<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/NCT03232788</url>
  </required_header>
  <id_info>
    <org_study_id>FOB3DPrint1</org_study_id>
    <nct_id>NCT03232788</nct_id>
  </id_info>
  <brief_title>Use of Scaffolds for Treatment of Gingival Recession Associated With Interproximal Tissue Deficiency</brief_title>
  <official_title>Use of Computer Aided Design-Computer Aided Manufacturing and Additively Manufactured Scaffolds for Treatment of Gingival Recession Associated With Interproximal Tissue Deficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</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>
      This study will seek to evaluate the predictability and efficacy of a Computer Aided&#xD;
      Design-Computer Aided Manufacturing and additively manufactured polycaprolactone and&#xD;
      hydroxyapatite scaffolds in these defects compared to traditional guided tissue regeneration.&#xD;
      40 gingival recessions associated with interproximal tissue deficiency will be divided into&#xD;
      two groups: control group (autogenous bone + collagen membrane; n = 20) and test group&#xD;
      (autogenous bone + scaffold; n = 20).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The treatment of gingival recessions associated with interproximal bone and gingival tissue&#xD;
      deficiency, and also the absence of interdental papilla, are major challenges within the&#xD;
      periodontics due to lacking predictability. However, an intervention in these cases is&#xD;
      extremely important, since the presence of these defects is associated with aesthetic,&#xD;
      phonetic, hypersensitivity and may be associated with other dental damages. This study will&#xD;
      seek to evaluate the predictability and efficacy of a Computer Aided Design-Computer Aided&#xD;
      Manufacturing and additively manufactured polycaprolactone and hydroxyapatite scaffolds in&#xD;
      these defects compared to traditional guided tissue regeneration. 40 gingival recessions&#xD;
      associated with interproximal tissue deficiency will be divided into two groups: control&#xD;
      group (autogenous bone + collagen membrane; n = 20) and test group (autogenous bone +&#xD;
      scaffold; n = 20). A split-mouth design will be used with both procedures performed at the&#xD;
      same surgical time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2019</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total root coverage measured with a periodontal probe in millimeters</measure>
    <time_frame>One year</time_frame>
    <description>Ideal if the distance from cemento-enamel junction to gingival margin = 0 mm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total interdental papilla formation measured with a periodontal probe in mm</measure>
    <time_frame>One year</time_frame>
    <description>Ideal if the distance from dental contact point to interdental papilla top = 0 mm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depth of probing measured with a periodontal probe in millimeters</measure>
    <time_frame>One year</time_frame>
    <description>The distance from gingival margin and the apical point of gingival pocket or sulcus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment level measured with a periodontal probe in millimeters</measure>
    <time_frame>One year</time_frame>
    <description>The distance from cemento-enamel junction and the apical point of gingival pocket or sulcus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival bleeding index measured with a periodontal probe</measure>
    <time_frame>One year</time_frame>
    <description>Evaluated by the presence or absence of bleeding after probing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic bone formation measured digitally in millimeters</measure>
    <time_frame>One year</time_frame>
    <description>The distance from interdental bone crest and cemento-enamel junction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tomographic bone formation measured digitally in cubic millimeters</measure>
    <time_frame>One year</time_frame>
    <description>The variation of bone volume observed by tomography digital reconstruction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of pink aesthetics by professionals using the Pink Esthetic Score</measure>
    <time_frame>One year</time_frame>
    <description>Photographic evaluation of gingival aesthetics during the treatment done by blinded periodontists.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's evaluation of aesthetics using a visual analogue scale</measure>
    <time_frame>One year</time_frame>
    <description>Patient's aesthetic evaluation with a score ranging from 0 (terrible aesthetic) to 10 (excellent aesthetic)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's evaluation of dental sensibility using a visual analogue scale</measure>
    <time_frame>One year</time_frame>
    <description>Patient's dental sensibility evaluation with a score ranging from 0 (no sensibility) to 10 (intense sensibility)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's evaluation of post-operatory pain using a visual analogue scale</measure>
    <time_frame>1 month</time_frame>
    <description>Patient's post-operatory pain evaluation with a score ranging from 0 (no pain) to 10 (intense pain)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Recession</condition>
  <condition>Periodontal Diseases</condition>
  <arm_group>
    <arm_group_label>Test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bone regeneration with autogenous bone + scaffold.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bone regeneration with autogenous bone + collagen membrane.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bone regeneration</intervention_name>
    <description>Autogenous bone will be placed over periodontal defect after root treatment with scaling and root planing.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Test group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Collagen membrane</intervention_name>
    <description>A collagen membrane will be used to cover the autogenous bone.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Scaffold</intervention_name>
    <description>A hydroxyapatite and polycaprolactone scaffolds will be used to cover the autogenous bone.</description>
    <arm_group_label>Test group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presenting at least two single-rooted teeth with Miller's Class III and IV recessions&#xD;
             with Norland &amp; Tarnow class I, II or III papilla deficiency&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of periodontal surgery at the area on the last 12 months&#xD;
&#xD;
          -  Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel&#xD;
             blockers, cyclosporine, bisphosphonates, hormone-based contraceptives, steroids)&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Diabetics&#xD;
&#xD;
          -  History of head and neck radiotherapy&#xD;
&#xD;
          -  Teeth without adjacent mesial and distal contact&#xD;
&#xD;
          -  Teeth with mobility&#xD;
&#xD;
          -  Malpositioned teeth&#xD;
&#xD;
          -  Teeth with endodontic treatment&#xD;
&#xD;
          -  Teeth without a visible cementoenamel junction&#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>Vitor T Stuni, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>PhD student</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vitor T Stuani, PhD</last_name>
    <phone>+55 (18) 99748-7279</phone>
    <email>vitortoledo@usp.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>Bauru School of Dentistry - University of Sao Paulo</name>
      <address>
        <city>Bauru</city>
        <state>Sao Paulo</state>
        <zip>17012-901</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vitor T Stuani, MSc</last_name>
      <phone>+55 (18) 99748-7279</phone>
      <email>vitortoledo@usp.br</email>
    </contact>
    <investigator>
      <last_name>Vitor T Stuani, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gustavo P Manfredi, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Adriana P Sant'Ana, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paulo N Lisboa Filho, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pedro Y Noritomi, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Vitor de Toledo Stuani</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Periodontal disease</keyword>
  <keyword>Recession</keyword>
  <keyword>Black space</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Diseases</mesh_term>
    <mesh_term>Gingival Recession</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03232788
org study id: FOB3DPrint1
nct id: NCT03232788
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will seek to evaluate the predictability and efficacy of a Computer Aided
      Design-Computer Aided Manufacturing and additively manufactured polycaprolactone and
      hydroxyapatite scaffolds in these defects compared to traditional guided tissue regeneration.
