<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/NCT02211547</url>
  </required_header>
  <id_info>
    <org_study_id>13-3091</org_study_id>
    <nct_id>NCT02211547</nct_id>
  </id_info>
  <brief_title>Effect of Low Level Laser Therapy on Pain Induced by Placement of Orthodontic Separators in Pediatric Patients</brief_title>
  <official_title>Effect of Low Level Laser Therapy on Pain Induced by Placement of Orthodontic Separators in Pediatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital Colorado</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal of the study is to determine if there is a difference in pain levels&#xD;
      following the use of low level laser therapy versus placebo and control after placement of&#xD;
      elastomeric orthodontic separators in pediatric patients. To test this, the investigators&#xD;
      will assess the patient's pain levels immediately following separator placement and 24 hours&#xD;
      post-operatively but having patients rate their pain on a 10 cm Visual Analog Scale (VAS).&#xD;
      Patients will be randomly assigned to one of three groups: treatment, placebo, and control.&#xD;
      The aim of this study is to establish whether or not low level laser therapy can be used to&#xD;
      reduce pain in pediatric patients following separator placement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No subjects enrolled&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">October 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain experienced by the patient</measure>
    <time_frame>24 hours</time_frame>
    <description>Pain will be assessed via a 10 cm non-hashed visual analog scale at two time points, immediately after placement of the elastomeric separators (time 0), and approximately 24 hours after placement when the patient returns to the clinic for separator removal.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Levels of Pain</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No treatment to be rendered following separator placement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single blind lack of laser treatment (the laser will be positioned and operated as if applying the treatment, but the energy transfer will not take place).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single blind laser treatment (the laser will be positioned and operated, and energy transfer will take place).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Epic 10 Diode Laser by Biolase Inc.</intervention_name>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>Epic 10 Diode Laser by Biolase Inc. (Irvine, CA)</other_name>
    <other_name>Product Code: GEX,ILY</other_name>
    <other_name>Regulatory Class: II</other_name>
    <other_name>Regulation number: 878.4810, 510(K)</other_name>
    <other_name>Number: K121286, with an InGaAsP diode, frequency of 50 Hz, wavelength of 940 nm, and output potency of 10 watts.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Single blind lack of laser treatment (the laser will be positioned and operated as if applying the treatment, but the energy transfer will not take place).</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Absence of acute or chronic dental disease and periodontal disease&#xD;
&#xD;
          -  Free from severe systemic disease&#xD;
&#xD;
          -  No fixed orthodontic appliances currently placed&#xD;
&#xD;
          -  No ankylosis or tooth implants within dentition&#xD;
&#xD;
          -  No analgesic drug consumption for 48 hours preceding the study and during the study, a&#xD;
             minimum age of 6 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of a diastema where the separator would be placed&#xD;
&#xD;
          -  Conditions that could alter nociception, such as current or previous use of&#xD;
             anti-inflammatory and analgesic drugs, antidepressants, anticonvulsants, and oral&#xD;
             contraceptives&#xD;
&#xD;
          -  Any medical conditions or medications that may contraindicate use of certain&#xD;
             light/laser sources such as low level laser therapy (LLLT)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linda Murzyn-Dantzer, DMD,MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital Colorado, Pediatric Dental Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>January 27, 2017</last_update_submitted>
  <last_update_submitted_qc>January 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02211547
org study id: 13-3091
nct id: NCT02211547
lead sponsor: 
collaborator: 
has dmc: Yes
The primary goal of the study is to determine if there is a difference in pain levels
      following the use of low level laser therapy versus placebo and control after placement of
      elastomeric orthodontic separators in pediatric patients. To test this, the investigators
      will assess the patient's pain levels immediately following separator placement and 24 hours
      post-operatively but having patients rate their pain on a 10 cm Visual Analog Scale (VAS).
      Patients will be randomly assigned to one of three groups: treatment, placebo, and control.
      The aim of this study is to establish whether or not low level laser therapy can be used to
      reduce pain in pediatric patients following separator placement.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Pain experienced by the patient
time frame: 24 hours
description: Pain will be assessed via a 10 cm non-hashed visual analog scale at two time points, immediately after placement of the elastomeric separators (time 0), and approximately 24 hours after placement when the patient returns to the clinic for separator removal.
arm group label: Control
arm group type: No Intervention
description: No treatment to be rendered following separator placement.
arm group label: Placebo
arm group type: Placebo Comparator
description: Single blind lack of laser treatment (the laser will be positioned and operated as if applying the treatment, but the energy transfer will not take place).
arm group label: Treatment
arm group type: Experimental
description: Single blind laser treatment (the laser will be positioned and operated, and energy transfer will take place).
intervention type: Device
intervention name: Epic 10 Diode Laser by Biolase Inc.
arm group label: Treatment
other name: Epic 10 Diode Laser by Biolase Inc. (Irvine, CA)
other name: Product Code: GEX,ILY
other name: Regulatory Class: II
other name: Regulation number: 878.4810, 510(K)
other name: Number: K121286, with an InGaAsP diode, frequency of 50 Hz, wavelength of 940 nm, and output potency of 10 watts.
intervention type: Other
intervention name: Placebo
description: Single blind lack of laser treatment (the laser will be positioned and operated as if applying the treatment, but the energy transfer will not take place).
arm group label: Placebo
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Linda Murzyn-Dantzer, DMD,MS
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor