<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/NCT02980055</url>
  </required_header>
  <id_info>
    <org_study_id>UFRN-3</org_study_id>
    <nct_id>NCT02980055</nct_id>
  </id_info>
  <brief_title>Comparison of Root Coverage of Gingival Recessions</brief_title>
  <official_title>Comparison of Root Coverage of Gingival Recessions Using Connective Tissue Graft and Collagen Matrix</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Rio Grande do Norte</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Rio Grande do Norte</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to analyze the percentage of root coverage in Miller class I and&#xD;
      II gingival recessions using connective tissue graft and collagen matrix with a two years&#xD;
      follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A sample calculation using a mean of 2.92 mm of the quantity of keratinized mucosa obtained&#xD;
      after six months in the most recent study (McGUIRE; SCHEYER, 2014) using the same collagen&#xD;
      matrix with a standard deviation of ± 0.88 mm, a difference of 0.4 mm being chosen as&#xD;
      statistically significant. In addition, a 95% bilateral confidence interval and 80% power&#xD;
      were used. A sample of 38 individuals per group was obtained. In addition, a 20% loss is&#xD;
      expected during follow-up, a total of 46 individuals should be evaluated.&#xD;
&#xD;
      Periapical radiographic examinations should be performed before the collection of data to&#xD;
      confirm the absence of bone loss. The following clinical parameters should be evaluated in&#xD;
      both test and control groups: visible plaque index, gingival bleeding index, gingival&#xD;
      recession, keratinized mucosa width and thickness, probing depth, bleeding on probing and&#xD;
      periodontal biotype for each teeth with a North Carolina periodontal probe. The periodontal&#xD;
      biotype for each teeth should be rated as thin or thick, according to probe transparency&#xD;
      during probing depth. For statistical purposes, percentages of faces with gingival recession&#xD;
      should be calculated. These parameters should be evaluated at baseline and at one, three and&#xD;
      six months, one and two years post-therapy.&#xD;
&#xD;
      Clinical parameters should be collected by two operators, calibrated by the Kappa test for&#xD;
      the keratinized mucosa width and thickness, periodontal biotype, probing depth and gingival&#xD;
      recession.&#xD;
&#xD;
      After the inclusion of the patients, anamnesis and initial examination were performed. The&#xD;
      subjects should be divided randomly, using a simple draw, in the following two groups: test -&#xD;
      (collagen matrix) and control - (connective tissue graft) placebo associated with basic&#xD;
      periodontal therapy). The data should be analyzed using descriptive and inferential&#xD;
      statistics, with parametric tests, through the software package Social Sciences (SPSS),&#xD;
      version 17.0 (free version).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">February 2018</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>gingival recession</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>gingival recession</measure>
    <time_frame>three months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>gingival recession</measure>
    <time_frame>six months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>gingival recession</measure>
    <time_frame>twelve months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>gingival recession</measure>
    <time_frame>eighteen months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>gingival recession</measure>
    <time_frame>twenty-four months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Width of keratinized mucosa</measure>
    <time_frame>baseline and three, six, twelve, eighteen and twenty-four months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Gingival Recession</condition>
  <arm_group>
    <arm_group_label>Test: collagen matrix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Root coverage using collagen matrix</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control: connective tissue graft</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Root coverage using connective tissue graft</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>collagen matrix</intervention_name>
    <description>Surgical procedure for root coverage using collagen matrix</description>
    <arm_group_label>Test: collagen matrix</arm_group_label>
    <other_name>xenogeneic collagen matrix</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>connective tissue graft</intervention_name>
    <description>Surgical procedure for root coverage using connective tissue graft</description>
    <arm_group_label>Control: connective tissue graft</arm_group_label>
    <other_name>autologous</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gingival recessions of class I or II types according to Miller (1985), in&#xD;
             contralateral, superior or inferior premolars and / or canines;&#xD;
&#xD;
          -  Fine periodontal biotype characterized by the transparency of the North Carolina probe&#xD;
             when introduced into the periodontal sulcus (KAN et al., 2003);&#xD;
&#xD;
          -  The teeth with gingival recession should not be restored in their cervical portion;&#xD;
&#xD;
          -  Periodontal health characterized by absence of bleeding at probing, depth of probing&#xD;
             less than 3 mm;&#xD;
&#xD;
          -  Visible Plaque Index and Gingival Bleeding Index less than or equal to 30%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Orthodontic appliances;&#xD;
&#xD;
          -  Fixed or removable prostheses involving the premolar teeth with gingival recession;&#xD;
&#xD;
          -  Being a smoker;&#xD;
&#xD;
          -  Pregnancy or lactation;&#xD;
&#xD;
          -  Systemic diseases that may interfere with healing or periodontal health (diabetes,&#xD;
             leukemia, hypertension, among others).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karyna M Menezes, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal do Rio Grande do Norte</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bruno CV Gurgel, Doctor</last_name>
    <phone>+558432154107</phone>
    <email>bcgurgel@yahoo.com.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Samuel B Borges, student</last_name>
    <email>sborges1990@gmail.com</email>
  </overall_contact_backup>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Rio Grande do Norte</investigator_affiliation>
    <investigator_full_name>Karyna de Melo Menezes</investigator_full_name>
    <investigator_title>Principal Invastigator</investigator_title>
  </responsible_party>
  <keyword>connective tissue graft</keyword>
  <keyword>transplantation</keyword>
  <keyword>collagen</keyword>
  <keyword>autologous</keyword>
  <keyword>gingiva</keyword>
  <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/NCT02980055
org study id: UFRN-3
nct id: NCT02980055
lead sponsor: 
has dmc: No
The purpose of this study is to analyze the percentage of root coverage in Miller class I and
      II gingival recessions using connective tissue graft and collagen matrix with a two years
      follow-up.
A sample calculation using a mean of 2.92 mm of the quantity of keratinized mucosa obtained
      after six months in the most recent study (McGUIRE; SCHEYER, 2014) using the same collagen
      matrix with a standard deviation of ± 0.88 mm, a difference of 0.4 mm being chosen as
      statistically significant. In addition, a 95% bilateral confidence interval and 80% power
      were used. A sample of 38 individuals per group was obtained. In addition, a 20% loss is
      expected during follow-up, a total of 46 individuals should be evaluated.

