<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/NCT03043885</url>
  </required_header>
  <id_info>
    <org_study_id>14-13360</org_study_id>
    <nct_id>NCT03043885</nct_id>
  </id_info>
  <brief_title>Ridge Preservation With Platelet Rich Fibrin Augmented With Freeze Dried Bone Allograft</brief_title>
  <official_title>Ridge Preservation With Platelet Rich Fibrin Augmented With Freeze Dried Bone Allograft: A Comparative Clinical, Histological, and Micro-computed Tomography Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Improved predictability and quality of bone healing after a tooth is removed is clinically&#xD;
      relevant, in that, it improves our ability to achieve successful implant placement at&#xD;
      edentulous sites. Currently, a variety of grafting materials and biologic agents are utilized&#xD;
      clinically to improve bone healing and provide sufficient dimensions of bone to support a&#xD;
      dental implant. Platelet rich fibrin (PRF) is one such product that can be used for this&#xD;
      application. PRF is a concentrated blood product attained from the patient's own blood&#xD;
      consisting of a natural bioscaffold with integrated growth factors capable of sustained&#xD;
      release. Once processed, PRF is implanted back into the patient at the wound or defect site&#xD;
      to encourage healing. The literature regarding PRF is currently dominated by heterogeneous&#xD;
      applications of PRF for reparative and regenerative therapies without a consensus of its&#xD;
      clinical efficacy and appropriate application. In this clinical study, PRF will be evaluated&#xD;
      to ascertain its clinical efficacy in improving bone formation and alveolar dimensional&#xD;
      stability after tooth extraction. A classic bone grafting material used for this purpose,&#xD;
      freeze dried bone allograft (FDBA), will be incorporated with the PRF or compared directly to&#xD;
      PRF alone. It is hypothesized that the natural scaffold and incorporated growth factors of&#xD;
      PRF augmented with the solubility resistance of FDBA will function as an ideal bioscaffold to&#xD;
      promote bone healing to a greater extent compared to PRF, FDBA, or blood clot alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized controlled clinical study evaluating the efficacy of four treatment&#xD;
      modalities for ridge preservation after extraction of a tooth in preparation for dental&#xD;
      implant placement. After tooth extraction the alveolar crest remodels during healing with&#xD;
      reductions in vertical and horizontal dimensions. The resulting reduced dimensions after&#xD;
      healing of the alveolar crest may be inadequate to successfully place a dental implant to&#xD;
      replace the missing tooth. In an attempt to minimize the reductions in dimensions and provide&#xD;
      mature healthy bone to support the dental implant, different ridge preservation techniques&#xD;
      (treatment of the extraction socket) have been utilized.&#xD;
&#xD;
      Forty subject from the UCSF Dental School who will be having a tooth extracted and replaced&#xD;
      with a dental implant will be randomly assigned into the four ridge preservation treatment&#xD;
      groups. After three months of healing bone samples from the ridge preservation site will be&#xD;
      collected during the implant placement when bone is removed during the osteotomy preparation&#xD;
      for the implant. Samples will be evaluated for the extent and quality of bone healing via&#xD;
      histomorphometric and micro-CT analysis. Clinical measures of alveolar ridge dimensions will&#xD;
      be taken before and after tooth extraction to determine extent of dimensional stability under&#xD;
      the different treatment groups.&#xD;
&#xD;
      The four treatments modalities for ridge preservation include autologous platelet rich fibrin&#xD;
      (PRF), PRF+freeze dried bone allograft (FDBA), FDBA, collagen barrier membrane. Subjects will&#xD;
      be enrolled in the study from the time the socket treated to the time of implant placement (3&#xD;
      months). The results of this study will help to elucidate the extent and quality of bone&#xD;
      healing using four different methods for ridge preservation in preparation for implant&#xD;
      placement. Further, this study will advance our knowledge of PRF, an autologous sourced blood&#xD;
      product used in dentoalveolar surgeries with proven in-vitro qualities but still requiring&#xD;
      more extensive clinical testing to demonstrate its full clinical utility.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2015</start_date>
  <completion_date type="Actual">March 1, 2017</completion_date>
  <primary_completion_date type="Actual">May 9, 2016</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>Percentage of Vital Bone</measure>
    <time_frame>3 months</time_frame>
    <description>Percentage of vital bone at healed extraction socket</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bone Mineral Density</measure>
    <time_frame>3 months</time_frame>
    <description>The bone mineral density (measured via micro-CT) at healed extraction sockets</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Alveolar Ridge Preservation</condition>
  <arm_group>
    <arm_group_label>PRF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PRF+FDBA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>FDBA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Blood Clot</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FDBA</intervention_name>
    <description>Graft material used to graft extraction socket</description>
    <arm_group_label>FDBA</arm_group_label>
    <arm_group_label>PRF+FDBA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PRF</intervention_name>
    <description>Autologous blood product used to graft extraction socket</description>
    <arm_group_label>PRF</arm_group_label>
    <arm_group_label>PRF+FDBA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood Clot</intervention_name>
    <description>Surgical treatment of extraction socket without addition of graft material</description>
    <arm_group_label>Blood Clot</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Single rooted teeth requiring extraction&#xD;
&#xD;
          2. Intact buccal and lingual plate within approximately 3-4 mm from gingival crest&#xD;
&#xD;
