patients without any known medical history of systemic complications contradicting&#xD;
             pulp treatment.&#xD;
&#xD;
          -  Patients are indicated for treatment under general anaesthesia due to polycaries /&#xD;
             fear / anxiety / very young age.&#xD;
&#xD;
          -  Written consent is obtained from the parent/guardian after explaining the full details&#xD;
             of the treatment procedure and its possible outcomes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luc Martens, PhD, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Ghent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ghent University Hospital</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>November 19, 2021</last_update_submitted>
  <last_update_submitted_qc>November 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01733420
org study id: 2011/538
nct id: NCT01733420
lead sponsor: 
has dmc: No
A clinical trial to evaluate and compare three different products used for endodontic
      treatment (taking the infected nerve out of the teeth) of primary teeth.

      Null Hypothesis: The new biological products (WMTA and Biodentine) behave as good as the
      former iodoform product.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Clinical successes after pulpotomy.
time frame: at baseline visit
description: clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.
measure: Clinical success after pulpotomy.
time frame: 3 months after pulpotomy.
description: clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.
measure: Clinical successes after pulpotomy.
time frame: 6 months after pulpotomy.
description: Clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.
measure: Clinical successes after pulpotomy.
time frame: 12 months after pulpotomy.
description: Clinical evaluation and radiography of the tooth is performed. Clinical criteria: abscence of post-operative pain, absence of pain on percussion and palpation, absence of abscess or swelling, absence of sinus tract or fistula and absence of pathologic tooth mobility.
measure: Radiographic successes after pulpotomy.
time frame: at baseline visit
description: Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.
measure: Radiographic successes after pulpotomy.
time frame: 6 months after pulpotomy.
description: Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.
measure: Radiographic successes after pulpotomy.
time frame: 12 months after pulpotomy.
description: Radiographic criteria: presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of periradicular radiolucency and no loss or break of lamina dura.
arm group label: Biodentine
arm group type: Experimental
description: Pulpotomy using Biodentine as pulpotomy medicine.
arm group label: White Mineral trioxide Aggregate (MTA)
arm group type: Active Comparator
description: Pulpotomy using white MTA as pulpotomy medicine.
arm group label: Tempophore
arm group type: Active Comparator
description: Pulpotomy using Tempophore as pulpotomy medicine in a control group.
intervention type: Drug
intervention name: Biodentine pulpotomy
arm group label: Biodentine
intervention type: Drug
intervention name: White MTA pulpotomy
arm group label: White Mineral trioxide Aggregate (MTA)
intervention type: Drug
intervention name: Tempophore pulpotomy
arm group label: Tempophore
criteria: 
gender: All
minimum age: 2 Years
maximum age: 9 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Luc Martens, PhD, DDS
role: Principal Investigator
affiliation: University Ghent
facility: 
country: Belgium
responsible party type: Sponsor