<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/NCT01728844</url>
  </required_header>
  <id_info>
    <org_study_id>CLP-2011-10-31-1</org_study_id>
    <nct_id>NCT01728844</nct_id>
  </id_info>
  <brief_title>GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery</brief_title>
  <official_title>A Randomized, Double-Blind, Controlled, Multicenter Dose Verification Clinical Trial to Evaluate the Safety and Effectiveness of GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunstar Americas</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunstar Americas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      GUIDOR Growth Factor Enchanted Bone Graft Substitute (GFeBGS) when used in periodontal&#xD;
      surgery will shown greater gum and bone regeneration when compare to bone graft substitute&#xD;
      alone. Also, to find the optimal dose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a prospective, randomized, double-blinded, controlled, multi-center,&#xD;
      dose-verification clinical study in subjects who require surgical intervention to treat a&#xD;
      qualifying periodontal defect.&#xD;
&#xD;
      Subjects 25 years and older with advanced periodontal disease in at least one site requiring&#xD;
      surgical treatment to correct a bone defect.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements</measure>
    <time_frame>6 months post-surgery</time_frame>
    <description>The primary effectiveness endpoint is a composite endpoint that considers radiographic and clinical measurements at six months post-implantation: the amount of linear bone growth (LBG), which is assessed with the use of radiographs, and the regain from baseline of clinical attachment level (∆CAL), which is assessed clinically. Linear bone growth (LBG) in a vertical and horizontal direction is determined radiographically at six months post-implantation. The clinical attachment level (CAL) is the distance from the cemento-enamel junction (CEJ) (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. The success criteria are ΔCAL ≥1.5 mm and LBG ≥1 mm at 6 months after the treatment. Both the ∆CAL and LBG must meet the success criteria for a subject to be considered a success.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Attachment Level at 3 Months</measure>
    <time_frame>Baseline and 3 months post-surgery</time_frame>
    <description>The clinical attachment level is the distance from the cemento-enamel junction (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. Change = (3 months measurement - Baseline measurement)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Attachment Level at 6 Months</measure>
    <time_frame>Baseline and 6 months post-surgery</time_frame>
    <description>The clinical attachment level is the distance from the cemento-enamel junction (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. Change = (6 months measurement - Baseline measurement)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear Bone Growth at 6 Months</measure>
    <time_frame>Baseline and 6 months post-surgery</time_frame>
    <description>Linear measurement of bone height in millimeters along mesial and/or distal root surfaces of the defect site is captured radiographically at baseline and 6 months. Linear Bone Growth = (Baseline measurement - 6 months measurement)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Bone Fill at 6 Months</measure>
    <time_frame>Baseline and 6 months post-surgery</time_frame>
    <description>Linear measurement of bone height in millimeters along mesial and/or distal root surfaces of the defect site is captured radiographically at baseline and 6 months. Percent Bone Fill is calculated by dividing Linear Bone Growth at 6 months by bone height at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pocket Depth Change at 3 Months</measure>
    <time_frame>Baseline and 3 months post-surgery</time_frame>
    <description>Length from free gingival margin to the base of the pocket in millimeter is measured with North Carolina 15 mm periodontal probes. Pocket Depth Change = (3 months measurement - Baseline measurement)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pocket Depth Change at 6 Months</measure>
    <time_frame>Baseline and 6 months post-surgery</time_frame>
    <description>Length from free gingival margin to the base of the pocket in millimeter is measured with North Carolina 15 mm periodontal probes. Pocket Depth Change = (6 months measurement - Baseline measurement)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gingival Recession at 3 Months</measure>
    <time_frame>Baseline and 3 months post-surgery</time_frame>
    <description>Length from the free gingival margin to the CEJ is measured in millimeter with North Carolina 15 mm periodontal probes. Gingival Recession = (3 months measurement - Baseline measurement)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gingival Recession at 6 Months</measure>
    <time_frame>Baseline and 6 months post-surgery</time_frame>
    <description>Length from the free gingival margin to the CEJ is measured in millimeter with North Carolina 15 mm periodontal probes. Gingival Recession = (6 months measurement - Baseline measurement)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Alveolar Bone Loss</condition>
  <condition>Periodontal Diseases</condition>
  <arm_group>
    <arm_group_label>beta-tricalcium phosphate alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>beta-tricalcium phosphate alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GFeBGS 0.1%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GFeBGS 0.3%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GFeGBS 0.4%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>beta-tricalcium phosphate alone</intervention_name>
    <arm_group_label>beta-tricalcium phosphate alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GFeBGS 0.1%</intervention_name>