      40 gingival recessions associated with interproximal tissue deficiency will be divided into
      two groups: control group (autogenous bone + collagen membrane; n = 20) and test group
      (autogenous bone + scaffold; n = 20).
The treatment of gingival recessions associated with interproximal bone and gingival tissue
      deficiency, and also the absence of interdental papilla, are major challenges within the
      periodontics due to lacking predictability. However, an intervention in these cases is
      extremely important, since the presence of these defects is associated with aesthetic,
      phonetic, hypersensitivity and may be associated with other dental damages. This study will
      seek to evaluate the predictability and efficacy of a Computer Aided Design-Computer Aided
      Manufacturing and additively manufactured polycaprolactone and hydroxyapatite scaffolds in
      these defects compared to traditional guided tissue regeneration. 40 gingival recessions
      associated with interproximal tissue deficiency will be divided into two groups: control
      group (autogenous bone + collagen membrane; n = 20) and test group (autogenous bone +
      scaffold; n = 20). A split-mouth design will be used with both procedures performed at the
      same surgical time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Total root coverage measured with a periodontal probe in millimeters
time frame: One year
description: Ideal if the distance from cemento-enamel junction to gingival margin = 0 mm
measure: Total interdental papilla formation measured with a periodontal probe in mm
time frame: One year
description: Ideal if the distance from dental contact point to interdental papilla top = 0 mm
measure: Depth of probing measured with a periodontal probe in millimeters
time frame: One year
description: The distance from gingival margin and the apical point of gingival pocket or sulcus
measure: Clinical attachment level measured with a periodontal probe in millimeters
time frame: One year
description: The distance from cemento-enamel junction and the apical point of gingival pocket or sulcus
measure: Gingival bleeding index measured with a periodontal probe
time frame: One year
description: Evaluated by the presence or absence of bleeding after probing
measure: Radiographic bone formation measured digitally in millimeters
time frame: One year
description: The distance from interdental bone crest and cemento-enamel junction
measure: Tomographic bone formation measured digitally in cubic millimeters
time frame: One year
description: The variation of bone volume observed by tomography digital reconstruction
measure: Evaluation of pink aesthetics by professionals using the Pink Esthetic Score
time frame: One year
description: Photographic evaluation of gingival aesthetics during the treatment done by blinded periodontists.
measure: Patient's evaluation of aesthetics using a visual analogue scale
time frame: One year
description: Patient's aesthetic evaluation with a score ranging from 0 (terrible aesthetic) to 10 (excellent aesthetic)
measure: Patient's evaluation of dental sensibility using a visual analogue scale
time frame: One year
description: Patient's dental sensibility evaluation with a score ranging from 0 (no sensibility) to 10 (intense sensibility)
measure: Patient's evaluation of post-operatory pain using a visual analogue scale
time frame: 1 month
description: Patient's post-operatory pain evaluation with a score ranging from 0 (no pain) to 10 (intense pain)
arm group label: Test group
arm group type: Experimental
description: Bone regeneration with autogenous bone + scaffold.
arm group label: Control group
arm group type: Active Comparator
description: Bone regeneration with autogenous bone + collagen membrane.
intervention type: Procedure
intervention name: Bone regeneration
description: Autogenous bone will be placed over periodontal defect after root treatment with scaling and root planing.
arm group label: Control group
arm group label: Test group
intervention type: Device
intervention name: Collagen membrane
description: A collagen membrane will be used to cover the autogenous bone.
arm group label: Control group
intervention type: Device
intervention name: Scaffold
description: A hydroxyapatite and polycaprolactone scaffolds will be used to cover the autogenous bone.
arm group label: Test group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Vitor T Stuni, MSc
role: Principal Investigator
affiliation: PhD student
last name: Vitor T Stuani, PhD
phone: +55 (18) 99748-7279
email: vitortoledo@usp.br
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Vitor de Toledo Stuani
investigator title: Principal investigator
mesh term: Periodontal Diseases
mesh term: Gingival Recession
sharing ipd: Undecided