<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/NCT03777449</url>
  </required_header>
  <id_info>
    <org_study_id>18002909-12/2018</org_study_id>
    <nct_id>NCT03777449</nct_id>
  </id_info>
  <brief_title>The Morphology of the Peri-Implantitis Defects: A Cone-Beam Computed Analysis</brief_title>
  <official_title>The Morphology of the Peri-Implantitis Defects: A Cone-Beam Computed</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To study the morphology of the peri-implant defects using cone-beam computed tomography based&#xD;
      on a priori case definition of peri-implantitis (≥3mm of radiographic bone loss +&#xD;
      inflammatory clinical parameters)&#xD;
&#xD;
      Diagnosis of peri-implantitis requires:&#xD;
&#xD;
        -  Presence of bleeding and/or suppuration on gentle probing.&#xD;
&#xD;
        -  Increased probing depth compared to previous examinations.&#xD;
&#xD;
        -  Presence of bone loss beyond crestal bone level changes resulting from initial bone&#xD;
           remodeling.&#xD;
&#xD;
      In the absence of previous examination data diagnosis of peri-implantitis can be based on the&#xD;
      combination of:&#xD;
&#xD;
        -  Presence of bleeding and/or suppuration on gentle probing.&#xD;
&#xD;
        -  Probing depths of ≥6 mm.&#xD;
&#xD;
        -  Bone levels ≥3 mm apical of the most coronal portion of the intraosseous part of the&#xD;
           implant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nowadays, several radiographic techniques are available to investigate the peri-implant bone&#xD;
      morphology by two-dimensional radiographs such as panoramic radiography and intraoral&#xD;
      radiography, or three-dimensional techniques such as computer tomography and cone beam&#xD;
      computer tomography (CBCT) (Harris et al. 2012). CBCT provides high-contrast 3D visualization&#xD;
      of bone beds; however, artifacts caused by the metallic character of implants could disguise&#xD;
      information around implants. The diagnostic outcomes of CBCT imaging of peri-implant bone&#xD;
      loss have been related to the type of study and defect morphology (Pelekos et al., 2018). The&#xD;
      ex vivo studies (cadaver models), considering sensitivity and specificity reported good&#xD;
      values for both circumferential and infrabony defects but lower for dehiscences&#xD;
      (de-Azevedo-Vaz et al., 2013, Kamburoglu et al., 2013). Contrastingly, CBCT imaging for&#xD;
      defect analysis in animal studies showed positive correlation with histology but tend to&#xD;
      overestimate (Fienitz et al., 2012, Golubovic et al., 2012) or underestimate (Corpas Ldos et&#xD;
      al., 2011, Ritter et al., 2014) the size of the defect. This variability in the measurement&#xD;
      is mainly dependent on the different configuration, location or size of the defect. and also&#xD;
      by the scattering, beam hardening artifacts, energy settings, exposure time, field of view.&#xD;
&#xD;
      Hence, it is aimed at assessing the morphology of the peri-implant defects using CBCT&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2018</start_date>
  <completion_date type="Actual">May 1, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Morphology</measure>
    <time_frame>6 months</time_frame>
    <description>Morphology of the peri-implant defects ivy number of existing bone walls present (1, 2, 3 or 4)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of the peri-implant bone loss</measure>
    <time_frame>6 months</time_frame>
    <description>Distance in mm from the top of the implant down to the defect base</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">47</enrollment>
  <condition>Peri-Implantitis</condition>
  <arm_group>
    <arm_group_label>Vertical bone loss</arm_group_label>
    <description>Infra-osseous defects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Horizontal bone loss</arm_group_label>
    <description>Supra-osseous defects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combined bone loss</arm_group_label>
    <description>Combined supra-osseous and infra-osseous defects</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>CBCT</intervention_name>
    <description>Patients will be taken a CBCT as a diagnostic tool to monitor peri-implant bone loss. This is a tool used on the daily basis for the evaluation of peri-implant bone loss. Patient will not be exposed to further radiation but the regular one.</description>
    <arm_group_label>Horizontal bone loss</arm_group_label>
    <arm_group_label>Vertical bone loss</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy partially/complete edentulous having previously received screw-retained implants&#xD;
        for oral rehabilitation for ≥3 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients between 18 and 80 years of age&#xD;
&#xD;
          -  Partial/complete edentulism missing one or more teeth and having it restored with&#xD;
             implant-supported prosthesis&#xD;
&#xD;
          -  No antibiotic in the last 2 months previous to examination&#xD;
&#xD;
          -  &gt;3 year after prosthesis delivery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled systemic disease&#xD;
&#xD;
          -  Cemented-retained restorations&#xD;
&#xD;
          -  Patients with uncontrolled/active periodontal disease in need of periodontal treatment&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Zygomatic implants&#xD;
&#xD;
          -  Implants placed in regenerated/augmented bone&#xD;
&#xD;
          -  Patients taking medications known to modify bone metabolism or known to have&#xD;
             degenerative diseases of bone (hyperparathyroidism, osteoporosis), vitamin D, patients&#xD;
             who had taken antibiotics, NSAIDS or corticosteroids for more than two weeks in the&#xD;
             past 3 months before examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>CICOM</name>
      <address>
        <city>Badajoz</city>
        <zip>06001</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>April 27, 2020</last_update_submitted>
  <last_update_submitted_qc>April 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 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>Peri-Implantitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03777449
org study id: 18002909-12/2018
nct id: NCT03777449
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To study the morphology of the peri-implant defects using cone-beam computed tomography based
      on a priori case definition of peri-implantitis (≥3mm of radiographic bone loss +
      inflammatory clinical parameters)

