<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/NCT03261869</url>
  </required_header>
  <id_info>
    <org_study_id>D-KA 15/07</org_study_id>
    <nct_id>NCT03261869</nct_id>
  </id_info>
  <brief_title>EFFICACY OF ICE PACK THERAPY AFTER IMPACTED THIRD MOLAR SURGERY</brief_title>
  <official_title>EFFICACY OF ICE PACK THERAPY AFTER IMPACTED THIRD MOLAR SURGERY: A RANDOMIZED CONTROLLED CLINICAL TRIAL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baskent University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baskent University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      this study evaluates the effect of cold application after impacted third molar extractions.&#xD;
      Patients have bilateral impacted third molar tooth included in this study. Patients do not&#xD;
      applied cold after extraction of third molar on one side and applied cold cold after&#xD;
      extraction of third molar on the other side.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Extraction of impacted teeth causes a trauma which results in an inflammatory response. Some&#xD;
      postoperative symptoms may occur such as edema, pain, limitations in mouth opening and&#xD;
      dysfunction as a consequence of the wisdom tooth extraction surgery.&#xD;
&#xD;
      Local cold application reduces the magnitude of postoperative symptoms. The physiological&#xD;
      effects of cold application are as follows: vasoconstriction of blood vessels, blood flow to&#xD;
      the region decreases, edema and inflammation decreases, slowdown in cell metabolism and a&#xD;
      decrease in local oxygen demand due to the vasoconstriction effect of the cold. Cold therapy&#xD;
      also induces muscle constriction which reduces muscle stress, pain and inflammation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">March 1, 2017</completion_date>
  <primary_completion_date type="Actual">March 1, 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post operative Visual Analogue Scale Scores</measure>
    <time_frame>pre-operative-postoperative 7th day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Post operative facial swelling</measure>
    <time_frame>pre-operative-postoperative 7th day</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative mouth opening</measure>
    <time_frame>pre-operative-postoperative 7th day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications after impacted third molar removal</measure>
    <time_frame>pre-operative-postoperative 7th day</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Impacted Third Molar Tooth</condition>
  <arm_group>
    <arm_group_label>Cold application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cold applied after extraction of third molar tooth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Cold application</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Cold application is not advised after extraction of third molar tooth</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cold application</intervention_name>
    <arm_group_label>Cold application</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bilateral bony mandibular third molar impactions&#xD;
&#xD;
          -  Has no systemic disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Different Pell-Gregory classification of impacted teeth&#xD;
&#xD;
          -  Previous or current gastric ulcer&#xD;
&#xD;
          -  Allergies or hypersensitivities to any common medications&#xD;
&#xD;
          -  pregnant or breastfeeding patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baskent University</investigator_affiliation>
    <investigator_full_name>Nurettin Diker</investigator_full_name>
    <investigator_title>Research Assistant at deparment of oral and maxillofacial surgery</investigator_title>
  </responsible_party>
  <keyword>Ice pack therapy, third molar surgery, swelling, pain, trismus</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/NCT03261869
org study id: D-KA 15/07
nct id: NCT03261869
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
this study evaluates the effect of cold application after impacted third molar extractions.
      Patients have bilateral impacted third molar tooth included in this study. Patients do not
      applied cold after extraction of third molar on one side and applied cold cold after
      extraction of third molar on the other side.
Extraction of impacted teeth causes a trauma which results in an inflammatory response. Some
      postoperative symptoms may occur such as edema, pain, limitations in mouth opening and
      dysfunction as a consequence of the wisdom tooth extraction surgery.

      Local cold application reduces the magnitude of postoperative symptoms. The physiological
      effects of cold application are as follows: vasoconstriction of blood vessels, blood flow to
      the region decreases, edema and inflammation decreases, slowdown in cell metabolism and a
      decrease in local oxygen demand due to the vasoconstriction effect of the cold. Cold therapy
      also induces muscle constriction which reduces muscle stress, pain and inflammation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Post operative Visual Analogue Scale Scores
time frame: pre-operative-postoperative 7th day
measure: Post operative facial swelling
time frame: pre-operative-postoperative 7th day
measure: Post-operative mouth opening
time frame: pre-operative-postoperative 7th day
measure: Complications after impacted third molar removal
time frame: pre-operative-postoperative 7th day
arm group label: Cold application
arm group type: Experimental
description: Cold applied after extraction of third molar tooth.
arm group label: No Cold application
arm group type: No Intervention
description: Cold application is not advised after extraction of third molar tooth
intervention type: Other
intervention name: Cold application
arm group label: Cold application
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Baskent University
investigator full name: Nurettin Diker
investigator title: Research Assistant at deparment of oral and maxillofacial surgery
mesh term: Tooth, Impacted
sharing ipd: No