<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/NCT01724827</url>
  </required_header>
  <id_info>
    <org_study_id>P110129</org_study_id>
    <nct_id>NCT01724827</nct_id>
  </id_info>
  <brief_title>Ceramic Versus Composite in the Treatment of Posterior Teeth by Inlays or Onlays</brief_title>
  <acronym>CECOIA</acronym>
  <official_title>Ceramic Versus Composite in the Treatment by Inlays or Onlays of Posterior Teeth Affected by Tooth Substance Loss : a Multicenter Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital Charles Foix</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôtel Dieu - Service d'odontologie (Toulouse)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dental practitionners</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this trial is to determine which material, between ceramic and composite,&#xD;
      is best to manufacture dental inlays and onlays in the treatment of moderate dental substance&#xD;
      losses, generally due to dental caries. Restorations will be done using direct Computer&#xD;
      Assisted Design and Manufacturing (CAD-CAM). Another aim of this study is to determine which&#xD;
      factors influence the success of these restorations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      WHO estimates dental caries prevalence to be over 90% adults worldwide. When tooth substance&#xD;
      loss due to the decayed tissue is small, a filling is done by the dentist directly. When the&#xD;
      substance loss is important, dentists often treat it with a crown, which presents the&#xD;
      disadvantage of further mutilating the tooth. An intermediate technique consists in&#xD;
      manufacturing an inlay or an onlay: these restorations become more and more common since they&#xD;
      are a minimally invasive solution in such cases. Inlays and onlays can be made of metal,&#xD;
      ceramic or composite. Patients tend to refuse metallic restorations, so that dentists&#xD;
      generally have to choose between composite and ceramic. Composite wears whereas ceramics&#xD;
      fracture. Published in vitro studies provide possible answers to which material is most&#xD;
      effective but very few clinical studies have been conducted to confirm them. Material\'s&#xD;
      choice for inlay manufacturing is thus more country-based than evidence-based (Most french&#xD;
      dentists choose composite while US dentists prefer ceramics for example). The main objective&#xD;
      of this trial is to compare the clinical performance of ceramic and composite inlays/onlays.&#xD;
      Other objectives include looking for the prognostic factors of these restorations and&#xD;
      validating the criteria proposed by the World Dental Federation (FDI) to evaluate dental&#xD;
      restorations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 13, 2012</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">September 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>FDI criteria for dental restorations assessment</measure>
    <time_frame>at 2 years</time_frame>
    <description>2 independent evaluators The primary outcome will consist in the FDI instrument for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010 . This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually.The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Restoration survival analysis</measure>
    <time_frame>at 2 years</time_frame>
    <description>The primary outcome will consist in the FDI instrument for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010 . This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually.The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>wear</measure>
    <time_frame>at 2 years</time_frame>
    <description>The primary outcome will consist in the FDI instrument for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010 . This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually.The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall quality of the restoration</measure>
    <time_frame>at 2 years</time_frame>
    <description>The primary outcome will consist in the FDI instrument for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010 . This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually.The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FDI instrument validity data</measure>
    <time_frame>at 2 years</time_frame>
    <description>The primary outcome will consist in the FDI instrument for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010 . This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually.The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">355</enrollment>
  <condition>Dental Caries</condition>
  <condition>Inlays</condition>
  <arm_group>
    <arm_group_label>ceramic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Leucite-reinforced glass ceramic (Empress CAD, Ivoclar Vivadent)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>composite</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nanohybrid composite resin (Lava Ultimate, 3M Espe)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ceramic (Empress CAD, Ivoclar Vivadent)</intervention_name>
    <description>Leucite-reinforced glass ceramic (Empress CAD, Ivoclar Vivadent)</description>
    <arm_group_label>ceramic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>composite (Lava Ultimate, 3M Espe)</intervention_name>
    <description>Nanohybrid composite resin (Lava Ultimate, 3M Espe)</description>
    <arm_group_label>composite</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  patient aged 18-70,who tolerates restorative procedures and presents a moderate-sized&#xD;
             dental caries or restoration (that needs to be replaced) necessitating an inlay/onlay&#xD;
             restoration.&#xD;
&#xD;
        Exclusion criteria :&#xD;
&#xD;
          -  allergy to one of the materials employed, bruxism, severe or acute periodontal or&#xD;
             carious disease, poor oral hygiene&#xD;
&#xD;
          -  Tooth presents a mobility &gt; II, a periodontal socket &gt; 3mm or supports a removable&#xD;
             partial denture&#xD;
&#xD;
        Randomization criterium :&#xD;
&#xD;
          -  tooth necessitates an inlay-onlay restoration after caries or former restoration&#xD;
             removal&#xD;
&#xD;
        Exclusion from randomization criteria :&#xD;
&#xD;
          -  subgingival margin after cavity preparation, rubber dam cannot be placed, all tooth&#xD;
             cuspids need to be covered by the restoration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>hélène fron chabouis, DDS, MSc</last_name>
    <role>Study Director</role>
    <affiliation>APHP, Hôpital Charles Foix, Service d'odontologie, Ivry-sur-Seine, France ; Faculté de chirurgie dentaire, Service de biomatériaux (URB2i EA4462), Université Paris Descartes, Sorbonne Paris Cité, Montrouge, France.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Charles Foix (APHP), Service d'odontologie</name>
