<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/NCT02190409</url>
  </required_header>
  <id_info>
    <org_study_id>D-KA11/06</org_study_id>
    <nct_id>NCT02190409</nct_id>
  </id_info>
  <brief_title>An Invivo Study to Compare the Stability of Dental Implants With or Without Platelet Rich Fibrin Application</brief_title>
  <official_title>The Effect Of Platelet Rich Fibrin on Implant Stability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ELİF ONCU</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baskent University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Necmettin Erbakan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the effects of (Platelet Rich Fibrin) PRF&#xD;
      application on implant osseointegration in the early phase of healing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives:Achieving accelerated implant osseointegration could provide immediate or early&#xD;
      loading of implants. Platelet-rich fibrin (PRF) is widely used to accelerate soft and hard&#xD;
      tissue healing. Activated platelets in PRF release growth factors resulting in cellular&#xD;
      proliferation, collagen synthesis and osteoid production. The aim of this study was to&#xD;
      compare the stability of dental implants inserted with one-stage surgical protocol with or&#xD;
      without PRF application.&#xD;
&#xD;
      Design: Non-randomized, Active Controlled Trial. Material and Methods: Twenty healthy&#xD;
      patients (n=10 test group, n= control group) with adequate alveolar bone, having 2 or more&#xD;
      adjacent missing teeth, extracted at least 6 months ago were included in this study. Minimum&#xD;
      two tapered implants (Ankylosis, DentsplyFriadent) were placed to each patient. After&#xD;
      surgical preparation of implant sockets, PRF that was prepared preoperatively was placed&#xD;
      randomly to one of the sockets (PRF+). Acellular plasma portion of PRF was used to wet the&#xD;
      implant placed into the PRF-coated socket. Resonance frequency measurements were made by&#xD;
      Osstell ISQ after placement of implants, at 1 week and one month postoperatively.&#xD;
&#xD;
      Key Words: Dental implant stability, Platelet Rich Fibrin, Resonance frequency analysis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">January 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Implant Stabilitty Quotient (ISQ) evaluation: analysis of the resonance frequency values 4 week period.</measure>
    <time_frame>Resonance frequency measurements were made by Osstell ISQ after placement of implants, at 1 week and one month postoperatively.</time_frame>
    <description>The stability of the implants were evaluated with the resonance frequency analysis (RFA) method. The measurements were carried out with Osstell ISQ (Implant Stability Quotient) (Osstell, Göteborg, Sweden) by connecting the transducer (smartpeg) to the implant. Two mesio-distal and bucco-lingual measurements were recorded and mean ISQ values were calculated. The resonance frequency measurements were repeated at first and fourth weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of osseointegration in different types of bone</measure>
    <time_frame>Resonance frequency measurements in different bone types were made by Osstell ISQ after placement of implants, at 1 week and one month postoperatively.</time_frame>
    <description>Evaluation early bone healing and compare stability of different bone type (based on the bone quality determined by the insertion torque value)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Dental Implant</condition>
  <arm_group>
    <arm_group_label>Test, Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test: Minimum two tapered implants (Ankylosis, Dentsply Friadent) were placed to each patient. After surgical preparation of implant sockets, PRF that was prepared preoperatively was placed randomly to one of the sockets (PRF+). Acellular plasma portion of PRF was used to wet the implant placed into the PRF-coated socket Control: Other socket was selected as a control group (No Platelet Rich Fibrin used): In the control group no extra intervention used and the conventional procedure was done. Thus the readings of the experimental arm compared with this control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dental implant</intervention_name>
    <description>This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 4 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach</description>
    <arm_group_label>Test, Control</arm_group_label>
    <other_name>The implant in this protocol</other_name>
    <other_name>3.5 mm width and 11 mm length) ANKYLOS C/X dental implants were used (Dentsply, Hanau, Germany</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The absence of any lesions in the oral cavity, and sufficient residual bone volume to&#xD;
             receive two or more adjacent implants of ≥3.5 mm in diameter and 11.0 mm in length,&#xD;
             and extracted at least 6 months ago.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insufficient bone volume&#xD;
&#xD;
          -  Parafunctional habits&#xD;
&#xD;
          -  Smoking more than 10 cigarettes per day&#xD;
&#xD;
          -  Excessive consumption of alcohol&#xD;
&#xD;
          -  Localized radiotherapy of the oral cavity&#xD;
&#xD;
          -  Antitumor chemotherapy&#xD;
&#xD;
          -  Liver, blood, and kidney diseases&#xD;
&#xD;
          -  Immunosuppression&#xD;
&#xD;
          -  Current corticosteroid or bisphosphonate use&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Mucocutaneous diseases involving oral cavity&#xD;
&#xD;
          -  Poor oral hygiene&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ELİF ÖNCÜ, 1</last_name>
    <role>Principal Investigator</role>
    <affiliation>NECMETTİN ERBAKAN UNIVERSITY</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NECMETTIN ERBAKAN University Faculty of Dentistry, Department of Periodontology,</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 14, 2014</last_update_submitted>
  <last_update_submitted_qc>July 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Necmettin Erbakan University</investigator_affiliation>
    <investigator_full_name>ELİF ONCU</investigator_full_name>
    <investigator_title>Assist.Prof.Dr.</investigator_title>
  </responsible_party>
  <keyword>Dental Implant,</keyword>
  <!-- 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/NCT02190409
org study id: D-KA11/06
nct id: NCT02190409
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study was to evaluate the effects of (Platelet Rich Fibrin) PRF
      application on implant osseointegration in the early phase of healing.
