<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/NCT04434703</url>
  </required_header>
  <id_info>
    <org_study_id>6-3-1</org_study_id>
    <nct_id>NCT04434703</nct_id>
  </id_info>
  <brief_title>Alveolar Ridge Preservation Following Tooth Extraction Using Advanced Platelet Rich Fibrin (A-PRF) Versus Platelet Rich Fibrin (PRF)</brief_title>
  <official_title>Alveolar Ridge Preservation Following Tooth Extraction Using Advanced Platelet Rich Fibrin (A-PRF) Versus Platelet Rich Fibrin (PRF) A Randomized Clinical Trail :Comparative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      the aim of this study is clinically and radiographically evaluate the use of advance platelet&#xD;
      rich fibrin (A-PRF) versus platelet rich fibrin (PRF) in preservation of alveolar ridge&#xD;
      following tooth extraction&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      systemically healthy patients who have at least one non-restorable tooth in the upper&#xD;
      inter-bicuspid region and are not seeking immediate or early implant treatment will be&#xD;
      allocated in this study after performing nonsurgical periodontal therapy and preoperative&#xD;
      periapical therapy to evaluate and improve the condition of the periodontal tissues.&#xD;
&#xD;
      Anesthesia will be given then flapless atraumatic extraction using periotomes followed by&#xD;
      forceps after luxation. For all groups, the socket will be debrided using curette then&#xD;
&#xD;
        -  group A, the socket will be filled with A.PRF&#xD;
&#xD;
        -  group B the socket will be filled with PRF.&#xD;
&#xD;
        -  group C no bio-additive will be added.&#xD;
&#xD;
        -  Criss cross horizontal mattress suture will be applied to close the extraction wound.&#xD;
&#xD;
      PRF and A-PRF preparation :&#xD;
&#xD;
      10 ml of blood will be drawn from each patient by vein puncture of the antecubital vein.&#xD;
&#xD;
        -  Plateletr ich fibrin (PRF) is 3000 rpm and 10 minutes without addition of anticoagulant&#xD;
&#xD;
        -  Advanced platelet rich fibrin (A-PRF) is 1300 rpm and 8 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2021</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in bucco-lingual dimensions</measure>
    <time_frame>6 months</time_frame>
    <description>clinical measurement using bone caliper in mm numerical</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in alveolar bone height</measure>
    <time_frame>6 months</time_frame>
    <description>radiographic measurement using CBCT in mm numerical</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bone dentistry</measure>
    <time_frame>6 months</time_frame>
    <description>radiographic measurement using CBCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>soft tissue healing</measure>
    <time_frame>6 months</time_frame>
    <description>clinical measurement using landr et al index (healing index) in numerical</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative pain scores</measure>
    <time_frame>2 weeks</time_frame>
    <description>clinical measurement using VAS scale in numerical where No pain (0-4 mm) - mild pain (5-44 mm) -moderate pain (45-74 mm), and severe pain (75- 100 mm).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Alveolar Bone Resorption</condition>
  <arm_group>
    <arm_group_label>Platelet rich fibrin (PRF)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Platelet rich fibrin is the secoond generation of platelet concentrates which is an autogenous biomaterial that is prepared from the patient's own blood</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Advanced platelet rich fibrin (A-PRF)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Advanced platelet rich fibrin is the last modification of PRF which is expected to contain a relatively greater number of white blood cellsand growth factors</description>
  </arm_group>
  <arm_group>
    <arm_group_label>blood clot</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>normal healing of the wound without adding any biomaterial</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Platelet rich fibrin (PRF)</intervention_name>
    <description>following atraumatic extraction of the tooth using periotomes , 10 ml of patient's blood will be drawn by vein puncture of the antecubital vein and prepared in a centrifuge at 3000 rpm for 10 minutes then criss horizontal mattress suture will be applied to close the extraction wound</description>
    <arm_group_label>Platelet rich fibrin (PRF)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Advanced platelet rich fibrin (A-PRF)</intervention_name>
    <description>following atraumatic extraction of the tooth using periotomes , 10 ml of patient's blood will be drawn by vein puncture of the antecubital vein and prepared in a centrifuge at 1300 rpm for 8 minutes then criss horizontal mattress suture will be applied to close the extraction wound</description>
    <arm_group_label>Advanced platelet rich fibrin (A-PRF)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>blood clot</intervention_name>
    <description>following atraumatic extraction of the tooth using periotomes, no bio-addative will be added and criss horizontal mattress suture will be applied to close the extraction wound</description>
    <arm_group_label>blood clot</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with at least one non restorable tooth in upper inter-bicuspid region.&#xD;
&#xD;
          -  Stable periodontal condition with no acute periapical infection.&#xD;
&#xD;
          -  Systematically healthy conditions.&#xD;
&#xD;
          -  Cooperative patients.&#xD;
&#xD;
          -  Intact buccal plate of bone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers.&#xD;
&#xD;
          -  Patients seeking immediate or early implants.&#xD;
&#xD;
          -  Pregnant females.&#xD;
&#xD;
          -  Bone diseases.&#xD;
&#xD;
          -  Drugs and diseases that may affect platelet count or function.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>School of dentistry , Cairo University</name>
      <address>
        <city>Cairo</city>
        <zip>11865</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>January 28, 2021</last_update_submitted>
  <last_update_submitted_qc>January 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Reem Mahmoud AbdAlhameed AbuBasha</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Resorption</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>it will include participant's contacts ( name, age , phone number , address ,medical and dental history , periodontal condition) ,periodontal chart and preoperative radiograph</ipd_description>
  </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/NCT04434703
org study id: 6-3-1
nct id: NCT04434703
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
the aim of this study is clinically and radiographically evaluate the use of advance platelet
      rich fibrin (A-PRF) versus platelet rich fibrin (PRF) in preservation of alveolar ridge
      following tooth extraction
systemically healthy patients who have at least one non-restorable tooth in the upper
      inter-bicuspid region and are not seeking immediate or early implant treatment will be
      allocated in this study after performing nonsurgical periodontal therapy and preoperative
      periapical therapy to evaluate and improve the condition of the periodontal tissues.

