<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/NCT02206009</url>
  </required_header>
  <id_info>
    <org_study_id>14-000767</org_study_id>
    <nct_id>NCT02206009</nct_id>
  </id_info>
  <brief_title>Use of a Collagen Membrane for Soft Tissue Grafting</brief_title>
  <official_title>PriMatrix Dermal Repair Scaffold Utilization Intraorally</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lauren M. F. Syrowik</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Is PriMatrix wound dressing capable of regenerating gum tissue inside the mouth?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PriMatrix is an acellular fetal bovine dermal matrix that has a wide array of FDA approved&#xD;
      uses. These uses include partial- and full-thickness wounds, pressure, diabetic, and venous&#xD;
      ulcers, surgical wounds, trauma wounds, tunneled wounds, and draining wounds. It is a&#xD;
      sheet-like matrix made up primarily of type I and type III collagen. An increased proportion&#xD;
      of type III collagen appears to play a key role in healing and regeneration.&#xD;
&#xD;
      The use of extracellular dermal matrices is a relatively young field, and the exact mechanism&#xD;
      by which PriMatrix promotes skin regeneration is still unknown. Despite this, PriMatrix has&#xD;
      demonstrated differences in manufacturing and molecular composition that make it conducive to&#xD;
      the harsh environments in which it has already been tested. Intraorally, where there is a&#xD;
      rich vascular bed, this material holds exceeding promise.&#xD;
&#xD;
      Utilizing this vascularity, autogenous free gingival grafts from the palate have already had&#xD;
      their efficacy proven as a method of augmenting the keratinized tissue.The need to increase&#xD;
      the keratinized tissue is based upon the postulation that less mobile, keratinized epithelium&#xD;
      is more resilient than the non-keratinized oral mucosa. This is especially important in areas&#xD;
      where recession and attachment loss has already occurred. Without having keratinized gingiva&#xD;
      apical to the recession area, it has been suggested that there is a greater risk for more&#xD;
      attachment loss to occur, thus reducing the support for the tooth. In addition, autogenous&#xD;
      free gingival grafts have demonstrated the phenomenon of &quot;creeping attachment&quot; where a&#xD;
      portion of the recession actually becomes covered as a result of grafting.&#xD;
&#xD;
      While autogenous grafting is the gold standard in soft tissue augmentation, the amount of&#xD;
      tissue that can be taken from the palate is limited, making it difficult to treat patients&#xD;
      with generalized recession. Furthermore, a secondary surgical site increases the morbidity&#xD;
      associated with the procedure. The hypothesis of this study is that PriMatrix will be able to&#xD;
      provide similar results to an autogenous free gingival graft.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 1</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 depth of keratinized tissue</measure>
    <time_frame>baseline, approximately 6 months after the procedure</time_frame>
    <description>The amount of gingival augmentation will be assessed by the depth of keratinized tissue, measured in millimeters. Change in the amount of keratinized tissue in the areas of interest from baseline to 6 months will be tested to see if they are statistically significant.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Localized Gingival Recession</condition>
  <arm_group>
    <arm_group_label>Collagen membrane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First, the recipient site is prepared, and the collagen membrane hydrated. The collagen membrane is sutured firmly against the prepared vascular bed with a long-lasting suture material. The subject is requested to minimize the amount of manipulation to the area to maintain graft stability.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Collagen Membrane</intervention_name>
    <description>First, the recipient site is prepared, and the collagen membrane hydrated. The collagen membrane is sutured firmly against the prepared vascular bed with a long-lasting suture material. The subject is requested to minimize the amount of manipulation to the area to maintain graft stability.</description>
    <arm_group_label>Collagen membrane</arm_group_label>
    <other_name>PriMatrix</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have one to three consecutive teeth with recession and less than 1 mm of&#xD;
             keratinized gingiva&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Asthma&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Uncontrolled diabetes&#xD;
&#xD;
          -  Use of continuous positive airway pressure (CPAP) machine for sleep apnea&#xD;
&#xD;
          -  Oral appliances (removable partial dentures, braces, mandibular advancement, bruxism&#xD;
             splints, etc.)&#xD;
&#xD;
          -  Tobacco use&#xD;
&#xD;
          -  Immunocompromised individual&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Assad, DDS</last_name>
    <role>Study Director</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lauren MF Syrowik, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>January 5, 2016</last_update_submitted>
  <last_update_submitted_qc>January 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Lauren M. F. Syrowik</investigator_full_name>
    <investigator_title>DDS</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingival Recession</mesh_term>
  </condition_browse>
  <!-- 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/NCT02206009
org study id: 14-000767
nct id: NCT02206009
lead sponsor: 
has dmc: No
Is PriMatrix wound dressing capable of regenerating gum tissue inside the mouth?
PriMatrix is an acellular fetal bovine dermal matrix that has a wide array of FDA approved
      uses. These uses include partial- and full-thickness wounds, pressure, diabetic, and venous
      ulcers, surgical wounds, trauma wounds, tunneled wounds, and draining wounds. It is a
      sheet-like matrix made up primarily of type I and type III collagen. An increased proportion
      of type III collagen appears to play a key role in healing and regeneration.

      The use of extracellular dermal matrices is a relatively young field, and the exact mechanism
      by which PriMatrix promotes skin regeneration is still unknown. Despite this, PriMatrix has
      demonstrated differences in manufacturing and molecular composition that make it conducive to
      the harsh environments in which it has already been tested. Intraorally, where there is a
      rich vascular bed, this material holds exceeding promise.

      Utilizing this vascularity, autogenous free gingival grafts from the palate have already had
      their efficacy proven as a method of augmenting the keratinized tissue.The need to increase
      the keratinized tissue is based upon the postulation that less mobile, keratinized epithelium
      is more resilient than the non-keratinized oral mucosa. This is especially important in areas
      where recession and attachment loss has already occurred. Without having keratinized gingiva
      apical to the recession area, it has been suggested that there is a greater risk for more
      attachment loss to occur, thus reducing the support for the tooth. In addition, autogenous
      free gingival grafts have demonstrated the phenomenon of "creeping attachment" where a
      portion of the recession actually becomes covered as a result of grafting.

      While autogenous grafting is the gold standard in soft tissue augmentation, the amount of
      tissue that can be taken from the palate is limited, making it difficult to treat patients
      with generalized recession. Furthermore, a secondary surgical site increases the morbidity
      associated with the procedure. The hypothesis of this study is that PriMatrix will be able to
      provide similar results to an autogenous free gingival graft.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in depth of keratinized tissue
time frame: baseline, approximately 6 months after the procedure
description: The amount of gingival augmentation will be assessed by the depth of keratinized tissue, measured in millimeters. Change in the amount of keratinized tissue in the areas of interest from baseline to 6 months will be tested to see if they are statistically significant.
arm group label: Collagen membrane
arm group type: Experimental
description: First, the recipient site is prepared, and the collagen membrane hydrated. The collagen membrane is sutured firmly against the prepared vascular bed with a long-lasting suture material. The subject is requested to minimize the amount of manipulation to the area to maintain graft stability.
intervention type: Device
intervention name: Collagen Membrane
description: First, the recipient site is prepared, and the collagen membrane hydrated. The collagen membrane is sutured firmly against the prepared vascular bed with a long-lasting suture material. The subject is requested to minimize the amount of manipulation to the area to maintain graft stability.
arm group label: Collagen membrane
other name: PriMatrix
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Assad, DDS
role: Study Director
affiliation: Mayo Clinic
last name: Lauren MF Syrowik, DDS
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Mayo Clinic
investigator full name: Lauren M. F. Syrowik
investigator title: DDS
mesh term: Gingival Recession