Objectives:Achieving accelerated implant osseointegration could provide immediate or early
      loading of implants. Platelet-rich fibrin (PRF) is widely used to accelerate soft and hard
      tissue healing. Activated platelets in PRF release growth factors resulting in cellular
      proliferation, collagen synthesis and osteoid production. The aim of this study was to
      compare the stability of dental implants inserted with one-stage surgical protocol with or
      without PRF application.

      Design: Non-randomized, Active Controlled Trial. Material and Methods: Twenty healthy
      patients (n=10 test group, n= control group) with adequate alveolar bone, having 2 or more
      adjacent missing teeth, extracted at least 6 months ago were included in this study. Minimum
      two tapered implants (Ankylosis, DentsplyFriadent) were placed to each patient. After
      surgical preparation of implant sockets, PRF that was prepared preoperatively was placed
      randomly to one of the sockets (PRF+). Acellular plasma portion of PRF was used to wet the
      implant placed into the PRF-coated socket. Resonance frequency measurements were made by
      Osstell ISQ after placement of implants, at 1 week and one month postoperatively.

      Key Words: Dental implant stability, Platelet Rich Fibrin, Resonance frequency analysis
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Implant Stabilitty Quotient (ISQ) evaluation: analysis of the resonance frequency values 4 week period.
time frame: Resonance frequency measurements were made by Osstell ISQ after placement of implants, at 1 week and one month postoperatively.
description: The stability of the implants were evaluated with the resonance frequency analysis (RFA) method. The measurements were carried out with Osstell ISQ (Implant Stability Quotient) (Osstell, Göteborg, Sweden) by connecting the transducer (smartpeg) to the implant. Two mesio-distal and bucco-lingual measurements were recorded and mean ISQ values were calculated. The resonance frequency measurements were repeated at first and fourth weeks.
measure: Evaluation of osseointegration in different types of bone
time frame: Resonance frequency measurements in different bone types were made by Osstell ISQ after placement of implants, at 1 week and one month postoperatively.
description: Evaluation early bone healing and compare stability of different bone type (based on the bone quality determined by the insertion torque value)
arm group label: Test, Control
arm group type: Experimental
description: Test: Minimum two tapered implants (Ankylosis, Dentsply Friadent) were placed to each patient. After surgical preparation of implant sockets, PRF that was prepared preoperatively was placed randomly to one of the sockets (PRF+). Acellular plasma portion of PRF was used to wet the implant placed into the PRF-coated socket Control: Other socket was selected as a control group (No Platelet Rich Fibrin used): In the control group no extra intervention used and the conventional procedure was done. Thus the readings of the experimental arm compared with this control.
intervention type: Device
intervention name: Dental implant
description: This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 4 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach
arm group label: Test, Control
other name: The implant in this protocol
other name: 3.5 mm width and 11 mm length) ANKYLOS C/X dental implants were used (Dentsply, Hanau, Germany
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ELİF ÖNCÜ, 1
role: Principal Investigator
affiliation: NECMETTİN ERBAKAN UNIVERSITY
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Necmettin Erbakan University
investigator full name: ELİF ONCU
investigator title: Assist.Prof.Dr.