    <arm_group_label>GFeBGS 0.1%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GFeBGS 0.3%</intervention_name>
    <arm_group_label>GFeBGS 0.3%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GFeBGS 0.4%</intervention_name>
    <arm_group_label>GFeGBS 0.4%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, age of 25 and older&#xD;
&#xD;
          -  Must have read, understood, and signed a consent form&#xD;
&#xD;
          -  Must be able and willing to follow study procedures and instructions&#xD;
&#xD;
          -  Must have undergone thorough scaling and root planing of the target tooth and be&#xD;
             expected to demonstrate good plaque control after instruction in oral hygiene&#xD;
&#xD;
          -  The target tooth must exhibit the following:&#xD;
&#xD;
               -  A pocket depth of 7 mm or greater&#xD;
&#xD;
               -  After surgical debridement, 4 mm or greater intrabony defect with at least 1 bony&#xD;
                  wall&#xD;
&#xD;
               -  Sufficient keratinized tissue to allow complete tissue coverage of the defect&#xD;
&#xD;
               -  Radiographic base of defect at least 3 mm coronal to the apex of the tooth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to maintain adequate oral hygiene during the screening phase&#xD;
&#xD;
          -  Women of child-bearing potential&#xD;
&#xD;
          -  A history within the last 6 months of HIV, Type IV heart disease, or end-stage renal&#xD;
             disease&#xD;
&#xD;
          -  A history of oral cancer or any other cancer (exception: subjects with a history of&#xD;
             skin cancers such as squamous and basal carcinoma with end of treatment at least 6&#xD;
             months ago and/or prostate cancer with end of treatment at least 5 years ago may be&#xD;
             enrolled)&#xD;
&#xD;
          -  A history within 12 months of previous open flap periodontal surgery on the study&#xD;
             tooth.&#xD;
&#xD;
          -  A diagnosis of pre-malignant oral lesion(s)&#xD;
&#xD;
          -  A traumatic occlusion of the target tooth&#xD;
&#xD;
          -  Target &quot;study&quot; tooth exhibiting Grade III mobility&#xD;
&#xD;
          -  Maxillary molars or maxillary first premolar with a prominent mesial concavity&#xD;
&#xD;
          -  Study tooth exhibiting a Class II or greater furcation defect&#xD;
&#xD;
          -  Clinical or radiographic signs of untreated acute or chronic periapical infection at&#xD;
             the surgical site, apical pathology, root fracture, severe root irregularities,&#xD;
             cemental pearls, cervical enamel projections not easily removed by odontoplasty,&#xD;
             untreated carious lesions at the cemento-enamel junction (CEJ) or on the root surface,&#xD;
             or restorations with open or otherwise defective margins at or below the CEJ&#xD;
&#xD;
          -  A history within the last 6 months of the daily use of any tobacco products besides&#xD;
             cigarettes (smokeless chewing tobacco, pipe or cigar smoking), or of smoking more than&#xD;
             10 cigarettes per day&#xD;
&#xD;
          -  Subjects participating in other clinical trials within 30 days of enrollment&#xD;
&#xD;
          -  Subjects having uncontrolled endocrine-induced diseases (e.g. uncontrolled diabetes&#xD;
             mellitus and hyperparathyroidism)&#xD;
&#xD;
          -  Subjects undergoing current therapy with systemic steroids or other drugs that&#xD;
             significantly alter bone metabolism&#xD;
&#xD;
          -  Subjects with Localized Juvenile Periodontitis (LJP) sites in the oral cavity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David L. Cochran, DDS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Health Sciences Center at San Antonio</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regenerative Solutions</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drs. McClain and Schallhorn</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perio Health Professionals</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <results_first_submitted>August 6, 2020</results_first_submitted>
  <results_first_submitted_qc>August 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 21, 2020</results_first_posted>
  <last_update_submitted>August 27, 2020</last_update_submitted>
  <last_update_submitted_qc>August 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bone grafting</keyword>
  <keyword>alveolar bone loss</keyword>
  <keyword>periodontal diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alveolar Bone Loss</mesh_term>
    <mesh_term>Periodontal Diseases</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 20, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT01728844/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited and enrolled at 6 dental clinical centers between November 2012 and December 2013.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Beta-tricalcium Phosphate Alone</title>
          <description>beta-tricalcium phosphate + placebo vehicle</description>
        </group>
        <group group_id="P2">
          <title>GFeBGS 0.1%</title>
          <description>GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)</description>
        </group>
        <group group_id="P3">
          <title>GFeBGS 0.3%</title>
          <description>GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF</description>
        </group>
        <group group_id="P4">
          <title>GFeGBS 0.4%</title>
          <description>GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="22"/>
                <participants group_id="P4" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="22"/>
                <participants group_id="P4" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Beta-tricalcium Phosphate Alone</title>
