<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/NCT02218515</url>
  </required_header>
  <id_info>
    <org_study_id>SAG-C-DRP-090909-0288</org_study_id>
    <nct_id>NCT02218515</nct_id>
  </id_info>
  <brief_title>Treatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft</brief_title>
  <official_title>Evaluation of Gingival Crevicular Fluid Transforming Growth Factor-β1 Level After Treatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haner Direskeneli, Prof</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marmara University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study aimed to evaluate the effects of enamel matrix derivatives either alone or&#xD;
      combined with autogenous bone graft applied to intrabony defects in chronic periodontitis&#xD;
      patients on clinical/radiographic parameters and gingival crevicular fluid transforming&#xD;
      growth factor-β1 level and, to compare with open flap debridement. Our hypothesis is to test&#xD;
      whether the use of autogenous bone graft and enamel matrix derivative combination in the&#xD;
      treatment of intrabony periodontal defects enhance the clinical, radiographic and biochemical&#xD;
      parameters in comparison to the use of open flap debridement alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study aimed to evaluate the effects of enamel matrix derivatives (EMD) either&#xD;
      alone or combined with autogenous bone graft (ABG) applied to intrabony defects in chronic&#xD;
      periodontitis patients on clinical/radiographic parameters and gingival crevicular fluid&#xD;
      (GCF) transforming growth factor-β1 (TGF-β1) level and, to compare with open flap debridement&#xD;
      (OFD). A total of 30 deep intrabony defects in 12 patients were randomly treated with EMD+ABG&#xD;
      (Combination group), EMD alone (EMD group) or OFD (Control group). Clinical parameters&#xD;
      including plaque index, gingival index, bleeding on probing, probing depth, relative&#xD;
      attachment level and recession were recorded at baseline and 6 months post-surgery. Intrabony&#xD;
      defect fill percentage was calculated on the standardized radiographs. TGF-β1 level was&#xD;
      evaluated in GCF just before surgery and 7, 14, 30, 90, 180 days after surgery using ELISA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <phase>Phase 4</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>Attachment Gain</measure>
    <time_frame>6 months after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gingival crevicular fluid TGF-β1 level</measure>
    <time_frame>1 week, 2 weeks, 4 weeks, 12 weeks and 72 weeks after surgery</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Plaque index</measure>
    <time_frame>Baseline and 6 months post-surgery.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Gingival index</measure>
    <time_frame>Baseline and 6 months post-surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Bleeding on probing</measure>
    <time_frame>Baseline and 6 months post-surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Probing depth</measure>
    <time_frame>Baseline and 6 months post-surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Relative attachment level</measure>
    <time_frame>Baseline and 6 months post-surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Recession</measure>
    <time_frame>Baseline and 6 months post-surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Intrabony defect fill percentage</measure>
    <time_frame>Baseline and 6 months post-surgery</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Periodontal Bone Loss</condition>
  <condition>Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>Open Flap Debridement</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Open Flap Debridement (Control Group)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enamel Matrix Derivative</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enamel Matrix Derivative+Autogenous Bone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open Flap Debridement</intervention_name>
    <description>Open Flap Debridement (Control Group)</description>
    <arm_group_label>Open Flap Debridement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>EmdogainⓇ(Enamel Matrix Derivative)</intervention_name>
    <description>Open Flap Debridement+Enamel Matrix Derivative</description>
    <arm_group_label>Enamel Matrix Derivative</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>EmdogainⓇEnamel Matrix Derivative+Autogenous Bone</intervention_name>
    <description>Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone</description>
    <arm_group_label>Enamel Matrix Derivative+Autogenous Bone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (a) no systemic diseases as diabetes mellitus or cardiovascular diseases that&#xD;
        contraindicated periodontal surgery and could influence the outcome of the therapy; (b) no&#xD;
        smoking (c) no medications affecting periodontal tissues; (d) no pregnancy or lactation;&#xD;
        (e) a good level of oral hygiene (plaque index &lt; 1, and full mouth bleeding on probing&#xD;
        score &lt;20% after initial periodontal treatment), (f) compliance with the maintenance&#xD;
        programme and (g) presence of at least one intra-bony defect with a probing depth ≥6 mm,&#xD;
        radiographic depth of the defect ≥3 mm as detected on the radiographs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (a) pregnancy or lactating, (b) required an antibiotic premedication, (c) received&#xD;
        antibiotic treatment in the previous 6 months, (d) smokers, (e) whose tooth had inadequate&#xD;
        amount of attached keratinized gingiva (&lt;1mm)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>32 Years</minimum_age>