      Periapical radiographic examinations should be performed before the collection of data to
      confirm the absence of bone loss. The following clinical parameters should be evaluated in
      both test and control groups: visible plaque index, gingival bleeding index, gingival
      recession, keratinized mucosa width and thickness, probing depth, bleeding on probing and
      periodontal biotype for each teeth with a North Carolina periodontal probe. The periodontal
      biotype for each teeth should be rated as thin or thick, according to probe transparency
      during probing depth. For statistical purposes, percentages of faces with gingival recession
      should be calculated. These parameters should be evaluated at baseline and at one, three and
      six months, one and two years post-therapy.

      Clinical parameters should be collected by two operators, calibrated by the Kappa test for
      the keratinized mucosa width and thickness, periodontal biotype, probing depth and gingival
      recession.

      After the inclusion of the patients, anamnesis and initial examination were performed. The
      subjects should be divided randomly, using a simple draw, in the following two groups: test -
      (collagen matrix) and control - (connective tissue graft) placebo associated with basic
      periodontal therapy). The data should be analyzed using descriptive and inferential
      statistics, with parametric tests, through the software package Social Sciences (SPSS),
      version 17.0 (free version).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: gingival recession
time frame: baseline
measure: gingival recession
time frame: three months
measure: gingival recession
time frame: six months
measure: gingival recession
time frame: twelve months
measure: gingival recession
time frame: eighteen months
measure: gingival recession
time frame: twenty-four months
measure: Width of keratinized mucosa
time frame: baseline and three, six, twelve, eighteen and twenty-four months
arm group label: Test: collagen matrix
arm group type: Experimental
description: Root coverage using collagen matrix
arm group label: Control: connective tissue graft
arm group type: Active Comparator
description: Root coverage using connective tissue graft
intervention type: Procedure
intervention name: collagen matrix
description: Surgical procedure for root coverage using collagen matrix
arm group label: Test: collagen matrix
other name: xenogeneic collagen matrix
intervention type: Procedure
intervention name: connective tissue graft
description: Surgical procedure for root coverage using connective tissue graft
arm group label: Control: connective tissue graft
other name: autologous
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Karyna M Menezes, Master
role: Principal Investigator
affiliation: Universidade Federal do Rio Grande do Norte
last name: Bruno CV Gurgel, Doctor
phone: +558432154107
email: bcgurgel@yahoo.com.br
last name: Samuel B Borges, student
email: sborges1990@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Rio Grande do Norte
investigator full name: Karyna de Melo Menezes
investigator title: Principal Invastigator
mesh term: Gingival Recession
sharing ipd: No