<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/NCT04437316</url>
  </required_header>
  <id_info>
    <org_study_id>2019-00949</org_study_id>
    <nct_id>NCT04437316</nct_id>
  </id_info>
  <brief_title>Effect of Low Level Laser Therapy After Wisdom Tooth Removal</brief_title>
  <official_title>Effect of Low Level Laser Therapy After Wisdom Tooth Removal on Swelling, Pain and Mouth Opening in a Randomized, Double-blind Split-mouth Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</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 is to test the effect of low level laser therapy on the relief of symptoms after&#xD;
      wisdom tooth removal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each Patient will get all four wisdom teeth removed, left and right side separately. After&#xD;
      the operation, low level laser therapy is applied intra- and extraorally. Two different&#xD;
      lasers are used, one for each side. The two lasers look identical. Only one of the lasers has&#xD;
      therapeutic light, the other one shows just non-therapeutic red light. The effect of the low&#xD;
      level laser is measured by several parameters and they are compared with the other side.&#xD;
      These parameters are pain, swelling and mouth opening. The selection of the lasers to the&#xD;
      sides is double-blind and randomized.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 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>split-mouth design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>double-blind, randomized study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Pain</measure>
    <time_frame>3 days after wisdom tooth removal</time_frame>
    <description>Measurement of Pain with a visual analogue scale (VAS) 0-10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative Pain</measure>
    <time_frame>7 days after wisdom tooth removal</time_frame>
    <description>Measurement of Pain with a visual analogue scale (VAS) 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Swelling</measure>
    <time_frame>3 and 7 days after wisdom tooth removal</time_frame>
    <description>Measurement of swelling with an extraoral scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Mouth opening</measure>
    <time_frame>3 and 7 days after wisdom tooth removal</time_frame>
    <description>Measurement of mouth opening</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Tooth, Impacted</condition>
  <condition>Wound Heal</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Low Level Laser</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>therapeutic laser</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Low Level Laser</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>non-therapeutic laser</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Use of Low level Laser after wisdom tooth removal</intervention_name>
    <description>Directly after the wisdom teeth removal of the right/left side, one of the low level laser (therapeutic and non-therapeutic (Placebo)) is used.</description>
    <arm_group_label>Low Level Laser</arm_group_label>
    <arm_group_label>Placebo Low Level Laser</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication for prophylactical wisdom tooth removal&#xD;
&#xD;
          -  4 wisdom teeth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  taking blood thinners&#xD;
&#xD;
          -  known infectious diseases&#xD;
&#xD;
          -  untreated diabetes mellitus&#xD;
&#xD;
          -  taking immunosuppressants&#xD;
&#xD;
          -  Previous infections in the area of the wisdom teeth&#xD;
&#xD;
          -  smoking&#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>Martin Ruecker, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Clinic for maxillofacial and oral surgery</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mona Schiefersteiner, Dr.</last_name>
    <phone>0041 44 634 32 90</phone>
    <email>mona.schiefersteiner@zzm.uzh.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Center of dental medicine</name>
      <address>
        <city>Zürich</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mona Schiefersteiner, Dr.</last_name>
      <phone>0041 44 634 32 90</phone>
      <email>mona.schiefersteiner@zzm.uzh.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>November 17, 2020</last_update_submitted>
  <last_update_submitted_qc>November 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Wisdom tooth</keyword>
  <keyword>Low Level Laser</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth, Impacted</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/NCT04437316
org study id: 2019-00949
nct id: NCT04437316
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim is to test the effect of low level laser therapy on the relief of symptoms after
      wisdom tooth removal.
Each Patient will get all four wisdom teeth removed, left and right side separately. After
      the operation, low level laser therapy is applied intra- and extraorally. Two different
      lasers are used, one for each side. The two lasers look identical. Only one of the lasers has
      therapeutic light, the other one shows just non-therapeutic red light. The effect of the low
      level laser is measured by several parameters and they are compared with the other side.
      These parameters are pain, swelling and mouth opening. The selection of the lasers to the
      sides is double-blind and randomized.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: split-mouth design
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: double-blind, randomized study
measure: Postoperative Pain
time frame: 3 days after wisdom tooth removal
description: Measurement of Pain with a visual analogue scale (VAS) 0-10
measure: Postoperative Pain
time frame: 7 days after wisdom tooth removal
description: Measurement of Pain with a visual analogue scale (VAS) 0-10
measure: Postoperative Swelling
time frame: 3 and 7 days after wisdom tooth removal
description: Measurement of swelling with an extraoral scan
measure: Postoperative Mouth opening
time frame: 3 and 7 days after wisdom tooth removal
description: Measurement of mouth opening
arm group label: Low Level Laser
arm group type: Active Comparator
description: therapeutic laser
arm group label: Placebo Low Level Laser
arm group type: Placebo Comparator
description: non-therapeutic laser
intervention type: Device
intervention name: Use of Low level Laser after wisdom tooth removal
description: Directly after the wisdom teeth removal of the right/left side, one of the low level laser (therapeutic and non-therapeutic (Placebo)) is used.
arm group label: Low Level Laser
arm group label: Placebo Low Level Laser
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Martin Ruecker, Prof.
role: Study Director
affiliation: Clinic for maxillofacial and oral surgery
last name: Mona Schiefersteiner, Dr.
phone: 0041 44 634 32 90
email: mona.schiefersteiner@zzm.uzh.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Sponsor
mesh term: Tooth, Impacted
sharing ipd: No