<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/NCT02980211</url>
  </required_header>
  <id_info>
    <org_study_id>201612718</org_study_id>
    <nct_id>NCT02980211</nct_id>
  </id_info>
  <brief_title>Treatment of Post-Extraction Dehisced Socket - A Case Series Study</brief_title>
  <acronym>OSTEO2</acronym>
  <official_title>Clinical, Radiographic and Histologic Evaluation of a Novel Alveolar Ridge Reconstruction Approach in Post-Extraction Dehiscence Defects: A Case Series Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gustavo Avila-Ortiz DDS, MS, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Osteogenics Biomedical</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      PURPOSE The purpose of this case series is to clinically, radiographically and histologically&#xD;
      evaluate the treatment of dehiscence defects in extraction sockets using a minimally-invasive&#xD;
      GBR technique that involves the application of a particulate bone allograft and a&#xD;
      non-resorbable PTFE membrane.&#xD;
&#xD;
      METHODS Subjects with single-rooted teeth indicated for extraction and interested in future&#xD;
      implant therapy for tooth replacement will be recruited on the basis of an eligibility&#xD;
      criteria. A buccal or lingual dehiscence defect must strongly be suspected or confirmed upon&#xD;
      clinical examination in order for the subject to qualify for study inclusion. A cone-beam&#xD;
      computer tomography (CBCT) scan of the arch containing the tooth to be extracted will be&#xD;
      obtained prior to tooth extraction. Following minimally invasive tooth extraction and&#xD;
      debridement, the socket will be evaluated to verify the presence of a dehiscence defect&#xD;
      affecting at least 50% of the bony plate height. After creating a soft tissue 'pouch' using&#xD;
      tunneling instruments, a non-absorbable dense-PTFE (dPTFE) barrier membrane that will be&#xD;
      trimmed to a size and shape that would allow for complete extension over the existing defect&#xD;
      will be tucked between the mucosa and the alveolar bone. Then, the extraction socket will be&#xD;
      grafted with particulate allograft and the access to the socket will be sealed with an&#xD;
      extension of the membrane and an external cross mattress suture. Subjects will be recalled at&#xD;
      1, 2 and 5 weeks to monitor healing and assess the level of discomfort using a visual analog&#xD;
      scale at the end of each visit. At the 5-week visit, the membrane will be gently removed and&#xD;
      the exposed area will be left to heal by secondary intention. At 20 weeks after tooth&#xD;
      extraction a second CBCT will be obtained to radiographically evaluate the site for implant&#xD;
      placement. Bone volumetric reconstructions of the alveolar ridge at baseline and at 20 weeks&#xD;
      will be made using the CBCT data to assess changes affecting the bone housing. If the site&#xD;
      has healed adequately, implant placement will be planned at 24 weeks after tooth extraction.&#xD;
      A bone core biopsy will be obtained at the time of implant placement in order to&#xD;
      histologically analyze the characteristics of the grafted substrate. Upon implant placement&#xD;
      with primary stability a healing abutment will be placed and sutures will be given to achieve&#xD;
      primary wound closure, as necessary. Subjects will return for the final study visit at 2&#xD;
      weeks following implant placement to evaluate the healing prior to being referred back to the&#xD;
      restorative dentist.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Visit 1 - Screening visit After reading and signing this informed consent form, you will&#xD;
      complete a detailed medical and dental history form. We will review this form with you to&#xD;
      ensure you can safely participate in the study. You will also have an oral exam to determine&#xD;
      if you qualify for the study. If you are a woman of childbearing age, you will be tested for&#xD;
      pregnancy. If you are pregnant or trying to become pregnant, you cannot participate in the&#xD;
      study. You will also have one digital dental x-ray of the area for tooth extraction, if not&#xD;
      available already, which is standard of care. You will also have dental impressions (molds of&#xD;
      your teeth), which are made in a non-invasive manner to collect data for some of the research&#xD;
      measurements. This visit will last between 1 and 1.5 hours.&#xD;
&#xD;
      Visit 2 - Baseline visit In less than 10 weeks after the screening visit, you will have the&#xD;
      tooth extraction and bone grafting, which will be just like the procedure performed for&#xD;
      patients who are not enrolled in the study and present a similar clinical scenario. Before&#xD;
      the surgical procedure, a special dental x-ray scan known as cone beam computed tomography&#xD;
      (CBCT) will be taken for the purpose of collecting research measurements. The CBCT scan&#xD;