          <description>beta-tricalcium phosphate + placebo vehicle</description>
        </group>
        <group group_id="B2">
          <title>GFeBGS 0.1%</title>
          <description>GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)</description>
        </group>
        <group group_id="B3">
          <title>GFeBGS 0.3%</title>
          <description>GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF</description>
        </group>
        <group group_id="B4">
          <title>GFeGBS 0.4%</title>
          <description>GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF</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="22"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="22"/>
            <count group_id="B4" value="23"/>
            <count group_id="B5" value="88"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="56.5" spread="10.7"/>
                    <measurement group_id="B2" value="59.7" spread="12.1"/>
                    <measurement group_id="B3" value="54.0" spread="10.6"/>
                    <measurement group_id="B4" value="54.0" spread="10.5"/>
                    <measurement group_id="B5" value="56.0" spread="11.0"/>
                  </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="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="54"/>
                  </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="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking history</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Current smoker or smoked within past 6 months</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements</title>
        <description>The primary effectiveness endpoint is a composite endpoint that considers radiographic and clinical measurements at six months post-implantation: the amount of linear bone growth (LBG), which is assessed with the use of radiographs, and the regain from baseline of clinical attachment level (∆CAL), which is assessed clinically. Linear bone growth (LBG) in a vertical and horizontal direction is determined radiographically at six months post-implantation. The clinical attachment level (CAL) is the distance from the cemento-enamel junction (CEJ) (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. The success criteria are ΔCAL ≥1.5 mm and LBG ≥1 mm at 6 months after the treatment. Both the ∆CAL and LBG must meet the success criteria for a subject to be considered a success.</description>
        <time_frame>6 months post-surgery</time_frame>
        <population>The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Beta-tricalcium Phosphate Alone</title>
            <description>beta-tricalcium phosphate + placebo vehicle</description>
          </group>
          <group group_id="O2">
            <title>GFeBGS 0.1%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)</description>
          </group>
          <group group_id="O3">
            <title>GFeBGS 0.3%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF</description>
          </group>
          <group group_id="O4">
            <title>GFeGBS 0.4%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements</title>
          <description>The primary effectiveness endpoint is a composite endpoint that considers radiographic and clinical measurements at six months post-implantation: the amount of linear bone growth (LBG), which is assessed with the use of radiographs, and the regain from baseline of clinical attachment level (∆CAL), which is assessed clinically. Linear bone growth (LBG) in a vertical and horizontal direction is determined radiographically at six months post-implantation. The clinical attachment level (CAL) is the distance from the cemento-enamel junction (CEJ) (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. The success criteria are ΔCAL ≥1.5 mm and LBG ≥1 mm at 6 months after the treatment. Both the ∆CAL and LBG must meet the success criteria for a subject to be considered a success.</description>
          <population>The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Clinical Attachment Level at 3 Months</title>
        <description>The clinical attachment level is the distance from the cemento-enamel junction (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. Change = (3 months measurement - Baseline measurement)</description>
        <time_frame>Baseline and 3 months post-surgery</time_frame>
        <population>The modified Intent-to-Treat population consisted of 84 subjects after a subject was removed for lack of compliance with the study protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Beta-tricalcium Phosphate Alone</title>
            <description>beta-tricalcium phosphate + placebo vehicle</description>
          </group>
          <group group_id="O2">
            <title>GFeBGS 0.1%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)</description>
          </group>
          <group group_id="O3">
            <title>GFeBGS 0.3%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF</description>
          </group>
          <group group_id="O4">
            <title>GFeGBS 0.4%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Clinical Attachment Level at 3 Months</title>
          <description>The clinical attachment level is the distance from the cemento-enamel junction (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. Change = (3 months measurement - Baseline measurement)</description>
          <population>The modified Intent-to-Treat population consisted of 84 subjects after a subject was removed for lack of compliance with the study protocol.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="1.4"/>
                    <measurement group_id="O2" value="2.9" spread="1.7"/>
                    <measurement group_id="O3" value="3.1" spread="1.6"/>
                    <measurement group_id="O4" value="3.5" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Clinical Attachment Level at 6 Months</title>
