<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/NCT03003819</url>
  </required_header>
  <id_info>
    <org_study_id>GPNA0001-2016</org_study_id>
    <nct_id>NCT03003819</nct_id>
  </id_info>
  <brief_title>A Comparison of Two Socket Sealing Collagen Matrices for Extraction Socket Management</brief_title>
  <official_title>A Prospective, Randomized, Controlled, Multi-center Evaluation of Extraction Socket Management Comparing Two Socket Sealing Collagen Matrices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGuire Institute</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McGuire Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective RCT of intact extractions with delayed implant placement comparing extraction&#xD;
      socket management effectiveness and office economics of two collagen matrices. Soft tissue&#xD;
      wound healing will be assessed out to 4-months post-operative, when implants will be placed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, randomized, multi-center, controlled clinical study of intact extractions&#xD;
      (bony dehiscences &lt;1/3 socket apico-coronal and mesial-distal dimension) with delayed implant&#xD;
      placement. Study objective: to compare extraction socket management effectiveness and office&#xD;
      economics of a frequently used wound dressing (control) with a soft tissue augmentation&#xD;
      matrix (test) in 32-64 subjects 18 -75 years of age with intact (bony dehiscence, if present,&#xD;
      &lt; 1/3 socket dimension) extractions intended for dental implant replacement. Following&#xD;
      screening subjects will undergo tooth extraction and randomization to either the control or&#xD;
      test therapy. After treatment, subjects will be followed until 4- months, the time of implant&#xD;
      placement. Primary outcome: soft tissue wound healing measured by (1) gap closure and (2)&#xD;
      graft containment at all time points.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">April 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Socket Soft Tissue Gap Closure - linear measures buccal-lingual in millimeters</measure>
    <time_frame>4-months</time_frame>
    <description>Longitudinal extraction socket soft tissue gap closure measured buccal-lingual from baseline to 4-months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Socket Soft Tissue Gap Closure - linear measures mesial-distal</measure>
    <time_frame>4-months</time_frame>
    <description>Longitudinal extraction socket soft tissue gap closure measured mesial-distal from baseline to 4-months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Graft Containment as observed by subject and examiner (yes/ no)</measure>
    <time_frame>4-months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation Score (Loe and Sillness)</measure>
    <time_frame>4-months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomaterial Integrity - 4-point scale</measure>
    <time_frame>4-months</time_frame>
    <description>Score 0-4, 0 = biomaterial completely present, 4 = no evidence of biomaterial/ complete granulation or other tissue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tissue Thickness - probe show-thru at baseline and biopsy measure in millimeters at 4-months</measure>
    <time_frame>4-months</time_frame>
    <description>Soft tissue thickness is measured using probe &quot;show-thru&quot; (tissue transparency) at baseline and soft tissue biopsy at the implant site immediately prior to implant placement</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Tooth Loss</condition>
  <arm_group>
    <arm_group_label>Control Collagen Wound Dressing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bovine collagen sponge used to control bleeding, stabilize blood clots and protect dental wounds</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Collagen Matrix</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bilayer, porcine collagen matrix for soft tissue regeneration used as a socket seal in extraction socket grafting</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control Collagen Wound Dressing</intervention_name>
    <description>Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic and local anesthetic, minimally traumatic extraction will be performed with periotomes . After degranulation and bone graft placement, control or test biomaterial will be placed according to the randomization schedule and surgical instructions for each biomaterial.</description>
    <arm_group_label>Control Collagen Wound Dressing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Test Collagen Matrix</intervention_name>
    <description>Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic and local anesthetic, minimally traumatic extraction will be performed with periotomes . After degranulation and bone graft placement, control or test biomaterial will be placed according to the randomization schedule and surgical instructions for each biomaterial.</description>
    <arm_group_label>Test Collagen Matrix</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject indicated for anterior tooth extraction (from premolars forward) intended for&#xD;
             implant placement.&#xD;
&#xD;
