xml: <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/NCT05962593</url>
    </required_header>
    <id_info>
      <org_study_id>H 22029533</org_study_id>
      <nct_id>NCT05962593</nct_id>
    </id_info>
    <brief_title>Different Inflammatory Biomarkers With Surgical Removal of Mandibular Third Molars</brief_title>
    <official_title>Surgical Removal of Mandibular Third Molars. Inflammation, Infection, Pain and Complications. Different Inflammatory Biomarkers With Surgical Removal of Mandibular Third Molars</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Copenhagen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Copenhagen</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Removal of mandibular third molars (M3s) is the most frequently performed surgical&#xD;
        intervention undertaken in dentistry. The indications and timing of surgical removal of M3s&#xD;
        has been a matter of international and national debate, and especially prophylactic removal&#xD;
        of M3s is controversial.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Removal of mandibular third molars (M3s) is the most frequently performed surgical&#xD;
        intervention undertaken in dentistry. The indications and timing of surgical removal of M3s&#xD;
        has been a matter of international and national debate, and especially prophylactic removal&#xD;
        of M3s is controversial.&#xD;
  &#xD;
        It is well documented that periodontally compromised patients are characterized by elevated&#xD;
        levels of systemic low-grade inflammation which can affect their general health and&#xD;
        contribute to development and aggravation of a number of chronic diseases including diabetes&#xD;
        mellitus and cardiovascular disorders. Inflammatory changes are frequent around erupted,&#xD;
        semi-erupted and retained M3s. However, only a few under-powered studies have addressed the&#xD;
        relationship between the presence of M3s and the level of systemic low-grade inflammation.&#xD;
  &#xD;
        Conservative guidelines recommend not to remove M3s until subjective and/or objective signs&#xD;
        of infection are observed. Overall, these guidelines result in a relatively equal&#xD;
        distribution of surgically removed M3s over the age span of a population. In contrast, more&#xD;
        proactive guidelines recommend removal of M3s that are not expected to erupt into functional&#xD;
        occlusion leading to frequent removal of M3s in the young population. Surgical removal of M3s&#xD;
        are associated with a varying degree of pain, facial swelling and the patients are on average&#xD;
        sick leave for 2-3 days. Furthermore, complications as nerve damage, infection, bleeding and&#xD;
        jaw fracture can occur. Therefore, unnecessary removal of M3s should be avoided. However, the&#xD;
        risk and severity of postoperative sequelae and complications is known to increase&#xD;
        significantly with age. Hence, the crucial point determining indications for surgical removal&#xD;
        of M3s is to balance the risk of developing local and systemic disease against the risk of&#xD;
        complications after surgical removal.&#xD;
  &#xD;
        The present project will investigate the systemic impact of retaining or removing M3s by&#xD;
        measuring low-grade systemic inflammation markers in blood and saliva. To further explore&#xD;
        measures to reduce postoperative complications, discomfort, and patient satisfaction, the&#xD;
        effect of prophylactic antibiotics, pre-emptive analgesics, and a postoperative follow-up&#xD;
        telephone call, will be investigated.&#xD;
  &#xD;
        The project consists of six prospective studies that will include more than 800 patients and&#xD;
        surgical removal of more than 1,000 mandibular third molars. It is expected that the project&#xD;
        will contribute with important information on the impact of mandibular third molars on&#xD;
        general health and prophylactic modalities that can influence postoperative sequelae and&#xD;
        complications following surgical removal of mandibular third molars.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</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>Diagnostic</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Inflammation</measure>
      <time_frame>3 months postoperative</time_frame>
      <description>High sensitive C-reactive protein</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain score</measure>
      <time_frame>1-7 days postoperative</time_frame>
      <description>NRS</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">124</enrollment>
    <condition>Wisdom Teeth</condition>
    <arm_group>
      <arm_group_label>Telephone call</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>A postoperative telephone call</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No telephone call</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No telephone call</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Telephone call</intervention_name>
      <description>The patients will be randomized for a postoperative telephone call</description>
      <arm_group_label>Telephone call</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Wisdom teeth&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  No wisdom teeth&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marie Kj Larsen, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Copenhagen</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marie Kjærgaard Larsen, PhD</last_name>
      <phone>+4520122781</phone>
      <email>marie.kjaergaard@sund.ku.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Simon St Jensen, Prof</last_name>
      <phone>+4535 33 30 52</phone>
      <email>simon.storgaard.jensen@sund.ku.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Rigshospitalet</name>
        <address>
          <city>Copenhagen</city>
          <zip>2100</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marie Kj Larsen, PhD</last_name>
        <phone>20122781</phone>
        <email>marie.kjaergaard@sund.ku.dk</email>
      </contact>
      <contact_backup>
        <last_name>Simon St Jensen, Prof</last_name>
        <phone>+4535 33 30 52</phone>
        <email>simon.storgaard.jensen@sund.ku.dk</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>wisdom teeth</keyword>
    <keyword>inflamation</keyword>
    <keyword>pain</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05962593
  org study id: H 22029533
  nct id: NCT05962593
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Removal of mandibular third molars (M3s) is the most frequently performed surgical
        intervention undertaken in dentistry. The indications and timing of surgical removal of M3s
        has been a matter of international and national debate, and especially prophylactic removal
        of M3s is controversial.
  Removal of mandibular third molars (M3s) is the most frequently performed surgical
        intervention undertaken in dentistry. The indications and timing of surgical removal of M3s
        has been a matter of international and national debate, and especially prophylactic removal
        of M3s is controversial.
  