          3. No clinical or radiographic signs of periapical pathology&#xD;
&#xD;
          4. Acceptable oral hygiene&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable to comply with necessary scheduled visits&#xD;
&#xD;
          2. Poor oral hygiene&#xD;
&#xD;
          3. Failing/failed endodontic treatment with history/presence of sinus tracts&#xD;
&#xD;
          4. Pregnant woman or patients who intend to become pregnant&#xD;
&#xD;
          5. Tobacco use&#xD;
&#xD;
          6. Immunosuppressed&#xD;
&#xD;
          7. Type I or type II diabetes&#xD;
&#xD;
          8. Patient with any blood disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Ryder, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <results_first_submitted>October 17, 2018</results_first_submitted>
  <results_first_submitted_qc>November 14, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 5, 2018</results_first_posted>
  <last_update_submitted>November 14, 2018</last_update_submitted>
  <last_update_submitted_qc>November 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Francisco</investigator_affiliation>
    <investigator_full_name>Mark Ryder</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Platelet-rich Fibrin</title>
          <description>PRF: Autologous blood product used to graft extraction socket</description>
        </group>
        <group group_id="P2">
          <title>PRF+FDBA</title>
          <description>FDBA: Graft material used to graft extraction socket&#xD;
PRF: Autologous blood product used to graft extraction socket</description>
        </group>
        <group group_id="P3">
          <title>FDBA</title>
          <description>FDBA: Graft material used to graft extraction socket</description>
        </group>
        <group group_id="P4">
          <title>Blood Clot</title>
          <description>Blood Clot: Surgical treatment of extraction socket without addition of graft material</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Platelet-rich Fibrin</title>
          <description>PRF: Autologous blood product used to graft extraction socket</description>
        </group>
        <group group_id="B2">
          <title>PRF+FDBA</title>
          <description>FDBA: Graft material used to graft extraction socket&#xD;
PRF: Autologous blood product used to graft extraction socket</description>
        </group>
        <group group_id="B3">
          <title>FDBA</title>
          <description>FDBA: Graft material used to graft extraction socket</description>
        </group>
        <group group_id="B4">
          <title>Blood Clot</title>
          <description>Blood Clot: Surgical treatment of extraction socket without addition of graft material</description>
        </group>
        <group group_id="B5">
          <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="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="10"/>
            <count group_id="B4" value="10"/>
            <count group_id="B5" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <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="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="10"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="11"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="10"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="18"/>
                  </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 group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B5" value="0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="10"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Vital Bone</title>
        <description>Percentage of vital bone at healed extraction socket</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Platelet-rich Fibrin</title>
            <description>PRF: Autologous blood product used to graft extraction socket</description>
          </group>
          <group group_id="O2">
            <title>PRF+FDBA</title>
            <description>FDBA: Graft material used to graft extraction socket&#xD;
PRF: Autologous blood product used to graft extraction socket</description>
          </group>
          <group group_id="O3">
            <title>FDBA</title>
            <description>FDBA: Graft material used to graft extraction socket</description>
          </group>
          <group group_id="O4">
            <title>Blood Clot</title>
            <description>Blood Clot: Surgical treatment of extraction socket without addition of graft material</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Vital Bone</title>
          <description>Percentage of vital bone at healed extraction socket</description>
          <units>percentage of vital bone</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46" spread="18"/>
                    <measurement group_id="O2" value="39" spread="10"/>
                    <measurement group_id="O3" value="29" spread="14"/>
                    <measurement group_id="O4" value="40" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bone Mineral Density</title>
        <description>The bone mineral density (measured via micro-CT) at healed extraction sockets</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Platelet-rich Fibrin</title>
            <description>PRF: Autologous blood product used to graft extraction socket</description>
          </group>
          <group group_id="O2">
            <title>PRF+FDBA</title>
            <description>FDBA: Graft material used to graft extraction socket&#xD;
PRF: Autologous blood product used to graft extraction socket</description>
          </group>
          <group group_id="O3">
            <title>FDBA</title>
            <description>FDBA: Graft material used to graft extraction socket</description>
          </group>
          <group group_id="O4">
            <title>Blood Clot</title>
            <description>Blood Clot: Surgical treatment of extraction socket without addition of graft material</description>
          </group>
        </group_list>
        <measure>
          <title>Bone Mineral Density</title>
          <description>The bone mineral density (measured via micro-CT) at healed extraction sockets</description>
          <units>mg/cm3</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="493" spread="70"/>
                    <measurement group_id="O2" value="521" spread="58"/>
                    <measurement group_id="O3" value="487" spread="64"/>
