<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/NCT03769376</url>
  </required_header>
  <id_info>
    <org_study_id>18-1722</org_study_id>
    <nct_id>NCT03769376</nct_id>
  </id_info>
  <brief_title>Histologic Comparison of Healing After Tooth Extraction With Ridge Preservation Using Two Different Xenografts</brief_title>
  <official_title>Histologic Comparison of Healing After Tooth Extraction With Ridge Preservation Using Two Different Xenografts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the speed of bone healing of the two most commonly&#xD;
      used xenografts on the market, Bio-Oss® and Salvin-Oss® using a tooth extraction ridge&#xD;
      preservation model in participants scheduled for tooth extraction and subsequent receipt of a&#xD;
      dental implant. Researchers hypothesize that there will be additional vital bone at 16-20&#xD;
      weeks with Salvin-Oss®.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study focuses on xenografts to preserve alveolar bone after tooth extraction prior to&#xD;
      placement of a dental implant. Extraction sites that are not grafted for ridge preservation&#xD;
      may lose up to 50 percent of their ridge width the first year after extraction. Xenografts&#xD;
      are one of several products on the market used to maintain ridge width after tooth&#xD;
      extraction. This study aims to compare the two most commonly used, FDA-approved xenografts on&#xD;
      the market, Bio-Oss® and Salvin-Oss, in the preservation of alveolar bone after extraction of&#xD;
      non-molar teeth.&#xD;
&#xD;
      The primary objective of this study is to histologically evaluate and compare the percentage&#xD;
      of new bone formation in healing extraction sockets of non-molar teeth grafted with Bio-Oss®&#xD;
      versus Salvin-Oss®. The secondary aim is to observe clinical changes in ridge height and&#xD;
      ridge width after grafting with these two materials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 22, 2019</start_date>
  <completion_date type="Actual">March 15, 2021</completion_date>
  <primary_completion_date type="Actual">March 15, 2021</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>Patients will be randomly assigned (1:1) to one of two treatment groups (Bio-Oss® or Salvin-Oss®) at the time of surgery through random selection of sealed envelopes.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Participants will be randomly assigned (1:1) to one of two treatment groups (Bio-Oss® or Salvin-Oss®) at the time of surgery through random selection of sealed envelopes. The outcome assessor for histological samples will not be aware of which group the participant was in until code unlocked.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks</measure>
    <time_frame>Baseline to 16-20 weeks</time_frame>
    <description>The amount of new bone formation at the tooth extraction/xenograft site as measured by the percent of vital bone, residual graft, and connective tissue observed in a histological sample (a bone biopsy) obtained at the time of dental implant insertion, 16-20 weeks after extraction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>New Bone Formation at Extraction/Xenograft Site Measured Clinically With Dental Probe at 16-20 Weeks</measure>
    <time_frame>Baseline to 16-20 weeks</time_frame>
    <description>The boney ridge height on both the buccal/lingual and width in area of the extraction/xenograft site as measured at time of implant placement with an intra-oral dental probe at 16-20 weeks after extraction. Percent change in ridge width from baseline is reported</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Partial Edentulism</condition>
  <arm_group>
    <arm_group_label>Bio-Oss®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Salvin-Oss®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bio-Oss®</intervention_name>
    <description>Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.</description>
    <arm_group_label>Bio-Oss®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Salvin-Oss®</intervention_name>
    <description>Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.</description>
    <arm_group_label>Salvin-Oss®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age.&#xD;
&#xD;
          -  Consent to be in the study.&#xD;
&#xD;
          -  Planned for non-emergent dental treatment.&#xD;
&#xD;
          -  American Society of Anesthesiologist Class I or II.&#xD;
&#xD;
          -  Require extraction of a single-rooted non-molar tooth.&#xD;
&#xD;
          -  Committed to have the dental implant placed at the site of extraction 16-20 weeks&#xD;
             after extraction and ridge preservation.&#xD;
&#xD;
          -  Adequate restorative space for implant-retained restoration.&#xD;
&#xD;
          -  &gt; 10mm alveolar bone height without impingement on the maxillary sinus or inferior&#xD;
             alveolar canal.&#xD;
&#xD;
          -  Root location and angulation that would be consistent with the subsequent implant&#xD;
             placement.&#xD;
&#xD;
          -  Roots with minimum of 10mm of radiographic bone support.&#xD;
&#xD;
          -  Root angulation similar to the angulation of the implant to be placed at the site.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years old.&#xD;
&#xD;
          -  Currently pregnant.&#xD;
&#xD;
          -  Require antibiotic prophylaxis prior to dental procedures as outlined by the 2017&#xD;
             American Heart Association guidelines.&#xD;
&#xD;
          -  Decisionally challenged individuals.&#xD;
&#xD;
          -  Current smokers.&#xD;
