xml: <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/NCT06006780</url>
    </required_header>
    <id_info>
      <org_study_id>59036822.4.1001.5418</org_study_id>
      <nct_id>NCT06006780</nct_id>
    </id_info>
    <brief_title>Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions A Multicenter Randomized Clinical Trial.</brief_title>
    <official_title>Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions: A Multicenter Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Campinas, Brazil</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Campinas, Brazil</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Aim: The aim of this randomized clinical trial is to evaluate the use of the porcine&#xD;
        acellular dermal matrix (PADM) for the treatment of RT1 localized gingival recessions.&#xD;
  &#xD;
        Material and methods: Forthy patients (n=20) with RT1 localized gingival recessions with&#xD;
        height ranging from 3 to 5 mm with and at least, 2mm of keratinized tissue width will be&#xD;
        selected to participate in the study. Patients will be allocated randomly in two treatment&#xD;
        groups: Coronally advanced flap (CAF) or coronally advanced flap associated with the porcine&#xD;
        acellular dermal matrix (CAF+ PADM). The clinical parameters evaluated at the baseline, 6 and&#xD;
        12 months will be: Plaque index (IPL); gingival index (GI); relative gingival recession&#xD;
        height (RGRH); gingival recession width (GRW); probing depth (PD); relative clinical&#xD;
        attachment level (RCAL); keratinized tissue height (KTH); keratinized tissue thickness (KTT);&#xD;
        papilla height (PH). Evaluations will be made by the professional and the patient regarding&#xD;
        dentin hypersensitivity (HD) (Schiff and VAS scales respectively), aesthetics (RES and VAS&#xD;
        scales, respectively) and patient&amp;#39;s centered outcomes, through the questionnaire&#xD;
        referring to the OHIP-14.&#xD;
  &#xD;
        Descriptive statistical analysis will be expressed as mean ± standard deviation (SD), median,&#xD;
        quartiles, percentages and confidence intervals (95% CI). To analyze the normality of the&#xD;
        residue, the Shapiro-Wilk test will be performed. Then, the Wilcoxon test will be applied to&#xD;
        compare the periodontal parameters and a quality of life, before and post-treatment.&#xD;
        Correlations between parameters and dental hypersensitivity will be analyzed through&#xD;
        Spearman&amp;#39;s test. Key words: Gingival recession, Root coverage, Biomaterial, Acellular&#xD;
        dermal matrix.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 10, 2022</start_date>
    <completion_date type="Anticipated">December 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recession reduction</measure>
      <time_frame>Baseline, 6 months and 12 months</time_frame>
      <description>Reduction of the gingival recession height</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Thickness of keratinized tissue</measure>
      <time_frame>Baseline, 6 months and 12 months</time_frame>
      <description>Thickness of keratinized tissue evaluation after periodontal plastic surgery</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Gingival Recession</condition>
    <arm_group>
      <arm_group_label>Coronally advanced flap (CAF)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Coronally advanced flap associated with the porcine acellular dermal matrix (CAF+ PADM)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Porcine acellular dermal matrix</intervention_name>
      <description>Coronally advanced flap associated with the porcine acellular dermal matrix for root coverage</description>
      <arm_group_label>Coronally advanced flap associated with the porcine acellular dermal matrix (CAF+ PADM)</arm_group_label>
      <other_name>Mucoderm</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Coronally advanced flap (CAF)</intervention_name>
      <description>Coronally advanced flap for root coverage</description>
      <arm_group_label>Coronally advanced flap (CAF)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  RT1 localized gingival recessions with height ranging from 3 to 5 mm with and at&#xD;
               least, 2mm of keratinized tissue width will be selected to participate in the study;&#xD;
               probing depth &lt;3mm, plaque and gingival index &lt; or = a 20%.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Smokers, pregnants, nursing, patients with diabetes mellitus or another condition who&#xD;
               interfere in the tissue repair, use of drugs or medications, allergies to any&#xD;
               composition of the devices of the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Enilson A. Sallum, PhD</last_name>
      <phone>+55(19)2106-5301</phone>
      <email>easallum@fop.unicamp.br</email>
    </overall_contact>
    <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>
      <status>Recruiting</status>
      <contact>
        <last_name>Enilson A Sallum, PhD</last_name>
        <phone>55 19 21065394</phone>
        <email>enilson@unicamp.br</email>
      </contact>
      <investigator>
        <last_name>Enilson A Sallum, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Tamires P Dutra, Graduate</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Isabela LF Grohmann, Master</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Campinas, Brazil</investigator_affiliation>
      <investigator_full_name>Enilson Antonio Sallum</investigator_full_name>
      <investigator_title>PhD, Chair of Periodontolgy Area</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>
  
