<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/NCT02218541</url>
  </required_header>
  <id_info>
    <org_study_id>13-2376</org_study_id>
    <nct_id>NCT02218541</nct_id>
  </id_info>
  <brief_title>Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study.</brief_title>
  <official_title>Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will involve placing a dental implant through a guided surgery protocol developed&#xD;
      using 3D CT technology. Because the implant position is planned digitally using the CT data&#xD;
      from the patient, this allows investigation of an abutment that supports the implant crown&#xD;
      and soft tissues to be fabricated prior to implant placement. In doing so, this makes the&#xD;
      protocol for patient care simpler and faster. In fabricating the the abutment prior to&#xD;
      surgery, the investigators will design the abutments at different heights below the gumline&#xD;
      to see an optimal margin height for fabrication of the abutment prior to surgery. The study&#xD;
      hypothesis is that more often the abutment margin placed just slightly below (.5mm) the&#xD;
      gumline will be visible about half of the time while the abutment margin placed further under&#xD;
      the gumline (1.5mm) will be visible only about 10% of the time. The optimal outcome is that&#xD;
      at delivery and follow-up, the abutment margin will not show intraorally.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Abutment Margin Exposure &gt; 0</measure>
    <time_frame>up to 6 months post surgery</time_frame>
    <description>Margin exposure of the abutment between groups at 6 months post surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Soft Tissue Response of Bleeding</measure>
    <time_frame>6 months post surgery</time_frame>
    <description>To assess the condition of the peri-implant mucosa, those with a soft tissue response of bleeding upon probing were counted. Fisher's exact test will be used after the site has been evaluated for presence of bleeding or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Provisional Crown Fit at Delivery</measure>
    <time_frame>8 weeks post surgery</time_frame>
    <description>To assess if the Provisional Crown was able to be cemented at time of abutment connection was reported as 'Yes' or 'No.'</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Single Edentulous Space</condition>
  <arm_group>
    <arm_group_label>abutment margin 0.5 mm subgingival</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>when fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>abutment margin 1.5 mm subgingival</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>when fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>abutment margin 0.5 mm subgingival</intervention_name>
    <arm_group_label>abutment margin 0.5 mm subgingival</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>abutment margin 1.5 mm subgingival</intervention_name>
    <arm_group_label>abutment margin 1.5 mm subgingival</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  partially edentulous with single edentulous space&#xD;
&#xD;
          -  edentulous site where previous tooth has been extracted for at least two months&#xD;
&#xD;
          -  minimum of 20 teeth present&#xD;
&#xD;
          -  able to tolerate dental implant surgical and restorative procedures&#xD;
&#xD;
          -  consent to participate in clinical trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  asa class 3+&#xD;
&#xD;
          -  present drug use&#xD;
&#xD;
          -  is pregnant or plans to become pregnant&#xD;
&#xD;
          -  patients in need of lateral window sinus graft&#xD;
&#xD;
          -  patients in need of grafting prior to implant placement&#xD;
&#xD;
          -  patients in need of extensive grafting at time of implant placement&#xD;
&#xD;
          -  tooth is present or extracted within the last 2 months&#xD;
&#xD;
          -  history of IV bisphosphonate use or oral bisphosphonate use contraindicating dental&#xD;
             implant therapy&#xD;
&#xD;
          -  untreated caries or periodontal disease&#xD;
&#xD;
          -  severe bruxism&#xD;
&#xD;
          -  smoker within past 6 months&#xD;
&#xD;
          -  unlikely to be able to comply with study procedures according to investigators&#xD;
&#xD;
          -  known allergy to any materials used in dental implant surgery&#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>Ingeborg De Kok, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina School of Dentistry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Graduate Prosthodontic Clinic, Dept. of Prosthodontics, UNC School of Dentistry</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <results_first_submitted>May 22, 2018</results_first_submitted>
  <results_first_submitted_qc>July 26, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">July 27, 2018</results_first_posted>
  <last_update_submitted>July 26, 2018</last_update_submitted>
  <last_update_submitted_qc>July 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth, Edentulous</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 4, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT02218541/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Abutment Margin 0.5 mm Subgingival</title>
          <description>When fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline abutment margin 0.5 mm subgingival</description>
        </group>
        <group group_id="P2">
          <title>Abutment Margin 1.5 mm Subgingival</title>
          <description>When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline abutment margin 1.5 mm subgingival</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Implant Failure</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Abutment Margin 0.5 mm Subgingival</title>
          <description>When fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline abutment margin 0.5 mm subgingival</description>
        </group>
        <group group_id="B2">
          <title>Abutment Margin 1.5 mm Subgingival</title>
          <description>When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline abutment margin 1.5 mm subgingival</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="22"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abutment Margin Exposure &gt; 0</title>
        <description>Margin exposure of the abutment between groups at 6 months post surgery.</description>
        <time_frame>up to 6 months post surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Abutment Margin 0.5 mm Subgingival</title>
            <description>When fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline abutment margin 0.5 mm subgingival</description>
          </group>
          <group group_id="O2">
            <title>Abutment Margin 1.5 mm Subgingival</title>
            <description>When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline abutment margin 1.5 mm subgingival</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abutment Margin Exposure &gt; 0</title>