      <address>
        <city>Ivry-sur-seine</city>
        <zip>94200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dental pratice</name>
      <address>
        <city>Lyon</city>
        <zip>69003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dental pratice</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dental pratice</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dental pratice</name>
      <address>
        <city>Paris</city>
        <zip>75017</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôtel Dieu, Service d'odontologie</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Science Committee Project 2/98--FDI World Dental Federation study design (Part I) and criteria for evaluation (Part II) of direct and indirect restorations including onlays and partial crowns. J Adhes Dent. 2007;9 Suppl 1:121-47. Erratum In: J Adhes Dent. 2007 Dec;9(6):546.</citation>
    <PMID>18341239</PMID>
  </results_reference>
  <results_reference>
    <citation>Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.</citation>
    <PMID>20628774</PMID>
  </results_reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>March 12, 2018</last_update_submitted>
  <last_update_submitted_qc>March 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dental caries</keyword>
  <keyword>inlays</keyword>
  <keyword>composite resins</keyword>
  <keyword>IPS-Empress ceramic</keyword>
  <keyword>bicuspid</keyword>
  <keyword>FDI dental restorations evaluation criteria</keyword>
  <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/NCT01724827
org study id: P110129
nct id: NCT01724827
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The main purpose of this trial is to determine which material, between ceramic and composite,
      is best to manufacture dental inlays and onlays in the treatment of moderate dental substance
      losses, generally due to dental caries. Restorations will be done using direct Computer
      Assisted Design and Manufacturing (CAD-CAM). Another aim of this study is to determine which
      factors influence the success of these restorations.
WHO estimates dental caries prevalence to be over 90% adults worldwide. When tooth substance
      loss due to the decayed tissue is small, a filling is done by the dentist directly. When the
      substance loss is important, dentists often treat it with a crown, which presents the
      disadvantage of further mutilating the tooth. An intermediate technique consists in
      manufacturing an inlay or an onlay: these restorations become more and more common since they
      are a minimally invasive solution in such cases. Inlays and onlays can be made of metal,
      ceramic or composite. Patients tend to refuse metallic restorations, so that dentists
      generally have to choose between composite and ceramic. Composite wears whereas ceramics
      fracture. Published in vitro studies provide possible answers to which material is most
      effective but very few clinical studies have been conducted to confirm them. Material\'s
      choice for inlay manufacturing is thus more country-based than evidence-based (Most french
      dentists choose composite while US dentists prefer ceramics for example). The main objective
      of this trial is to compare the clinical performance of ceramic and composite inlays/onlays.
      Other objectives include looking for the prognostic factors of these restorations and
      validating the criteria proposed by the World Dental Federation (FDI) to evaluate dental
      restorations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: FDI criteria for dental restorations assessment
time frame: at 2 years
description: 2 independent evaluators The primary outcome will consist in the FDI instrument for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010 . This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually.The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome.
measure: Restoration survival analysis
time frame: at 2 years
description: The primary outcome will consist in the FDI instrument for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010 . This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually.The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome.
measure: wear
time frame: at 2 years
description: The primary outcome will consist in the FDI instrument for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010 . This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually.The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome.
measure: overall quality of the restoration
time frame: at 2 years
description: The primary outcome will consist in the FDI instrument for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010 . This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually.The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome.
measure: FDI instrument validity data
time frame: at 2 years
description: The primary outcome will consist in the FDI instrument for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010 . This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually.The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome.
arm group label: ceramic
arm group type: Active Comparator
description: Leucite-reinforced glass ceramic (Empress CAD, Ivoclar Vivadent)
arm group label: composite
arm group type: Active Comparator
description: Nanohybrid composite resin (Lava Ultimate, 3M Espe)
intervention type: Device
intervention name: ceramic (Empress CAD, Ivoclar Vivadent)
description: Leucite-reinforced glass ceramic (Empress CAD, Ivoclar Vivadent)
arm group label: ceramic
intervention type: Device
intervention name: composite (Lava Ultimate, 3M Espe)
description: Nanohybrid composite resin (Lava Ultimate, 3M Espe)
arm group label: composite
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: hélène fron chabouis, DDS, MSc
role: Study Director
affiliation: APHP, Hôpital Charles Foix, Service d'odontologie, Ivry-sur-Seine, France ; Faculté de chirurgie dentaire, Service de biomatériaux (URB2i EA4462), Université Paris Descartes, Sorbonne Paris Cité, Montrouge, France.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
citation: Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Science Committee Project 2/98--FDI World Dental Federation study design (Part I) and criteria for evaluation (Part II) of direct and indirect restorations including onlays and partial crowns. J Adhes Dent. 2007;9 Suppl 1:121-47. Erratum In: J Adhes Dent. 2007 Dec;9(6):546.
PMID: 18341239
citation: Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
PMID: 20628774
responsible party type: Sponsor
mesh term: Dental Caries