      Anesthesia will be given then flapless atraumatic extraction using periotomes followed by
      forceps after luxation. For all groups, the socket will be debrided using curette then

        -  group A, the socket will be filled with A.PRF

        -  group B the socket will be filled with PRF.

        -  group C no bio-additive will be added.

        -  Criss cross horizontal mattress suture will be applied to close the extraction wound.

      PRF and A-PRF preparation :

      10 ml of blood will be drawn from each patient by vein puncture of the antecubital vein.

        -  Plateletr ich fibrin (PRF) is 3000 rpm and 10 minutes without addition of anticoagulant

        -  Advanced platelet rich fibrin (A-PRF) is 1300 rpm and 8 minutes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in bucco-lingual dimensions
time frame: 6 months
description: clinical measurement using bone caliper in mm numerical
measure: change in alveolar bone height
time frame: 6 months
description: radiographic measurement using CBCT in mm numerical
measure: bone dentistry
time frame: 6 months
description: radiographic measurement using CBCT
measure: soft tissue healing
time frame: 6 months
description: clinical measurement using landr et al index (healing index) in numerical
measure: postoperative pain scores
time frame: 2 weeks
description: clinical measurement using VAS scale in numerical where No pain (0-4 mm) - mild pain (5-44 mm) -moderate pain (45-74 mm), and severe pain (75- 100 mm).
arm group label: Platelet rich fibrin (PRF)
arm group type: Active Comparator
description: Platelet rich fibrin is the secoond generation of platelet concentrates which is an autogenous biomaterial that is prepared from the patient's own blood
arm group label: Advanced platelet rich fibrin (A-PRF)
arm group type: Experimental
description: Advanced platelet rich fibrin is the last modification of PRF which is expected to contain a relatively greater number of white blood cellsand growth factors
arm group label: blood clot
arm group type: Placebo Comparator
description: normal healing of the wound without adding any biomaterial
intervention type: Procedure
intervention name: Platelet rich fibrin (PRF)
description: following atraumatic extraction of the tooth using periotomes , 10 ml of patient's blood will be drawn by vein puncture of the antecubital vein and prepared in a centrifuge at 3000 rpm for 10 minutes then criss horizontal mattress suture will be applied to close the extraction wound
arm group label: Platelet rich fibrin (PRF)
intervention type: Procedure
intervention name: Advanced platelet rich fibrin (A-PRF)
description: following atraumatic extraction of the tooth using periotomes , 10 ml of patient's blood will be drawn by vein puncture of the antecubital vein and prepared in a centrifuge at 1300 rpm for 8 minutes then criss horizontal mattress suture will be applied to close the extraction wound
arm group label: Advanced platelet rich fibrin (A-PRF)
intervention type: Procedure
intervention name: blood clot
description: following atraumatic extraction of the tooth using periotomes, no bio-addative will be added and criss horizontal mattress suture will be applied to close the extraction wound
arm group label: blood clot
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Reem Mahmoud AbdAlhameed AbuBasha
investigator title: principal investigator
mesh term: Bone Resorption
sharing ipd: Undecided
ipd description: it will include participant's contacts ( name, age , phone number , address ,medical and dental history , periodontal condition) ,periodontal chart and preoperative radiograph