      generates 3D images of your teeth and surrounding tissues. After numbing the area, clinical&#xD;
      measurements will be gathered. These measurements are non-invasive (do not involve cutting&#xD;
      your body or putting instruments inside it) and will not harm the gums or surrounding teeth.&#xD;
      The extraction (removal of the tooth) will be performed and the tooth socket (the area&#xD;
      surrounding the tooth that was removed) will be cleaned, which is what would happen to&#xD;
      patients who are not enrolled in the study. At this time, additional measurements of the area&#xD;
      will be taken. These measurements will not cause you any extra discomfort, since that area&#xD;
      will be numbed. Then, the socket grafting technique will be performed. The treatment will&#xD;
      consist on the combination of a bone grafting material from a human donor (EnCore,&#xD;
      Osteogenics Biomedical Inc.) and a non-dissolvable barrier membrane (Cytoplast TXT-200,&#xD;
      Osteogenics Biomedical Inc.), to protect the bone graft and that will be removed in 5 weeks.&#xD;
      You will be given prescriptions for an antibiotic, a pain reliever and a mouth rinse. You&#xD;
      will also receive home care instructions before you leave. This visit will last about between&#xD;
      1.5 to 2 hours.&#xD;
&#xD;
      Visits 3, 4, 5 and 6 - Post-operative follow up visits You will return to the clinic at 1, 2,&#xD;
      5 and 20 weeks, which is standard of care in many cases of tooth extraction and grafting. In&#xD;
      these visits, you will have an oral exam, check-up, and the researchers will monitor how well&#xD;
      you are healing. These visits will last approximately 30 minutes.&#xD;
&#xD;
      At the 5-week visit, the barrier membrane will be removed. You will not have to be numbed for&#xD;
      this.&#xD;
&#xD;
      Additionally, only at the 20-week visit after tooth extraction, a second CBCT x-ray scan will&#xD;
      be obtained to determine how much bone is available after the healing period to plan the&#xD;
      implant placement and for research measurements. The second CBCT x-ray scan will allow your&#xD;
      surgical doctor to evaluate the amount of bone volume and is standard of care when planning&#xD;
      for dental implant placement. A dental impression (mold) will be made to collect information&#xD;
      about the gum tissue. Recommendations on further treatment, including the potential for&#xD;
      implant therapy or possible additional grafting, will be provided based on the findings from&#xD;
      this visit.&#xD;
&#xD;
      Visit 7 - Implant placement visit If you can receive the implant, a surgical placement visit&#xD;
      will be scheduled at approximately 24 weeks after tooth extraction. After numbing the area, a&#xD;
      small gum flap will be opened to access the area underneath that was bone grafted. A bone&#xD;
      sample biopsy will be taken and analyzed for research purposes. This bone would be disposed&#xD;
      otherwise, since a bed must be created in the bone to allow for implant placement. After an&#xD;
      adequate space for implant placement is created in your bone, the implant will be placed. If&#xD;
      implant primary stability (sufficient retention) is not achieved, the doctor may need to&#xD;
      place a larger implant (in length, diameter or both) or, if this is not possible, discontinue&#xD;
      the procedure and plan for delayed implant placement at another time. If this is the case,&#xD;
      the study will cover the costs associated with additional grafting and implant placement.&#xD;
      Upon implant placement, your gums will be stitched and you will be given prescriptions for an&#xD;
      antibiotic, a pain reliever and a mouth rinse. You will also receive home care instructions&#xD;
      before you leave. This visit will last between 1.5 and 2 hours.&#xD;
&#xD;
      Visit 8 - Post-operative follow up visit You will be seen by your surgical doctor for a&#xD;
      postoperative visit at approximately 2 weeks after the implant is placed to monitor the&#xD;
      healing and to remove sutures, which is standard of care. You will have an oral exam,&#xD;
      check-up, and the researchers will monitor how well you are healing. These visits will last&#xD;
      approximately 30 minutes. This is the last visit of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">May 17, 2018</completion_date>
  <primary_completion_date type="Actual">May 3, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bone Volumetric Reduction From Baseline to 20 Weeks Post-extraction</measure>
    <time_frame>Baseline and 20 weeks post-extraction</time_frame>
    <description>Alveolar bone volumetric reduction from baseline to 20 weeks using CBCT scans</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Tooth Loss</condition>
  <arm_group>
    <arm_group_label>Tooth Extraction and Graft Dehisced Socket</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alveolar Ridge Reconstruction</intervention_name>
