<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/NCT04404374</url>
  </required_header>
  <id_info>
    <org_study_id>SE TUKEB: 254/2017</org_study_id>
    <nct_id>NCT04404374</nct_id>
  </id_info>
  <brief_title>Treatment of Periodontal Intrabony Defects With A-PRF+ or EMD</brief_title>
  <official_title>Efficacy of a New-generation Platelet-rich Fibrin vs. Enamel Matrix Derivatives in the Treatment of Periodontal Intrabony Defects : a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Semmelweis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Semmelweis University</source>
  <oversight_info>
    <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>
      The aim of this randomized clinical trial was to clinically evaluate and compare the healing&#xD;
      of intrabony defects after treatment with advanced platelet-rich fibrin (A-PRF+) to enamel&#xD;
      matrix derivatives (EMD) in periodontitis patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thirty (30) intrabony defects of 18 patients (9 males, 9 females) were randomly divided in&#xD;
      two treatment groups: test (n = 15) and control (n = 15). The intrabony defects were filled&#xD;
      with A-PRF+ (n=15) in the test group, respectively with EMD in the control group, and fixed&#xD;
      with sutures to ensure wound closure and stability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 27, 2018</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Periodontal clinical parameters - to determine the clinical attachment level (CAL)</measure>
    <time_frame>Change from baseline after 6 month and after 12 month</time_frame>
    <description>With a calibrated periodontal probe we are examining the changes of periodontal probing depth (PPD) and gingival recession (GR) after surgical procedure in mm, the two parameters are used to determine the clinical attachment level (CAL).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Periodontal clinical parameters</measure>
    <time_frame>Change from baseline after 6 month and after 12 month</time_frame>
    <description>With a calibrated periodontal probe we are examining the changes of periodontal probing depth (PPD) and gingival recession (GR) after surgical procedure in mm, the two parameters are used to determine the clinical attachment level (CAL).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Periodontal Diseases</condition>
  <arm_group>
    <arm_group_label>A-PRF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Advanced Platelet-Rich Fibrin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EMD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Enamel Matrix Derivatives</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>A-PRF/EMD</intervention_name>
    <description>Comparing healing effect of an autologous and a xenogenic product</description>
    <arm_group_label>A-PRF</arm_group_label>
    <arm_group_label>EMD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  no systemic diseases that could influence the outcome of the therapy, a good level of&#xD;
             oral hygiene, he presence of a 2-, 3-, or combined 2-3-wall intrabony defect with a&#xD;
             defect angle of 20-40 (+/- 5) degrees, with a minimum PPD of 6 mm and intrabony&#xD;
             component of a minimum 4 mm as detected on radiographs, no smoking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic diseases that could influence the outcome of the therapy, poor oral hygiene,&#xD;
             smoking, horizontal bone loss&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ferenc Dr.Dőri, professor</last_name>
    <role>Study Director</role>
    <affiliation>Semmelweis University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Semmelweis University, Department of Periodontology</name>
      <address>
        <city>Budapest</city>
        <zip>1088</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>March 4, 2021</last_update_submitted>
  <last_update_submitted_qc>March 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Semmelweis University</investigator_affiliation>
    <investigator_full_name>Boroka Csifo-Nagy</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Intrabony Defects</keyword>
  <keyword>New-Generation Platelet-Rich Fibrin</keyword>
  <keyword>Enamel Matrix Derivatives</keyword>
  <keyword>Periodontal Regeneration</keyword>
  <keyword>EMD</keyword>
  <keyword>A-PRF+</keyword>
  <keyword>Advanced Platelet-Rich Fibrin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Diseases</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/NCT04404374
org study id: SE TUKEB: 254/2017
nct id: NCT04404374
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of this randomized clinical trial was to clinically evaluate and compare the healing
      of intrabony defects after treatment with advanced platelet-rich fibrin (A-PRF+) to enamel
      matrix derivatives (EMD) in periodontitis patients.
Thirty (30) intrabony defects of 18 patients (9 males, 9 females) were randomly divided in
      two treatment groups: test (n = 15) and control (n = 15). The intrabony defects were filled
      with A-PRF+ (n=15) in the test group, respectively with EMD in the control group, and fixed
      with sutures to ensure wound closure and stability.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Periodontal clinical parameters - to determine the clinical attachment level (CAL)
time frame: Change from baseline after 6 month and after 12 month
description: With a calibrated periodontal probe we are examining the changes of periodontal probing depth (PPD) and gingival recession (GR) after surgical procedure in mm, the two parameters are used to determine the clinical attachment level (CAL).
measure: Periodontal clinical parameters
time frame: Change from baseline after 6 month and after 12 month
description: With a calibrated periodontal probe we are examining the changes of periodontal probing depth (PPD) and gingival recession (GR) after surgical procedure in mm, the two parameters are used to determine the clinical attachment level (CAL).
arm group label: A-PRF
arm group type: Active Comparator
description: Advanced Platelet-Rich Fibrin
arm group label: EMD
arm group type: Active Comparator
description: Enamel Matrix Derivatives
intervention type: Procedure
intervention name: A-PRF/EMD
description: Comparing healing effect of an autologous and a xenogenic product
arm group label: A-PRF
arm group label: EMD
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ferenc Dr.Dőri, professor
role: Study Director
affiliation: Semmelweis University
facility: 
country: Hungary
responsible party type: Principal Investigator
investigator affiliation: Semmelweis University
investigator full name: Boroka Csifo-Nagy
investigator title: Assistant Professor
mesh term: Periodontal Diseases