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/NCT06001515</url>
    </required_header>
    <id_info>
      <org_study_id>FDASU-RecID012328</org_study_id>
      <nct_id>NCT06001515</nct_id>
    </id_info>
    <brief_title>Effect of Face Scanning on Accuracy of Dental Implant Placement in Fixed Implant Supported Maxillary Prostheses</brief_title>
    <official_title>Effect of Face Scanning on Accuracy of Dental Implant Placement in Fixed Implant Supported Maxillary Prostheses</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study will compare the accuracy of surgical guides fabricated by two different scanning&#xD;
        protocols; facially driven scanning versus dual scanning protocol regarding the deviation of&#xD;
        implant placement.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Twelve completely edentulous patients will be selected for full arch maxillary guided&#xD;
        implants placement with immediately loaded restoration. The patients will make a complete&#xD;
        oral and radiographic examination before inclusion in this study. All patients will receive&#xD;
        maxillary and mandibular complete dentures that will be made in a conventional way. The&#xD;
        patients will be randomly divided into two equal groups; group (I) and group (II). In both&#xD;
        groups two CBCT scans will be made. A CBCT scan will be made for each patient while wearing&#xD;
        the radiographic stent and another CBCT scan will be made for the radiographic stent alone.&#xD;
        However, for patients in group II a face scan will be added to previous scans. For each&#xD;
        patient in group I, the DICOM files will be exported to Blue Sky implant designing software&#xD;
        (Langenhagener, Mdi Europa GmbH), fusion of the scan prosthesis via the markers is&#xD;
        accomplished and the ideal surgical site and optimal implant dimensions will be selected. All&#xD;
        the surgical guides will be planned to be totally limiting in this study. The immediate&#xD;
        provisional restoration will be planned on the software according to the previously planned&#xD;
        implants sites. The surgical guide will be 3D printed. The approved tooth arrangement will be&#xD;
        subsequently sent as an STL file to a milling machine. For each patient in group II, the&#xD;
        DICOM files and the STL files obtained from the face scans will be exported to Blue Sky&#xD;
        implant designing software (Langenhagener, Mdi Europa GmbH). The facial scan will be used to&#xD;
        define the interpupillary and midsagittal planes and to examine the tooth form and buccal&#xD;
        corridor width with regard to the patient's smile line. Both files data will be superimposed&#xD;
        and the planning for the implants sites, surgical guide and immediate restoration will be&#xD;
        done as in group I. After implant insertion, CBCT scan will be made for each patient while&#xD;
        wearing the scan appliance. Superimposition of CBCT scans pre and post implant insertion and&#xD;
        restoration will be made. Deviations between planned and placed implant will be measured in&#xD;
        the lateral apical, lateral coronal and angular aspects. Also, the patient satisfaction will&#xD;
        be measured on a likert scale.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</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>one experimental group and one active comparator group</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <masking_description>Triple blinded</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>( Assessment of linear deviation</measure>
      <time_frame>1day</time_frame>
      <description>Accurate details recorded by superimposition of CBCTs using the blue sky software program by measuring the lateral coronal deviation in millimeters.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>( Assessment of linear deviation</measure>
      <time_frame>1day</time_frame>
      <description>Accurate details recorded by superimposition of CBCTs using the blue sky software program by measuring the lateral apical deviation in millimeter.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>( Assessment of angular deviation</measure>
      <time_frame>1day</time_frame>
      <description>Accurate details recorded by superimposition of CBCTs using the blue sky software program by measuring the angular deviation in degrees.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>patient satisfaction</measure>
      <time_frame>1 day</time_frame>
      <description>Accurate details recorded by using a 5 points likert scale for measuring the patient satisfaction by filling specific questionnaire: Oral Health Impact Profile 14 questions ( OHIP-14) and taking the answer of each question on a 5 point likert scale with 0 for the worst score and 5 for the best one</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Computer-Assisted Surgery</condition>
    <arm_group>
      <arm_group_label>Dual scan protocol</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Two CBCT scans will be made.One while the patient wearing the radiographic stent and another CBCT for the radiographic stent alone.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dual scan protocol +3D facial scan record</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>3D face scan record will be made plus Two CBCT scans. One while the patient wearing the radiographic stent and another CBCT for the radiographic stent alone.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Dual scan protocol</intervention_name>
      <description>one CBCT scan for the patient while wearing the scan appliance and another scan for the appliance alone</description>
      <arm_group_label>Dual scan protocol</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>triple scan protocol</intervention_name>
      <description>3D facial Scanning for the patients while wearing their dentures in addition to the dual scan protocol</description>
      <arm_group_label>Dual scan protocol +3D facial scan record</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - The inclusion criteria will be completely edentulous patients, non-smokers, 50-70 years&#xD;
          in age, have Good oral hygiene and motivation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The excluded patients will include patients with major systemic diseases that may&#xD;
               affect osseointegration as uncontrolled diabetes mellitus, the need for extensive bone&#xD;
               grafting in planned implant site, pregnancy, patients under bisphosphonate treatment,&#xD;
               and limited mouth-opening for executing the guided implant surgery.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Noha H Nawar, BDS MSc MD</last_name>
      <role>Study Director</role>
      <affiliation>Ain Shams University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dina Abd Elmoez, BDS MSc</last_name>
      <phone>01030762236</phone>
      <email>Dodo1992am@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ahmed Mostafa, BDS MSc MD</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Faculty of Dentistry Ain Shams University</name>
        <address>
          <city>Cairo</city>
          <zip>11361</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ahmed Abdelfattah, BSc, MSc, MD</last_name>
        <phone>01111191337</phone>
        <email>ahmedmostafa@dent.asu.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams University</investigator_affiliation>
      <investigator_full_name>Dina Abdelmoez</investigator_full_name>
      <investigator_title>assistant lecturer of oral and maxillofacial prosthodontics</investigator_title>
    </responsible_party>
    <keyword>guided implant placement- face scanning - edentulous maxilla</keyword>
    <!-- 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/NCT06001515
  org study id: FDASU-RecID012328
  nct id: NCT06001515
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The study will compare the accuracy of surgical guides fabricated by two different scanning
        protocols; facially driven scanning versus dual scanning protocol regarding the deviation of
        implant placement.
