<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/NCT03764176</url>
  </required_header>
  <id_info>
    <org_study_id>H1497613138277</org_study_id>
    <nct_id>NCT03764176</nct_id>
  </id_info>
  <brief_title>Accuracy of Computer-assisted Template-based Implant Placement Using Conventional or Digital Impression</brief_title>
  <official_title>Accuracy of Computer-assisted Template-based Implant Placement Using Conventional Impression and Scan Model or Digital Impression: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Valencia</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>
      Proper implant position has a significant impact in esthetic and functional outcomes of&#xD;
      implant-supported restorations. Computer-assisted template-based implant placement (guided&#xD;
      surgery) have become increasingly popular due to improved planning and the higher transfer&#xD;
      accuracy of the virtual plan to the surgical site compared with freehand insertion or&#xD;
      freehand final drilling. Digital impressions replace the need for traditional materials that&#xD;
      can be inconvenient and messy for patients. To the best of our knowledge, at the time of&#xD;
      planning this study, there were no published RCTs evaluating a fully digital approach for&#xD;
      computer-assisted template-based implant placement.&#xD;
&#xD;
      The aim of the present study is to compare early implant failure, template-related&#xD;
      complications, and virtual planning accuracy of computer-assisted template-based implant&#xD;
      placement using conventional impression and scan model or digital impression.&#xD;
&#xD;
      The null hypothesis is that there will be no difference between these interventions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 8, 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Linear distance between planned and real implant apex position</measure>
    <time_frame>Immediate post-surgery</time_frame>
    <description>The change in mm between the apex of the planned and the final (real) position of the implant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Angle between the planned and real implant axis</measure>
    <time_frame>Immediate post-surgery</time_frame>
    <description>Change in angulation between the planned and the final (real) position of the implant.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Dental Implant Failure</condition>
  <arm_group>
    <arm_group_label>Conventional impression</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The intervention of this arm will be &quot;conventional impression&quot;: polyether impression will be taken with a customized tray.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Digital impression</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention of this arm will be &quot;digital impression&quot;: digital impression will be taken using a CS 3600 intraoral scanner .</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional impressions</intervention_name>
    <description>In the conventional group, a polyether impression (ImpregumTM, 3M ESPE, Seefeld, Germany) will be taken with a customized tray (Diatray Top, Dental Kontor, Stockelsdorf, Germany). The impression will be poured with Gypsum IV Class Scale 5° (T6, Techim, Techim Group s.r.l., Arese, Italy) and then, the models mounted in a fully adjustable articulator (Protar Evo 7, KaVo Dental, Biberach, Germany). Afterwards, a dental wax-up will be made accordingly to the functional and esthetic requirements. Finally, master model and wax-up will be digitalized by using a lab scanner.&#xD;
A surgical template will be derived from the mounted casts (conventional group) and used to place the implants using guided surgery.</description>
    <arm_group_label>Conventional impression</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Digital impressions</intervention_name>
    <description>Patients will be randomly assigned to undergo intraoral digital impression (digital group) or conventional impression (conventional group). In the digital group, a digital impression will be taken using CS 3600 intraoral scanner (Carestream Dental LLC, Atlanta, GA, USA). The digital data (STL, STereo Lithography interface format) will be imported in a 3D design software to realize a virtual wax-up according to the functional and esthetic requirements.&#xD;
A surgical template will be derived from the virtual plane (digital group) and used to place the implants using guided surgery.</description>
    <arm_group_label>Digital impression</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  fully or partially edentulous patient, aged 18 years or older, able to sign an&#xD;
             informed consent, in need of an implant-supported fixed restoration will be considered&#xD;
             eligible for this study. Any potential implant locations based on individual patient&#xD;
             requirements will be considered eligible in the present trial. No set location or&#xD;