  
text: 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/NCT06006780
  org study id: 59036822.4.1001.5418
  nct id: NCT06006780
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Aim: The aim of this randomized clinical trial is to evaluate the use of the porcine
        acellular dermal matrix (PADM) for the treatment of RT1 localized gingival recessions.
  
        Material and methods: Forthy patients (n=20) with RT1 localized gingival recessions with
        height ranging from 3 to 5 mm with and at least, 2mm of keratinized tissue width will be
        selected to participate in the study. Patients will be allocated randomly in two treatment
        groups: Coronally advanced flap (CAF) or coronally advanced flap associated with the porcine
        acellular dermal matrix (CAF+ PADM). The clinical parameters evaluated at the baseline, 6 and
        12 months will be: Plaque index (IPL); gingival index (GI); relative gingival recession
        height (RGRH); gingival recession width (GRW); probing depth (PD); relative clinical
        attachment level (RCAL); keratinized tissue height (KTH); keratinized tissue thickness (KTT);
        papilla height (PH). Evaluations will be made by the professional and the patient regarding
        dentin hypersensitivity (HD) (Schiff and VAS scales respectively), aesthetics (RES and VAS
        scales, respectively) and patient&#39;s centered outcomes, through the questionnaire
        referring to the OHIP-14.
  
        Descriptive statistical analysis will be expressed as mean ± standard deviation (SD), median,
        quartiles, percentages and confidence intervals (95% CI). To analyze the normality of the
        residue, the Shapiro-Wilk test will be performed. Then, the Wilcoxon test will be applied to
        compare the periodontal parameters and a quality of life, before and post-treatment.
        Correlations between parameters and dental hypersensitivity will be analyzed through
        Spearman&#39;s test. Key words: Gingival recession, Root coverage, Biomaterial, Acellular
        dermal matrix.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Recession reduction
  time frame: Baseline, 6 months and 12 months
  description: Reduction of the gingival recession height
  measure: Thickness of keratinized tissue
  time frame: Baseline, 6 months and 12 months
  description: Thickness of keratinized tissue evaluation after periodontal plastic surgery
  arm group label: Coronally advanced flap (CAF)
  arm group type: Active Comparator
  arm group label: Coronally advanced flap associated with the porcine acellular dermal matrix (CAF+ PADM)
  arm group type: Experimental
  intervention type: Device
  intervention name: Porcine acellular dermal matrix
  description: Coronally advanced flap associated with the porcine acellular dermal matrix for root coverage
  arm group label: Coronally advanced flap associated with the porcine acellular dermal matrix (CAF+ PADM)
  other name: Mucoderm
  intervention type: Other
  intervention name: Coronally advanced flap (CAF)
  description: Coronally advanced flap for root coverage
  arm group label: Coronally advanced flap (CAF)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Enilson A. Sallum, PhD
  phone: +55(19)2106-5301
  email: easallum@fop.unicamp.br
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: Brazil
  responsible party type: Principal Investigator
  investigator affiliation: University of Campinas, Brazil
  investigator full name: Enilson Antonio Sallum
  investigator title: PhD, Chair of Periodontolgy Area
  mesh term: Gingival Recession