<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/NCT04475913</url>
  </required_header>
  <id_info>
    <org_study_id>5</org_study_id>
    <nct_id>NCT04475913</nct_id>
  </id_info>
  <brief_title>Digital vs Analog Impression in Cases of All-on-4 - Prosthesis</brief_title>
  <official_title>In a Post -Covid-19 World, What is the Clinical Influence of Digital vs Analog Impression in Cases of All-on-4 - Prosthesis ?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>October University for Modern Sciences and Arts</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>October University for Modern Sciences and Arts</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>
      Fifty six patients were randomly enrolled in the study. Participants were randomly stratified&#xD;
      into two control groups and two test groups, from which conventional pick up and digital&#xD;
      impressions were made respectively. Patients of group 1 (CIG Axial) and 3 (DIG Axial)&#xD;
      received 4 axial implants whereas, group 2 patients (CIG Tilted), and group 4 (DIG Tilted)&#xD;
      received two anterior axial implants and two distal tilted implants.&#xD;
&#xD;
      All participants received hybrid dentures. Bone loss, implant loss, maintenance of prosthesis&#xD;
      were evaluated at 6m,12m, and 24 months follow up period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 11, 2018</start_date>
  <completion_date type="Actual">August 20, 2020</completion_date>
  <primary_completion_date type="Actual">July 11, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>implant loss</measure>
    <time_frame>24 months</time_frame>
    <description>The implants were considered surviving if they were clinically stable and functioning without any mobility. Failure was defined removal of implants due to loss of integration, pain, implant mobility, paraesthesia, neuropathies or psychological reasons. Calculation of the estimated failure rate was performed by dividing the number of implant failures by the total exposure time of the implant. The total exposure time is the interval of time the implants could be followed for the entire observation time or up to failure of the implants that were lost during the follow-up period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>crestal bone loss</measure>
    <time_frame>24 months</time_frame>
    <description>Standardized periapical radiographs with long cone paralleling technique using film holders were used for the assessment of crestal bone loss. The loss of marginal bone relative to the implant shoulder at the mesial and distal of each implant was measured in mm and then the mean was calculated and statistically estimated. A digital intraoral imaging system was used (Digora phosphor plate reader, Soredex Tuusula, Finland). All the radiographs were scanned and then uploaded into the computer for assessing bone loss over time. The &quot;ImageJ&quot; software was used to take the measurements on the computer screen. Postoperative radiographs with the implants placed at the crest of the bone were compared with the 6,12 and 24 m radiographs.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>maintenance</measure>
    <time_frame>24 months</time_frame>
    <description>During the follow-up period, prosthodontic (mechanical) complications for the four groups were registered and calculated according to the following events: number of screw loosening or screw fracture of the abutment, number of screw loosening or screw fracture of the prosthesis, number of framework fracture, fractured acrylic resin, number of prosthetic teeth fracture and loss of cover of access hole.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Edentulous Mouth</condition>
  <arm_group>
    <arm_group_label>(CIG Axial)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>received 4 axial implants and conventional impression</description>
  </arm_group>
  <arm_group>
    <arm_group_label>(DIG Axial)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>received 4 axial implants and digital impression</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CIG Tilted</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>received two anterior axial implants and two distal tilted implants, and conventional impression</description>
  </arm_group>
  <arm_group>
    <arm_group_label>(DIG Tilted)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>received two anterior axial implants and two distal tilted implants, and digital impression</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DIG Axial</intervention_name>
    <description>patients received 4 axial implants and digital impression</description>
    <arm_group_label>(CIG Axial)</arm_group_label>
    <arm_group_label>(DIG Tilted)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DIG Tilted</intervention_name>
    <description>received two anterior axial implants and two distal tilted implants, and digital impression</description>
    <arm_group_label>(DIG Axial)</arm_group_label>
    <arm_group_label>CIG Tilted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CIG Axial</intervention_name>
    <description>patients received 4 axial implants and conventional impression</description>
    <arm_group_label>(DIG Axial)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CIG Tilted</intervention_name>
    <description>received two anterior axial implants and two distal tilted implants, and conventional impression</description>