          -  Subjects with essentially intact extraction sockets - bony dehiscences &lt; 1/3 the depth&#xD;
             of socket and mesial-distal width of tooth socket&#xD;
&#xD;
          -  Subjects will have read, understood and signed an institutional review board (IRB)&#xD;
             approved Informed Consent Form (ICF).&#xD;
&#xD;
          -  Subjects must be able and willing to follow study procedures and instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with healing disorders (i.e., diabetes mellitus, cancer, HIV, bone metabolic&#xD;
             diseases) that could compromise wound healing and/ or preclude implant surgery; or who&#xD;
             are currently receiving or have received within two months prior to study entry,&#xD;
             systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or&#xD;
             chemotherapy which could compromise wound healing and preclude periodontal surgery.&#xD;
&#xD;
          -  Subjects taking intramuscular or intravenous bisphosphonates.&#xD;
&#xD;
          -  Subjects who have a known allergy or sensitivity to collagen.&#xD;
&#xD;
          -  Subjects with acute, suppurative lesions with pain, swelling and apical lesions &gt; 5mm&#xD;
             will be excluded, though antibiotic prophylaxis may be employed to reduce infection&#xD;
             and provide possible subject reconsideration for inclusion.&#xD;
&#xD;
          -  Heavy smokers/tobacco users defined as those smoking ≥ 10 cigarettes or ≥ 4 cigars or&#xD;
             ≥ 4 pipes per day. For non-heavy smokers, smoking ≥ 10 cigarettes or ≥ 4 cigars or ≥ 4&#xD;
             pipes per day is prohibited for the duration of the study.&#xD;
&#xD;
          -  Female subjects who are pregnant or lactating, or who intend to become pregnant during&#xD;
             the study duration&#xD;
&#xD;
          -  Subjects participating in other clinical studies involving therapeutic intervention&#xD;
             (either medical or dental).&#xD;
&#xD;
          -  Subjects, who in the opinion of the Investigator, for any reason other than those&#xD;
             listed above, will not be able to complete the study per protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Todd V Scantlebury, BS</last_name>
    <role>Study Director</role>
    <affiliation>The McGuire Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Diego Velasquez, DDS, MSD</last_name>
    <phone>810.750.3500</phone>
    <email>Periomichigan@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seven Lakes Periodontics</name>
      <address>
        <city>Fenton</city>
        <state>Michigan</state>
        <zip>48430</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diego Velasquez, DDS, MSD</last_name>
      <phone>810-750-3400</phone>
      <email>Periomichigan@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Rick Heard, DDS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jim Janakievski, DDS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marc Nevins, DDS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Brian Pope, DDS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gregory Toback, DDS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chris Richardson, DMD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Diego Velasquez, DDS, MSD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Don Clem, DDS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michael Pikos, DDS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pamela McClain, DDS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michael McGuire, DDS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Craig Misch, DDS, MDS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Greg Santarelli, DDS</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rachel Schallhorn, DDS, MS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eric T Scheyer, DDS, MS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stephen Pickering, DDS, MSD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Thoma DS, Sancho-Puchades M, Ettlin DA, Hammerle CH, Jung RE. Impact of a collagen matrix on early healing, aesthetics and patient morbidity in oral mucosal wounds - a randomized study in humans. J Clin Periodontol. 2012 Feb;39(2):157-65. doi: 10.1111/j.1600-051X.2011.01823.x. Epub 2011 Dec 6.</citation>
    <PMID>22145767</PMID>
  </reference>
  <reference>
    <citation>Sclar AG. Strategies for management of single-tooth extraction sites in aesthetic implant therapy. J Oral Maxillofac Surg. 2004 Sep;62(9 Suppl 2):90-105. doi: 10.1016/j.joms.2004.06.041. Erratum In: J Oral Maxillofac Surg. 2005 Jan;63(1):158.</citation>
    <PMID>15332186</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>February 18, 2020</last_update_submitted>
  <last_update_submitted_qc>February 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03003819
org study id: GPNA0001-2016
nct id: NCT03003819
lead sponsor: 
has dmc: No
A prospective RCT of intact extractions with delayed implant placement comparing extraction
      socket management effectiveness and office economics of two collagen matrices. Soft tissue
      wound healing will be assessed out to 4-months post-operative, when implants will be placed.