    <description>Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane</description>
    <arm_group_label>Tooth Extraction and Graft Dehisced Socket</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA&#xD;
&#xD;
          -  Provision of informed consent&#xD;
&#xD;
          -  Age: 18 years or older&#xD;
&#xD;
          -  Subjects with a single-rooted tooth indicated for extraction bounded by stable,&#xD;
             natural teeth&#xD;
&#xD;
          -  Tooth planned for extraction must have a dehiscence defect in the surrounding bone,&#xD;
             observed clinically and/or radiographically, that affects at least 50% of the bone&#xD;
             height&#xD;
&#xD;
          -  Subjects must be interested in replacing the tooth with a single implant-supported&#xD;
             fixed restoration&#xD;
&#xD;
          -  Subjects must be able and willing to follow instructions related to the study&#xD;
             procedures&#xD;
&#xD;
          -  Subjects must have read, understood and signed an informed consent form&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
          -  Mandibular incisors&#xD;
&#xD;
          -  Subjects with a history of organ failure (e.g. liver, kidney)&#xD;
&#xD;
          -  Subjects with severe hematologic disorders, such as hemophilia or leukemia&#xD;
&#xD;
          -  Subjects with uncontrolled and/or severe metabolic bone diseases or disorders, such as&#xD;
             osteoporosis, thyroid disorders or Paget's disease&#xD;
&#xD;
          -  Subjects taking any medication or supplement known to largely influence bone&#xD;
             metabolism, such as IV bisphosphonates, long-term history of oral bisphosphonates or&#xD;
             chronic intake of glucocorticoids&#xD;
&#xD;
          -  Pregnant women (as indicated by positive serum HCG test) or nursing mothers&#xD;
&#xD;
          -  Subjects with conditions that would result in compromised healing (e.g. poorly&#xD;
             controlled diabetes, active heavy tobacco use [&gt;10 cigs/day])&#xD;
&#xD;
          -  Subjects who, at the discretion of the investigators, would be unsuitable candidates&#xD;
             for the study due to safety, psychological or practical reasons (e.g. known allergies&#xD;
             to any product used for the study, limited mouth opening, etc.)&#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>Gustavo Avila-Ortiz, DDS, MS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>College of Dentistry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa College of Dentistry - Craniofacial Clinical Research Program</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <results_first_submitted>December 26, 2019</results_first_submitted>
  <results_first_submitted_qc>January 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 22, 2020</results_first_posted>
  <last_update_submitted>January 21, 2020</last_update_submitted>
  <last_update_submitted_qc>January 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Gustavo Avila-Ortiz DDS, MS, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Alveolar Bone</keyword>
  <keyword>Alveolar Ridge</keyword>
  <keyword>Bone Resorption</keyword>
  <keyword>Bone Grafting</keyword>
  <keyword>Barrier Membrane</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth Loss</mesh_term>
  </condition_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>December 26, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT02980211/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Tooth Extraction and Graft Dehisced Socket</title>
          <description>Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane.&#xD;
Alveolar Ridge Reconstruction: Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tooth Extraction and Graft Dehisced Socket</title>
          <description>Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane.&#xD;
Alveolar Ridge Reconstruction: Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="17"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.82" spread="13.61"/>
                  </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_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Bone Volumetric Reduction From Baseline to 20 Weeks Post-extraction</title>
        <description>Alveolar bone volumetric reduction from baseline to 20 weeks using CBCT scans</description>
        <time_frame>Baseline and 20 weeks post-extraction</time_frame>
        <population>Two of the 17 DICOM datasets could not be analyzed due to extensive scattering, therefore the final sample size for this outcome was 15</population>
        <group_list>
          <group group_id="O1">
            <title>Tooth Extraction and Graft Dehisced Socket</title>
            <description>Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane.&#xD;
Alveolar Ridge Reconstruction: Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane</description>
          </group>
        </group_list>
        <measure>
          <title>Bone Volumetric Reduction From Baseline to 20 Weeks Post-extraction</title>
