<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/NCT02198001</url>
  </required_header>
  <id_info>
    <org_study_id>B403201318408</org_study_id>
    <nct_id>NCT02198001</nct_id>
  </id_info>
  <brief_title>Prospective Randomized Study: Assessment of PRF Efficacy in Prevention of Jaw Osteonecrosis After Tooth Extraction</brief_title>
  <acronym>PRF</acronym>
  <official_title>Prospective Randomized Clinical Study: Role of Platelet Rich Fibrin (PRF) in the Tooth Extraction Site in the Prevention of Jaw Osteonecrosis on Patients Under Bisphosphonates Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective study will include patients taking or having taken bisphosphonates and&#xD;
      needing dental extractions.&#xD;
&#xD;
      The aim of this study is to validate the contribution of PRF (Platelet Rich Fibrin) in tooth&#xD;
      extraction sites.&#xD;
&#xD;
      In the test group (PRF) and in the control group (no PRF), we use the same atraumatic&#xD;
      extraction protocol associated with the same antibiotic procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dental extractions are the main cause of jaw osteonecrosis in patients taking oral or iv&#xD;
      bisphosphonates.&#xD;
&#xD;
      This prospective randomized study will include a cohort of 100 patients treated with&#xD;
      bisphosphonates (for benign or malignant conditions) and requiring dental extractions&#xD;
      (non-retainable teeth for infectious, traumatic or parodontal reasons). 50 patients will&#xD;
      benefit of PRF placement in the tooth extraction site (group 1) while 50 patients do not&#xD;
      (group 2).&#xD;
&#xD;
      The rest of the procedure will be the same in the 2 arms. In the literature, studies suggest&#xD;
      a benefit from a long term antibiotherapy before and after tooth extraction. Extraction&#xD;
      procedure should be the least traumatic as possible.&#xD;
&#xD;
      The main objective of our study is to assess, after tooth extraction, the contribution of PRF&#xD;
      in the prevention of jaw osteonecrosis induced by bisphosphonates.&#xD;
&#xD;
      A follow-up period of one year after extraction is indicated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">January 2017</completion_date>
  <primary_completion_date type="Anticipated">January 2016</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of jaw osteonecrosis after tooth extraction</measure>
    <time_frame>1year</time_frame>
    <description>7 symptoms &gt; 6 weeks for the diagnosis of osteonecrosis:&#xD;
bone exposure&#xD;
bone spicule&#xD;
mucosal inflammation&#xD;
pain&#xD;
paresthésias&#xD;
suppuration&#xD;
jaw fracture&#xD;
number of jaw osteonecrosis after tooth extraction in the oral bisphosphonates group in comparison with the IV bisphosphonates group</description>
  </primary_outcome>
  <other_outcome>
    <measure>Contribution of comorbidities factors in the appearance of osteonecrosis</measure>
    <time_frame>1 year</time_frame>
    <description>comorbidities:&#xD;
diabetes,&#xD;
immunosuppression (corticoids, chemotherapy, immunosuppressive treatment)&#xD;
tobacco</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of days in tooth-extraction healing in the two groups</measure>
    <time_frame>2 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Bisphosphonate-Associated Osteonecrosis of the Jaw</condition>
  <arm_group>
    <arm_group_label>tooth extraction and insertion of PRF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Experimental: Atraumatic tooth extraction with antibiotics( amoxicillin clavulanate combination) .Insertion of PRF membrane in tooth-extraction site.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No PRF</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Atraumatic extraction with antibiotic without PRF insertion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine)</intervention_name>
    <description>BPs per os&lt; 3ans: amoxicillin- clavulanate J-1 à J+10&#xD;
BPs IV ou per os&gt; 3ans ou per os + comordibities (diabetes, immunosuppression, tobacco):&#xD;
amoxicillin- clavulanate J-3 à J+10&#xD;
In case of allergy:&#xD;
BPs per os: clindamycine J-1 à J+10&#xD;
BPs IV ou per os&gt; 3ans ou per os + comordibities (diabetes, immunosuppression, tobacco):&#xD;
clindamycine J-3 à J+10</description>
    <arm_group_label>No PRF</arm_group_label>
    <arm_group_label>tooth extraction and insertion of PRF</arm_group_label>
    <other_name>antibiotherapy before and after extraction</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>atraumatic extraction</intervention_name>
    <description>Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure</description>
    <arm_group_label>No PRF</arm_group_label>
    <arm_group_label>tooth extraction and insertion of PRF</arm_group_label>
    <other_name>- atraumatic tooth extraction</other_name>
    <other_name>- hermetic mucosal closure</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients taking bisphosphonates whatever the indication, the type, the administration&#xD;
             and the duration of treatment (we include patients taking or having taken&#xD;
             bisphosphonates, even several years ago)&#xD;
&#xD;
          -  And who need tooth extraction (not recoverable in conservative dentistry and&#xD;
             symptomatic tooth: dental and periodontal infections, symptomatic traumatic tooth&#xD;
             fracture).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  younger than 50 years old&#xD;
&#xD;
          -  jaw's radiotherapy&#xD;
&#xD;
          -  history of jaw osteonecrosis&#xD;
&#xD;
          -  jaw metastasis from an other cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hervé P Reychler, MD, DMD</last_name>
    <role>Study Chair</role>
    <affiliation>Cliniques universitaires Saint-Luc</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dorothée L Deneubourg, MD, DDS</last_name>
    <phone>003227645702</phone>
    <phone_ext>003227645774</phone_ext>
    <email>dorothee.deneubourg@uclouvain.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michèle Magremanne, MD, DDS</last_name>
    <phone>003227645711</phone>
    <email>michele.magremanne@uclouvain.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint Luc</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michele Magremanne, MD, DDS</last_name>
      <phone>003227645711</phone>
      <email>michele.magremanne@uclouvain.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitaliser Ambroise Paré</name>
      <address>
        <city>Mons</city>
        <zip>7000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine Vervaet, MD DDS</last_name>
      <phone>003265414190</phone>
      <email>catherine.vervaet@hap.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinique et maternité Sainte Elisabeth</name>
      <address>
        <city>Namur</city>
        <zip>5000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrice Lejuste, MD, DDS</last_name>
      <phone>003281720631</phone>
      <email>patrice.lejuste@cmsenamur.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>July 22, 2014</last_update_submitted>
  <last_update_submitted_qc>July 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Platelets</keyword>
  <keyword>fibrin</keyword>
  <keyword>growth factors</keyword>
  <keyword>bisphosphonates</keyword>
  <keyword>tooth extraction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteonecrosis</mesh_term>
    <mesh_term>Bisphosphonate-Associated Osteonecrosis of the Jaw</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Clavulanic Acid</mesh_term>
    <mesh_term>Clavulanic Acids</mesh_term>
    <mesh_term>Amoxicillin-Potassium Clavulanate Combination</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02198001
org study id: B403201318408
nct id: NCT02198001
lead sponsor: 
has dmc: Yes
This prospective study will include patients taking or having taken bisphosphonates and
      needing dental extractions.

