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/NCT06023524</url>
    </required_header>
    <id_info>
      <org_study_id>23-06-0952</org_study_id>
      <nct_id>NCT06023524</nct_id>
    </id_info>
    <brief_title>The Effectiveness of Laser Acupuncture and Standard Medication Therapy on Mandibular Post-Odontectomy Patients</brief_title>
    <official_title>The Effectiveness Combination of Laser Acupuncture and Standard Medication on Pain Score, Interincisal Distance and Swelling in Mandibular Third Molar Post-Odontectomy Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Indonesia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Indonesia University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Acute toothache is a problem that often occurs in the oral cavity. Toothache can be caused by&#xD;
        an impacted tooth, in which the tooth cannot or will not erupt into its normal position. The&#xD;
        American Association of Oral and Maxillofacial Surgeons (AAOMFS) states that 9 out of 10&#xD;
        people have at least one impacted tooth, and impacted mandibular third molars have the&#xD;
        greatest prevalence. Laser acupuncture is an acupuncture modality that has the benefit of&#xD;
        reducing pain after third molar extraction. The goal of this randomized controlled trial is&#xD;
        to evaluate the group that received a combination of laser acupuncture and standard&#xD;
        medication compared to the group that received the combination of sham laser acupuncture and&#xD;
        standard medication alone, in management of post-mandibular odontectomy patients. The main&#xD;
        objective of this study is to analyze the combination of laser acupuncture and medication&#xD;
        significantly improving the patient's pain intensity, interincisal distance and&#xD;
        post-odontectomy swelling compared to the combination group of sham laser acupuncture and&#xD;
        medication.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a clinical trial study to evaluate the group that received a combination of laser&#xD;
        acupuncture and standard medication compared to the group that received the combination of&#xD;
        sham laser acupuncture and standard medication alone, in management of post-mandibular&#xD;
        odontectomy patients. The required sample was 57 mandibular third molars in male/female&#xD;
        subjects post-odontectomy and randomized into 2 groups: (1) combination of laser acupuncture&#xD;
        with standard medication and (2) combination of sham laser acupuncture with standard&#xD;
        medication. The subjects will receive two times treatment, on day-1 (baseline) and day-3&#xD;
        after odontectomy. The outcome will be assessed on day-1 (baseline), day-3 and day-7&#xD;
        post-odontectomy. Patients and outcome assessors will be blinded to the group allocation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</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>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analog Scale</measure>
      <time_frame>Day-1 (baseline), Day-3 and Day-7 post-odontectomy</time_frame>
      <description>Rating scale for measuring pain, where the minimum value is 0 = no pain, and the maximum value is 100 = severe pain. A higher scale means worse outcomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Interincisal Space</measure>
      <time_frame>Day-1 (baseline), Day-3 and Day-7 post-odontectomy</time_frame>
      <description>Assess the maximum distance of opening the mouth (interincisal space) using calipers</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Swelling</measure>
      <time_frame>Day-1 (baseline), Day-3 and Day-7 post-odontectomy</time_frame>
      <description>Assess the swelling dimensions using a tape measure</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Laser Acupuncture</condition>
    <condition>Impacted Third Molar Tooth</condition>
    <arm_group>
      <arm_group_label>Laser Acupuncture and Standard Medication</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. Dose 4 Joule at the acupuncture body points and 1 Joule at the ear points.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham Laser Acupuncture and Standard Medication</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Sham Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. The laser is turned on but not activated</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Laser Acupuncture and Standard Medication</intervention_name>
      <description>Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. Dose 4 Joule at the acupuncture body points and 1 Joule at the ear points</description>
      <arm_group_label>Laser Acupuncture and Standard Medication</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sham Laser Acupuncture and Standard Medication</intervention_name>
      <description>Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. The laser is turned on but not activated</description>
      <arm_group_label>Sham Laser Acupuncture and Standard Medication</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female subject&#xD;
  &#xD;
            -  Age 18 - 40 years&#xD;
  &#xD;
            -  Classification of Pell and Gregory class I, II and positions A, B, C&#xD;
  &#xD;
            -  Willing to participate in this research and sign informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Have a history of using corticosteroid drugs in the last 3 months&#xD;
  &#xD;
            -  Have a history of medication with analgesics at least 24 hours before surgery&#xD;
  &#xD;
            -  Have an unstable systemic disease (such as uncontrolled hypertension and diabetes&#xD;
               etc.)&#xD;
  &#xD;
            -  The patient has a medical emergency / hemodynamically unstable (such as having a&#xD;
               hypertensive crisis)&#xD;
  &#xD;
            -  Wounds or skin diseases at the location of the acupuncture point irradiation&#xD;
  &#xD;
            -  Patients with a history of epilepsy&#xD;