        <description>The clinical attachment level is the distance from the cemento-enamel junction (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. Change = (6 months measurement - Baseline measurement)</description>
        <time_frame>Baseline and 6 months post-surgery</time_frame>
        <population>The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Beta-tricalcium Phosphate Alone</title>
            <description>beta-tricalcium phosphate + placebo vehicle</description>
          </group>
          <group group_id="O2">
            <title>GFeBGS 0.1%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)</description>
          </group>
          <group group_id="O3">
            <title>GFeBGS 0.3%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF</description>
          </group>
          <group group_id="O4">
            <title>GFeGBS 0.4%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Clinical Attachment Level at 6 Months</title>
          <description>The clinical attachment level is the distance from the cemento-enamel junction (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. Change = (6 months measurement - Baseline measurement)</description>
          <population>The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="2.1"/>
                    <measurement group_id="O2" value="2.5" spread="2.1"/>
                    <measurement group_id="O3" value="3.0" spread="1.4"/>
                    <measurement group_id="O4" value="3.6" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Linear Bone Growth at 6 Months</title>
        <description>Linear measurement of bone height in millimeters along mesial and/or distal root surfaces of the defect site is captured radiographically at baseline and 6 months. Linear Bone Growth = (Baseline measurement - 6 months measurement)</description>
        <time_frame>Baseline and 6 months post-surgery</time_frame>
        <population>The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Beta-tricalcium Phosphate Alone</title>
            <description>beta-tricalcium phosphate + placebo vehicle</description>
          </group>
          <group group_id="O2">
            <title>GFeBGS 0.1%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)</description>
          </group>
          <group group_id="O3">
            <title>GFeBGS 0.3%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF</description>
          </group>
          <group group_id="O4">
            <title>GFeGBS 0.4%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF</description>
          </group>
        </group_list>
        <measure>
          <title>Linear Bone Growth at 6 Months</title>
          <description>Linear measurement of bone height in millimeters along mesial and/or distal root surfaces of the defect site is captured radiographically at baseline and 6 months. Linear Bone Growth = (Baseline measurement - 6 months measurement)</description>
          <population>The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="1.8"/>
                    <measurement group_id="O2" value="3.0" spread="1.2"/>
                    <measurement group_id="O3" value="3.7" spread="1.3"/>
                    <measurement group_id="O4" value="3.6" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Bone Fill at 6 Months</title>
        <description>Linear measurement of bone height in millimeters along mesial and/or distal root surfaces of the defect site is captured radiographically at baseline and 6 months. Percent Bone Fill is calculated by dividing Linear Bone Growth at 6 months by bone height at baseline.</description>
        <time_frame>Baseline and 6 months post-surgery</time_frame>
        <population>The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Beta-tricalcium Phosphate Alone</title>
            <description>beta-tricalcium phosphate + placebo vehicle</description>
          </group>
          <group group_id="O2">
            <title>GFeBGS 0.1%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)</description>
          </group>
          <group group_id="O3">
            <title>GFeBGS 0.3%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF</description>
          </group>
          <group group_id="O4">
            <title>GFeGBS 0.4%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Bone Fill at 6 Months</title>
          <description>Linear measurement of bone height in millimeters along mesial and/or distal root surfaces of the defect site is captured radiographically at baseline and 6 months. Percent Bone Fill is calculated by dividing Linear Bone Growth at 6 months by bone height at baseline.</description>
          <population>The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.</population>
          <units>percentage of bone height change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.5" spread="26.4"/>
                    <measurement group_id="O2" value="61.0" spread="23.0"/>
                    <measurement group_id="O3" value="74.6" spread="20"/>
                    <measurement group_id="O4" value="71.1" spread="37.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pocket Depth Change at 3 Months</title>
        <description>Length from free gingival margin to the base of the pocket in millimeter is measured with North Carolina 15 mm periodontal probes. Pocket Depth Change = (3 months measurement - Baseline measurement)</description>
        <time_frame>Baseline and 3 months post-surgery</time_frame>
        <population>The modified Intent-to-Treat population consisted of 84 subjects after a subject was removed for lack of compliance with the study protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Beta-tricalcium Phosphate Alone</title>
            <description>beta-tricalcium phosphate + placebo vehicle</description>
          </group>
          <group group_id="O2">