                    <measurement group_id="O4" value="551" spread="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Platelet-rich Fibrin</title>
          <description>PRF: Autologous blood product used to graft extraction socket</description>
        </group>
        <group group_id="E2">
          <title>PRF+FDBA</title>
          <description>FDBA: Graft material used to graft extraction socket&#xD;
PRF: Autologous blood product used to graft extraction socket</description>
        </group>
        <group group_id="E3">
          <title>FDBA</title>
          <description>FDBA: Graft material used to graft extraction socket</description>
        </group>
        <group group_id="E4">
          <title>Blood Clot</title>
          <description>Blood Clot: Surgical treatment of extraction socket without addition of graft material</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Daniel Clark</name_or_title>
      <organization>UCSF</organization>
      <phone>415.476.1101</phone>
      <email>daniel.clark@ucsf.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/NCT03043885
org study id: 14-13360
nct id: NCT03043885
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Improved predictability and quality of bone healing after a tooth is removed is clinically
      relevant, in that, it improves our ability to achieve successful implant placement at
      edentulous sites. Currently, a variety of grafting materials and biologic agents are utilized
      clinically to improve bone healing and provide sufficient dimensions of bone to support a
      dental implant. Platelet rich fibrin (PRF) is one such product that can be used for this
      application. PRF is a concentrated blood product attained from the patient's own blood
      consisting of a natural bioscaffold with integrated growth factors capable of sustained
      release. Once processed, PRF is implanted back into the patient at the wound or defect site
      to encourage healing. The literature regarding PRF is currently dominated by heterogeneous
      applications of PRF for reparative and regenerative therapies without a consensus of its
      clinical efficacy and appropriate application. In this clinical study, PRF will be evaluated
      to ascertain its clinical efficacy in improving bone formation and alveolar dimensional
      stability after tooth extraction. A classic bone grafting material used for this purpose,
      freeze dried bone allograft (FDBA), will be incorporated with the PRF or compared directly to
      PRF alone. It is hypothesized that the natural scaffold and incorporated growth factors of
      PRF augmented with the solubility resistance of FDBA will function as an ideal bioscaffold to
      promote bone healing to a greater extent compared to PRF, FDBA, or blood clot alone.
This is a randomized controlled clinical study evaluating the efficacy of four treatment
      modalities for ridge preservation after extraction of a tooth in preparation for dental
      implant placement. After tooth extraction the alveolar crest remodels during healing with
      reductions in vertical and horizontal dimensions. The resulting reduced dimensions after
      healing of the alveolar crest may be inadequate to successfully place a dental implant to
      replace the missing tooth. In an attempt to minimize the reductions in dimensions and provide
      mature healthy bone to support the dental implant, different ridge preservation techniques
      (treatment of the extraction socket) have been utilized.

      Forty subject from the UCSF Dental School who will be having a tooth extracted and replaced
      with a dental implant will be randomly assigned into the four ridge preservation treatment
      groups. After three months of healing bone samples from the ridge preservation site will be
      collected during the implant placement when bone is removed during the osteotomy preparation
      for the implant. Samples will be evaluated for the extent and quality of bone healing via
      histomorphometric and micro-CT analysis. Clinical measures of alveolar ridge dimensions will
      be taken before and after tooth extraction to determine extent of dimensional stability under
      the different treatment groups.

      The four treatments modalities for ridge preservation include autologous platelet rich fibrin
      (PRF), PRF+freeze dried bone allograft (FDBA), FDBA, collagen barrier membrane. Subjects will
      be enrolled in the study from the time the socket treated to the time of implant placement (3
      months). The results of this study will help to elucidate the extent and quality of bone
      healing using four different methods for ridge preservation in preparation for implant
      placement. Further, this study will advance our knowledge of PRF, an autologous sourced blood
      product used in dentoalveolar surgeries with proven in-vitro qualities but still requiring
      more extensive clinical testing to demonstrate its full clinical utility.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Percentage of Vital Bone
time frame: 3 months
description: Percentage of vital bone at healed extraction socket
measure: Bone Mineral Density
time frame: 3 months
description: The bone mineral density (measured via micro-CT) at healed extraction sockets
arm group label: PRF
arm group type: Experimental
arm group label: PRF+FDBA
arm group type: Experimental
arm group label: FDBA
arm group type: Active Comparator
arm group label: Blood Clot
arm group type: Active Comparator
intervention type: Device
intervention name: FDBA
description: Graft material used to graft extraction socket
arm group label: FDBA
arm group label: PRF+FDBA
intervention type: Device
intervention name: PRF
description: Autologous blood product used to graft extraction socket
arm group label: PRF
arm group label: PRF+FDBA
intervention type: Procedure
intervention name: Blood Clot
description: Surgical treatment of extraction socket without addition of graft material
arm group label: Blood Clot
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Ryder, DDS
role: Principal Investigator
affiliation: University of California, San Francisco
responsible party type: Principal Investigator
investigator affiliation: University of California, San Francisco
investigator full name: Mark Ryder
investigator title: Professor
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 