  Twelve completely edentulous patients will be selected for full arch maxillary guided
        implants placement with immediately loaded restoration. The patients will make a complete
        oral and radiographic examination before inclusion in this study. All patients will receive
        maxillary and mandibular complete dentures that will be made in a conventional way. The
        patients will be randomly divided into two equal groups; group (I) and group (II). In both
        groups two CBCT scans will be made. A CBCT scan will be made for each patient while wearing
        the radiographic stent and another CBCT scan will be made for the radiographic stent alone.
        However, for patients in group II a face scan will be added to previous scans. For each
        patient in group I, the DICOM files will be exported to Blue Sky implant designing software
        (Langenhagener, Mdi Europa GmbH), fusion of the scan prosthesis via the markers is
        accomplished and the ideal surgical site and optimal implant dimensions will be selected. All
        the surgical guides will be planned to be totally limiting in this study. The immediate
        provisional restoration will be planned on the software according to the previously planned
        implants sites. The surgical guide will be 3D printed. The approved tooth arrangement will be
        subsequently sent as an STL file to a milling machine. For each patient in group II, the
        DICOM files and the STL files obtained from the face scans will be exported to Blue Sky
        implant designing software (Langenhagener, Mdi Europa GmbH). The facial scan will be used to
        define the interpupillary and midsagittal planes and to examine the tooth form and buccal
        corridor width with regard to the patient's smile line. Both files data will be superimposed
        and the planning for the implants sites, surgical guide and immediate restoration will be
        done as in group I. After implant insertion, CBCT scan will be made for each patient while
        wearing the scan appliance. Superimposition of CBCT scans pre and post implant insertion and
        restoration will be made. Deviations between planned and placed implant will be measured in
        the lateral apical, lateral coronal and angular aspects. Also, the patient satisfaction will
        be measured on a likert scale.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: one experimental group and one active comparator group
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  masking description: Triple blinded
  measure: ( Assessment of linear deviation
  time frame: 1day
  description: Accurate details recorded by superimposition of CBCTs using the blue sky software program by measuring the lateral coronal deviation in millimeters.
  measure: ( Assessment of linear deviation
  time frame: 1day
  description: Accurate details recorded by superimposition of CBCTs using the blue sky software program by measuring the lateral apical deviation in millimeter.
  measure: ( Assessment of angular deviation
  time frame: 1day
  description: Accurate details recorded by superimposition of CBCTs using the blue sky software program by measuring the angular deviation in degrees.
  measure: patient satisfaction
  time frame: 1 day
  description: Accurate details recorded by using a 5 points likert scale for measuring the patient satisfaction by filling specific questionnaire: Oral Health Impact Profile 14 questions ( OHIP-14) and taking the answer of each question on a 5 point likert scale with 0 for the worst score and 5 for the best one
  arm group label: Dual scan protocol
  arm group type: Active Comparator
  description: Two CBCT scans will be made.One while the patient wearing the radiographic stent and another CBCT for the radiographic stent alone.
  arm group label: Dual scan protocol +3D facial scan record
  arm group type: Experimental
  description: 3D face scan record will be made plus Two CBCT scans. One while the patient wearing the radiographic stent and another CBCT for the radiographic stent alone.
  intervention type: Device
  intervention name: Dual scan protocol
  description: one CBCT scan for the patient while wearing the scan appliance and another scan for the appliance alone
  arm group label: Dual scan protocol
  intervention type: Device
  intervention name: triple scan protocol
  description: 3D facial Scanning for the patients while wearing their dentures in addition to the dual scan protocol
  arm group label: Dual scan protocol +3D facial scan record
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Noha H Nawar, BDS MSc MD
  role: Study Director
  affiliation: Ain Shams University
  last name: Dina Abd Elmoez, BDS MSc
  phone: 01030762236
  email: Dodo1992am@gmail.com
  last name: Ahmed Mostafa, BDS MSc MD
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams University
  investigator full name: Dina Abdelmoez
  investigator title: assistant lecturer of oral and maxillofacial prosthodontics