            <title>GFeBGS 0.1%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)</description>
          </group>
          <group group_id="O3">
            <title>GFeBGS 0.3%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF</description>
          </group>
          <group group_id="O4">
            <title>GFeGBS 0.4%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF</description>
          </group>
        </group_list>
        <measure>
          <title>Pocket Depth Change at 3 Months</title>
          <description>Length from free gingival margin to the base of the pocket in millimeter is measured with North Carolina 15 mm periodontal probes. Pocket Depth Change = (3 months measurement - Baseline measurement)</description>
          <population>The modified Intent-to-Treat population consisted of 84 subjects after a subject was removed for lack of compliance with the study protocol.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="1.4"/>
                    <measurement group_id="O2" value="3.5" spread="1.4"/>
                    <measurement group_id="O3" value="3.5" spread="1.6"/>
                    <measurement group_id="O4" value="3.8" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pocket Depth Change at 6 Months</title>
        <description>Length from free gingival margin to the base of the pocket in millimeter is measured with North Carolina 15 mm periodontal probes. Pocket Depth Change = (6 months measurement - Baseline measurement)</description>
        <time_frame>Baseline and 6 months post-surgery</time_frame>
        <population>The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Beta-tricalcium Phosphate Alone</title>
            <description>beta-tricalcium phosphate + placebo vehicle</description>
          </group>
          <group group_id="O2">
            <title>GFeBGS 0.1%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)</description>
          </group>
          <group group_id="O3">
            <title>GFeBGS 0.3%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF</description>
          </group>
          <group group_id="O4">
            <title>GFeGBS 0.4%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF</description>
          </group>
        </group_list>
        <measure>
          <title>Pocket Depth Change at 6 Months</title>
          <description>Length from free gingival margin to the base of the pocket in millimeter is measured with North Carolina 15 mm periodontal probes. Pocket Depth Change = (6 months measurement - Baseline measurement)</description>
          <population>The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="1.2"/>
                    <measurement group_id="O2" value="2.9" spread="2.0"/>
                    <measurement group_id="O3" value="3.4" spread="1.0"/>
                    <measurement group_id="O4" value="3.7" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Gingival Recession at 3 Months</title>
        <description>Length from the free gingival margin to the CEJ is measured in millimeter with North Carolina 15 mm periodontal probes. Gingival Recession = (3 months measurement - Baseline measurement)</description>
        <time_frame>Baseline and 3 months post-surgery</time_frame>
        <population>The modified Intent-to-Treat population consisted of 84 subjects after a subject was removed for lack of compliance with the study protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Beta-tricalcium Phosphate Alone</title>
            <description>beta-tricalcium phosphate + placebo vehicle</description>
          </group>
          <group group_id="O2">
            <title>GFeBGS 0.1%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)</description>
          </group>
          <group group_id="O3">
            <title>GFeBGS 0.3%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF</description>
          </group>
          <group group_id="O4">
            <title>GFeGBS 0.4%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Gingival Recession at 3 Months</title>
          <description>Length from the free gingival margin to the CEJ is measured in millimeter with North Carolina 15 mm periodontal probes. Gingival Recession = (3 months measurement - Baseline measurement)</description>
          <population>The modified Intent-to-Treat population consisted of 84 subjects after a subject was removed for lack of compliance with the study protocol.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="1.4"/>
                    <measurement group_id="O2" value="-0.6" spread="1.1"/>
                    <measurement group_id="O3" value="-0.3" spread="1.2"/>
                    <measurement group_id="O4" value="-0.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Gingival Recession at 6 Months</title>
        <description>Length from the free gingival margin to the CEJ is measured in millimeter with North Carolina 15 mm periodontal probes. Gingival Recession = (6 months measurement - Baseline measurement)</description>
        <time_frame>Baseline and 6 months post-surgery</time_frame>
        <population>The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Beta-tricalcium Phosphate Alone</title>
            <description>beta-tricalcium phosphate + placebo vehicle</description>
          </group>
          <group group_id="O2">
            <title>GFeBGS 0.1%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)</description>
          </group>
          <group group_id="O3">
            <title>GFeBGS 0.3%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF</description>
          </group>
          <group group_id="O4">
            <title>GFeGBS 0.4%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Gingival Recession at 6 Months</title>
          <description>Length from the free gingival margin to the CEJ is measured in millimeter with North Carolina 15 mm periodontal probes. Gingival Recession = (6 months measurement - Baseline measurement)</description>
