<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/NCT04429373</url>
  </required_header>
  <id_info>
    <org_study_id>ORF42004</org_study_id>
    <nct_id>NCT04429373</nct_id>
  </id_info>
  <brief_title>Effect of Platelet-rich Plasm (PRF) on Two-implant Mandibular Overdenture: a Split Mouth</brief_title>
  <acronym>PRF</acronym>
  <official_title>Effect of Platelet-rich Plasm (PRF) on Two-implant Mandibular Overdenture: a Split Mouth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chile</source>
  <oversight_info>
    <has_dmc>No</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>
      Implant retained overdentures are a cost-effective treatment for elderly patients suffering&#xD;
      from complete tooth loss. Despite the high success rate of implants in the general&#xD;
      population, older adults lacking all teeth are a challenging population for implant therapy,&#xD;
      often presenting limited bone disponibility, narrow alveolar ridges, diminished bone density,&#xD;
      scarce inserted gingiva and several co-morbidities.Thus, improving their possibility of&#xD;
      success in implant therapy avoiding further surgical interventions is key.&#xD;
&#xD;
      Platelet-rich fibrin (PRF) is a blood derivate that can be easily and economically obtained&#xD;
      from patients and that has shown promise of reducing the complications and improving the&#xD;
      success of implant therapy, nevertheless its benefits in patients receiving implant retained&#xD;
      overdentures has not been stablished. It is possible that PRF can improve the results and&#xD;
      diminish the complications of implant therapy in older adults.&#xD;
&#xD;
      The investigation aims to demonstrate that the use of platelet-rich fibirn (PRF) is safe and&#xD;
      beneficial for implant treatment in older adults suffering from complete tooth loss.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will conduct a split-mouth design randomized clinical trial assessing the&#xD;
      effect of PRF in primary stability and bone/soft tissue healing around mandibular implants in&#xD;
      edentulous elderly adults.&#xD;
&#xD;
      Aim and purpose&#xD;
&#xD;
        1. To assess the effect of PRF on primary implant stability of mandibular implants in&#xD;
           edentulous patients using resonance frequency analysis (RFA).&#xD;
&#xD;
        2. To evaluate the effect of PRF on clinical parameters related to soft tissue healing,&#xD;
           post-surgical pain/inflammation and early complications of mandibular implants in&#xD;
           edentulous patients.&#xD;
&#xD;
        3. To examine soft tissues volumetric changes pre and post- surgery using intraoral scans&#xD;
           and bone changes using cone-beam computed tomography (CBCT) around mandibular implants&#xD;
           in edentulous patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 30, 2020</start_date>
  <completion_date type="Anticipated">December 20, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2022</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>We will conduct a split-mouth design randomized clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Allocation sequence will be masked from participant, outcome assessor and statistician</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Implant stability</measure>
    <time_frame>6 months</time_frame>
    <description>primary implant stability of mandibular implants in edentulous patients using resonance frequency analysis (RFA).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Keratinized tissue thickness around implant neck</measure>
    <time_frame>6 months</time_frame>
    <description>Distance in mm from the surface of keratinized gingiva 1 mm apical to implant neck to bone contact</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Keratinized tissue width around implant neck</measure>
    <time_frame>6 months</time_frame>
    <description>Distance in mm of keratinized tissue from implant neck to mucogingival junction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Edentulous Jaw</condition>
  <condition>Dental Implant Failed</condition>
  <arm_group>
    <arm_group_label>Implant installation with PRF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PRF membrane over the buccal aspect of implant site</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Implant installation without PRF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Implant installation contralateral to the the experimental implant, without PRF membrane</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Implant installation with PRF membrane</intervention_name>
    <description>Platelet-rich fibrin membrane over the buccal aspect of implant site after dental implant installation</description>
    <arm_group_label>Implant installation with PRF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Implant installation without PRF membrane</intervention_name>
    <description>Implant installation contralateral to the experimental side without PRF membrane</description>
    <arm_group_label>Implant installation without PRF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  mandibular edentulous&#xD;
&#xD;
          -  &gt; 60 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  physical or psychological impediment for dental surgery&#xD;
&#xD;
          -  dental extraction &lt; 6 months in the mandible&#xD;
&#xD;
          -  anticoagulant treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Franco Cavalla, DDS PhD</last_name>
    <phone>+56932035746</phone>
    <email>icavalla@odontologia.uchile.cl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Patricio Neira, DDS</last_name>
    <phone>+56995193394</phone>
    <email>pneira@odontologia.uchile.cl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>San Camilo Hospital</name>
      <address>
        <city>San Felipe</city>
        <state>Aconcagua</state>
        <zip>969696</zip>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patricio Neira, DDS</last_name>
      <phone>(34) 249 3200</phone>
      <email>patricioneiraguerra@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Marcelo Tejedor, DDS</last_name>
      <phone>(34) 249 3200</phone>
      <email>marcelo.tejedor@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>April 20, 2021</last_update_submitted>
  <last_update_submitted_qc>April 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Chile</investigator_affiliation>
    <investigator_full_name>Franco Cavalla</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>dental implants</keyword>
  <keyword>platelet-rich plasm</keyword>
  <keyword>edentulous jaw</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Jaw, Edentulous</mesh_term>
    <mesh_term>Mouth, Edentulous</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/NCT04429373
org study id: ORF42004
nct id: NCT04429373
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Implant retained overdentures are a cost-effective treatment for elderly patients suffering
      from complete tooth loss. Despite the high success rate of implants in the general
      population, older adults lacking all teeth are a challenging population for implant therapy,
      often presenting limited bone disponibility, narrow alveolar ridges, diminished bone density,
      scarce inserted gingiva and several co-morbidities.Thus, improving their possibility of
      success in implant therapy avoiding further surgical interventions is key.

