<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/NCT02242500</url>
  </required_header>
  <id_info>
    <org_study_id>130/2010</org_study_id>
    <nct_id>NCT02242500</nct_id>
  </id_info>
  <brief_title>Coronally Advanced Flap With or Without Porcine Collagen Matrix for Root Coverage</brief_title>
  <official_title>Phase IV Study of Coronally Advanced Flap With or Without Porcine Collagen Matrix for Treatment of Gingival Recession: a Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Enilson Antonio Sallum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Campinas, Brazil</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the clinical outcomes after coronally advanced flap&#xD;
      technique (CAF) associated or not to a porcine collagen matrix graft (CM) in the treatment of&#xD;
      single gingival recessions. For this blinded randomized controlled clinical trial, 40&#xD;
      patients with Miller Class I or II gingival recession ≥ 2 mm in canines or premolars will&#xD;
      selected and randomly assigned to receive either CAF or CAF+CM. The clinical parameters&#xD;
      evaluated will be probing depth, clinical attachment level, gingival recession height, height&#xD;
      and thickness of keratinized tissue. Clinical measurements will be taken at baseline and 45&#xD;
      days, 2, 3 and 6 months after surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>Phase 4</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recession Reduction</measure>
    <time_frame>6 months</time_frame>
    <description>Measured as a difference between gingival margin between gingival recession depth at baseline and gingival recession at 6 months follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete root coverage</measure>
    <time_frame>6 months</time_frame>
    <description>Assessed as percentage of sites with complete root coverage</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Keratinized tissue thickness</measure>
    <time_frame>6 months</time_frame>
    <description>Measured at a midpoint between gingival margin and mucogingival junction using a endodontic spreader pierced perpendicular and through the soft tissue</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Gingival Recession</condition>
  <arm_group>
    <arm_group_label>Coronally advanced flap + Mucograft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>coronally advanced flap associated with a porcine collagen matrix graft as a subepithelial graft</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Coronally advanced flap</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Coronally advanced flap procedure alone</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Coronally Advanced Flap</intervention_name>
    <arm_group_label>Coronally advanced flap</arm_group_label>
    <arm_group_label>Coronally advanced flap + Mucograft</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mucograft</intervention_name>
    <arm_group_label>Coronally advanced flap + Mucograft</arm_group_label>
    <other_name>Porcine collagen matrix for soft tissue regeneration</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  Presence of at least one Class I or II Miller gingival recession ≥ 2 mm in maxillary&#xD;
             canines or premolars with identifiable cementum-enamel junction (CEJ) and without deep&#xD;
             non-carious cervical lesions (&lt; 0.5 mm): A + (Pini-Prato et al. 2010).&#xD;
&#xD;
          -  Aesthetic complaint and/or presence of dentin hypersensitivity to air stimulus.&#xD;
&#xD;
          -  Full-mouth visible plaque index ≤ 20% (Ainamo &amp; Bay 1975).&#xD;
&#xD;
          -  Full-mouth sulcus bleeding index ≤ 20% (Mühlemann &amp; Son 1971).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoking.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Presence of systemic disorders (diabetes, hypertension, heart disease or any other&#xD;
             condition that could contraindicate periodontal surgery).&#xD;
&#xD;
          -  Use of medications (immunosuppressants, phenytoin or anything else that might affect&#xD;
             mucosal healing and repair).&#xD;
&#xD;
          -  Previous periodontal surgery in the area.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Piracicaba Dental School, State University of Campinas</name>
      <address>
        <city>Piracicaba</city>
        <state>São Paulo</state>
        <zip>13414-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 13, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>December 26, 2015</last_update_submitted>
  <last_update_submitted_qc>December 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Campinas, Brazil</investigator_affiliation>
    <investigator_full_name>Enilson Antonio Sallum</investigator_full_name>
    <investigator_title>Chair of the Department of Prosthodontics and Periodontics, Division of Periodontics, Piracicaba Dental School</investigator_title>
  </responsible_party>
  <keyword>Gingival recession/surgery</keyword>
  <keyword>Collagen/therapeutic use</keyword>
  <keyword>Root coverage</keyword>
  <keyword>Treatment outcome</keyword>
  <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/NCT02242500
org study id: 130/2010
nct id: NCT02242500
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to compare the clinical outcomes after coronally advanced flap
      technique (CAF) associated or not to a porcine collagen matrix graft (CM) in the treatment of
      single gingival recessions. For this blinded randomized controlled clinical trial, 40
      patients with Miller Class I or II gingival recession ≥ 2 mm in canines or premolars will
      selected and randomly assigned to receive either CAF or CAF+CM. The clinical parameters
      evaluated will be probing depth, clinical attachment level, gingival recession height, height
      and thickness of keratinized tissue. Clinical measurements will be taken at baseline and 45
      days, 2, 3 and 6 months after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Recession Reduction
time frame: 6 months
description: Measured as a difference between gingival margin between gingival recession depth at baseline and gingival recession at 6 months follow-up.
measure: Complete root coverage
time frame: 6 months
description: Assessed as percentage of sites with complete root coverage
measure: Keratinized tissue thickness
time frame: 6 months
description: Measured at a midpoint between gingival margin and mucogingival junction using a endodontic spreader pierced perpendicular and through the soft tissue
arm group label: Coronally advanced flap + Mucograft
arm group type: Experimental
description: coronally advanced flap associated with a porcine collagen matrix graft as a subepithelial graft
arm group label: Coronally advanced flap
arm group type: Other
description: Coronally advanced flap procedure alone
intervention type: Procedure
intervention name: Coronally Advanced Flap
arm group label: Coronally advanced flap
arm group label: Coronally advanced flap + Mucograft
intervention type: Device
intervention name: Mucograft
arm group label: Coronally advanced flap + Mucograft
other name: Porcine collagen matrix for soft tissue regeneration
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: University of Campinas, Brazil
investigator full name: Enilson Antonio Sallum
investigator title: Chair of the Department of Prosthodontics and Periodontics, Division of Periodontics, Piracicaba Dental School
mesh term: Gingival Recession