          <description>Margin exposure of the abutment between groups at 6 months post surgery.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>1.00</p_value>
            <p_value_desc>threshold for significance will be p-value &lt;0.05</p_value_desc>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Soft Tissue Response of Bleeding</title>
        <description>To assess the condition of the peri-implant mucosa, those with a soft tissue response of bleeding upon probing were counted. Fisher's exact test will be used after the site has been evaluated for presence of bleeding or not.</description>
        <time_frame>6 months post surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Abutment Margin 0.5 mm Subgingival</title>
            <description>When fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline abutment margin 0.5 mm subgingival</description>
          </group>
          <group group_id="O2">
            <title>Abutment Margin 1.5 mm Subgingival</title>
            <description>When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline abutment margin 1.5 mm subgingival</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Soft Tissue Response of Bleeding</title>
          <description>To assess the condition of the peri-implant mucosa, those with a soft tissue response of bleeding upon probing were counted. Fisher's exact test will be used after the site has been evaluated for presence of bleeding or not.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes bleeding</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No bleeding</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.039</p_value>
            <p_value_desc>This statistical analysis applies to Yes bleeding</p_value_desc>
            <method>Binomial</method>
            <method_desc>The statistical analysis was changed during the analysis phase but the protocol was not amended to reflect this change</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Provisional Crown Fit at Delivery</title>
        <description>To assess if the Provisional Crown was able to be cemented at time of abutment connection was reported as 'Yes' or 'No.'</description>
        <time_frame>8 weeks post surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Abutment Margin 0.5 mm Subgingival</title>
            <description>When fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline abutment margin 0.5 mm subgingival</description>
          </group>
          <group group_id="O2">
            <title>Abutment Margin 1.5 mm Subgingival</title>
            <description>When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline&#xD;
abutment margin 1.5 mm subgingival</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Provisional Crown Fit at Delivery</title>
          <description>To assess if the Provisional Crown was able to be cemented at time of abutment connection was reported as 'Yes' or 'No.'</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>No power calculation was done as this was a pilot study.</non_inferiority_desc>
            <p_value>1.0</p_value>
            <p_value_desc>This statistical analysis applies to Yes Provisional Crown fit</p_value_desc>
            <method>Binomial</method>
            <method_desc>The statistical analysis was changed during the analysis phase but the protocol was not amended to reflect this change</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the date of consent until six months after surgery</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Abutment Margin 0.5 mm Subgingival</title>
          <description>When fabricating an abutment to support the crown, the margin will be placed 0.5mm below the gumline abutment margin 0.5 mm subgingival</description>
        </group>
        <group group_id="E2">
          <title>Abutment Margin 1.5 mm Subgingival</title>
          <description>When fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline abutment margin 1.5 mm subgingival</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Gidgetta Jenkins</name_or_title>
      <organization>University of North Carolina at Chapel Hill</organization>
      <phone>919-537-3968</phone>
      <email>gidget_jenkins@unc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02218541
org study id: 13-2376
nct id: NCT02218541
lead sponsor: 
has dmc: No
The study will involve placing a dental implant through a guided surgery protocol developed
      using 3D CT technology. Because the implant position is planned digitally using the CT data
      from the patient, this allows investigation of an abutment that supports the implant crown
      and soft tissues to be fabricated prior to implant placement. In doing so, this makes the
      protocol for patient care simpler and faster. In fabricating the the abutment prior to
      surgery, the investigators will design the abutments at different heights below the gumline
      to see an optimal margin height for fabrication of the abutment prior to surgery. The study
      hypothesis is that more often the abutment margin placed just slightly below (.5mm) the
      gumline will be visible about half of the time while the abutment margin placed further under
      the gumline (1.5mm) will be visible only about 10% of the time. The optimal outcome is that
      at delivery and follow-up, the abutment margin will not show intraorally.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Number of Participants With Abutment Margin Exposure > 0
time frame: up to 6 months post surgery
description: Margin exposure of the abutment between groups at 6 months post surgery.
measure: Number of Participants With a Soft Tissue Response of Bleeding
time frame: 6 months post surgery
description: To assess the condition of the peri-implant mucosa, those with a soft tissue response of bleeding upon probing were counted. Fisher's exact test will be used after the site has been evaluated for presence of bleeding or not.
measure: Number of Participants With Provisional Crown Fit at Delivery
time frame: 8 weeks post surgery
description: To assess if the Provisional Crown was able to be cemented at time of abutment connection was reported as 'Yes' or 'No.'
arm group label: abutment margin 0.5 mm subgingival
arm group type: Other
description: when fabricating an abutment to support the crown, the margin will be placed 0.5 mm below the gumline
arm group label: abutment margin 1.5 mm subgingival
arm group type: Other
description: when fabricating the abutment to support the crown, the margin will be placed 1.5 mm below the gumline
intervention type: Device
intervention name: abutment margin 0.5 mm subgingival
arm group label: abutment margin 0.5 mm subgingival
intervention type: Device
intervention name: abutment margin 1.5 mm subgingival
arm group label: abutment margin 1.5 mm subgingival
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ingeborg De Kok, DDS
role: Principal Investigator
affiliation: University of North Carolina School of Dentistry
facility: 
country: United States
responsible party type: Sponsor
mesh term: Mouth, Edentulous
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 