xml: <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/NCT06038695</url>
    </required_header>
    <id_info>
      <org_study_id>202212227</org_study_id>
      <nct_id>NCT06038695</nct_id>
    </id_info>
    <brief_title>Immediate Implant Placement Using Volume-Stable Collagen Matrix Combined With rhPDGF-BB</brief_title>
    <official_title>Ultrasound-based Imaging to Detect Early Changes of Hard and Soft Tissue Around Immediately Placed Implants With Volume-Stable Collagen Matrix Combined With rhPDGF-BB: Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>I-Ching Wang</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Iowa</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to test a volume-stable collagen matrix in combination with&#xD;
        recombinant human platelet-derived growth factor-BB, specifically in patients who have an&#xD;
        immediate implant placement for teeth #5-#12.&#xD;
  &#xD;
        The main question this study aims to answer is does the recombinant human platelet-derived&#xD;
        growth factor-BB accelerate the formation of blood vessels and augment tissue volume around&#xD;
        the immediate implant.&#xD;
  &#xD;
        Participants will be asked to undergo immediate implant placement using volume-stable&#xD;
        collagen matrix in combination with recombinant human platelet-derived growth factor-BB, as&#xD;
        well as attend 11 study visits over the course of 1.25 years.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <phase>N/A</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>Change in from Baseline in Soft and Hard Tissue Thickness as assessed by ultrasound.</measure>
      <time_frame>Multiple time points (i.e. 0, Immediately after implant placement, 1 week, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 16 weeks, 24 weeks, and 48 weeks after immediate implant placement</time_frame>
      <description>Tissues will be measured in millimeters.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Tooth Extraction</condition>
    <condition>Immediate Implant Placement</condition>
    <arm_group>
      <arm_group_label>Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects in this arm will have a xenogeneic volume-stable collagen matrix in combination with recombinant human platelet-derived growth factor-BB at the time of immediate implant placement.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB</intervention_name>
      <description>Fibro-Gide is the Volume-Stable Collagen Matrix.&#xD;
  Recombinant human platelet-derived growth factor-BB will be found within the device of GEM21S.</description>
      <arm_group_label>Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB</arm_group_label>
      <other_name>Fibro-Gide, Geistlich Pharma</other_name>
      <other_name>GEM21S, Lynch Biologics</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18-95&#xD;
  &#xD;
            -  Has a single hopeless tooth in the maxillary esthetic zone (i.e., first premolar to&#xD;
               first premolar, tooth #5-tooth #13)&#xD;
  &#xD;
            -  Adequate oral hygiene (i.e., full-mouth bleeding score (FMBS) and full mouth plaque&#xD;
               score (FMPS) of less than 25%)&#xD;
  &#xD;
            -  Adequate tooth space to support an immediate implant placement (i.e., adequate&#xD;
               mesiodistal space of greater than or equal to 6 mm and interocclusal space to support&#xD;
               a non-occluding provisionalization).&#xD;
  &#xD;
            -  Postextraction vertical bone defect of the buccal socket wall was less than or equal&#xD;
               to 3mm&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients taking long-term (more than 3 months) medications affecting bone metabolism&#xD;
  &#xD;
            -  generalized untreated periodontitis with greater than of 30% of sites with greater&#xD;
               than 5mm pocket depths and bleeding upon probing with a dental probe&#xD;
  &#xD;
            -  medical contraindications for having a surgical procedure (i.e., ASA Status of III,&#xD;
               patient with a severe systemic disease that is not life-threatening; ASA Status of IV,&#xD;
               a patient with a severe systemic disease that is a constant threat to life).&#xD;
  &#xD;
            -  history of radiotherapy in the head and neck region&#xD;
  &#xD;
            -  heavy smoker (greater than 10 cigarettes per day)&#xD;
  &#xD;
            -  pregnancy&#xD;
  &#xD;
            -  gingival recession before extraction in relation to the contralateral tooth&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>95 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>I-Ching Wang, DDS,MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Iowa</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>I-Ching Wang, DDS, MS</last_name>
      <phone>(319) 467-4390</phone>
      <email>i-ching-wang@uiowa.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Iowa College of Dentistry and Dental Clinics</name>
        <address>
          <city>Iowa City</city>
          <state>Iowa</state>
          <zip>52242</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>I-Ching Wang, DDS, MS</last_name>
        <phone>319-467-4390</phone>
        <email>i-ching-wang@uiowa.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Iowa</investigator_affiliation>
      <investigator_full_name>I-Ching Wang</investigator_full_name>
      <investigator_title>Clinical Assistant Professor</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mitogens</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038695
  org study id: 202212227
  nct id: NCT06038695
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  The goal of this study is to test a volume-stable collagen matrix in combination with
        recombinant human platelet-derived growth factor-BB, specifically in patients who have an
        immediate implant placement for teeth #5-#12.
  
        The main question this study aims to answer is does the recombinant human platelet-derived
        growth factor-BB accelerate the formation of blood vessels and augment tissue volume around
        the immediate implant.
  
        Participants will be asked to undergo immediate implant placement using volume-stable
        collagen matrix in combination with recombinant human platelet-derived growth factor-BB, as
        well as attend 11 study visits over the course of 1.25 years.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in from Baseline in Soft and Hard Tissue Thickness as assessed by ultrasound.
  time frame: Multiple time points (i.e. 0, Immediately after implant placement, 1 week, 2 weeks, 4 weeks, 6 weeks, 12 weeks, 16 weeks, 24 weeks, and 48 weeks after immediate implant placement
  description: Tissues will be measured in millimeters.
  arm group label: Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB
  arm group type: Experimental
  description: Subjects in this arm will have a xenogeneic volume-stable collagen matrix in combination with recombinant human platelet-derived growth factor-BB at the time of immediate implant placement.
  intervention type: Device
  intervention name: Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB
  description: Fibro-Gide is the Volume-Stable Collagen Matrix.
  Recombinant human platelet-derived growth factor-BB will be found within the device of GEM21S.
  arm group label: Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB
  other name: Fibro-Gide, Geistlich Pharma
  other name: GEM21S, Lynch Biologics
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 95 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: I-Ching Wang, DDS,MS
  role: Principal Investigator
  affiliation: University of Iowa
  last name: I-Ching Wang, DDS, MS
  phone: (319) 467-4390
  email: i-ching-wang@uiowa.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Iowa
  investigator full name: I-Ching Wang
  investigator title: Clinical Assistant Professor
  mesh term: Mitogens
  sharing ipd: No