<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/NCT04462237</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00177214</org_study_id>
    <nct_id>NCT04462237</nct_id>
  </id_info>
  <brief_title>Recombinant Human Platelet-derived Growth Factor in Combination With Collagen Matrix</brief_title>
  <official_title>The Effect of Recombinant Human Platelet-derived Growth Factor in Combination With Collagen Matrix for the Treatment of Multiple Adjacent Gingival Recessions: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present randomized clinical trial is aimed at evaluating the efficacy of recombinant&#xD;
      human platelet-derived growth factor in combination with collagen matrix for the treatment of&#xD;
      multiple adjacent gingival recessions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the fact that gingival recession is most often a generalized condition rather than&#xD;
      being localized to a single tooth, most of the data currently found in the literature&#xD;
      pertains to the treatment of localized gingival recessions.&#xD;
&#xD;
      The gold standard treatment for this condition involves the use of an autogenous connective&#xD;
      tissue graft, that is associated with increased patient morbidity.&#xD;
&#xD;
      Biomaterials have progressively gained popularity due to their advantages when compared to&#xD;
      autogenous grafts, such as unrestricted availability, avoidance of a secondary surgical site,&#xD;
      reduction of the surgical time, and the patient's preference.&#xD;
&#xD;
      Collagen matrix is one of the most used soft tissue substitute for the treatment of gingival&#xD;
      recessions. Combining this scaffold material with a growth factor could enhance its outcomes.&#xD;
      In particular, root coverage using platelet-derived growth factor can also promote&#xD;
      regeneration of new cementum, periodontal ligament and bone.&#xD;
&#xD;
      Therefore, the aim of the present study is to investigate the effect of platelet-derived&#xD;
      growth factor in combination with collagen matrix outcomes for the treatment of multiple&#xD;
      adjacent gingival recessions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 9, 2020</start_date>
  <completion_date type="Actual">August 18, 2021</completion_date>
  <primary_completion_date type="Actual">August 18, 2021</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Root Coverage</measure>
    <time_frame>6 months</time_frame>
    <description>amount of recession reduction compared to the baseline recession depth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Keratinized tissue width gain</measure>
    <time_frame>6 months</time_frame>
    <description>amount of keratinized tissue width gain from the baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gingival thickness gain</measure>
    <time_frame>6 months</time_frame>
    <description>amount of gingival thickness gain from the baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>3D volumetric changes</measure>
    <time_frame>6 months</time_frame>
    <description>Soft tissue volumetric variation evaluated with digital softwares</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tissue perfusion variations</measure>
    <time_frame>6 months</time_frame>
    <description>Tissue perfusion variations compared to baseline at the different follow-up using ultrasonography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-related outcomes</measure>
    <time_frame>6 months</time_frame>
    <description>Patient self reported perception of the procedure in terms of morbidity, satisfaction and esthetic outcomes. Visual analogue scales (from 0 to 100) will be used to assess these outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Esthetic outcomes</measure>
    <time_frame>6 months</time_frame>
    <description>evaluated using the root coverage esthetic score (from 0 to 10)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Differences in Angiogenic Biomarkers</measure>
    <time_frame>3 months</time_frame>
    <description>Within-subject difference between the concentrations at the control and test sites</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Gingival Recession</condition>
  <condition>Platelet Derived Growth Factor</condition>
  <arm_group>
    <arm_group_label>collagen matrix + platelet-derived growth factor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Root coverage procedure using collagen matrix + platelet-derived growth factor for the treatment of multiple adjacent gingival recessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>collagen matrix alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Root coverage procedure using collagen matrix alone (without the use of the platelet-derived growth factor) for the treatment of multiple adjacent gingival recessions</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Root coverage procedures</intervention_name>
    <description>Treatment of multiple adjacent gingival recession using a coronally advanced flap</description>
    <arm_group_label>collagen matrix + platelet-derived growth factor</arm_group_label>
    <arm_group_label>collagen matrix alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Periodontally and systemically healthy&#xD;
&#xD;
          -  Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites&#xD;
             per tooth)&#xD;
&#xD;
          -  At least two multiple adjacent gingival recessions (with at least one 2 mm or deeper)&#xD;
             requiring surgical intervention for root coverage&#xD;
&#xD;
          -  No interproximal attachment/bone loss&#xD;
&#xD;
          -  No prior experience of root coverage procedures within the last 1 year&#xD;
&#xD;
          -  The patient must be able to perform good oral hygiene&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for periodontal surgery&#xD;
&#xD;
          -  Patients pregnant or attempting to get pregnant (self-reported)&#xD;
&#xD;
          -  Untreated periodontitis&#xD;
&#xD;
          -  Persistence of uncorrected gingival trauma from traumatic toothbrushing&#xD;
&#xD;
          -  Interdental attachment loss greater than 1 mm or furcation involvement in the teeth to&#xD;
             be treated&#xD;
&#xD;
          -  Presence of severe tooth malposition, rotation or clinically significant&#xD;
             super-eruption&#xD;
&#xD;
          -  Self-reported current smoking more than 10 cigarettes/day or pipe or cigar smoking&#xD;
&#xD;
          -  Allergy to collagen-based medical products&#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>Lorenzo Tavelli, DDS, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>William Giannobile, DDS, MS, DMSc</last_name>
    <role>Study Chair</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hom-Lay Wang, DDS, MS, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan School of Dentistry</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>September 26, 2021</last_update_submitted>
  <last_update_submitted_qc>September 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Lorenzo Tavelli</investigator_full_name>
    <investigator_title>Principal Investigator</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>
  <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/NCT04462237
org study id: HUM00177214
nct id: NCT04462237
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The present randomized clinical trial is aimed at evaluating the efficacy of recombinant
      human platelet-derived growth factor in combination with collagen matrix for the treatment of
      multiple adjacent gingival recessions
Despite the fact that gingival recession is most often a generalized condition rather than
      being localized to a single tooth, most of the data currently found in the literature
      pertains to the treatment of localized gingival recessions.

