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/NCT06015906</url>
    </required_header>
    <id_info>
      <org_study_id>Plenum Guide</org_study_id>
      <nct_id>NCT06015906</nct_id>
    </id_info>
    <brief_title>Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction</brief_title>
    <official_title>Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction: a Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>M3 Health</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>São Paulo State University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>M3 Health</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 goal of this clinical trial is to compare the maintenance of socket volume in the groups&#xD;
        treated by a resorbable regenerative membrane (Plenum® Guide) covered or not with mucous&#xD;
        tissue, with control without treatment. The main question it aims to answer is the&#xD;
        effectiveness of the Plenum® Guide membrane in the process of guided bone regeneration,&#xD;
        exposed or not, through the preservation and neoformation of bone tissue in the tooth&#xD;
        extraction socket procedures.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients will be submitted to tooth extraction, the surgical procedure of guided bone&#xD;
        regeneration using regenerative membranes and synthetic bone graft, and subsequent&#xD;
        installation of dental implants. The 05 groups will be compared to observe if the proposed&#xD;
        medical devices effectively will maintain the socket's bone volume during the healing phase&#xD;
        before the installation of the dental implants (1. socket filled only with clot, 2. socket&#xD;
        associated with exposed absorbable membrane, 3. socket associated with covered absorbable&#xD;
        membrane, 4. socket filled with synthetic bone graft and covered absorbable membrane, 5.&#xD;
        socket filled with synthetic bone graft and exposed absorbable membrane).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">June 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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>alveolar bone volume</measure>
      <time_frame>Comparison of exams obtained in the preoperative period, immediate postoperative period (7 days) and late postoperative period (3 months)</time_frame>
      <description>Accessed via cone beam computed tomography</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Newly formed bone tissue, soft tissue and residual bone graft material</measure>
      <time_frame>4 months after extraction</time_frame>
      <description>immunohistochemical analyzes of histological sections</description>
    </primary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Surgery, Oral</condition>
    <arm_group>
      <arm_group_label>socket</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Tooth extraction socket filled only clot.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Socket associated with exposed absorbable membrane</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Socket filled with clot and covered with the Plenum® Guide membrane exposed in the intraoral region.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Socket associated with covered absorbable membrane</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Socket filled with clot and covered with the Plenum® Guide membrane and covered by mucosa (gingival tissue) in the intraoral region.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Socket filled with synthetic bone graft and covered absorbable membrane</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Socket filled with synthetic bone graft and the Plenum® Guide membrane covered by gingival tissue in the intraoral region.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Socket filled with synthetic bone graft and exposed absorbable membrane</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Socket filled with synthetic bone graft and Plenum® Guide membrane, where this membrane will be exposed in the intraoral region.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Plenum® Guide</intervention_name>
      <description>Plenum® Guide is a white, absorbable synthetic regenerative membrane composed of poly(dioxanone), which will be installed on the tooth extraction sockets.</description>
      <arm_group_label>Socket associated with covered absorbable membrane</arm_group_label>
      <arm_group_label>Socket associated with exposed absorbable membrane</arm_group_label>
      <arm_group_label>Socket filled with synthetic bone graft and covered absorbable membrane</arm_group_label>
      <arm_group_label>Socket filled with synthetic bone graft and exposed absorbable membrane</arm_group_label>
      <other_name>PDO absorbable membrane</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Plenum® Oss</intervention_name>
      <description>Plenum® Oss is a synthetic bone graft based on biphasic calcium phosphate, which will be used to fill the tooth extraction sockets.</description>
      <arm_group_label>Socket filled with synthetic bone graft and covered absorbable membrane</arm_group_label>
      <arm_group_label>Socket filled with synthetic bone graft and exposed absorbable membrane</arm_group_label>
      <other_name>Synthetic bone graft</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Tooth extraction</intervention_name>
      <description>Tooth extraction and subsequent surgical procedure of guided bone regeneration.</description>
      <arm_group_label>Socket associated with covered absorbable membrane</arm_group_label>
      <arm_group_label>Socket associated with exposed absorbable membrane</arm_group_label>
      <arm_group_label>Socket filled with synthetic bone graft and covered absorbable membrane</arm_group_label>
      <arm_group_label>Socket filled with synthetic bone graft and exposed absorbable membrane</arm_group_label>
      <arm_group_label>socket</arm_group_label>
      <other_name>Guided bone regeneration</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Possess the four bone walls after the extraction procedure;&#xD;
  &#xD;
            -  Over 18 years old;&#xD;
  &#xD;
            -  And who have signed the TCLE.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Uncontrolled systemic impairments;&#xD;
  &#xD;
            -  Teeth in areas of tumor lesions;&#xD;
  &#xD;
            -  Acute infectious processes;&#xD;
  &#xD;
            -  Deciduous dental elements;&#xD;
  &#xD;
            -  Untreated periodontal problems;&#xD;
  &#xD;
            -  Smokers;&#xD;
  &#xD;
            -  Radiated in the head or neck region;&#xD;
  &#xD;
            -  Allergy to any component used in the research;&#xD;
  &#xD;
            -  Psychological disorders;&#xD;
  &#xD;
            -  Pregnant and lactating women.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sybele Saska Specian, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Study Director</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Eduardo Hochuli Vieira, PhD</last_name>
      <phone>+55(16)3301-6459</phone>
      <email>eduardo.hochuli@unesp.br</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sybele Saska Specian, PhD</last_name>
      <phone>+55(11)31099068</phone>
      <email>pesquisa@plenum.bio</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Guided bone regeneration</keyword>
    <keyword>Resorbable membrane</keyword>
    <keyword>Plenum® Guide</keyword>
    <keyword>Dental implant</keyword>
    <keyword>Extraction socket preservation</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06015906
  org study id: Plenum Guide
  nct id: NCT06015906
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare the maintenance of socket volume in the groups
        treated by a resorbable regenerative membrane (Plenum® Guide) covered or not with mucous
        tissue, with control without treatment. The main question it aims to answer is the
        effectiveness of the Plenum® Guide membrane in the process of guided bone regeneration,
        exposed or not, through the preservation and neoformation of bone tissue in the tooth
        extraction socket procedures.
