<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/NCT03814655</url>
  </required_header>
  <id_info>
    <org_study_id>MINEC 2/2019</org_study_id>
    <nct_id>NCT03814655</nct_id>
  </id_info>
  <brief_title>Evaluation of the Accuracy of Full Digital Workflow for Guided Implant Surgery Using the R2 Gate Software</brief_title>
  <acronym>DIGIMPLGD</acronym>
  <official_title>Evaluation of the Accuracy of Full Digital Workflow for Guided Implant Surgery Using the R2 Gate Software - a Randomized Clinical Trial (RCT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Concordia Dent Srl</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Carol Davila University of Medicine and Pharmacy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>MINEC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Concordia Dent Srl</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 primary aim of the present study is to compare the accuracy of a full digital workflow&#xD;
      for dental implants insertion to a partially digital workflow, for a limited edentulous space&#xD;
      (1 to 3 dental units), in the maxilla or mandible.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Improvements of dental digital technologies are nowadays enabling clinicians to take the&#xD;
      digital impressions of the dental arches, therefore avoiding the use of conventional&#xD;
      impression materials. Digital impression procedures are claimed to be an approach to improve&#xD;
      the accuracy of dental restorations by minimizing the error prone to conventional impression&#xD;
      and gypsum model casting, enabling a high degree of standardization. Patients often prefer&#xD;
      intraoral scan when compared to the traditional impression. Digital impression is also&#xD;
      recommended when patients have remaining teeth that are extremely mobile or misaligned, due&#xD;
      to the risk of exfoliation during the conventional impression procedure.&#xD;
&#xD;
      Despite its poor scientific and clinical evidence, the use of digital technologies into the&#xD;
      daily practice registers a rapidly growing.&#xD;
&#xD;
      The precision of digital impressions depends on two different parameters: the resolution of&#xD;
      the optical scanning system, and the precision of the matching algorithm which may&#xD;
      significantly influence the precision of full arch scans. In order to minimize the effect of&#xD;
      matching artifacts, only small parts of the dental arch in close vicinity of the teeth are&#xD;
      recommended to be scanned.&#xD;
&#xD;
      For prosthetic restoration purpose, several studies regarding the accuracy of digital vs&#xD;
      analogue impression have been performed, but none comparing the accuracy of digital vs&#xD;
      partially digital workflow for prosthetically driven guided dental implant insertion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">July 13, 2020</completion_date>
  <primary_completion_date type="Actual">February 15, 2020</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>54 partially edentulous patients filling the inclusion criteria and with signed consent form are expected to be enrolled in this RCT.&#xD;
Each patient will be randomly assigned to one of the following protocol for dental implant insertion:&#xD;
Full digital workflow (n=27 patients/sites),&#xD;
Partially digital workflow (n=27 patients/sites).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of dental implant insertion</measure>
    <time_frame>6 weeks</time_frame>
    <description>Accuracy is described, by the International Organization for Standardization (ISO) standard 5725-1, through the use of two parameters: trueness and precision.&#xD;
Trueness refers to the deviation between the actual dimension of the measured object and the resulting measurement, while precision indicates how closely repeated the measurements in a set are.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Partially Edentulous Maxilla</condition>
  <condition>Partially Edentulous Mandible</condition>
  <arm_group>
    <arm_group_label>Full digital workflow</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intraoral scan of the partially edentulous site, antagonists and occlusion registration. Radiopaque tray customization over the partially edentulous arch.&#xD;
CBCT with customized radiopaque tray.&#xD;
Merging files in R2 Gate software and implant planning.&#xD;
Guided implant insertion with immediate loading, if possible. Megagen dental implants will be inserted.&#xD;
Digital impression for final screw-retained crown/bridge.&#xD;
Assessment of accuracy by comparing stl files (planned and postimplant insertion).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Partially digital workflow</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Impression of the edentulous arch and antagonist, occlusion registration. Radiopaque tray customization over the edentulous arch.&#xD;
CBCT with customized radiopaque tray.&#xD;
Stone models alone, maximum intercuspal position and customized radiopaque tray will be scanned using a desktop scanner.&#xD;
Merging files (CBCT and model stl) in R2 Gate software and implant planning.&#xD;