    <arm_group_label>(DIG Tilted)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  completely edentulous patients with age range from 50-65 years.&#xD;
&#xD;
          -  physically and psychologically eligible participants for implants placement.&#xD;
&#xD;
          -  adequate bone to receive 4 interforaminal implants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        participants were excluded if&#xD;
&#xD;
          -  medical conditions that precludes implants placement&#xD;
&#xD;
          -  smokers&#xD;
&#xD;
          -  patients suffering from any parafunctional habits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dina Elawady</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lecturer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OctoberUMSA</name>
      <address>
        <city>Giza</city>
        <zip>12451</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>February 24, 2021</last_update_submitted>
  <last_update_submitted_qc>February 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>impressions</keyword>
  <keyword>analogue</keyword>
  <keyword>digital</keyword>
  <keyword>All-on-Four</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth, Edentulous</mesh_term>
  </condition_browse>
  <!-- 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/NCT04475913
org study id: 5
nct id: NCT04475913
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Fifty six patients were randomly enrolled in the study. Participants were randomly stratified
      into two control groups and two test groups, from which conventional pick up and digital
      impressions were made respectively. Patients of group 1 (CIG Axial) and 3 (DIG Axial)
      received 4 axial implants whereas, group 2 patients (CIG Tilted), and group 4 (DIG Tilted)
      received two anterior axial implants and two distal tilted implants.

      All participants received hybrid dentures. Bone loss, implant loss, maintenance of prosthesis
      were evaluated at 6m,12m, and 24 months follow up period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: implant loss
time frame: 24 months
description: The implants were considered surviving if they were clinically stable and functioning without any mobility. Failure was defined removal of implants due to loss of integration, pain, implant mobility, paraesthesia, neuropathies or psychological reasons. Calculation of the estimated failure rate was performed by dividing the number of implant failures by the total exposure time of the implant. The total exposure time is the interval of time the implants could be followed for the entire observation time or up to failure of the implants that were lost during the follow-up period.
measure: crestal bone loss
time frame: 24 months
description: Standardized periapical radiographs with long cone paralleling technique using film holders were used for the assessment of crestal bone loss. The loss of marginal bone relative to the implant shoulder at the mesial and distal of each implant was measured in mm and then the mean was calculated and statistically estimated. A digital intraoral imaging system was used (Digora phosphor plate reader, Soredex Tuusula, Finland). All the radiographs were scanned and then uploaded into the computer for assessing bone loss over time. The "ImageJ" software was used to take the measurements on the computer screen. Postoperative radiographs with the implants placed at the crest of the bone were compared with the 6,12 and 24 m radiographs.
measure: maintenance
time frame: 24 months
description: During the follow-up period, prosthodontic (mechanical) complications for the four groups were registered and calculated according to the following events: number of screw loosening or screw fracture of the abutment, number of screw loosening or screw fracture of the prosthesis, number of framework fracture, fractured acrylic resin, number of prosthetic teeth fracture and loss of cover of access hole.
arm group label: (CIG Axial)
arm group type: Active Comparator
description: received 4 axial implants and conventional impression
arm group label: (DIG Axial)
arm group type: Experimental
description: received 4 axial implants and digital impression
arm group label: CIG Tilted
arm group type: Active Comparator
description: received two anterior axial implants and two distal tilted implants, and conventional impression
arm group label: (DIG Tilted)
arm group type: Experimental
description: received two anterior axial implants and two distal tilted implants, and digital impression
intervention type: Other
intervention name: DIG Axial
description: patients received 4 axial implants and digital impression
arm group label: (CIG Axial)
arm group label: (DIG Tilted)
intervention type: Other
intervention name: DIG Tilted
description: received two anterior axial implants and two distal tilted implants, and digital impression
arm group label: (DIG Axial)
arm group label: CIG Tilted
intervention type: Other
intervention name: CIG Axial
description: patients received 4 axial implants and conventional impression
arm group label: (DIG Axial)
intervention type: Other
intervention name: CIG Tilted
description: received two anterior axial implants and two distal tilted implants, and conventional impression
arm group label: (DIG Tilted)
criteria: 
gender: All
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: No
last name: Dina Elawady
role: Principal Investigator
affiliation: Lecturer
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Mouth, Edentulous