      The aim of this study is to validate the contribution of PRF (Platelet Rich Fibrin) in tooth
      extraction sites.

      In the test group (PRF) and in the control group (no PRF), we use the same atraumatic
      extraction protocol associated with the same antibiotic procedure.
Dental extractions are the main cause of jaw osteonecrosis in patients taking oral or iv
      bisphosphonates.

      This prospective randomized study will include a cohort of 100 patients treated with
      bisphosphonates (for benign or malignant conditions) and requiring dental extractions
      (non-retainable teeth for infectious, traumatic or parodontal reasons). 50 patients will
      benefit of PRF placement in the tooth extraction site (group 1) while 50 patients do not
      (group 2).

      The rest of the procedure will be the same in the 2 arms. In the literature, studies suggest
      a benefit from a long term antibiotherapy before and after tooth extraction. Extraction
      procedure should be the least traumatic as possible.

      The main objective of our study is to assess, after tooth extraction, the contribution of PRF
      in the prevention of jaw osteonecrosis induced by bisphosphonates.

      A follow-up period of one year after extraction is indicated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Number of jaw osteonecrosis after tooth extraction
time frame: 1year
description: 7 symptoms > 6 weeks for the diagnosis of osteonecrosis:
bone exposure
bone spicule
mucosal inflammation
pain
paresthésias
suppuration
jaw fracture
number of jaw osteonecrosis after tooth extraction in the oral bisphosphonates group in comparison with the IV bisphosphonates group
measure: Contribution of comorbidities factors in the appearance of osteonecrosis
time frame: 1 year
description: comorbidities:
diabetes,
immunosuppression (corticoids, chemotherapy, immunosuppressive treatment)
tobacco
measure: Number of days in tooth-extraction healing in the two groups
time frame: 2 months
arm group label: tooth extraction and insertion of PRF
arm group type: Active Comparator
description: Experimental: Atraumatic tooth extraction with antibiotics( amoxicillin clavulanate combination) .Insertion of PRF membrane in tooth-extraction site.
arm group label: No PRF
arm group type: Placebo Comparator
description: Atraumatic extraction with antibiotic without PRF insertion
intervention type: Drug
intervention name: tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine)
description: BPs per os< 3ans: amoxicillin- clavulanate J-1 à J+10
BPs IV ou per os> 3ans ou per os + comordibities (diabetes, immunosuppression, tobacco):
amoxicillin- clavulanate J-3 à J+10
In case of allergy:
BPs per os: clindamycine J-1 à J+10
BPs IV ou per os> 3ans ou per os + comordibities (diabetes, immunosuppression, tobacco):
clindamycine J-3 à J+10
arm group label: No PRF
arm group label: tooth extraction and insertion of PRF
other name: antibiotherapy before and after extraction
intervention type: Procedure
intervention name: atraumatic extraction
description: Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure
arm group label: No PRF
arm group label: tooth extraction and insertion of PRF
other name: - atraumatic tooth extraction
other name: - hermetic mucosal closure
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Hervé P Reychler, MD, DMD
role: Study Chair
affiliation: Cliniques universitaires Saint-Luc
last name: Dorothée L Deneubourg, MD, DDS
phone: 003227645702
phone ext: 003227645774
email: dorothee.deneubourg@uclouvain.be
last name: Michèle Magremanne, MD, DDS
phone: 003227645711
email: michele.magremanne@uclouvain.be
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Sponsor
mesh term: Osteonecrosis
mesh term: Bisphosphonate-Associated Osteonecrosis of the Jaw
mesh term: Anti-Bacterial Agents
mesh term: Amoxicillin
mesh term: Clavulanic Acid
mesh term: Clavulanic Acids
mesh term: Amoxicillin-Potassium Clavulanate Combination