Guided implant insertion with immediate loading, if possible. Megagen dental implants will be inserted.&#xD;
Classic impression in customized tray with Impregum.&#xD;
Functional models will be scanned using the same desktop scanner.&#xD;
Final screw-retained crown/bridge manufacturing.&#xD;
Assessment of accuracy by comparing stl files (planned and postimplant insertion).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Full digital workflow</intervention_name>
    <description>Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be full digital.</description>
    <arm_group_label>Full digital workflow</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Partially digital workflow</intervention_name>
    <description>Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be partially digital.</description>
    <arm_group_label>Partially digital workflow</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Kennedy Class III partially edentulism with 3 or less missing teeth,&#xD;
&#xD;
          -  Good general health with no contraindications for implant surgery,&#xD;
&#xD;
          -  Acceptance of dental implant treatment,&#xD;
&#xD;
          -  Acceptance of 1 or 2 CBCTs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Limited bone volume with stadial bone graft requirement,&#xD;
&#xD;
          -  Limited mouth opening (impossible to use the surgical stent),&#xD;
&#xD;
          -  Parkinson disease (impossible to perform an accurate CBCT).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Corina Marilena Cristache, DMD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Carol Davila University of Medicine and Pharmacy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Concordia Dent Clinic</name>
      <address>
        <city>Bucharest</city>
        <zip>041335</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Carol Davila&quot;University of Medicine and Pharmacy</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <reference>
    <citation>Seelbach P, Brueckel C, Wostmann B. Accuracy of digital and conventional impression techniques and workflow. Clin Oral Investig. 2013 Sep;17(7):1759-64. doi: 10.1007/s00784-012-0864-4. Epub 2012 Oct 21.</citation>
    <PMID>23086333</PMID>
  </reference>
  <reference>
    <citation>Mehl A, Ender A, Mormann W, Attin T. Accuracy testing of a new intraoral 3D camera. Int J Comput Dent. 2009;12(1):11-28. English, German.</citation>
    <PMID>19213357</PMID>
  </reference>
  <reference>
    <citation>Pinto A, Raffone C. Postextraction computer-guided implant surgery in partially edentate patients with metal restorations: a case report. Oral Implantol (Rome). 2017 Apr 10;10(1):71-77. doi: 10.11138/orl/2017.10.1.071. eCollection 2017 Jan-Mar.</citation>
    <PMID>28757938</PMID>
  </reference>
  <reference>
    <citation>Joda T, Ferrari M, Braegger U. A digital approach for one-step formation of the supra-implant emergence profile with an individualized CAD/CAM healing abutment. J Prosthodont Res. 2016 Jul;60(3):220-3. doi: 10.1016/j.jpor.2016.01.005. Epub 2016 Feb 9.</citation>
    <PMID>26868927</PMID>
  </reference>
  <reference>
    <citation>Cristache CM, Gurbanescu S. Accuracy Evaluation of a Stereolithographic Surgical Template for Dental Implant Insertion Using 3D Superimposition Protocol. Int J Dent. 2017;2017:4292081. doi: 10.1155/2017/4292081. Epub 2017 May 7.</citation>
    <PMID>28555157</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Concordia Dent Srl</investigator_affiliation>
    <investigator_full_name>Corina Marilena Cristache</investigator_full_name>
    <investigator_title>Senior Lecturer, DMD, PhD, Dr. Habil., Oral and Maxillofacial Surgeon, Project responsable</investigator_title>
  </responsible_party>
  <keyword>Dental implants</keyword>
  <keyword>digital workflow</keyword>
  <keyword>guided surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth, Edentulous</mesh_term>
  </condition_browse>
  <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/NCT03814655
org study id: MINEC 2/2019
nct id: NCT03814655
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary aim of the present study is to compare the accuracy of a full digital workflow
      for dental implants insertion to a partially digital workflow, for a limited edentulous space
      (1 to 3 dental units), in the maxilla or mandible.
Improvements of dental digital technologies are nowadays enabling clinicians to take the
      digital impressions of the dental arches, therefore avoiding the use of conventional
      impression materials. Digital impression procedures are claimed to be an approach to improve
      the accuracy of dental restorations by minimizing the error prone to conventional impression
      and gypsum model casting, enabling a high degree of standardization. Patients often prefer
      intraoral scan when compared to the traditional impression. Digital impression is also
      recommended when patients have remaining teeth that are extremely mobile or misaligned, due
      to the risk of exfoliation during the conventional impression procedure.

      Despite its poor scientific and clinical evidence, the use of digital technologies into the
      daily practice registers a rapidly growing.