        It is well documented that periodontally compromised patients are characterized by elevated
        levels of systemic low-grade inflammation which can affect their general health and
        contribute to development and aggravation of a number of chronic diseases including diabetes
        mellitus and cardiovascular disorders. Inflammatory changes are frequent around erupted,
        semi-erupted and retained M3s. However, only a few under-powered studies have addressed the
        relationship between the presence of M3s and the level of systemic low-grade inflammation.
  
        Conservative guidelines recommend not to remove M3s until subjective and/or objective signs
        of infection are observed. Overall, these guidelines result in a relatively equal
        distribution of surgically removed M3s over the age span of a population. In contrast, more
        proactive guidelines recommend removal of M3s that are not expected to erupt into functional
        occlusion leading to frequent removal of M3s in the young population. Surgical removal of M3s
        are associated with a varying degree of pain, facial swelling and the patients are on average
        sick leave for 2-3 days. Furthermore, complications as nerve damage, infection, bleeding and
        jaw fracture can occur. Therefore, unnecessary removal of M3s should be avoided. However, the
        risk and severity of postoperative sequelae and complications is known to increase
        significantly with age. Hence, the crucial point determining indications for surgical removal
        of M3s is to balance the risk of developing local and systemic disease against the risk of
        complications after surgical removal.
  
        The present project will investigate the systemic impact of retaining or removing M3s by
        measuring low-grade systemic inflammation markers in blood and saliva. To further explore
        measures to reduce postoperative complications, discomfort, and patient satisfaction, the
        effect of prophylactic antibiotics, pre-emptive analgesics, and a postoperative follow-up
        telephone call, will be investigated.
  
        The project consists of six prospective studies that will include more than 800 patients and
        surgical removal of more than 1,000 mandibular third molars. It is expected that the project
        will contribute with important information on the impact of mandibular third molars on
        general health and prophylactic modalities that can influence postoperative sequelae and
        complications following surgical removal of mandibular third molars.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: Single (Participant)
  measure: Inflammation
  time frame: 3 months postoperative
  description: High sensitive C-reactive protein
  measure: Pain score
  time frame: 1-7 days postoperative
  description: NRS
  arm group label: Telephone call
  arm group type: Placebo Comparator
  description: A postoperative telephone call
  arm group label: No telephone call
  arm group type: No Intervention
  description: No telephone call
  intervention type: Other
  intervention name: Telephone call
  description: The patients will be randomized for a postoperative telephone call
  arm group label: Telephone call
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Marie Kj Larsen, PhD
  role: Principal Investigator
  affiliation: University of Copenhagen
  last name: Marie Kjærgaard Larsen, PhD
  phone: +4520122781
  email: marie.kjaergaard@sund.ku.dk
  last name: Simon St Jensen, Prof
  phone: +4535 33 30 52
  email: simon.storgaard.jensen@sund.ku.dk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Denmark
  responsible party type: Sponsor