  Patients will be submitted to tooth extraction, the surgical procedure of guided bone
        regeneration using regenerative membranes and synthetic bone graft, and subsequent
        installation of dental implants. The 05 groups will be compared to observe if the proposed
        medical devices effectively will maintain the socket's bone volume during the healing phase
        before the installation of the dental implants (1. socket filled only with clot, 2. socket
        associated with exposed absorbable membrane, 3. socket associated with covered absorbable
        membrane, 4. socket filled with synthetic bone graft and covered absorbable membrane, 5.
        socket filled with synthetic bone graft and exposed absorbable membrane).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: alveolar bone volume
  time frame: Comparison of exams obtained in the preoperative period, immediate postoperative period (7 days) and late postoperative period (3 months)
  description: Accessed via cone beam computed tomography
  measure: Newly formed bone tissue, soft tissue and residual bone graft material
  time frame: 4 months after extraction
  description: immunohistochemical analyzes of histological sections
  arm group label: socket
  arm group type: Sham Comparator
  description: Tooth extraction socket filled only clot.
  arm group label: Socket associated with exposed absorbable membrane
  arm group type: Active Comparator
  description: Socket filled with clot and covered with the Plenum® Guide membrane exposed in the intraoral region.
  arm group label: Socket associated with covered absorbable membrane
  arm group type: Active Comparator
  description: Socket filled with clot and covered with the Plenum® Guide membrane and covered by mucosa (gingival tissue) in the intraoral region.
  arm group label: Socket filled with synthetic bone graft and covered absorbable membrane
  arm group type: Experimental
  description: Socket filled with synthetic bone graft and the Plenum® Guide membrane covered by gingival tissue in the intraoral region.
  arm group label: Socket filled with synthetic bone graft and exposed absorbable membrane
  arm group type: Experimental
  description: Socket filled with synthetic bone graft and Plenum® Guide membrane, where this membrane will be exposed in the intraoral region.
  intervention type: Device
  intervention name: Plenum® Guide
  description: Plenum® Guide is a white, absorbable synthetic regenerative membrane composed of poly(dioxanone), which will be installed on the tooth extraction sockets.
  arm group label: Socket associated with covered absorbable membrane
  arm group label: Socket associated with exposed absorbable membrane
  arm group label: Socket filled with synthetic bone graft and covered absorbable membrane
  arm group label: Socket filled with synthetic bone graft and exposed absorbable membrane
  other name: PDO absorbable membrane
  intervention type: Device
  intervention name: Plenum® Oss
  description: Plenum® Oss is a synthetic bone graft based on biphasic calcium phosphate, which will be used to fill the tooth extraction sockets.
  arm group label: Socket filled with synthetic bone graft and covered absorbable membrane
  arm group label: Socket filled with synthetic bone graft and exposed absorbable membrane
  other name: Synthetic bone graft
  intervention type: Procedure
  intervention name: Tooth extraction
  description: Tooth extraction and subsequent surgical procedure of guided bone regeneration.
  arm group label: Socket associated with covered absorbable membrane
  arm group label: Socket associated with exposed absorbable membrane
  arm group label: Socket filled with synthetic bone graft and covered absorbable membrane
  arm group label: Socket filled with synthetic bone graft and exposed absorbable membrane
  arm group label: socket
  other name: Guided bone regeneration
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sybele Saska Specian, PhD
  role: Study Director
  affiliation: Study Director
  last name: Eduardo Hochuli Vieira, PhD
  phone: +55(16)3301-6459
  email: eduardo.hochuli@unesp.br
  last name: Sybele Saska Specian, PhD
  phone: +55(11)31099068
  email: pesquisa@plenum.bio
  responsible party type: Sponsor
  sharing ipd: No