    <maximum_age>57 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ömer Birkan Ağralı, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Marmara University Faculty of Dentistry, Department of Periodontology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bahar Kuru, Prof. Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Marmara University, Faculty of Dentistry, Department of Periodontology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Leyla Kuru, Prof. Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Marmara University, Faculty of Dentistry, Department of Periodontology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marmara University Faculty of Dentistry, Department of Periodontology</name>
      <address>
        <city>İstanbul</city>
        <state>Şişli/Nişantaşı</state>
        <zip>34365</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>August 14, 2014</last_update_submitted>
  <last_update_submitted_qc>August 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Marmara University</investigator_affiliation>
    <investigator_full_name>Haner Direskeneli, Prof</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>Autogenous bone graft</keyword>
  <keyword>Chronic periodontitis</keyword>
  <keyword>Enamel matrix derivatives</keyword>
  <keyword>Gingival crevicular fluid</keyword>
  <keyword>Periodontal flap surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alveolar Bone Loss</mesh_term>
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Chronic Periodontitis</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/NCT02218515
org study id: SAG-C-DRP-090909-0288
nct id: NCT02218515
lead sponsor: 
has dmc: No
The present study aimed to evaluate the effects of enamel matrix derivatives either alone or
      combined with autogenous bone graft applied to intrabony defects in chronic periodontitis
      patients on clinical/radiographic parameters and gingival crevicular fluid transforming
      growth factor-β1 level and, to compare with open flap debridement. Our hypothesis is to test
      whether the use of autogenous bone graft and enamel matrix derivative combination in the
      treatment of intrabony periodontal defects enhance the clinical, radiographic and biochemical
      parameters in comparison to the use of open flap debridement alone.
The present study aimed to evaluate the effects of enamel matrix derivatives (EMD) either
      alone or combined with autogenous bone graft (ABG) applied to intrabony defects in chronic
      periodontitis patients on clinical/radiographic parameters and gingival crevicular fluid
      (GCF) transforming growth factor-β1 (TGF-β1) level and, to compare with open flap debridement
      (OFD). A total of 30 deep intrabony defects in 12 patients were randomly treated with EMD+ABG
      (Combination group), EMD alone (EMD group) or OFD (Control group). Clinical parameters
      including plaque index, gingival index, bleeding on probing, probing depth, relative
      attachment level and recession were recorded at baseline and 6 months post-surgery. Intrabony
      defect fill percentage was calculated on the standardized radiographs. TGF-β1 level was
      evaluated in GCF just before surgery and 7, 14, 30, 90, 180 days after surgery using ELISA.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Attachment Gain
time frame: 6 months after surgery
measure: Gingival crevicular fluid TGF-β1 level
time frame: 1 week, 2 weeks, 4 weeks, 12 weeks and 72 weeks after surgery
measure: Plaque index
time frame: Baseline and 6 months post-surgery.
measure: Gingival index
time frame: Baseline and 6 months post-surgery
measure: Bleeding on probing
time frame: Baseline and 6 months post-surgery
measure: Probing depth
time frame: Baseline and 6 months post-surgery
measure: Relative attachment level
time frame: Baseline and 6 months post-surgery
measure: Recession
time frame: Baseline and 6 months post-surgery
measure: Intrabony defect fill percentage
time frame: Baseline and 6 months post-surgery
arm group label: Open Flap Debridement
arm group type: Other
description: Open Flap Debridement (Control Group)
arm group label: Enamel Matrix Derivative
arm group type: Experimental
description: Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)
arm group label: Enamel Matrix Derivative+Autogenous Bone
arm group type: Experimental
description: Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone
intervention type: Procedure
intervention name: Open Flap Debridement
description: Open Flap Debridement (Control Group)
arm group label: Open Flap Debridement
intervention type: Biological
intervention name: EmdogainⓇ(Enamel Matrix Derivative)
description: Open Flap Debridement+Enamel Matrix Derivative
arm group label: Enamel Matrix Derivative
intervention type: Biological
intervention name: EmdogainⓇEnamel Matrix Derivative+Autogenous Bone
description: Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone
arm group label: Enamel Matrix Derivative+Autogenous Bone
criteria: 
gender: All
minimum age: 32 Years
maximum age: 57 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ömer Birkan Ağralı, Dr.
role: Principal Investigator
affiliation: Marmara University Faculty of Dentistry, Department of Periodontology
last name: Bahar Kuru, Prof. Dr.
role: Study Chair
affiliation: Marmara University, Faculty of Dentistry, Department of Periodontology
last name: Leyla Kuru, Prof. Dr.
role: Study Director
affiliation: Marmara University, Faculty of Dentistry, Department of Periodontology
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Marmara University
investigator full name: Haner Direskeneli, Prof
investigator title: Prof. Dr.
mesh term: Alveolar Bone Loss
mesh term: Periodontitis
mesh term: Chronic Periodontitis