<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/NCT03274674</url>
  </required_header>
  <id_info>
    <org_study_id>boz002</org_study_id>
    <nct_id>NCT03274674</nct_id>
  </id_info>
  <brief_title>Use of Injectable-platelet-rich-fibrin (I-PRF) to Thicken Gingival Phenotype</brief_title>
  <official_title>New Approach to Increasing Gingival Thickness in Individuals With Fine Gingival Phenotype:Injectable Platelet Rich Fibrin (I-PRF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bezmialem Vakif University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study is to investigate whether the for individuals with thin&#xD;
      gingival thickness who are susceptible to gingival recession, the investigators will use&#xD;
      i-PRF with microneedle to increase gingival thickness without the need for surgical&#xD;
      procedures&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Due to the thin gingival phenotype, gingival recession is a problem. The investigators aimed&#xD;
      to increase the gingival thickness using i-PRF with microneedle without considering surgical&#xD;
      procedures, considering the positive effects of platelet concentrations on revascularization&#xD;
      and wound healing in individuals with bone defect, fenestration and gingival thickness which&#xD;
      are prone to gingival recession .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 4, 2017</start_date>
  <completion_date type="Actual">June 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</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>
    <intervention_model_description>Blinded, Parallel group, Randomized Controlled Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gingival thickness (mm)</measure>
    <time_frame>2 months</time_frame>
    <description>Change in clinical measures of gingival thickness</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plaque Index (PI)</measure>
    <time_frame>2 months</time_frame>
    <description>Change in clinical measures of gingival parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival Index (GI)</measure>
    <time_frame>2 months</time_frame>
    <description>Change in clinical measures of gingival parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding on probing (BOP)</measure>
    <time_frame>2 months</time_frame>
    <description>Change in clinical measures of gingival parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment level (CAL)</measure>
    <time_frame>2 months</time_frame>
    <description>Change in clinical measures of gingival parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probing pocket depth (PD)</measure>
    <time_frame>2 months</time_frame>
    <description>Change in clinical measures of gingival parameters</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Periodontoclasia</condition>
  <condition>Gingiva; Injury</condition>
  <condition>Condition</condition>
  <condition>Blood Clot</condition>
  <condition>Gingiva Disorder</condition>
  <arm_group>
    <arm_group_label>I-PRF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge.I-PRF injected on one side of bilateral thin gingival thickness.Apply once a week and one month after the end of the injections, the patient will be called to the control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>I-PRF and Microneedling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge.Microneedle application plus I-PRF injected on the other side in patients with bilateral region with thin gingival phenotype.Apply once a week and one month after the end of the injections, the patient will be called to the control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>I-PRF</intervention_name>
    <description>Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge.I-PRF injected on one side of bilateral thin gingival thickness.Microneedle application plus I-PRF injected on the other side in patients with bilateral region with thin gingival phenotype.Apply once a week and one month after the end of the injections, the patient will be called to the control.</description>
    <arm_group_label>I-PRF</arm_group_label>
    <arm_group_label>I-PRF and Microneedling</arm_group_label>
    <other_name>I-PRF and Microneedling</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Never smokers&#xD;
&#xD;
          -  Had no history of systemic disease&#xD;
&#xD;
          -  Aged ≥18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of diabetes mellitus or systemic disease&#xD;
&#xD;
          -  Patients who were under any medication that was known to influence periodontal tissues&#xD;
&#xD;
          -  Patients with hormonal changes such as pregnancy or lactation&#xD;
&#xD;
          -  Toothless individuals&#xD;
&#xD;
          -  Patients who were clotting disorders&#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>Zeliha Betül Özsağır</last_name>
    <role>Study Chair</role>
    <affiliation>Bezmialem VU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zeliha Betül ÖZSAĞIR</name>
      <address>
        <city>İstanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>September 8, 2020</last_update_submitted>
  <last_update_submitted_qc>September 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PRF</keyword>
  <keyword>I-PRF</keyword>
  <keyword>Microneedle</keyword>
  <keyword>Gingival Thickness</keyword>
  <keyword>Injectable-Platelet-Rich-Fibrin</keyword>
  <keyword>Platelet Rich Fibrin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</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/NCT03274674
org study id: boz002
nct id: NCT03274674
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The main objective of this study is to investigate whether the for individuals with thin
      gingival thickness who are susceptible to gingival recession, the investigators will use
      i-PRF with microneedle to increase gingival thickness without the need for surgical
      procedures
Due to the thin gingival phenotype, gingival recession is a problem. The investigators aimed
      to increase the gingival thickness using i-PRF with microneedle without considering surgical
      procedures, considering the positive effects of platelet concentrations on revascularization
      and wound healing in individuals with bone defect, fenestration and gingival thickness which
      are prone to gingival recession .
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Blinded, Parallel group, Randomized Controlled Trial
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Gingival thickness (mm)
time frame: 2 months
description: Change in clinical measures of gingival thickness
measure: Plaque Index (PI)
time frame: 2 months
description: Change in clinical measures of gingival parameters
measure: Gingival Index (GI)
time frame: 2 months
description: Change in clinical measures of gingival parameters
measure: Bleeding on probing (BOP)
time frame: 2 months
description: Change in clinical measures of gingival parameters
measure: Clinical attachment level (CAL)
time frame: 2 months
description: Change in clinical measures of gingival parameters
measure: Probing pocket depth (PD)
time frame: 2 months
description: Change in clinical measures of gingival parameters
arm group label: I-PRF
arm group type: Experimental
description: Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge.I-PRF injected on one side of bilateral thin gingival thickness.Apply once a week and one month after the end of the injections, the patient will be called to the control.
arm group label: I-PRF and Microneedling
arm group type: Active Comparator
description: Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge.Microneedle application plus I-PRF injected on the other side in patients with bilateral region with thin gingival phenotype.Apply once a week and one month after the end of the injections, the patient will be called to the control.
intervention type: Other
intervention name: I-PRF
description: Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge.I-PRF injected on one side of bilateral thin gingival thickness.Microneedle application plus I-PRF injected on the other side in patients with bilateral region with thin gingival phenotype.Apply once a week and one month after the end of the injections, the patient will be called to the control.
arm group label: I-PRF
arm group label: I-PRF and Microneedling
other name: I-PRF and Microneedling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Zeliha Betül Özsağır
role: Study Chair
affiliation: Bezmialem VU
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Thrombosis
sharing ipd: Undecided