             group of locations will be excluded.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  general medical contraindication to oral surgery (American Society of&#xD;
             Anesthesiologist, ASA, class III or IV); irradiation in the head and neck area less&#xD;
             than one year before implantation; psychiatric problems; alcohol or drug abuse;&#xD;
             pregnant or nursing; untreated periodontitis; severe bruxism or clenching;&#xD;
             uncontrolled diabetes; poor oral hygiene and motivation; and inability to complete the&#xD;
             follow-up.&#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_contact>
    <last_name>David Peñarrocha Oltra</last_name>
    <phone>649952560</phone>
    <email>dpenarrocha@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Peñarrocha Oltra</last_name>
      <phone>649952560</phone>
      <email>david.penarrocha@uv.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Valencia</investigator_affiliation>
    <investigator_full_name>David Peñarrocha Oltra</investigator_full_name>
    <investigator_title>Assistant Postdoctoral Lecturer (Profesor Ayudante Doctor)</investigator_title>
  </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/NCT03764176
org study id: H1497613138277
nct id: NCT03764176
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Proper implant position has a significant impact in esthetic and functional outcomes of
      implant-supported restorations. Computer-assisted template-based implant placement (guided
      surgery) have become increasingly popular due to improved planning and the higher transfer
      accuracy of the virtual plan to the surgical site compared with freehand insertion or
      freehand final drilling. Digital impressions replace the need for traditional materials that
      can be inconvenient and messy for patients. To the best of our knowledge, at the time of
      planning this study, there were no published RCTs evaluating a fully digital approach for
      computer-assisted template-based implant placement.

      The aim of the present study is to compare early implant failure, template-related
      complications, and virtual planning accuracy of computer-assisted template-based implant
      placement using conventional impression and scan model or digital impression.

      The null hypothesis is that there will be no difference between these interventions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Linear distance between planned and real implant apex position
time frame: Immediate post-surgery
description: The change in mm between the apex of the planned and the final (real) position of the implant.
measure: Angle between the planned and real implant axis
time frame: Immediate post-surgery
description: Change in angulation between the planned and the final (real) position of the implant.
arm group label: Conventional impression
arm group type: Active Comparator
description: The intervention of this arm will be "conventional impression": polyether impression will be taken with a customized tray.
arm group label: Digital impression
arm group type: Experimental
description: The intervention of this arm will be "digital impression": digital impression will be taken using a CS 3600 intraoral scanner .
intervention type: Procedure
intervention name: Conventional impressions
description: In the conventional group, a polyether impression (ImpregumTM, 3M ESPE, Seefeld, Germany) will be taken with a customized tray (Diatray Top, Dental Kontor, Stockelsdorf, Germany). The impression will be poured with Gypsum IV Class Scale 5° (T6, Techim, Techim Group s.r.l., Arese, Italy) and then, the models mounted in a fully adjustable articulator (Protar Evo 7, KaVo Dental, Biberach, Germany). Afterwards, a dental wax-up will be made accordingly to the functional and esthetic requirements. Finally, master model and wax-up will be digitalized by using a lab scanner.
A surgical template will be derived from the mounted casts (conventional group) and used to place the implants using guided surgery.
arm group label: Conventional impression
intervention type: Procedure
intervention name: Digital impressions
description: Patients will be randomly assigned to undergo intraoral digital impression (digital group) or conventional impression (conventional group). In the digital group, a digital impression will be taken using CS 3600 intraoral scanner (Carestream Dental LLC, Atlanta, GA, USA). The digital data (STL, STereo Lithography interface format) will be imported in a 3D design software to realize a virtual wax-up according to the functional and esthetic requirements.
A surgical template will be derived from the virtual plane (digital group) and used to place the implants using guided surgery.
arm group label: Digital impression
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Peñarrocha Oltra
phone: 649952560
email: dpenarrocha@gmail.com
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Valencia
investigator full name: David Peñarrocha Oltra
investigator title: Assistant Postdoctoral Lecturer (Profesor Ayudante Doctor)