xml: <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/NCT05972148</url>
    </required_header>
    <id_info>
      <org_study_id>IRB18-0660</org_study_id>
      <nct_id>NCT05972148</nct_id>
    </id_info>
    <brief_title>Precision of Complete-arch Digital Implant Impressions With Intraoral Scanning Versus Photogrammetry</brief_title>
    <official_title>The Accuracy of Intraoral Scanning and Photogrammetry on the Clinical Fit of Long-span Frameworks</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>William Negreiros</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>ITI International Team for Implantology, Switzerland</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Harvard School of Dental Medicine</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>
        The goal of this cross-over clinical trial is to investigate the precision of digital implant&#xD;
        impressions using an intraoral scanner and photogrammetry in obtaining complete-arch&#xD;
        implant-supported scans.&#xD;
  &#xD;
        The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  Is there a difference in precision between intraoral scans and photogrammetry in&#xD;
             obtaining digital implant scans?&#xD;
  &#xD;
          -  Will arch perimeter and jaw type (maxilla vs. mandible) affect the precision results?&#xD;
  &#xD;
        Procedures: At each appointment, participants existing permanent/temporary prosthesis or&#xD;
        healing caps were unscrewed and temporarily removed for the period of the consultation&#xD;
        appointment.&#xD;
  &#xD;
        Scanbodies were screwed into their implants for the duration of the appointment.&#xD;
  &#xD;
        They underwent two types of digital implant impression procedures (five times each),&#xD;
        including intraoral scan and photogrammetry.&#xD;
  &#xD;
        Intraoral and extraoral photography were taken.&#xD;
  &#xD;
        At the end of each appointment, the scanbodies were removed, and existing bridge/healing caps&#xD;
        were reinserted.&#xD;
  &#xD;
        The procedures were not painful or required any form of local anesthetic&#xD;
  &#xD;
        Comparison group: Researchers compared the precision of intraoral scanning vs. photogrammetry&#xD;
        to see which device provided the best precision outcomes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 12, 2019</start_date>
    <completion_date type="Actual">May 2, 2022</completion_date>
    <primary_completion_date type="Actual">September 20, 2020</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To investigate the precision of intraoral scanner compared with photogrammetry in performing complete-arch digital implant impressions</measure>
      <time_frame>During procedure [two hours]</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">22</enrollment>
    <condition>Edentulous Jaw</condition>
    <arm_group>
      <arm_group_label>Intraoral Scanning</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Photogrammetry Scanning</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Digital scanning</intervention_name>
      <description>Five intraoral scans, one for each arch before the insertion of scanbodies, were obtained. The implant locations were then marked, and the software trimmed a 6mm diameter circular section of the scan from the implant locations to allow the scanbodies to be added. Abutment-level polyetheretherketone (PEEK) scanbodies were hand-tightened onto each implant and not moved for the remainder of the scans. Scanbodies were scanned using a circular scan path, and scanning was finalized.</description>
      <arm_group_label>Intraoral Scanning</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Photogrammetry</intervention_name>
      <description>Rectangular-shaped titanium photogrammetry scanbodies were hand-tightened onto the Implants. Scanbodies were not moved before completing all scans for each arch. A total of five scans of each arch were obtained using a photogrammetry device. Measurements were successfully recorded by turning them green on the computer screen.</description>
      <arm_group_label>Photogrammetry Scanning</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Present with a completely edentulous arch with at least four implants&#xD;
  &#xD;
            -  Have bone-level implants&#xD;
  &#xD;
            -  Intended for restoration with a screw-retained abutment-level fixed implant-supported&#xD;
               prosthesis.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients unable to tolerate the digital scans impressions&#xD;
  &#xD;
            -  Presented with implants other than bone-level platforms&#xD;
  &#xD;
            -  Not intended for restorations with screw-retained abutment-level fixed&#xD;
               implant-supported prosthesis&#xD;
  &#xD;
            -  Not completely edentulous.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>German O Gallucci, DMD</last_name>
      <role>Study Chair</role>
      <affiliation>Harvard School of Dental Medicine</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Harvard School of Dental Medicine</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02115</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Harvard School of Dental Medicine</investigator_affiliation>
      <investigator_full_name>William Negreiros</investigator_full_name>
      <investigator_title>Research Associate</investigator_title>
    </responsible_party>
    <keyword>edentulous/edentulism</keyword>
    <keyword>CAD-CAM</keyword>
    <keyword>implantology</keyword>
    <keyword>prosthetic dentistry</keyword>
    <keyword>clinical studies/trial</keyword>
    <keyword>clinical outcomes</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Jaw, Edentulous</mesh_term>
      <mesh_term>Mouth, Edentulous</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There are no plans for IPD sharing because the study is complete.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05972148
  org study id: IRB18-0660
  nct id: NCT05972148
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this cross-over clinical trial is to investigate the precision of digital implant
        impressions using an intraoral scanner and photogrammetry in obtaining complete-arch
        implant-supported scans.
  
        The main question[s] it aims to answer are:
  
          -  Is there a difference in precision between intraoral scans and photogrammetry in
             obtaining digital implant scans?
  
          -  Will arch perimeter and jaw type (maxilla vs. mandible) affect the precision results?
  
        Procedures: At each appointment, participants existing permanent/temporary prosthesis or
        healing caps were unscrewed and temporarily removed for the period of the consultation
        appointment.
  
        Scanbodies were screwed into their implants for the duration of the appointment.
  
        They underwent two types of digital implant impression procedures (five times each),
        including intraoral scan and photogrammetry.
  
        Intraoral and extraoral photography were taken.
  
        At the end of each appointment, the scanbodies were removed, and existing bridge/healing caps
        were reinserted.
  
        The procedures were not painful or required any form of local anesthetic
  
        Comparison group: Researchers compared the precision of intraoral scanning vs. photogrammetry
        to see which device provided the best precision outcomes.
  allocation: Non-Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: To investigate the precision of intraoral scanner compared with photogrammetry in performing complete-arch digital implant impressions
  time frame: During procedure [two hours]
  arm group label: Intraoral Scanning
  arm group type: Active Comparator
  arm group label: Photogrammetry Scanning
  arm group type: Experimental
  intervention type: Other
  intervention name: Digital scanning
  description: Five intraoral scans, one for each arch before the insertion of scanbodies, were obtained. The implant locations were then marked, and the software trimmed a 6mm diameter circular section of the scan from the implant locations to allow the scanbodies to be added. Abutment-level polyetheretherketone (PEEK) scanbodies were hand-tightened onto each implant and not moved for the remainder of the scans. Scanbodies were scanned using a circular scan path, and scanning was finalized.
  arm group label: Intraoral Scanning
  intervention type: Other
  intervention name: Photogrammetry
  description: Rectangular-shaped titanium photogrammetry scanbodies were hand-tightened onto the Implants. Scanbodies were not moved before completing all scans for each arch. A total of five scans of each arch were obtained using a photogrammetry device. Measurements were successfully recorded by turning them green on the computer screen.
  arm group label: Photogrammetry Scanning
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: German O Gallucci, DMD
  role: Study Chair
  affiliation: Harvard School of Dental Medicine
  facility: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: Harvard School of Dental Medicine
  investigator full name: William Negreiros
  investigator title: Research Associate
  mesh term: Jaw, Edentulous
  mesh term: Mouth, Edentulous
  sharing ipd: No
  ipd description: There are no plans for IPD sharing because the study is complete.