&#xD;
          -  American Society of Anesthesiologist Class III or IV.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kerri Font, DDS, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Charles A Powell, DDS, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado School of Dental Medicine</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <results_first_submitted>October 26, 2021</results_first_submitted>
  <results_first_submitted_qc>December 13, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 15, 2021</results_first_posted>
  <last_update_submitted>December 13, 2021</last_update_submitted>
  <last_update_submitted_qc>December 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>toothlessness</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Salvin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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 15, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT03769376/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bio-Oss®</title>
          <description>Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).&#xD;
Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.</description>
        </group>
        <group group_id="P2">
          <title>Salvin-Oss®</title>
          <description>Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).&#xD;
Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Detailed demographics data was not collected for any participant for this study beyond what was required to be verified to confirm study eligibility.</population>
      <group_list>
        <group group_id="B1">
          <title>Bio-Oss®</title>
          <description>Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).&#xD;
Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.</description>
        </group>
        <group group_id="B2">
          <title>Salvin-Oss®</title>
          <description>Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).&#xD;
Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.</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="20"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="38"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <description>More specific age demographics information was not collected for any participant.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;18 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Between 18 and 100 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Sex/Gender demographics information was not collected for any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks</title>
        <description>The amount of new bone formation at the tooth extraction/xenograft site as measured by the percent of vital bone, residual graft, and connective tissue observed in a histological sample (a bone biopsy) obtained at the time of dental implant insertion, 16-20 weeks after extraction.</description>
        <time_frame>Baseline to 16-20 weeks</time_frame>
        <population>Only participants that completed the study are included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Bio-Oss®</title>
            <description>Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).&#xD;
Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.</description>
          </group>
          <group group_id="O2">
            <title>Salvin-Oss®</title>
            <description>Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).&#xD;
Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.</description>
          </group>
        </group_list>
        <measure>
          <title>New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks</title>
          <description>The amount of new bone formation at the tooth extraction/xenograft site as measured by the percent of vital bone, residual graft, and connective tissue observed in a histological sample (a bone biopsy) obtained at the time of dental implant insertion, 16-20 weeks after extraction.</description>
          <population>Only participants that completed the study are included in the analysis.</population>
          <units>Percent</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Vital bone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.38" lower_limit="14.07" upper_limit="54.91"/>
                    <measurement group_id="O2" value="32.05" lower_limit="16.53" upper_limit="60.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Residual graft</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.02" lower_limit="5.32" upper_limit="22.30"/>
                    <measurement group_id="O2" value="16.56" lower_limit="5.95" upper_limit="50.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Connective Tissue/other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.61" lower_limit="39.74" upper_limit="78.51"/>
                    <measurement group_id="O2" value="51.39" lower_limit="20.35" upper_limit="69.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>New Bone Formation at Extraction/Xenograft Site Measured Clinically With Dental Probe at 16-20 Weeks</title>
        <description>The boney ridge height on both the buccal/lingual and width in area of the extraction/xenograft site as measured at time of implant placement with an intra-oral dental probe at 16-20 weeks after extraction. Percent change in ridge width from baseline is reported</description>
        <time_frame>Baseline to 16-20 weeks</time_frame>
        <population>Only participants that completed the study are included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Bio-Oss®</title>
            <description>Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).&#xD;
Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.</description>
          </group>
          <group group_id="O2">
            <title>Salvin-Oss®</title>
            <description>Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).&#xD;
Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.</description>
          </group>
        </group_list>
        <measure>
          <title>New Bone Formation at Extraction/Xenograft Site Measured Clinically With Dental Probe at 16-20 Weeks</title>
          <description>The boney ridge height on both the buccal/lingual and width in area of the extraction/xenograft site as measured at time of implant placement with an intra-oral dental probe at 16-20 weeks after extraction. Percent change in ridge width from baseline is reported</description>
          <population>Only participants that completed the study are included in the analysis.</population>
          <units>Percent</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.38" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="O2" value="9.09" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>20 Weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bio-Oss®</title>
          <description>Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).&#xD;
Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.</description>
        </group>
        <group group_id="E2">
          <title>Salvin-Oss®</title>
          <description>Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).&#xD;
Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.</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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </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>Kerri Font, DDS, MS</name_or_title>
      <organization>University of Colorado Denver | Anschutz</organization>
      <phone>303-724-1111</phone>
      <email>clinicalresearchsupportcenter@ucdenver.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/NCT03769376
org study id: 18-1722
nct id: NCT03769376
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to compare the speed of bone healing of the two most commonly
      used xenografts on the market, Bio-Oss® and Salvin-Oss® using a tooth extraction ridge
      preservation model in participants scheduled for tooth extraction and subsequent receipt of a
      dental implant. Researchers hypothesize that there will be additional vital bone at 16-20
      weeks with Salvin-Oss®.
This study focuses on xenografts to preserve alveolar bone after tooth extraction prior to
      placement of a dental implant. Extraction sites that are not grafted for ridge preservation
      may lose up to 50 percent of their ridge width the first year after extraction. Xenografts
      are one of several products on the market used to maintain ridge width after tooth
      extraction. This study aims to compare the two most commonly used, FDA-approved xenografts on
      the market, Bio-Oss® and Salvin-Oss, in the preservation of alveolar bone after extraction of
      non-molar teeth.

      The primary objective of this study is to histologically evaluate and compare the percentage
      of new bone formation in healing extraction sockets of non-molar teeth grafted with Bio-Oss®
      versus Salvin-Oss®. The secondary aim is to observe clinical changes in ridge height and
      ridge width after grafting with these two materials.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomly assigned (1:1) to one of two treatment groups (Bio-Oss® or Salvin-Oss®) at the time of surgery through random selection of sealed envelopes.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Participants will be randomly assigned (1:1) to one of two treatment groups (Bio-Oss® or Salvin-Oss®) at the time of surgery through random selection of sealed envelopes. The outcome assessor for histological samples will not be aware of which group the participant was in until code unlocked.
measure: New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks
time frame: Baseline to 16-20 weeks
description: The amount of new bone formation at the tooth extraction/xenograft site as measured by the percent of vital bone, residual graft, and connective tissue observed in a histological sample (a bone biopsy) obtained at the time of dental implant insertion, 16-20 weeks after extraction.
measure: New Bone Formation at Extraction/Xenograft Site Measured Clinically With Dental Probe at 16-20 Weeks
time frame: Baseline to 16-20 weeks
description: The boney ridge height on both the buccal/lingual and width in area of the extraction/xenograft site as measured at time of implant placement with an intra-oral dental probe at 16-20 weeks after extraction. Percent change in ridge width from baseline is reported
arm group label: Bio-Oss®
arm group type: Active Comparator
description: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).
arm group label: Salvin-Oss®
arm group type: Active Comparator
description: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).
intervention type: Device
intervention name: Bio-Oss®
description: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.
arm group label: Bio-Oss®
intervention type: Device
intervention name: Salvin-Oss®
description: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.
arm group label: Salvin-Oss®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kerri Font, DDS, MS
role: Principal Investigator
affiliation: University of Colorado, Denver
last name: Charles A Powell, DDS, MS
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Salvin
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 