<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/NCT03018457</url>
  </required_header>
  <id_info>
    <org_study_id>1608111</org_study_id>
    <secondary_id>ANSM</secondary_id>
    <nct_id>NCT03018457</nct_id>
  </id_info>
  <brief_title>Evaluation of Trabecular Microarchitecture of the Alveolar Bone by Micro-computed Tomography and of Osseointegration of Dental Implants by Resonance Frequency Analysis</brief_title>
  <official_title>Evaluation of Trabecular Microarchitecture of the Alveolar Bone by Micro-computed Tomography and of Osseointegration of Dental Implants by Resonance Frequency Analysis: Correlation Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dental implants are a prosthetic rehabilitation device whose success depends of the bone&#xD;
      morphology and quality, in more the surgical procedure.&#xD;
&#xD;
      This study aims to assess whether the parameters of the trabecular microarchitecture of&#xD;
      alveolar bone taken from the site of the placement of the dental implant, calculated by&#xD;
      micro-CT are correlated with ISQ (implant stability quotient) using the Osstell according the&#xD;
      principle of the resonance frequency analysis at the 10th postoperative week during the&#xD;
      osseointegration of dental implants (secondary stability).&#xD;
&#xD;
      The cortical alveolar bone is a recognized factor in the phase of primary stability of&#xD;
      osseointegration. The role of trabecular bone in the secondary stability is not clearly&#xD;
      determined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to check whether the trabecular bone with its microarchitecture&#xD;
      plays a predictive role in osseointegration of dental implants precisely in its biological&#xD;
      stability phase or its secondary stability phase.&#xD;
&#xD;
      If this correlation is established, a larger study must be conducted to identify a profile of&#xD;
      patients at risk for failure of osseointegration of the dental implant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 5, 2017</start_date>
  <completion_date type="Actual">May 4, 2018</completion_date>
  <primary_completion_date type="Actual">May 4, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Implant Stability Quotient (ISQ)</measure>
    <time_frame>10 weeks</time_frame>
    <description>The Osstell is a portable hand instrument used to measure the stability of the dental implant according to the principle of the resonance frequency analysis. It is allow to measure the ISQ.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>volume fraction of the bone</measure>
    <time_frame>10 weeks</time_frame>
    <description>Measured by Scanco microscanner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>thickness between trabecular</measure>
    <time_frame>10 weeks</time_frame>
    <description>Measured by Scanco microscanner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thickness of trabecular</measure>
    <time_frame>10 weeks</time_frame>
    <description>Measured by Scanco microscanner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>trabecular separation</measure>
    <time_frame>10 weeks</time_frame>
    <description>Measured by Scanco microscanner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>trabecular number</measure>
    <time_frame>10 weeks</time_frame>
    <description>Measured by Scanco microscanner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>structural model index</measure>
    <time_frame>10 weeks</time_frame>
    <description>Measured by Scanco microscanner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>trabecular pattern factor</measure>
    <time_frame>10 weeks</time_frame>
    <description>Measured by Scanco microscanner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>connectivity density</measure>
    <time_frame>10 weeks</time_frame>
    <description>Measured by Scanco microscanner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>degree of anisotropy</measure>
    <time_frame>10 weeks</time_frame>
    <description>Measured by Scanco microscanner</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Dental Implant</condition>
  <arm_group>
    <arm_group_label>patients who need a dental implants</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ISQ</intervention_name>
    <description>Measured by Osstell.</description>
    <arm_group_label>patients who need a dental implants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who need a dental implant&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  affiliated patient or entitled to a social security scheme&#xD;
&#xD;
          -  requiring the installation of one or more dental implants&#xD;
&#xD;
          -  partial or total loss teeth, the height and width od the alveolar bone does not&#xD;
             require bone grafting or guides regeneration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient who underwent pre-implant surgery (bone grafting, elevation of the maxillary&#xD;
             sinus, guided regeneration)&#xD;
&#xD;
          -  patient under corticosteroid therapy in the long term&#xD;
&#xD;
          -  patient who benefited from the head and neck radiotherapy&#xD;
&#xD;
          -  patient under bisphosphonates intravenously treatment&#xD;
&#xD;
          -  all cases immediate implantation and extraction of all implant put into immediate&#xD;
             expenses&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thierry THOMAS, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU SAINT-ETIENNE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cabinet dentaire MOLIMARD</name>
      <address>
        <city>Le Puy En Velay</city>
        <zip>43000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>May 18, 2018</last_update_submitted>
  <last_update_submitted_qc>May 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Trabecular microarchitecture</keyword>
  <keyword>alveolar bone</keyword>
  <keyword>osseointegration</keyword>
  <keyword>dental implant</keyword>
  <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/NCT03018457
org study id: 1608111
secondary id: ANSM
nct id: NCT03018457
lead sponsor: 
has dmc: No
Dental implants are a prosthetic rehabilitation device whose success depends of the bone
      morphology and quality, in more the surgical procedure.

      This study aims to assess whether the parameters of the trabecular microarchitecture of
      alveolar bone taken from the site of the placement of the dental implant, calculated by
      micro-CT are correlated with ISQ (implant stability quotient) using the Osstell according the
      principle of the resonance frequency analysis at the 10th postoperative week during the
      osseointegration of dental implants (secondary stability).

      The cortical alveolar bone is a recognized factor in the phase of primary stability of
      osseointegration. The role of trabecular bone in the secondary stability is not clearly
      determined.
The aim of this study is to check whether the trabecular bone with its microarchitecture
      plays a predictive role in osseointegration of dental implants precisely in its biological
      stability phase or its secondary stability phase.

      If this correlation is established, a larger study must be conducted to identify a profile of
      patients at risk for failure of osseointegration of the dental implant.
observational model: Cohort
time perspective: Prospective
measure: Implant Stability Quotient (ISQ)
time frame: 10 weeks
description: The Osstell is a portable hand instrument used to measure the stability of the dental implant according to the principle of the resonance frequency analysis. It is allow to measure the ISQ.
measure: volume fraction of the bone
time frame: 10 weeks
description: Measured by Scanco microscanner
measure: thickness between trabecular
time frame: 10 weeks
description: Measured by Scanco microscanner
measure: Thickness of trabecular
time frame: 10 weeks
description: Measured by Scanco microscanner
measure: trabecular separation
time frame: 10 weeks
description: Measured by Scanco microscanner
measure: trabecular number
time frame: 10 weeks
description: Measured by Scanco microscanner
measure: structural model index
time frame: 10 weeks
description: Measured by Scanco microscanner
measure: trabecular pattern factor
time frame: 10 weeks
description: Measured by Scanco microscanner
measure: connectivity density
time frame: 10 weeks
description: Measured by Scanco microscanner
measure: degree of anisotropy
time frame: 10 weeks
description: Measured by Scanco microscanner
arm group label: patients who need a dental implants
intervention type: Device
intervention name: ISQ
description: Measured by Osstell.
arm group label: patients who need a dental implants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thierry THOMAS, MD PhD
role: Principal Investigator
affiliation: CHU SAINT-ETIENNE
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No