A prospective, randomized, multi-center, controlled clinical study of intact extractions
      (bony dehiscences <1/3 socket apico-coronal and mesial-distal dimension) with delayed implant
      placement. Study objective: to compare extraction socket management effectiveness and office
      economics of a frequently used wound dressing (control) with a soft tissue augmentation
      matrix (test) in 32-64 subjects 18 -75 years of age with intact (bony dehiscence, if present,
      < 1/3 socket dimension) extractions intended for dental implant replacement. Following
      screening subjects will undergo tooth extraction and randomization to either the control or
      test therapy. After treatment, subjects will be followed until 4- months, the time of implant
      placement. Primary outcome: soft tissue wound healing measured by (1) gap closure and (2)
      graft containment at all time points.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Socket Soft Tissue Gap Closure - linear measures buccal-lingual in millimeters
time frame: 4-months
description: Longitudinal extraction socket soft tissue gap closure measured buccal-lingual from baseline to 4-months.
measure: Socket Soft Tissue Gap Closure - linear measures mesial-distal
time frame: 4-months
description: Longitudinal extraction socket soft tissue gap closure measured mesial-distal from baseline to 4-months.
measure: Graft Containment as observed by subject and examiner (yes/ no)
time frame: 4-months
measure: Inflammation Score (Loe and Sillness)
time frame: 4-months
measure: Biomaterial Integrity - 4-point scale
time frame: 4-months
description: Score 0-4, 0 = biomaterial completely present, 4 = no evidence of biomaterial/ complete granulation or other tissue
measure: Tissue Thickness - probe show-thru at baseline and biopsy measure in millimeters at 4-months
time frame: 4-months
description: Soft tissue thickness is measured using probe "show-thru" (tissue transparency) at baseline and soft tissue biopsy at the implant site immediately prior to implant placement
arm group label: Control Collagen Wound Dressing
arm group type: Active Comparator
description: Bovine collagen sponge used to control bleeding, stabilize blood clots and protect dental wounds
arm group label: Test Collagen Matrix
arm group type: Active Comparator
description: Bilayer, porcine collagen matrix for soft tissue regeneration used as a socket seal in extraction socket grafting
intervention type: Device
intervention name: Control Collagen Wound Dressing
description: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic and local anesthetic, minimally traumatic extraction will be performed with periotomes . After degranulation and bone graft placement, control or test biomaterial will be placed according to the randomization schedule and surgical instructions for each biomaterial.
arm group label: Control Collagen Wound Dressing
intervention type: Device
intervention name: Test Collagen Matrix
description: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic and local anesthetic, minimally traumatic extraction will be performed with periotomes . After degranulation and bone graft placement, control or test biomaterial will be placed according to the randomization schedule and surgical instructions for each biomaterial.
arm group label: Test Collagen Matrix
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Todd V Scantlebury, BS
role: Study Director
affiliation: The McGuire Institute
last name: Diego Velasquez, DDS, MSD
phone: 810.750.3500
email: Periomichigan@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
citation: Thoma DS, Sancho-Puchades M, Ettlin DA, Hammerle CH, Jung RE. Impact of a collagen matrix on early healing, aesthetics and patient morbidity in oral mucosal wounds - a randomized study in humans. J Clin Periodontol. 2012 Feb;39(2):157-65. doi: 10.1111/j.1600-051X.2011.01823.x. Epub 2011 Dec 6.
PMID: 22145767
citation: Sclar AG. Strategies for management of single-tooth extraction sites in aesthetic implant therapy. J Oral Maxillofac Surg. 2004 Sep;62(9 Suppl 2):90-105. doi: 10.1016/j.joms.2004.06.041. Erratum In: J Oral Maxillofac Surg. 2005 Jan;63(1):158.
PMID: 15332186
responsible party type: Sponsor
mesh term: Tooth Loss
sharing ipd: No