<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/NCT04476121</url>
  </required_header>
  <id_info>
    <org_study_id>0002</org_study_id>
    <nct_id>NCT04476121</nct_id>
  </id_info>
  <brief_title>Use of PRF in Treatment of Dry Socket.</brief_title>
  <official_title>Evaluation of Platelet Rich Fibrin Use in the Treatment of Dry Socket.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Lodz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Lodz</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>
      The aim of the study is to evaluate the influence of PRF application in case of alveolar&#xD;
      osteitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective was to compare the effects of using two different methods in the treatment&#xD;
      of dry socket (alveolar osteitis), which is a postoperative complication of dental&#xD;
      extraction. The first was Nipas, applied, if dry socket was diagnosed following a tooth&#xD;
      extraction. In case of subsequent extraction of homonymous tooth and reoccurrence of dry&#xD;
      socket, patients were treated with application of PRF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">July 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>
    <intervention_model_description>The first medicine was applied, if dry socket was diagnosed following a tooth extraction. In case of subsequent extraction of homonymous tooth in the same patient and reoccurrence of dry socket, patients were treated with PRF application.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intensity of pain vs. PRF and Nipas application</measure>
    <time_frame>24 hours</time_frame>
    <description>In order to evaluate the relationship between intensity of pain after application of PRF and Nipas, Numeric Rating Scale pain scale is used. NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible.&#xD;
The higher score means worse outcome in case of present study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Influence of treatment on bacteria levels in wounds</measure>
    <time_frame>24 hours</time_frame>
    <description>The second part of the study was dedicated to analyzing the number of bacteria in tooth extraction wounds.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Alveolar Osteitis</condition>
  <arm_group>
    <arm_group_label>PRF application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with alveolar osteitis in which PRF application was performed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aspirin application</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with alveolar osteitis in which Nipas was used.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PRF application</intervention_name>
    <description>PRF application into post-operative wound.</description>
    <arm_group_label>PRF application</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nipas application</intervention_name>
    <description>Nipas application into post-operative wound.</description>
    <arm_group_label>Aspirin application</arm_group_label>
    <other_name>Aspirin paste</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  no known medical history of abnormal platelet counts,&#xD;
&#xD;
          -  patients with symmetric teeth qualified for extraction,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients treated previously for existing dry socket,&#xD;
&#xD;
          -  patients allergic to acetylsalicylic acid ,&#xD;
&#xD;
          -  systemic diseases,&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  lactation,&#xD;
&#xD;
          -  drugs known to affect the number or function of platelets,&#xD;
&#xD;
          -  abnormal platelet counts,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna Janas-Naze, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Lodz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Oral Surgery</name>
      <address>
        <city>Lodz</city>
        <zip>92-213</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>April 23, 2021</last_update_submitted>
  <last_update_submitted_qc>April 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dry socket</keyword>
  <keyword>PRF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteitis</mesh_term>
    <mesh_term>Dry Socket</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</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/NCT04476121
org study id: 0002
nct id: NCT04476121
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to evaluate the influence of PRF application in case of alveolar
      osteitis.
The main objective was to compare the effects of using two different methods in the treatment
      of dry socket (alveolar osteitis), which is a postoperative complication of dental
      extraction. The first was Nipas, applied, if dry socket was diagnosed following a tooth
      extraction. In case of subsequent extraction of homonymous tooth and reoccurrence of dry
      socket, patients were treated with application of PRF.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The first medicine was applied, if dry socket was diagnosed following a tooth extraction. In case of subsequent extraction of homonymous tooth in the same patient and reoccurrence of dry socket, patients were treated with PRF application.
primary purpose: Treatment
masking: None (Open Label)
measure: Intensity of pain vs. PRF and Nipas application
time frame: 24 hours
description: In order to evaluate the relationship between intensity of pain after application of PRF and Nipas, Numeric Rating Scale pain scale is used. NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible.
The higher score means worse outcome in case of present study.
measure: Influence of treatment on bacteria levels in wounds
time frame: 24 hours
description: The second part of the study was dedicated to analyzing the number of bacteria in tooth extraction wounds.
arm group label: PRF application
arm group type: Experimental
description: Patients with alveolar osteitis in which PRF application was performed.
arm group label: Aspirin application
arm group type: Active Comparator
description: Patients with alveolar osteitis in which Nipas was used.
intervention type: Procedure
intervention name: PRF application
description: PRF application into post-operative wound.
arm group label: PRF application
intervention type: Drug
intervention name: Nipas application
description: Nipas application into post-operative wound.
arm group label: Aspirin application
other name: Aspirin paste
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anna Janas-Naze, Prof.
role: Principal Investigator
affiliation: Medical University of Lodz
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Osteitis
mesh term: Dry Socket
mesh term: Aspirin