<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/NCT03027050</url>
  </required_header>
  <id_info>
    <org_study_id>BAP-2011301</org_study_id>
    <nct_id>NCT03027050</nct_id>
  </id_info>
  <brief_title>T-PRF Provides Advantages on Periodontal Healing: A Split Mouth Clinical Study</brief_title>
  <official_title>T-PRF Contributes to Periodontal Healing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ataturk University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ataturk University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It was aimed to evaluate the contributions of T-PRF treatment combined with open flap&#xD;
      debridement on biological markers in GCF and periodontal outcomes in chronic periodontitis&#xD;
      patients. 29 patients (58 sites) with chronic periodontitis were treated either with&#xD;
      autologous T-PRF with OFD or OFD alone. GCF growth factor levels and relative RANKL/OPG ratio&#xD;
      at baseline and 2, 4 and 6 weeks postoperatively were analyzed, and clinical parameters such&#xD;
      as probing depth (PD), relative attachment level (RAL) and gingival margin level (GML) at&#xD;
      baseline and 9 months after surgery were compromised.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 29 medically healthy patients (12 females and 17 males; age range 28-49 years,&#xD;
      mean±SD: 38.22±8.21) with chronic periodontitis at the outpatient Ataturk University,&#xD;
      Department of Periodontology, Faculty of Dentistry, Erzurum, Turkey, were selected for the&#xD;
      study. The study, conducted from November 2015 to June 2016, was planned as a randomized,&#xD;
      double-blinded, controlled clinical trial that used a split-mouth design. This study was&#xD;
      proved by the ethics committee of Ataturk University Faculty of Dentistry, and all patients&#xD;
      received verbal information regarding participation and provided written informed consent for&#xD;
      including to the study.&#xD;
&#xD;
      Bone loss characteristics of the patients were diagnosed with full-mouth radiographs and&#xD;
      cone-beam computed tomography. This study included the patients with moderate-to-severe&#xD;
      chronic periodontitis with a probing depth of 5 mm or deeper and horizontal bone loss (one-&#xD;
      or two-wall shallow interproximal defects) of at least two quadrants of the jaws after&#xD;
      Phase-I periodontal therapy. After re-evaluating the results of Phase-I therapy, patients&#xD;
      with any of the following were excluded from the study: 1) smoking or tobacco use in any&#xD;
      form; 2) medications known to affect periodontal treatment and blood coagulation; 3) systemic&#xD;
      conditions known to affect periodontal status; 4) pregnancy/lactation; and 5) poor oral&#xD;
      hygiene (plaque index [PI] &gt;1.5) (Sillness and Loe; 1964). Patients with teeth with 3-wall&#xD;
      intrabony defects, gingival recession, endodontic lesion, or furcation involvement were also&#xD;
      excluded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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 (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Level of Growth Factor</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change from baseline growth factors levels of GCF at 6 weeks were measured by periopaper</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>relative RANKL/OPG ratio in GCF</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change in relative RANKL/OPG ratio from baseline to 6 weeks were measured by periopaper</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alteration of Clinical Attachment Level</measure>
    <time_frame>9 months</time_frame>
    <description>Change from baseline Clinical Attachment Levels at 9 months were measured with periodontal probe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alteration of Periodontal Pocket Depth</measure>
    <time_frame>9 months</time_frame>
    <description>Change from baseline Pocket Depth at 9 months were measured with periodontal probe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival Margin Level</measure>
    <time_frame>9 months</time_frame>
    <description>Change from baseline to 9 months were measured with periodontal probe.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Periodontitis</condition>
  <condition>Periodontal Attachment Loss</condition>
  <arm_group>
    <arm_group_label>Titanium-prepared platelet rich fibrine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>T-PRF was applied with open flap debridement in test group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open Flap Debridement alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>T-PRF was not applied to control groups. Only open flap debridement was applied to control groups.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>T-PRF</intervention_name>
    <description>Applied for treatment of periodontal bone loss.</description>
    <arm_group_label>Open Flap Debridement alone</arm_group_label>
    <arm_group_label>Titanium-prepared platelet rich fibrine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open Flap Debridement alone</intervention_name>
    <arm_group_label>Open Flap Debridement alone</arm_group_label>
    <arm_group_label>Titanium-prepared platelet rich fibrine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with CP who had pocket depth ≤ 5 mm and at least two area (grouped as Control&#xD;
             and PRF) with horizontal bone loss after initial treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subjects excluded in the study had history of systemic disease, were smokers, had&#xD;
             allergy to any drug, had need for prophylaxis of antibiotic and had taken antibiotics&#xD;
             at least 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Taner Arabacı</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ataturk University</affiliation>
  </overall_official>
  <reference>
    <citation>Pradeep AR, Shetty SK, Garg G, Pai S. Clinical effectiveness of autologous platelet-rich plasma and Peptide-enhanced bone graft in the treatment of intrabony defects. J Periodontol. 2009 Jan;80(1):62-71. doi: 10.1902/jop.2009.080214.</citation>
    <PMID>19228091</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ataturk University</investigator_affiliation>
    <investigator_full_name>Taner ARABACI</investigator_full_name>
    <investigator_title>Clinical Associate Professor</investigator_title>
  </responsible_party>
  <keyword>periodontitis</keyword>
  <keyword>Growth factors</keyword>
  <keyword>Periodontal healing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Periodontal Attachment Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03027050
org study id: BAP-2011301
nct id: NCT03027050
lead sponsor: 
has dmc: Yes
It was aimed to evaluate the contributions of T-PRF treatment combined with open flap
      debridement on biological markers in GCF and periodontal outcomes in chronic periodontitis
      patients. 29 patients (58 sites) with chronic periodontitis were treated either with
      autologous T-PRF with OFD or OFD alone. GCF growth factor levels and relative RANKL/OPG ratio
      at baseline and 2, 4 and 6 weeks postoperatively were analyzed, and clinical parameters such
      as probing depth (PD), relative attachment level (RAL) and gingival margin level (GML) at
      baseline and 9 months after surgery were compromised.
