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/NCT05992233</url>
    </required_header>
    <id_info>
      <org_study_id>21-KAEK-078</org_study_id>
      <nct_id>NCT05992233</nct_id>
    </id_info>
    <brief_title>&quot;Effectiveness of Dual-Wavelength Laser Therapy in Third Molar Extraction Pain, Swelling, and Trismus&quot;</brief_title>
    <official_title>Is Dual-wavelength Low-level Laser Therapy Effective in Reducing Pain, Swelling and Trismus After Impacted Mandibular Third Molar Extraction?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tokat Gaziosmanpasa University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tokat Gaziosmanpasa 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>
        Objective: To investigate the effects of single session dual wavelength low dose laser&#xD;
        therapy to be applied after third molar tooth extraction on postoperative pain, edema and&#xD;
        physical activities.&#xD;
  &#xD;
        Materials and Methods: Thirty-six patients who applied for the extraction of a Class III and&#xD;
        position B lower impacted wisdom tooth were included in the study. The patients were divided&#xD;
        into 2 groups as laser and control group. Envelope selection method was used for&#xD;
        randomization of patients. After the surgery, a single session of double wavelength low-dose&#xD;
        laser therapy was applied to the patients. On the 2nd and 7th postoperative days, pain was&#xD;
        measured with the VAS scale, edema was measured by face measurements of 3 different points,&#xD;
        and quality of life was measured with the modified Posse scale.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objective and background: Pain, edema, and trismus are common problems after tooth&#xD;
        extraction. Photobiomodulation therapy (PBMT) is frequently used as an adjunctive method to&#xD;
        reduce these problems. However, there is no consensus in the literature regarding the type,&#xD;
        power, session duration, and application frequency of the laser for this treatment method.&#xD;
        The aim of this study is to examine the effectiveness of a single-session application of&#xD;
        dual-wavelength PBMT (using a 904 nm GaAlAs infrared laser and a 650 nm red laser) on pain,&#xD;
        edema, trismus, and the quality of life of patients following impacted mandibular third molar&#xD;
        extraction.&#xD;
  &#xD;
        Methods: The study included patients whose impacted mandibular third molars were to be&#xD;
        extracted for prophylactic purposes. The patients were divided into two groups as the PBMT&#xD;
        group and the placebo control group. Pain, swelling, maximum mouth opening, and quality of&#xD;
        life parameters of the patients were evaluated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 18, 2021</start_date>
    <completion_date type="Actual">December 16, 2022</completion_date>
    <primary_completion_date type="Actual">October 16, 2022</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>hee primary outcome was postoperative pain, evaluated using the visual analogue scale (VAS) score at Baseline, for 7 days following surgery, postoperative swelling and maximum mouth opening values evaluated at 2nd and 7th days in subject treated for third molar surgery with piezoelectric surgery or rotating drills. The secondary outcomes chosen were changes in quality of life using a questionnaire form.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Swelling</measure>
      <time_frame>Preoperative-Postoperative (Day 2 and 7)</time_frame>
      <description>It was determined according to facial swelling measurements. Tragus and soft tissue pogonion, tragus and lateral corner of the mouth were measured and recorded with a flexible ruler.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum Mouth Opening</measure>
      <time_frame>Preoperative-Postoperative (Day 2 and 7)</time_frame>
      <description>It is the procedure for determining the maximum mouth opening of the patient in mm. Measurements were determined as the distance between the incisal edges of the superior and inferior central teeth 11 and 41. In the absence of these teeth, other incisal teeth (21/31) in the adjacent half jaw were used. The maximum mouth opening determined before the operation was measured and recorded again on the 2nd and 7th days after the operation. The maximum mouth opening was measured with the help of a caliper.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain after surgery</measure>
      <time_frame>Preoperative-Postoperative (Day 2 and 7)</time_frame>
      <description>Pain assessment of the patient was done with visual analog scale (VAS). According to this evaluation, the line of a certain length was divided into 10 equal parts. 0 = no pain on the line, 5 = moderate pain, 10 = unbearable pain. This statement will also be verbally reported to the patient and the patient was asked to mark the severity of his pain on this hide.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Operation Time</measure>
      <time_frame>During the surgery</time_frame>
      <description>The time from incision to the last suture was recorded.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life of the Patients'</measure>
      <time_frame>At 7th day.</time_frame>
      <description>A questionnaire form evaluates quality of life. This questionnaire was divided into subscales corresponding to seven main adverse effects, and for each possible answer there was a score ranging from 0 to a variable number. It is a valid and reliable measure of the severity of symptoms after extraction of third molars, and of the impact of those symptoms on patients' perceived health.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Molar, Third</condition>
    <condition>Low-level Laser Therapy</condition>
    <arm_group>
      <arm_group_label>Dual wavelength low dose laser</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Immediately after suturing the patient, a low-dose laser application was performed on the laser group using the square probe (16 J/min) of the locally produced GRR laser device (Ankara, Turkey) for 5 minutes. The device combines a 22 mW GaAlAs infrared laser with a wavelength of 904 nm and a 10 mW red laser with a wavelength of 650 nm. The square probe contains 5 red lasers and 4 infrared lasers, covering an area of 30mm X 30mm.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Plasebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Laser probe will be applied to the control group patients, but the device was not operated.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Dual wavelength low level laser</intervention_name>
      <description>Application of double wavelength low level laser to the related area after tooth extraction.</description>
      <arm_group_label>Dual wavelength low dose laser</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Only red light applied.</description>
      <arm_group_label>Plasebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Volunteer ASA I individuals aged 18-40 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Those who are pregnant or lactating, Those receiving anticoagulant or antiaggregant&#xD;
          medication, Those who have received radiotherapy to the head and face area, Those who are&#xD;
          allergic to local anesthetics and prescribed drugs&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Gaziosmanpasa University</name>
        <address>
          <city>Tokat</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tokat Gaziosmanpasa University</investigator_affiliation>
      <investigator_full_name>Esengul Sen</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>photobiomodulation,</keyword>
    <keyword>Impacted third molar</keyword>
    <keyword>Pain</keyword>
    <keyword>Edema</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Trismus</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/NCT05992233
  org study id: 21-KAEK-078
  nct id: NCT05992233
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Objective: To investigate the effects of single session dual wavelength low dose laser
        therapy to be applied after third molar tooth extraction on postoperative pain, edema and
        physical activities.
  
        Materials and Methods: Thirty-six patients who applied for the extraction of a Class III and
        position B lower impacted wisdom tooth were included in the study. The patients were divided
        into 2 groups as laser and control group. Envelope selection method was used for
        randomization of patients. After the surgery, a single session of double wavelength low-dose
        laser therapy was applied to the patients. On the 2nd and 7th postoperative days, pain was
        measured with the VAS scale, edema was measured by face measurements of 3 different points,
        and quality of life was measured with the modified Posse scale.
  Objective and background: Pain, edema, and trismus are common problems after tooth
        extraction. Photobiomodulation therapy (PBMT) is frequently used as an adjunctive method to
        reduce these problems. However, there is no consensus in the literature regarding the type,
        power, session duration, and application frequency of the laser for this treatment method.
        The aim of this study is to examine the effectiveness of a single-session application of
        dual-wavelength PBMT (using a 904 nm GaAlAs infrared laser and a 650 nm red laser) on pain,
        edema, trismus, and the quality of life of patients following impacted mandibular third molar
        extraction.
  
        Methods: The study included patients whose impacted mandibular third molars were to be
        extracted for prophylactic purposes. The patients were divided into two groups as the PBMT
        group and the placebo control group. Pain, swelling, maximum mouth opening, and quality of
        life parameters of the patients were evaluated.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: hee primary outcome was postoperative pain, evaluated using the visual analogue scale (VAS) score at Baseline, for 7 days following surgery, postoperative swelling and maximum mouth opening values evaluated at 2nd and 7th days in subject treated for third molar surgery with piezoelectric surgery or rotating drills. The secondary outcomes chosen were changes in quality of life using a questionnaire form.
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: Swelling
  time frame: Preoperative-Postoperative (Day 2 and 7)
  description: It was determined according to facial swelling measurements. Tragus and soft tissue pogonion, tragus and lateral corner of the mouth were measured and recorded with a flexible ruler.
  measure: Maximum Mouth Opening
  time frame: Preoperative-Postoperative (Day 2 and 7)
  description: It is the procedure for determining the maximum mouth opening of the patient in mm. Measurements were determined as the distance between the incisal edges of the superior and inferior central teeth 11 and 41. In the absence of these teeth, other incisal teeth (21/31) in the adjacent half jaw were used. The maximum mouth opening determined before the operation was measured and recorded again on the 2nd and 7th days after the operation. The maximum mouth opening was measured with the help of a caliper.
  measure: Pain after surgery
  time frame: Preoperative-Postoperative (Day 2 and 7)
  description: Pain assessment of the patient was done with visual analog scale (VAS). According to this evaluation, the line of a certain length was divided into 10 equal parts. 0 = no pain on the line, 5 = moderate pain, 10 = unbearable pain. This statement will also be verbally reported to the patient and the patient was asked to mark the severity of his pain on this hide.
  measure: Operation Time
  time frame: During the surgery
  description: The time from incision to the last suture was recorded.
  measure: Quality of Life of the Patients'
  time frame: At 7th day.
  description: A questionnaire form evaluates quality of life. This questionnaire was divided into subscales corresponding to seven main adverse effects, and for each possible answer there was a score ranging from 0 to a variable number. It is a valid and reliable measure of the severity of symptoms after extraction of third molars, and of the impact of those symptoms on patients' perceived health.
  arm group label: Dual wavelength low dose laser
  arm group type: Experimental
  description: Immediately after suturing the patient, a low-dose laser application was performed on the laser group using the square probe (16 J/min) of the locally produced GRR laser device (Ankara, Turkey) for 5 minutes. The device combines a 22 mW GaAlAs infrared laser with a wavelength of 904 nm and a 10 mW red laser with a wavelength of 650 nm. The square probe contains 5 red lasers and 4 infrared lasers, covering an area of 30mm X 30mm.
  arm group label: Plasebo
  arm group type: Placebo Comparator
  description: Laser probe will be applied to the control group patients, but the device was not operated.
  intervention type: Device
  intervention name: Dual wavelength low level laser
  description: Application of double wavelength low level laser to the related area after tooth extraction.
  arm group label: Dual wavelength low dose laser
  intervention type: Device
  intervention name: Placebo
  description: Only red light applied.
  arm group label: Plasebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Tokat Gaziosmanpasa University
  investigator full name: Esengul Sen
  investigator title: Assistant Professor
  mesh term: Trismus
  sharing ipd: No