          <description>Alveolar bone volumetric reduction from baseline to 20 weeks using CBCT scans</description>
          <population>Two of the 17 DICOM datasets could not be analyzed due to extensive scattering, therefore the final sample size for this outcome was 15</population>
          <units>mm3</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.26" spread="77.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 weeks post-extraction</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Tooth Extraction and Graft Dehisced Socket</title>
          <description>Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane.&#xD;
Alveolar Ridge Reconstruction: Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane</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="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Premature barrier membrane exfoliation</sub_title>
                <description>One patient decided to remove the membrane himself between 2 and 5 weeks because it was &quot;bothersome&quot;</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </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>Dr. Gustavo Avila-Ortiz, Professor and Chair, Department of Periodontics</name_or_title>
      <organization>University of Iowa College of Dentistry</organization>
      <phone>3193357241</phone>
      <email>gustavo-avila@uiowa.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/NCT02980211
org study id: 201612718
nct id: NCT02980211
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
PURPOSE The purpose of this case series is to clinically, radiographically and histologically
      evaluate the treatment of dehiscence defects in extraction sockets using a minimally-invasive
      GBR technique that involves the application of a particulate bone allograft and a
      non-resorbable PTFE membrane.

      METHODS Subjects with single-rooted teeth indicated for extraction and interested in future
      implant therapy for tooth replacement will be recruited on the basis of an eligibility
      criteria. A buccal or lingual dehiscence defect must strongly be suspected or confirmed upon
      clinical examination in order for the subject to qualify for study inclusion. A cone-beam
      computer tomography (CBCT) scan of the arch containing the tooth to be extracted will be
      obtained prior to tooth extraction. Following minimally invasive tooth extraction and
      debridement, the socket will be evaluated to verify the presence of a dehiscence defect
      affecting at least 50% of the bony plate height. After creating a soft tissue 'pouch' using
      tunneling instruments, a non-absorbable dense-PTFE (dPTFE) barrier membrane that will be
      trimmed to a size and shape that would allow for complete extension over the existing defect
      will be tucked between the mucosa and the alveolar bone. Then, the extraction socket will be
      grafted with particulate allograft and the access to the socket will be sealed with an
      extension of the membrane and an external cross mattress suture. Subjects will be recalled at
      1, 2 and 5 weeks to monitor healing and assess the level of discomfort using a visual analog
      scale at the end of each visit. At the 5-week visit, the membrane will be gently removed and
      the exposed area will be left to heal by secondary intention. At 20 weeks after tooth
      extraction a second CBCT will be obtained to radiographically evaluate the site for implant
      placement. Bone volumetric reconstructions of the alveolar ridge at baseline and at 20 weeks
      will be made using the CBCT data to assess changes affecting the bone housing. If the site
      has healed adequately, implant placement will be planned at 24 weeks after tooth extraction.
      A bone core biopsy will be obtained at the time of implant placement in order to
      histologically analyze the characteristics of the grafted substrate. Upon implant placement
      with primary stability a healing abutment will be placed and sutures will be given to achieve
      primary wound closure, as necessary. Subjects will return for the final study visit at 2
      weeks following implant placement to evaluate the healing prior to being referred back to the
      restorative dentist.
Visit 1 - Screening visit After reading and signing this informed consent form, you will
      complete a detailed medical and dental history form. We will review this form with you to
      ensure you can safely participate in the study. You will also have an oral exam to determine
      if you qualify for the study. If you are a woman of childbearing age, you will be tested for
      pregnancy. If you are pregnant or trying to become pregnant, you cannot participate in the
      study. You will also have one digital dental x-ray of the area for tooth extraction, if not
      available already, which is standard of care. You will also have dental impressions (molds of
      your teeth), which are made in a non-invasive manner to collect data for some of the research
      measurements. This visit will last between 1 and 1.5 hours.