A total of 29 medically healthy patients (12 females and 17 males; age range 28-49 years,
      mean±SD: 38.22±8.21) with chronic periodontitis at the outpatient Ataturk University,
      Department of Periodontology, Faculty of Dentistry, Erzurum, Turkey, were selected for the
      study. The study, conducted from November 2015 to June 2016, was planned as a randomized,
      double-blinded, controlled clinical trial that used a split-mouth design. This study was
      proved by the ethics committee of Ataturk University Faculty of Dentistry, and all patients
      received verbal information regarding participation and provided written informed consent for
      including to the study.

      Bone loss characteristics of the patients were diagnosed with full-mouth radiographs and
      cone-beam computed tomography. This study included the patients with moderate-to-severe
      chronic periodontitis with a probing depth of 5 mm or deeper and horizontal bone loss (one-
      or two-wall shallow interproximal defects) of at least two quadrants of the jaws after
      Phase-I periodontal therapy. After re-evaluating the results of Phase-I therapy, patients
      with any of the following were excluded from the study: 1) smoking or tobacco use in any
      form; 2) medications known to affect periodontal treatment and blood coagulation; 3) systemic
      conditions known to affect periodontal status; 4) pregnancy/lactation; and 5) poor oral
      hygiene (plaque index [PI] >1.5) (Sillness and Loe; 1964). Patients with teeth with 3-wall
      intrabony defects, gingival recession, endodontic lesion, or furcation involvement were also
      excluded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Level of Growth Factor
time frame: 6 weeks
description: Change from baseline growth factors levels of GCF at 6 weeks were measured by periopaper
measure: relative RANKL/OPG ratio in GCF
time frame: 6 weeks
description: Change in relative RANKL/OPG ratio from baseline to 6 weeks were measured by periopaper
measure: Alteration of Clinical Attachment Level
time frame: 9 months
description: Change from baseline Clinical Attachment Levels at 9 months were measured with periodontal probe.
measure: Alteration of Periodontal Pocket Depth
time frame: 9 months
description: Change from baseline Pocket Depth at 9 months were measured with periodontal probe.
measure: Gingival Margin Level
time frame: 9 months
description: Change from baseline to 9 months were measured with periodontal probe.
arm group label: Titanium-prepared platelet rich fibrine
arm group type: Experimental
description: T-PRF was applied with open flap debridement in test group.
arm group label: Open Flap Debridement alone
arm group type: Active Comparator
description: T-PRF was not applied to control groups. Only open flap debridement was applied to control groups.
intervention type: Procedure
intervention name: T-PRF
description: Applied for treatment of periodontal bone loss.
arm group label: Open Flap Debridement alone
arm group label: Titanium-prepared platelet rich fibrine
intervention type: Procedure
intervention name: Open Flap Debridement alone
arm group label: Open Flap Debridement alone
arm group label: Titanium-prepared platelet rich fibrine
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Taner Arabacı
role: Principal Investigator
affiliation: Ataturk University
citation: Pradeep AR, Shetty SK, Garg G, Pai S. Clinical effectiveness of autologous platelet-rich plasma and Peptide-enhanced bone graft in the treatment of intrabony defects. J Periodontol. 2009 Jan;80(1):62-71. doi: 10.1902/jop.2009.080214.
PMID: 19228091
responsible party type: Principal Investigator
investigator affiliation: Ataturk University
investigator full name: Taner ARABACI
investigator title: Clinical Associate Professor
mesh term: Periodontitis
mesh term: Periodontal Attachment Loss
sharing ipd: No