          <population>The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="1.5"/>
                    <measurement group_id="O2" value="-0.4" spread="1.0"/>
                    <measurement group_id="O3" value="-0.4" spread="1.1"/>
                    <measurement group_id="O4" value="-0.1" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements (Updated Success Criteria)</title>
        <description>The primary effectiveness endpoint is a composite endpoint that considers radiographic and clinical measurements at six months post-implantation: the amount of linear bone growth (LBG), which is assessed with the use of radiographs, and the regain from baseline of clinical attachment level (∆CAL), which is assessed clinically. Linear bone growth (LBG) in a vertical and horizontal direction is determined radiographically at six months post-implantation. The clinical attachment level (CAL) is the distance from the cemento-enamel junction (CEJ) (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. The updated success criteria are ΔCAL ≥1.5 mm and LBG ≥ 2.5 mm at 6 months after the treatment. Both the ∆CAL and LBG must meet the success criteria for a subject to be considered a success.</description>
        <time_frame>6 months post-surgery</time_frame>
        <population>The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Beta-tricalcium Phosphate Alone</title>
            <description>beta-tricalcium phosphate + placebo vehicle</description>
          </group>
          <group group_id="O2">
            <title>GFeBGS 0.1%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)</description>
          </group>
          <group group_id="O3">
            <title>GFeBGS 0.3%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF</description>
          </group>
          <group group_id="O4">
            <title>GFeGBS 0.4%</title>
            <description>GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements (Updated Success Criteria)</title>
          <description>The primary effectiveness endpoint is a composite endpoint that considers radiographic and clinical measurements at six months post-implantation: the amount of linear bone growth (LBG), which is assessed with the use of radiographs, and the regain from baseline of clinical attachment level (∆CAL), which is assessed clinically. Linear bone growth (LBG) in a vertical and horizontal direction is determined radiographically at six months post-implantation. The clinical attachment level (CAL) is the distance from the cemento-enamel junction (CEJ) (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. The updated success criteria are ΔCAL ≥1.5 mm and LBG ≥ 2.5 mm at 6 months after the treatment. Both the ∆CAL and LBG must meet the success criteria for a subject to be considered a success.</description>
          <population>The modified Intent-to-Treat population consisted of 83 subjects after two subjects were removed for lack of compliance with the study protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Beta-tricalcium Phosphate Alone</title>
          <description>beta-tricalcium phosphate + placebo vehicle</description>
        </group>
        <group group_id="E2">
          <title>GFeBGS 0.1%</title>
          <description>GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)</description>
        </group>
        <group group_id="E3">
          <title>GFeBGS 0.3%</title>
          <description>GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF</description>
        </group>
        <group group_id="E4">
          <title>GFeGBS 0.4%</title>
          <description>GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Bunion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma basal</sub_title>
                <description>Pre-existing condition was updated.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Chronic lymphocytic leukemia</sub_title>
                <description>Pre-existing condition was updated.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Coma</sub_title>
                <description>An accident caused serious head trauma.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Non-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="4" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Application site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Application site inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Application site hyperaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
              </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>Institution will submit the manuscript of the proposed publication to Sponsor at least 30 days prior to publication, and Sponsor shall have the right to review and comment upon the publication in order to protect Sponsor's confidential information. Upon Sponsor's written request, publication will be delayed up to 60 additional days to enable Sponsor to secure adequate intellectual property protection on Sponsor's intellectual property that would be affected by said publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Akane Takemura</name_or_title>
      <organization>Sunstar Americas, Inc.</organization>
      <phone>8477944276</phone>
      <email>akane.takemura@us.sunstar.com</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/NCT01728844
org study id: CLP-2011-10-31-1
nct id: NCT01728844
lead sponsor: 
has dmc: No
GUIDOR Growth Factor Enchanted Bone Graft Substitute (GFeBGS) when used in periodontal
      surgery will shown greater gum and bone regeneration when compare to bone graft substitute
      alone. Also, to find the optimal dose.
This will be a prospective, randomized, double-blinded, controlled, multi-center,
      dose-verification clinical study in subjects who require surgical intervention to treat a
      qualifying periodontal defect.

