<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/NCT03296709</url>
  </required_header>
  <id_info>
    <org_study_id>17-PP-08</org_study_id>
    <nct_id>NCT03296709</nct_id>
  </id_info>
  <brief_title>Preformed Pediatric Crown Zirconia Versus Preformed Pediatric Metal Crown</brief_title>
  <acronym>PPC Z-M</acronym>
  <official_title>Preformed Pediatric Crown Zirconia Versus Preformed Pediatric Metal Crown PPC Z-M</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</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>
      Preformed metal pediatric crowns (PPCm) are currently considered the best method of restoring&#xD;
      Primary molars affected by severe carious lesions compared to restorations made with various&#xD;
      restorative materials (amalgams, composites, CVI-based materials). Due to their unsightly&#xD;
      appearance, denounced by many parents, more aesthetic zirconia (PPCz) preformed pediatric&#xD;
      crowns have been recently marketed. In the absence of an evaluation of the latter, this&#xD;
      multi-center split-mouth two-year randomized clinical trial (RCT) proposes to to investigate&#xD;
      the effectiveness of PPCz for the management of dental caries or structural anomalies. More&#xD;
      specifically, the primary objective of this RCT is to assess in primary molars the success of&#xD;
      PPCz in comparison with PPCm. The control treatment will be PPCm since this is the standard&#xD;
      crown option.&#xD;
&#xD;
      One hundred children and one aged at least 4 years must be recruited in ninedepartments of&#xD;
      Pediatric Dentistry in the university hospitals of Bordeaux, Lille, Nancy, Nantes, Nice,&#xD;
      Paris 1&amp;2, Strasbourg and Toulouse. They will be included if they have two similar&#xD;
      primarymolars of the same arch (for example first right and left maxillary primary molars )&#xD;
      and equally affected, to be crowned. The two types of crowns to be used in the same child,&#xD;
      PPCm(3M Espe) and PPCz(Ezpédo), will be affected by randomization using a computerized and&#xD;
      centralized system: primary molars will first be allocated to PPCm and, one to two weeks&#xD;
      later, the contralateral primary molar will be restored by PPCz. The children will be checked&#xD;
      every 6 months for a period of 2 years after the placement of the two types of crowns .&#xD;
      During these four control visits, primary and secondary outcomes will be assessed clinically&#xD;
      and radiographically. The primary outcome is the success of the treatment defined by the&#xD;
      absence of major failure. A composite measure of signs and symptoms leading to diagnosis of&#xD;
      irreversible pulpitis or periradicular periodontitis will be used to define major failure&#xD;
      (pain, pulp infection, dental abscess, periradicular pathology visible on radiograph). The&#xD;
      secondary outcomes are parental and child satisfaction (size, form and color), retention and&#xD;
      fracture of the PPC, the wear of the antagonist tooth, the gingival state near PPC using the&#xD;
      indices Löe and Silness to record plaque index (PI), gingival index (GI) and depth of the&#xD;
      pocket (DI) on the crowned tooth and the two adjacent ones. Each center has a trained and /&#xD;
      or calibrated operator and evaluator.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 10, 2018</start_date>
  <completion_date type="Anticipated">March 31, 2023</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</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>
    <intervention_model_description>Split mouth design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical and radiographique observations</measure>
    <time_frame>2 years</time_frame>
    <description>Success of the treatment defined by the absence of major failure. A composite measure of signs and symptoms leading to diagnosis of irreversible pulpitis or periradicular periodontitis will be used to define major failure (pain, pulp infection, dental abscess, periradicular pathology visible on radiograph</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">101</enrollment>
  <condition>Tooth Decay</condition>
  <arm_group>
    <arm_group_label>PPC m</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PPC z</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PPC z</intervention_name>
    <description>Installation of a preformed pediatric zircona crown</description>
    <arm_group_label>PPC z</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PPC m</intervention_name>
    <description>Installation of a preformed pediatric metal crown</description>
    <arm_group_label>PPC m</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children of at least 4 years of good general health (ASAI or II),&#xD;
&#xD;
          -  Child with at least two temporary molars of the same type, 1st or 2nd molar,&#xD;
             contralateral (fractional mouth), meeting the following criteria:&#xD;
&#xD;
        The two temporary molars are affected by a cavitary carious lesion or a hypoplastic defect&#xD;
        of at least 2 faces,&#xD;
&#xD;
          -  the two temporary molars of the pair (54-64, 55-65, 74-84 or 75-85), should or should&#xD;
             not be subjected to pulpotomy prior to the realization of the CPP,&#xD;
&#xD;
          -  the two molars must have an antagonistic tooth.&#xD;
&#xD;
               -  Consent of parents (legal guardians) and child,&#xD;
&#xD;
               -  Child and parents (legal guardians) speaking French,&#xD;
&#xD;
               -  Child covered by his parents' social security cover,&#xD;
&#xD;
               -  Child cooperating in the vigilant or sedated state (cooperation evaluated with a&#xD;
                  Venham score 0, 1, 2).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child who does not cooperate in care under vigil or under conscious sedation, who must&#xD;
             therefore be treated under general anesthesia.&#xD;
&#xD;
          -  Child allergic to local anesthetics, chromium or nickel. Exclusion dental criteria&#xD;
