<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/NCT03307083</url>
  </required_header>
  <id_info>
    <org_study_id>CLIMAX</org_study_id>
    <nct_id>NCT03307083</nct_id>
  </id_info>
  <brief_title>Operating Check List During Consultation for Dental Implant</brief_title>
  <official_title>Operating Check List During Consultation for Dental Implant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</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>
      Various studies showed how extent elements not directly linked to the state of the patient&#xD;
      were involved in the failures in particular in surgery. That's why it's common to use check&#xD;
      list system to avoid human mistakes or any other situation which could impact on the surgery.&#xD;
&#xD;
      Here the study 's aim is to assess a tool set up by the Foundation for Oral Rehabilitation ;&#xD;
      it's a check list which cover all the treatment phases concerning dental implant surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 6, 2016</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of adverst events</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">140</enrollment>
  <condition>Dental Implant</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Check list FOR (Foundation for Oral Rehabilitation)</intervention_name>
    <description>the surgeon uses this check list during the pre surgery consultation</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient with dental implant surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusing the participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint Joseph</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>October 10, 2017</last_update_submitted>
  <last_update_submitted_qc>October 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2017</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/NCT03307083
org study id: CLIMAX
nct id: NCT03307083
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Various studies showed how extent elements not directly linked to the state of the patient
      were involved in the failures in particular in surgery. That's why it's common to use check
      list system to avoid human mistakes or any other situation which could impact on the surgery.

      Here the study 's aim is to assess a tool set up by the Foundation for Oral Rehabilitation ;
      it's a check list which cover all the treatment phases concerning dental implant surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: number of adverst events
time frame: 1 year
intervention type: Other
intervention name: Check list FOR (Foundation for Oral Rehabilitation)
description: the surgeon uses this check list during the pre surgery consultation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor