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/NCT06020053</url>
    </required_header>
    <id_info>
      <org_study_id>FiratUniversitydentistry</org_study_id>
      <nct_id>NCT06020053</nct_id>
    </id_info>
    <brief_title>Effect of Using Irrigations at Different Temperatures on Postoperative Period During the Extraction of Impacted Mandibular Molars</brief_title>
    <official_title>Effect of Using Irrigations at Different Temperatures on Postoperative Period During the Extraction of Impacted Mandibular Molars</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Firat University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Firat University</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>
        An Evaluation of the Effect of Using Irrigations at Different Temperatures on Pain, Edema,&#xD;
        and Trismus During the Extraction of Bilateral Impacted Mandibular Third Molars: A Randomized&#xD;
        Split-Mouth Clinical Trial&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Abstract Introduction: The surgical extraction of impacted wisdom teeth is a standard&#xD;
        practice in dentistry. Unfortunately, inflammatory reactions such as discomfort, edema, and&#xD;
        trismus frequently jeopardize patients' well-being after the extraction of third molars.&#xD;
        Saline solutions at room temperature (25°C) are routinely used in impacted tooth extraction.&#xD;
        Refrigerated serums were used to work with cold serum, and since the refrigerator temperature&#xD;
        was 4°C, this study was designed to have a cold serum temperature of 4°C. This study aims to&#xD;
        assess the influence of saline irrigation at various temperatures (4°C, 25°C) on&#xD;
        postoperative edema, pain, and trismus after the extraction of impacted third molars.&#xD;
  &#xD;
        Materials and Methods: Eighteen patients with bilateral symmetrical mandibular impacted third&#xD;
        molars were enrolled in this split-mouth, randomized, prospective, double-blind clinical&#xD;
        trial. For each patient, one side was irrigated with a solution at 4°C (test), and the other&#xD;
        side was irrigated with a solution at room temperature (25°C) (control). Pain, trismus, and&#xD;
        facial edema were noted on the 2nd, 4th, and 7th days. A Mann-Whitney U-test was used to&#xD;
        compare pairs, and a Wilcoxon signed-rank test was used to compare groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 2, 2021</start_date>
    <completion_date type="Actual">June 9, 2022</completion_date>
    <primary_completion_date type="Actual">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>Crossover Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain was noted on the 2nd, 4th, and 7th days.</measure>
      <time_frame>on the 2nd, 4th, and 7th days.</time_frame>
      <description>Pain was evaluated with a 10-unit visual analog scale (VAS), which was included in the patient follow-up form on the postoperative second, fourth, and seventh days.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>trismus was noted on the 2nd, 4th, and 7th days.</measure>
      <time_frame>on the 2nd, 4th, and 7th days.</time_frame>
      <description>For trismus, preoperative and postoperative mouth openings were evaluated on the second, fourth, and seventh days by measuring the maximum distance between the incisal surface of the right maxillary incisor and the incisal surface of the right mandibular incisor with a caliper.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>facial edema was noted on the 2nd, 4th, and 7th days</measure>
      <time_frame>on the 2nd, 4th, and 7th days.</time_frame>
      <description>The level of facial edema was evaluated using Amin Laskin's protocol. Two measurements between four reference points were taken using a tape measure to assess facial edema. The distance between the tragus and the lip commissure and between the gonion and the lateral (outer) canthus of the eye were measured with a tape measure preoperatively and on the second, fourth, and seventh days after the operation.</description>
    </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>One of the symmetrical Impacted Mandibular Third Molars, control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Serum at room temperature (25°C) was applied to one of the mandibular impacted third molars</description>
    </arm_group>
    <arm_group>
      <arm_group_label>One of the symmetrical Impacted Mandibular Third Molars, intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Serum at temperature (4°C) was applied to one of the mandibular impacted third molars</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>saline irrigation at various temperatures (4°C, 25°C)</intervention_name>
      <description>cold serum application</description>
      <arm_group_label>One of the symmetrical Impacted Mandibular Third Molars, intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged 18 to 30 who were classified as ASA (American Society of&#xD;
               Anesthesiologists)1 and who required the removal of impacted third molars on either&#xD;
               the right or left side of the mandible;&#xD;
  &#xD;
            -  Presence of impacted mandibular third molars on panoramic radiographs, bilaterally&#xD;
               symmetrical, with bone retention and bone removal for extraction, position B class 2&#xD;
               of impacted teeth according to the Pell and Gregory Classification System, and&#xD;
               mesioangular position according to the Winter Classification;&#xD;
  &#xD;
            -  Absence of systemic disease and habitual smoking behavior and absence of an allergy to&#xD;
               the drugs to be used postoperatively.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a history of taking antibiotics and analgesics for at least one month;&#xD;
  &#xD;
            -  Having an infection in the operation area and acute pericoronitis or severe&#xD;
               periodontal disease before the operation;&#xD;
  &#xD;
            -  The existence of cysts and tumors within proximity of the impacted third molar.&#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>
    <overall_official>
      <last_name>muhammet ozupek</last_name>
      <role>Study Director</role>
      <affiliation>Firat University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Fırat Üniversitesi</name>
        <address>
          <city>Merkez</city>
          <state>Elaziğ</state>
          <zip>23200</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Firat University</investigator_affiliation>
      <investigator_full_name>Ceren Dayanan</investigator_full_name>
      <investigator_title>research assistant</investigator_title>
    </responsible_party>
    <keyword>irrigation,</keyword>
    <keyword>third molar surgery,</keyword>
    <keyword>temperature,</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>
  
  
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/NCT06020053
  org study id: FiratUniversitydentistry
  nct id: NCT06020053
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  An Evaluation of the Effect of Using Irrigations at Different Temperatures on Pain, Edema,
        and Trismus During the Extraction of Bilateral Impacted Mandibular Third Molars: A Randomized
        Split-Mouth Clinical Trial
  Abstract Introduction: The surgical extraction of impacted wisdom teeth is a standard
        practice in dentistry. Unfortunately, inflammatory reactions such as discomfort, edema, and
        trismus frequently jeopardize patients' well-being after the extraction of third molars.
        Saline solutions at room temperature (25°C) are routinely used in impacted tooth extraction.
        Refrigerated serums were used to work with cold serum, and since the refrigerator temperature
        was 4°C, this study was designed to have a cold serum temperature of 4°C. This study aims to
        assess the influence of saline irrigation at various temperatures (4°C, 25°C) on
        postoperative edema, pain, and trismus after the extraction of impacted third molars.
  
        Materials and Methods: Eighteen patients with bilateral symmetrical mandibular impacted third
        molars were enrolled in this split-mouth, randomized, prospective, double-blind clinical
        trial. For each patient, one side was irrigated with a solution at 4°C (test), and the other
        side was irrigated with a solution at room temperature (25°C) (control). Pain, trismus, and
        facial edema were noted on the 2nd, 4th, and 7th days. A Mann-Whitney U-test was used to
        compare pairs, and a Wilcoxon signed-rank test was used to compare groups.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Supportive Care
  masking: Double (Investigator, Outcomes Assessor)
  measure: Pain was noted on the 2nd, 4th, and 7th days.
  time frame: on the 2nd, 4th, and 7th days.
  description: Pain was evaluated with a 10-unit visual analog scale (VAS), which was included in the patient follow-up form on the postoperative second, fourth, and seventh days.
  measure: trismus was noted on the 2nd, 4th, and 7th days.
  time frame: on the 2nd, 4th, and 7th days.
  description: For trismus, preoperative and postoperative mouth openings were evaluated on the second, fourth, and seventh days by measuring the maximum distance between the incisal surface of the right maxillary incisor and the incisal surface of the right mandibular incisor with a caliper.
  measure: facial edema was noted on the 2nd, 4th, and 7th days
  time frame: on the 2nd, 4th, and 7th days.
  description: The level of facial edema was evaluated using Amin Laskin's protocol. Two measurements between four reference points were taken using a tape measure to assess facial edema. The distance between the tragus and the lip commissure and between the gonion and the lateral (outer) canthus of the eye were measured with a tape measure preoperatively and on the second, fourth, and seventh days after the operation.
  arm group label: One of the symmetrical Impacted Mandibular Third Molars, control group
  arm group type: No Intervention
  description: Serum at room temperature (25°C) was applied to one of the mandibular impacted third molars
  arm group label: One of the symmetrical Impacted Mandibular Third Molars, intervention group
  arm group type: Experimental
  description: Serum at temperature (4°C) was applied to one of the mandibular impacted third molars
  intervention type: Procedure
  intervention name: saline irrigation at various temperatures (4°C, 25°C)
  description: cold serum application
  arm group label: One of the symmetrical Impacted Mandibular Third Molars, intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: muhammet ozupek
  role: Study Director
  affiliation: Firat University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Firat University
  investigator full name: Ceren Dayanan
  investigator title: research assistant
  mesh term: Tooth, Impacted
  sharing ipd: No