&#xD;
          -  Primary molar whose physiological exfoliation will appear within 24 months or pimary&#xD;
             molar with a root resorption of more than a third of the radicular length.&#xD;
&#xD;
          -  Severely decayed PM prohibiting the retention and the sealing of the restoration.&#xD;
&#xD;
          -  Primary molar with exposed cement or with evidence of swelling in the surrounding&#xD;
             tissues&#xD;
&#xD;
          -  Molar with spontaneous pain.&#xD;
&#xD;
          -  Primary molar in infraclusion.&#xD;
&#xD;
          -  Primary molar whose radiographic examination reveals a widening of the desmodontal&#xD;
             space, the presence of radiolucent image on the root furcation and/or apices, internal&#xD;
             or external resorption&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Michele MULLER BOLLA</last_name>
    <phone>33 4 92 03 32 70</phone>
    <email>michele.muller@unice.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>mélanie bonnard</last_name>
    <email>bonnard.m@chu-nice.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHRU Lille</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caroline DELFOSSE</last_name>
      <email>caroline.delfosse@univ-lille.fr</email>
    </contact>
    <investigator>
      <last_name>Caroline DELFOSSE</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>serena LOPEZ CAZAUX</last_name>
      <email>serena.lopezcazaux@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Serena LOPEZ CAZAUX</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Nice</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michele MULLER BOLLA</last_name>
      <email>muller@unice.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Stransbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>françois CLAUSS</last_name>
      <email>francois_clauss@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>françois CLAUSS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>October 15, 2020</last_update_submitted>
  <last_update_submitted_qc>October 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03296709
org study id: 17-PP-08
nct id: NCT03296709
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Preformed metal pediatric crowns (PPCm) are currently considered the best method of restoring
      Primary molars affected by severe carious lesions compared to restorations made with various
      restorative materials (amalgams, composites, CVI-based materials). Due to their unsightly
      appearance, denounced by many parents, more aesthetic zirconia (PPCz) preformed pediatric
      crowns have been recently marketed. In the absence of an evaluation of the latter, this
      multi-center split-mouth two-year randomized clinical trial (RCT) proposes to to investigate
      the effectiveness of PPCz for the management of dental caries or structural anomalies. More
      specifically, the primary objective of this RCT is to assess in primary molars the success of
      PPCz in comparison with PPCm. The control treatment will be PPCm since this is the standard
      crown option.

      One hundred children and one aged at least 4 years must be recruited in ninedepartments of
      Pediatric Dentistry in the university hospitals of Bordeaux, Lille, Nancy, Nantes, Nice,
      Paris 1&2, Strasbourg and Toulouse. They will be included if they have two similar
      primarymolars of the same arch (for example first right and left maxillary primary molars )
      and equally affected, to be crowned. The two types of crowns to be used in the same child,
      PPCm(3M Espe) and PPCz(Ezpédo), will be affected by randomization using a computerized and
      centralized system: primary molars will first be allocated to PPCm and, one to two weeks
      later, the contralateral primary molar will be restored by PPCz. The children will be checked
      every 6 months for a period of 2 years after the placement of the two types of crowns .
      During these four control visits, primary and secondary outcomes will be assessed clinically
      and radiographically. The primary outcome is the success of the treatment defined by the
      absence of major failure. A composite measure of signs and symptoms leading to diagnosis of
      irreversible pulpitis or periradicular periodontitis will be used to define major failure
      (pain, pulp infection, dental abscess, periradicular pathology visible on radiograph). The
      secondary outcomes are parental and child satisfaction (size, form and color), retention and
      fracture of the PPC, the wear of the antagonist tooth, the gingival state near PPC using the
      indices Löe and Silness to record plaque index (PI), gingival index (GI) and depth of the
      pocket (DI) on the crowned tooth and the two adjacent ones. Each center has a trained and /
      or calibrated operator and evaluator.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Split mouth design
primary purpose: Treatment
masking: None (Open Label)
measure: clinical and radiographique observations
time frame: 2 years
description: Success of the treatment defined by the absence of major failure. A composite measure of signs and symptoms leading to diagnosis of irreversible pulpitis or periradicular periodontitis will be used to define major failure (pain, pulp infection, dental abscess, periradicular pathology visible on radiograph
arm group label: PPC m
arm group type: Active Comparator
arm group label: PPC z
arm group type: Experimental
intervention type: Device
intervention name: PPC z
description: Installation of a preformed pediatric zircona crown
arm group label: PPC z
intervention type: Device
intervention name: PPC m
description: Installation of a preformed pediatric metal crown
arm group label: PPC m
criteria: 
gender: All
minimum age: 4 Years
maximum age: 18 Years
healthy volunteers: No
last name: Michele MULLER BOLLA
phone: 33 4 92 03 32 70
email: michele.muller@unice.fr
last name: mélanie bonnard
email: bonnard.m@chu-nice.fr
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Dental Caries
sharing ipd: No