      The precision of digital impressions depends on two different parameters: the resolution of
      the optical scanning system, and the precision of the matching algorithm which may
      significantly influence the precision of full arch scans. In order to minimize the effect of
      matching artifacts, only small parts of the dental arch in close vicinity of the teeth are
      recommended to be scanned.

      For prosthetic restoration purpose, several studies regarding the accuracy of digital vs
      analogue impression have been performed, but none comparing the accuracy of digital vs
      partially digital workflow for prosthetically driven guided dental implant insertion.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 54 partially edentulous patients filling the inclusion criteria and with signed consent form are expected to be enrolled in this RCT.
Each patient will be randomly assigned to one of the following protocol for dental implant insertion:
Full digital workflow (n=27 patients/sites),
Partially digital workflow (n=27 patients/sites).
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Accuracy of dental implant insertion
time frame: 6 weeks
description: Accuracy is described, by the International Organization for Standardization (ISO) standard 5725-1, through the use of two parameters: trueness and precision.
Trueness refers to the deviation between the actual dimension of the measured object and the resulting measurement, while precision indicates how closely repeated the measurements in a set are.
arm group label: Full digital workflow
arm group type: Experimental
description: Intraoral scan of the partially edentulous site, antagonists and occlusion registration. Radiopaque tray customization over the partially edentulous arch.
CBCT with customized radiopaque tray.
Merging files in R2 Gate software and implant planning.
Guided implant insertion with immediate loading, if possible. Megagen dental implants will be inserted.
Digital impression for final screw-retained crown/bridge.
Assessment of accuracy by comparing stl files (planned and postimplant insertion).
arm group label: Partially digital workflow
arm group type: Active Comparator
description: Impression of the edentulous arch and antagonist, occlusion registration. Radiopaque tray customization over the edentulous arch.
CBCT with customized radiopaque tray.
Stone models alone, maximum intercuspal position and customized radiopaque tray will be scanned using a desktop scanner.
Merging files (CBCT and model stl) in R2 Gate software and implant planning.
Guided implant insertion with immediate loading, if possible. Megagen dental implants will be inserted.
Classic impression in customized tray with Impregum.
Functional models will be scanned using the same desktop scanner.
Final screw-retained crown/bridge manufacturing.
Assessment of accuracy by comparing stl files (planned and postimplant insertion).
intervention type: Procedure
intervention name: Full digital workflow
description: Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be full digital.
arm group label: Full digital workflow
intervention type: Procedure
intervention name: Partially digital workflow
description: Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be partially digital.
arm group label: Partially digital workflow
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Corina Marilena Cristache, DMD, PhD
role: Principal Investigator
affiliation: Carol Davila University of Medicine and Pharmacy
facility: 
facility: 
country: Romania
citation: Seelbach P, Brueckel C, Wostmann B. Accuracy of digital and conventional impression techniques and workflow. Clin Oral Investig. 2013 Sep;17(7):1759-64. doi: 10.1007/s00784-012-0864-4. Epub 2012 Oct 21.
PMID: 23086333
citation: Mehl A, Ender A, Mormann W, Attin T. Accuracy testing of a new intraoral 3D camera. Int J Comput Dent. 2009;12(1):11-28. English, German.
PMID: 19213357
citation: Pinto A, Raffone C. Postextraction computer-guided implant surgery in partially edentate patients with metal restorations: a case report. Oral Implantol (Rome). 2017 Apr 10;10(1):71-77. doi: 10.11138/orl/2017.10.1.071. eCollection 2017 Jan-Mar.
PMID: 28757938
citation: Joda T, Ferrari M, Braegger U. A digital approach for one-step formation of the supra-implant emergence profile with an individualized CAD/CAM healing abutment. J Prosthodont Res. 2016 Jul;60(3):220-3. doi: 10.1016/j.jpor.2016.01.005. Epub 2016 Feb 9.
PMID: 26868927
citation: Cristache CM, Gurbanescu S. Accuracy Evaluation of a Stereolithographic Surgical Template for Dental Implant Insertion Using 3D Superimposition Protocol. Int J Dent. 2017;2017:4292081. doi: 10.1155/2017/4292081. Epub 2017 May 7.
PMID: 28555157
responsible party type: Principal Investigator
investigator affiliation: Concordia Dent Srl
investigator full name: Corina Marilena Cristache
investigator title: Senior Lecturer, DMD, PhD, Dr. Habil., Oral and Maxillofacial Surgeon, Project responsable
mesh term: Mouth, Edentulous
sharing ipd: No