<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/NCT03268512</url>
  </required_header>
  <id_info>
    <org_study_id>B322201525149</org_study_id>
    <nct_id>NCT03268512</nct_id>
  </id_info>
  <brief_title>Effect of L-PRF and A-PRF in Ridge Preservation</brief_title>
  <official_title>The Use of L-PRF and A-PRF in Ridge Preservation: a Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</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>
      A split-mouth design study will be performed regarding the use of platelet concentrates on&#xD;
      ridge preservation: L-PRF vs A-PRF vs control. Patient needing multiple teeth extractions in&#xD;
      the upper jaw (single-rooted teeth) will be recruited. The use of each platelet concentrate&#xD;
      or control will be randomized by means of a computer program. The results will be analysed&#xD;
      clinical and radiographically (CBCT). When the subject will choose for implant&#xD;
      rehabilitation, a biopsy will be taken in the site of the preserved sockets. The region will&#xD;
      be localized with a customized stent, fabricated with the position of the extracted teeth.&#xD;
      VAS scales will be provided to evaluate the post-operative discomfort.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2015</start_date>
  <completion_date type="Actual">October 10, 2018</completion_date>
  <primary_completion_date type="Actual">October 10, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes horizontal width at crest -1mm</measure>
    <time_frame>3 months</time_frame>
    <description>Primary outcome variables were deﬁned as the changes in horizontal width at crest-1 mm levels.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes horizontal width at crest -3 mm and 5 mm; vertical resorption; socket fill</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in horizontal width at crest -3 mm and 5 mm; vertical resorption at the lingual and buccal side; socket ﬁll.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Post-operative scores</measure>
    <time_frame>1 week</time_frame>
    <description>Post-operative discomfort measured with VAS</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Atrophic Maxilla</condition>
  <condition>Ridge Preservation</condition>
  <arm_group>
    <arm_group_label>L-PRF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One socket will be filled with L-PRF membranes and covered with at least 2 L-PRF membranes. A modified horizontal mattress will be place as suture to keep the L-PRF in place.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A-PRF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One socket will be filled with A-PRF membranes and covered with at least 2 A-PRF membranes. A modified horizontal mattress will be place as suture to keep the A-PRF in place.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The socket will be filled with a natural blood clot. A modified horizontal mattress will be place as suture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>L-PRF</intervention_name>
    <description>Platelet concentrates are produced from a small peripheral blood sample, which is immediately centrifuged without any anticoagulant. Coagulation starts during the centrifugation, and three layers are obtained: red blood corpuscles (RBCs) at the bottom of the tube, platelet-poor plasma (PPP) on the top and an intermediate layer called &quot;buffy coat&quot; where most platelets and leucocytes are concentrated. L-PRF has potential advantages, namely: it creates a bioactive construct that stimulates the local environment for differentiation and proliferation of stem and progenitor cells and it acts as an immune regulation node with inflammation control abilities, such as slow continuous release of growth factors over a period of 7-14 days.</description>
    <arm_group_label>L-PRF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>A-PRF</intervention_name>
    <description>Platelet concentrates are produced from a small peripheral blood sample, which is immediately centrifuged without any anticoagulant. Coagulation starts during the centrifugation, and three layers are obtained: red blood corpuscles (RBCs) at the bottom of the tube, platelet-poor plasma (PPP) on the top and an intermediate layer called &quot;buffy coat&quot; where most platelets and leucocytes are concentrated. L-PRF has potential advantages, namely: it creates a bioactive construct that stimulates the local environment for differentiation and proliferation of stem and progenitor cells and it acts as an immune regulation node with inflammation control abilities, such as slow continuous release of growth factors over a period of 7-14 days.</description>
    <arm_group_label>A-PRF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  3 single-rooted teeth needed to be extracted in the upper jaw&#xD;
&#xD;
          -  patient in good general health as documented by self-assessment&#xD;
&#xD;
          -  patients must be committed to the study and must be willing to sing the informed&#xD;
             consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any systemic medical condition that could interfere with the surgical procedure or&#xD;
             planned treatment.&#xD;
&#xD;
          -  current pregnancy or breast feeding&#xD;
&#xD;
          -  radiotherapy or chemotherapy in head and neck area&#xD;
&#xD;
          -  intravenous and oral bisphosphonate&#xD;
&#xD;
          -  patients smoking &gt;20 cig/day&#xD;
&#xD;
          -  unwillingness to return for the follow-up examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ana B Castro, PhD student</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitaire Ziekenhuizen KU Leuven</investigator_affiliation>
    <investigator_full_name>Ana CASTRO SARDA</investigator_full_name>
    <investigator_title>Doctoral researcher</investigator_title>
  </responsible_party>
  <keyword>leucocyte- and platelet rich fibrin</keyword>
  <keyword>ridge preservation</keyword>
  <keyword>growth factors</keyword>
  <keyword>platelet concentrates</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrophy</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/NCT03268512
org study id: B322201525149
nct id: NCT03268512
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A split-mouth design study will be performed regarding the use of platelet concentrates on
      ridge preservation: L-PRF vs A-PRF vs control. Patient needing multiple teeth extractions in
      the upper jaw (single-rooted teeth) will be recruited. The use of each platelet concentrate
      or control will be randomized by means of a computer program. The results will be analysed
      clinical and radiographically (CBCT). When the subject will choose for implant
      rehabilitation, a biopsy will be taken in the site of the preserved sockets. The region will
      be localized with a customized stent, fabricated with the position of the extracted teeth.
      VAS scales will be provided to evaluate the post-operative discomfort.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Changes horizontal width at crest -1mm
time frame: 3 months
description: Primary outcome variables were deﬁned as the changes in horizontal width at crest-1 mm levels.
measure: Changes horizontal width at crest -3 mm and 5 mm; vertical resorption; socket fill
time frame: 3 months
description: Changes in horizontal width at crest -3 mm and 5 mm; vertical resorption at the lingual and buccal side; socket ﬁll.
measure: Post-operative scores
time frame: 1 week
description: Post-operative discomfort measured with VAS
arm group label: L-PRF
arm group type: Experimental
description: One socket will be filled with L-PRF membranes and covered with at least 2 L-PRF membranes. A modified horizontal mattress will be place as suture to keep the L-PRF in place.
arm group label: A-PRF
arm group type: Experimental
description: One socket will be filled with A-PRF membranes and covered with at least 2 A-PRF membranes. A modified horizontal mattress will be place as suture to keep the A-PRF in place.
arm group label: Control
arm group type: No Intervention
description: The socket will be filled with a natural blood clot. A modified horizontal mattress will be place as suture.
intervention type: Other
intervention name: L-PRF
description: Platelet concentrates are produced from a small peripheral blood sample, which is immediately centrifuged without any anticoagulant. Coagulation starts during the centrifugation, and three layers are obtained: red blood corpuscles (RBCs) at the bottom of the tube, platelet-poor plasma (PPP) on the top and an intermediate layer called "buffy coat" where most platelets and leucocytes are concentrated. L-PRF has potential advantages, namely: it creates a bioactive construct that stimulates the local environment for differentiation and proliferation of stem and progenitor cells and it acts as an immune regulation node with inflammation control abilities, such as slow continuous release of growth factors over a period of 7-14 days.
arm group label: L-PRF
intervention type: Other
intervention name: A-PRF
description: Platelet concentrates are produced from a small peripheral blood sample, which is immediately centrifuged without any anticoagulant. Coagulation starts during the centrifugation, and three layers are obtained: red blood corpuscles (RBCs) at the bottom of the tube, platelet-poor plasma (PPP) on the top and an intermediate layer called "buffy coat" where most platelets and leucocytes are concentrated. L-PRF has potential advantages, namely: it creates a bioactive construct that stimulates the local environment for differentiation and proliferation of stem and progenitor cells and it acts as an immune regulation node with inflammation control abilities, such as slow continuous release of growth factors over a period of 7-14 days.
arm group label: A-PRF
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ana B Castro, PhD student
role: Principal Investigator
affiliation: UZ Leuven
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universitaire Ziekenhuizen KU Leuven
investigator full name: Ana CASTRO SARDA
investigator title: Doctoral researcher
mesh term: Atrophy
sharing ipd: No