  &#xD;
            -  High fever (&gt; 38oC).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>KEPK FKUI RSCM</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Ethics Committee of the Faculty of Medicine, University of Indonesia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Antonius H Kasim, Doctor</last_name>
      <phone>+6281296838259</phone>
      <email>hapindra@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>The Ethics Committee of the Faculty of Medicine University of Indonesia - Cipto Mangunkusumo Hospital</last_name>
      <phone>+6221315 7008</phone>
      <email>ec_fkui@yahoo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Special dental and oral hospital, Faculty of Dentistry, University of Indonesia</name>
        <address>
          <city>Jakarta Pusat</city>
          <state>DKI Jakarta</state>
          <zip>10430</zip>
          <country>Indonesia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Special dental and oral hospital University of Indonesia</last_name>
        <phone>0213923145</phone>
        <email>rskgm.fkg@ui.ac.id</email>
      </contact>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Indonesia University</investigator_affiliation>
      <investigator_full_name>Antonius Hapindra Kasim</investigator_full_name>
      <investigator_title>doctor</investigator_title>
    </responsible_party>
    <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>Yes</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/NCT06023524
  org study id: 23-06-0952
  nct id: NCT06023524
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Acute toothache is a problem that often occurs in the oral cavity. Toothache can be caused by
        an impacted tooth, in which the tooth cannot or will not erupt into its normal position. The
        American Association of Oral and Maxillofacial Surgeons (AAOMFS) states that 9 out of 10
        people have at least one impacted tooth, and impacted mandibular third molars have the
        greatest prevalence. Laser acupuncture is an acupuncture modality that has the benefit of
        reducing pain after third molar extraction. The goal of this randomized controlled trial is
        to evaluate the group that received a combination of laser acupuncture and standard
        medication compared to the group that received the combination of sham laser acupuncture and
        standard medication alone, in management of post-mandibular odontectomy patients. The main
        objective of this study is to analyze the combination of laser acupuncture and medication
        significantly improving the patient's pain intensity, interincisal distance and
        post-odontectomy swelling compared to the combination group of sham laser acupuncture and
        medication.
  This is a clinical trial study to evaluate the group that received a combination of laser
        acupuncture and standard medication compared to the group that received the combination of
        sham laser acupuncture and standard medication alone, in management of post-mandibular
        odontectomy patients. The required sample was 57 mandibular third molars in male/female
        subjects post-odontectomy and randomized into 2 groups: (1) combination of laser acupuncture
        with standard medication and (2) combination of sham laser acupuncture with standard
        medication. The subjects will receive two times treatment, on day-1 (baseline) and day-3
        after odontectomy. The outcome will be assessed on day-1 (baseline), day-3 and day-7
        post-odontectomy. Patients and outcome assessors will be blinded to the group allocation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Visual Analog Scale
  time frame: Day-1 (baseline), Day-3 and Day-7 post-odontectomy
  description: Rating scale for measuring pain, where the minimum value is 0 = no pain, and the maximum value is 100 = severe pain. A higher scale means worse outcomes.
  measure: Interincisal Space
  time frame: Day-1 (baseline), Day-3 and Day-7 post-odontectomy
  description: Assess the maximum distance of opening the mouth (interincisal space) using calipers
  measure: Swelling
  time frame: Day-1 (baseline), Day-3 and Day-7 post-odontectomy
  description: Assess the swelling dimensions using a tape measure
  arm group label: Laser Acupuncture and Standard Medication
  arm group type: Experimental
  description: Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. Dose 4 Joule at the acupuncture body points and 1 Joule at the ear points.
  arm group label: Sham Laser Acupuncture and Standard Medication
  arm group type: Sham Comparator
  description: Sham Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. The laser is turned on but not activated
  intervention type: Device
  intervention name: Laser Acupuncture and Standard Medication
  description: Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. Dose 4 Joule at the acupuncture body points and 1 Joule at the ear points
  arm group label: Laser Acupuncture and Standard Medication
  intervention type: Device
  intervention name: Sham Laser Acupuncture and Standard Medication
  description: Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. The laser is turned on but not activated
  arm group label: Sham Laser Acupuncture and Standard Medication
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: KEPK FKUI RSCM
  role: Principal Investigator
  affiliation: The Ethics Committee of the Faculty of Medicine, University of Indonesia
  last name: Antonius H Kasim, Doctor
  phone: +6281296838259
  email: hapindra@gmail.com
  last name: The Ethics Committee of the Faculty of Medicine University of Indonesia - Cipto Mangunkusumo Hospital
  phone: +6221315 7008
  email: ec_fkui@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  country: Indonesia
  responsible party type: Principal Investigator
  investigator affiliation: Indonesia University
  investigator full name: Antonius Hapindra Kasim
  investigator title: doctor
  mesh term: Tooth, Impacted
  sharing ipd: Yes