      Platelet-rich fibrin (PRF) is a blood derivate that can be easily and economically obtained
      from patients and that has shown promise of reducing the complications and improving the
      success of implant therapy, nevertheless its benefits in patients receiving implant retained
      overdentures has not been stablished. It is possible that PRF can improve the results and
      diminish the complications of implant therapy in older adults.

      The investigation aims to demonstrate that the use of platelet-rich fibirn (PRF) is safe and
      beneficial for implant treatment in older adults suffering from complete tooth loss.
The investigators will conduct a split-mouth design randomized clinical trial assessing the
      effect of PRF in primary stability and bone/soft tissue healing around mandibular implants in
      edentulous elderly adults.

      Aim and purpose

        1. To assess the effect of PRF on primary implant stability of mandibular implants in
           edentulous patients using resonance frequency analysis (RFA).

        2. To evaluate the effect of PRF on clinical parameters related to soft tissue healing,
           post-surgical pain/inflammation and early complications of mandibular implants in
           edentulous patients.

        3. To examine soft tissues volumetric changes pre and post- surgery using intraoral scans
           and bone changes using cone-beam computed tomography (CBCT) around mandibular implants
           in edentulous patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: We will conduct a split-mouth design randomized clinical trial
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Allocation sequence will be masked from participant, outcome assessor and statistician
measure: Implant stability
time frame: 6 months
description: primary implant stability of mandibular implants in edentulous patients using resonance frequency analysis (RFA).
measure: Keratinized tissue thickness around implant neck
time frame: 6 months
description: Distance in mm from the surface of keratinized gingiva 1 mm apical to implant neck to bone contact
measure: Keratinized tissue width around implant neck
time frame: 6 months
description: Distance in mm of keratinized tissue from implant neck to mucogingival junction
arm group label: Implant installation with PRF
arm group type: Experimental
description: PRF membrane over the buccal aspect of implant site
arm group label: Implant installation without PRF
arm group type: Active Comparator
description: Implant installation contralateral to the the experimental implant, without PRF membrane
intervention type: Procedure
intervention name: Implant installation with PRF membrane
description: Platelet-rich fibrin membrane over the buccal aspect of implant site after dental implant installation
arm group label: Implant installation with PRF
intervention type: Procedure
intervention name: Implant installation without PRF membrane
description: Implant installation contralateral to the experimental side without PRF membrane
arm group label: Implant installation without PRF
criteria: 
gender: All
minimum age: 60 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Franco Cavalla, DDS PhD
phone: +56932035746
email: icavalla@odontologia.uchile.cl
last name: Patricio Neira, DDS
phone: +56995193394
email: pneira@odontologia.uchile.cl
facility: 
status: Recruiting
contact: 
contact backup: 
country: Chile
responsible party type: Principal Investigator
investigator affiliation: University of Chile
investigator full name: Franco Cavalla
investigator title: Assistant Professor
mesh term: Jaw, Edentulous
mesh term: Mouth, Edentulous
sharing ipd: No