      The gold standard treatment for this condition involves the use of an autogenous connective
      tissue graft, that is associated with increased patient morbidity.

      Biomaterials have progressively gained popularity due to their advantages when compared to
      autogenous grafts, such as unrestricted availability, avoidance of a secondary surgical site,
      reduction of the surgical time, and the patient's preference.

      Collagen matrix is one of the most used soft tissue substitute for the treatment of gingival
      recessions. Combining this scaffold material with a growth factor could enhance its outcomes.
      In particular, root coverage using platelet-derived growth factor can also promote
      regeneration of new cementum, periodontal ligament and bone.

      Therefore, the aim of the present study is to investigate the effect of platelet-derived
      growth factor in combination with collagen matrix outcomes for the treatment of multiple
      adjacent gingival recessions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Mean Root Coverage
time frame: 6 months
description: amount of recession reduction compared to the baseline recession depth
measure: Keratinized tissue width gain
time frame: 6 months
description: amount of keratinized tissue width gain from the baseline
measure: Gingival thickness gain
time frame: 6 months
description: amount of gingival thickness gain from the baseline
measure: 3D volumetric changes
time frame: 6 months
description: Soft tissue volumetric variation evaluated with digital softwares
measure: Tissue perfusion variations
time frame: 6 months
description: Tissue perfusion variations compared to baseline at the different follow-up using ultrasonography
measure: Patient-related outcomes
time frame: 6 months
description: Patient self reported perception of the procedure in terms of morbidity, satisfaction and esthetic outcomes. Visual analogue scales (from 0 to 100) will be used to assess these outcomes
measure: Esthetic outcomes
time frame: 6 months
description: evaluated using the root coverage esthetic score (from 0 to 10)
measure: Differences in Angiogenic Biomarkers
time frame: 3 months
description: Within-subject difference between the concentrations at the control and test sites
arm group label: collagen matrix + platelet-derived growth factor
arm group type: Experimental
description: Root coverage procedure using collagen matrix + platelet-derived growth factor for the treatment of multiple adjacent gingival recessions
arm group label: collagen matrix alone
arm group type: Active Comparator
description: Root coverage procedure using collagen matrix alone (without the use of the platelet-derived growth factor) for the treatment of multiple adjacent gingival recessions
intervention type: Procedure
intervention name: Root coverage procedures
description: Treatment of multiple adjacent gingival recession using a coronally advanced flap
arm group label: collagen matrix + platelet-derived growth factor
arm group label: collagen matrix alone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lorenzo Tavelli, DDS, MS
role: Principal Investigator
affiliation: University of Michigan
last name: William Giannobile, DDS, MS, DMSc
role: Study Chair
affiliation: University of Michigan
last name: Hom-Lay Wang, DDS, MS, PhD
role: Study Director
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Lorenzo Tavelli
investigator title: Principal Investigator
mesh term: Gingival Recession
sharing ipd: No