      Visit 2 - Baseline visit In less than 10 weeks after the screening visit, you will have the
      tooth extraction and bone grafting, which will be just like the procedure performed for
      patients who are not enrolled in the study and present a similar clinical scenario. Before
      the surgical procedure, a special dental x-ray scan known as cone beam computed tomography
      (CBCT) will be taken for the purpose of collecting research measurements. The CBCT scan
      generates 3D images of your teeth and surrounding tissues. After numbing the area, clinical
      measurements will be gathered. These measurements are non-invasive (do not involve cutting
      your body or putting instruments inside it) and will not harm the gums or surrounding teeth.
      The extraction (removal of the tooth) will be performed and the tooth socket (the area
      surrounding the tooth that was removed) will be cleaned, which is what would happen to
      patients who are not enrolled in the study. At this time, additional measurements of the area
      will be taken. These measurements will not cause you any extra discomfort, since that area
      will be numbed. Then, the socket grafting technique will be performed. The treatment will
      consist on the combination of a bone grafting material from a human donor (EnCore,
      Osteogenics Biomedical Inc.) and a non-dissolvable barrier membrane (Cytoplast TXT-200,
      Osteogenics Biomedical Inc.), to protect the bone graft and that will be removed in 5 weeks.
      You will be given prescriptions for an antibiotic, a pain reliever and a mouth rinse. You
      will also receive home care instructions before you leave. This visit will last about between
      1.5 to 2 hours.

      Visits 3, 4, 5 and 6 - Post-operative follow up visits You will return to the clinic at 1, 2,
      5 and 20 weeks, which is standard of care in many cases of tooth extraction and grafting. In
      these visits, you will have an oral exam, check-up, and the researchers will monitor how well
      you are healing. These visits will last approximately 30 minutes.

      At the 5-week visit, the barrier membrane will be removed. You will not have to be numbed for
      this.

      Additionally, only at the 20-week visit after tooth extraction, a second CBCT x-ray scan will
      be obtained to determine how much bone is available after the healing period to plan the
      implant placement and for research measurements. The second CBCT x-ray scan will allow your
      surgical doctor to evaluate the amount of bone volume and is standard of care when planning
      for dental implant placement. A dental impression (mold) will be made to collect information
      about the gum tissue. Recommendations on further treatment, including the potential for
      implant therapy or possible additional grafting, will be provided based on the findings from
      this visit.

      Visit 7 - Implant placement visit If you can receive the implant, a surgical placement visit
      will be scheduled at approximately 24 weeks after tooth extraction. After numbing the area, a
      small gum flap will be opened to access the area underneath that was bone grafted. A bone
      sample biopsy will be taken and analyzed for research purposes. This bone would be disposed
      otherwise, since a bed must be created in the bone to allow for implant placement. After an
      adequate space for implant placement is created in your bone, the implant will be placed. If
      implant primary stability (sufficient retention) is not achieved, the doctor may need to
      place a larger implant (in length, diameter or both) or, if this is not possible, discontinue
      the procedure and plan for delayed implant placement at another time. If this is the case,
      the study will cover the costs associated with additional grafting and implant placement.
      Upon implant placement, your gums will be stitched and you will be given prescriptions for an
      antibiotic, a pain reliever and a mouth rinse. You will also receive home care instructions
      before you leave. This visit will last between 1.5 and 2 hours.

      Visit 8 - Post-operative follow up visit You will be seen by your surgical doctor for a
      postoperative visit at approximately 2 weeks after the implant is placed to monitor the
      healing and to remove sutures, which is standard of care. You will have an oral exam,
      check-up, and the researchers will monitor how well you are healing. These visits will last
      approximately 30 minutes. This is the last visit of the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Bone Volumetric Reduction From Baseline to 20 Weeks Post-extraction
time frame: Baseline and 20 weeks post-extraction
description: Alveolar bone volumetric reduction from baseline to 20 weeks using CBCT scans
arm group label: Tooth Extraction and Graft Dehisced Socket
arm group type: Experimental
description: Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane.
intervention type: Drug
intervention name: Alveolar Ridge Reconstruction
description: Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane
arm group label: Tooth Extraction and Graft Dehisced Socket
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gustavo Avila-Ortiz, DDS, MS, PhD
role: Principal Investigator
affiliation: College of Dentistry
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: Gustavo Avila-Ortiz DDS, MS, PhD
investigator title: Associate Professor
mesh term: Tooth Loss
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 