      Subjects 25 years and older with advanced periodontal disease in at least one site requiring
      surgical treatment to correct a bone defect.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants That Met the Success Criteria of Radiographic and Clinical Measurements
time frame: 6 months post-surgery
description: The primary effectiveness endpoint is a composite endpoint that considers radiographic and clinical measurements at six months post-implantation: the amount of linear bone growth (LBG), which is assessed with the use of radiographs, and the regain from baseline of clinical attachment level (∆CAL), which is assessed clinically. Linear bone growth (LBG) in a vertical and horizontal direction is determined radiographically at six months post-implantation. The clinical attachment level (CAL) is the distance from the cemento-enamel junction (CEJ) (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. The success criteria are ΔCAL ≥1.5 mm and LBG ≥1 mm at 6 months after the treatment. Both the ∆CAL and LBG must meet the success criteria for a subject to be considered a success.
measure: Change in Clinical Attachment Level at 3 Months
time frame: Baseline and 3 months post-surgery
description: The clinical attachment level is the distance from the cemento-enamel junction (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. Change = (3 months measurement - Baseline measurement)
measure: Change in Clinical Attachment Level at 6 Months
time frame: Baseline and 6 months post-surgery
description: The clinical attachment level is the distance from the cemento-enamel junction (or other fixed reference point) generally along the long axis of the tooth to the deepest extent of the periodontal pocket. Change = (6 months measurement - Baseline measurement)
measure: Linear Bone Growth at 6 Months
time frame: Baseline and 6 months post-surgery
description: Linear measurement of bone height in millimeters along mesial and/or distal root surfaces of the defect site is captured radiographically at baseline and 6 months. Linear Bone Growth = (Baseline measurement - 6 months measurement)
measure: Percent Bone Fill at 6 Months
time frame: Baseline and 6 months post-surgery
description: Linear measurement of bone height in millimeters along mesial and/or distal root surfaces of the defect site is captured radiographically at baseline and 6 months. Percent Bone Fill is calculated by dividing Linear Bone Growth at 6 months by bone height at baseline.
measure: Pocket Depth Change at 3 Months
time frame: Baseline and 3 months post-surgery
description: Length from free gingival margin to the base of the pocket in millimeter is measured with North Carolina 15 mm periodontal probes. Pocket Depth Change = (3 months measurement - Baseline measurement)
measure: Pocket Depth Change at 6 Months
time frame: Baseline and 6 months post-surgery
description: Length from free gingival margin to the base of the pocket in millimeter is measured with North Carolina 15 mm periodontal probes. Pocket Depth Change = (6 months measurement - Baseline measurement)
measure: Change in Gingival Recession at 3 Months
time frame: Baseline and 3 months post-surgery
description: Length from the free gingival margin to the CEJ is measured in millimeter with North Carolina 15 mm periodontal probes. Gingival Recession = (3 months measurement - Baseline measurement)
measure: Change in Gingival Recession at 6 Months
time frame: Baseline and 6 months post-surgery
description: Length from the free gingival margin to the CEJ is measured in millimeter with North Carolina 15 mm periodontal probes. Gingival Recession = (6 months measurement - Baseline measurement)
arm group label: beta-tricalcium phosphate alone
arm group type: Active Comparator
description: beta-tricalcium phosphate alone
arm group label: GFeBGS 0.1%
arm group type: Experimental
description: GFeBGS consisting of beta-tricalcium phosphate + 0.1% recombinant human basic fibroblast growth factor (rh-bFGF)
arm group label: GFeBGS 0.3%
arm group type: Experimental
description: GFeBGS consisting of beta-tricalcium phosphate + 0.3% rh-bFGF
arm group label: GFeGBS 0.4%
arm group type: Experimental
description: GFeBGS consisting of beta-tricalcium phosphate + 0.4% rh-bFGF
intervention type: Device
intervention name: beta-tricalcium phosphate alone
arm group label: beta-tricalcium phosphate alone
intervention type: Device
intervention name: GFeBGS 0.1%
arm group label: GFeBGS 0.1%
intervention type: Device
intervention name: GFeBGS 0.3%
arm group label: GFeBGS 0.3%
intervention type: Device
intervention name: GFeBGS 0.4%
arm group label: GFeGBS 0.4%
criteria: 
gender: All
minimum age: 25 Years
maximum age: N/A
healthy volunteers: No
last name: David L. Cochran, DDS, PhD
role: Principal Investigator
affiliation: University of Texas Health Sciences Center at San Antonio
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alveolar Bone Loss
mesh term: Periodontal Diseases
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 