      Diagnosis of peri-implantitis requires:

        -  Presence of bleeding and/or suppuration on gentle probing.

        -  Increased probing depth compared to previous examinations.

        -  Presence of bone loss beyond crestal bone level changes resulting from initial bone
           remodeling.

      In the absence of previous examination data diagnosis of peri-implantitis can be based on the
      combination of:

        -  Presence of bleeding and/or suppuration on gentle probing.

        -  Probing depths of ≥6 mm.

        -  Bone levels ≥3 mm apical of the most coronal portion of the intraosseous part of the
           implant.
Nowadays, several radiographic techniques are available to investigate the peri-implant bone
      morphology by two-dimensional radiographs such as panoramic radiography and intraoral
      radiography, or three-dimensional techniques such as computer tomography and cone beam
      computer tomography (CBCT) (Harris et al. 2012). CBCT provides high-contrast 3D visualization
      of bone beds; however, artifacts caused by the metallic character of implants could disguise
      information around implants. The diagnostic outcomes of CBCT imaging of peri-implant bone
      loss have been related to the type of study and defect morphology (Pelekos et al., 2018). The
      ex vivo studies (cadaver models), considering sensitivity and specificity reported good
      values for both circumferential and infrabony defects but lower for dehiscences
      (de-Azevedo-Vaz et al., 2013, Kamburoglu et al., 2013). Contrastingly, CBCT imaging for
      defect analysis in animal studies showed positive correlation with histology but tend to
      overestimate (Fienitz et al., 2012, Golubovic et al., 2012) or underestimate (Corpas Ldos et
      al., 2011, Ritter et al., 2014) the size of the defect. This variability in the measurement
      is mainly dependent on the different configuration, location or size of the defect. and also
      by the scattering, beam hardening artifacts, energy settings, exposure time, field of view.

      Hence, it is aimed at assessing the morphology of the peri-implant defects using CBCT
observational model: Cohort
time perspective: Prospective
measure: Morphology
time frame: 6 months
description: Morphology of the peri-implant defects ivy number of existing bone walls present (1, 2, 3 or 4)
measure: Severity of the peri-implant bone loss
time frame: 6 months
description: Distance in mm from the top of the implant down to the defect base
arm group label: Vertical bone loss
description: Infra-osseous defects
arm group label: Horizontal bone loss
description: Supra-osseous defects
arm group label: Combined bone loss
description: Combined supra-osseous and infra-osseous defects
intervention type: Radiation
intervention name: CBCT
description: Patients will be taken a CBCT as a diagnostic tool to monitor peri-implant bone loss. This is a tool used on the daily basis for the evaluation of peri-implant bone loss. Patient will not be exposed to further radiation but the regular one.
arm group label: Horizontal bone loss
arm group label: Vertical bone loss
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Peri-Implantitis
sharing ipd: Undecided