<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/NCT03023761</url>
  </required_header>
  <id_info>
    <org_study_id>123</org_study_id>
    <nct_id>NCT03023761</nct_id>
  </id_info>
  <brief_title>Management of Post Endodontic Re-treatment Pain With Low-Level Laser Therapy</brief_title>
  <official_title>Management of Post Endodontic Re-treatment Pain With Low-Level Laser Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shahid Beheshti University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shahid Beheshti University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this clinical trial investigators aimed to evaluate Post endodontic re-treatment pain&#xD;
      after irradiation of low level laser therapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this clinical trial, 61 patients requiring endodontic retreatments in the posterior teeth&#xD;
      were selected. A single visit Endodontic retreatment was done. After biomechanical&#xD;
      preparation, Low Level Laser was irradiated to the buccal and lingual mucosa overlying the&#xD;
      apices of the target tooth in the experimental group. In the control group patients received&#xD;
      placebo laser to eliminate the probable psychological effects of laser. Laser irradiation was&#xD;
      done with a single dose of 808 nm wavelength (Whitening Lase II- Laser DMC, Samsung, Korea)&#xD;
      with 100 mw power, and dose of 70 J/cm2 for 80 seconds. Pain severity was recorded before the&#xD;
      treatment, immediately after the treatment and 4, 8, 12, 24 and 48 hours after the treatment&#xD;
      by visual analogue scale (VAS). The pain scores were statistically analyzed by chi-square&#xD;
      test between two groups. The effects of different variables on the post-operative pain&#xD;
      experience were also studied by means of Logistic regression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>reduction of pain after low level laser irradiation</measure>
    <time_frame>baseline and 4, 8, 12, 24 and 48 hours after the treatment</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">61</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>low level laser</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A single visit Endodontic retreatment was done. After biomechanical preparation, Low Level Laser was irradiated to the buccal and lingual mucosa overlying the apices of the target tooth in the experimental group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>laser sham</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In the control group patients received placebo laser to eliminate the probable psychological effects of laser.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>low level laser</intervention_name>
    <description>low level laser irradiation</description>
    <arm_group_label>low level laser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>laser sham</intervention_name>
    <description>laser without irradiation</description>
    <arm_group_label>laser sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - patients requiring endodontic retreatments in the posterior teeth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic diseases psychologic disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>mohammad asnaashari</last_name>
    <role>Study Chair</role>
    <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>saranaz azari-marhabi</last_name>
    <phone>09190129151</phone>
    <email>saranazazari@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shahid Beheshti University</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Saranaz azari marhabi</last_name>
      <phone>09190129151</phone>
    </contact>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 17, 2017</last_update_submitted>
  <last_update_submitted_qc>January 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shahid Beheshti University</investigator_affiliation>
    <investigator_full_name>saranaz azari-marhabi</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>Endodontic retreatments</keyword>
  <keyword>Low level laser</keyword>
  <keyword>Pain</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03023761
org study id: 123
nct id: NCT03023761
lead sponsor: 
has dmc: No
In this clinical trial investigators aimed to evaluate Post endodontic re-treatment pain
      after irradiation of low level laser therapy
In this clinical trial, 61 patients requiring endodontic retreatments in the posterior teeth
      were selected. A single visit Endodontic retreatment was done. After biomechanical
      preparation, Low Level Laser was irradiated to the buccal and lingual mucosa overlying the
      apices of the target tooth in the experimental group. In the control group patients received
      placebo laser to eliminate the probable psychological effects of laser. Laser irradiation was
      done with a single dose of 808 nm wavelength (Whitening Lase II- Laser DMC, Samsung, Korea)
      with 100 mw power, and dose of 70 J/cm2 for 80 seconds. Pain severity was recorded before the
      treatment, immediately after the treatment and 4, 8, 12, 24 and 48 hours after the treatment
      by visual analogue scale (VAS). The pain scores were statistically analyzed by chi-square
      test between two groups. The effects of different variables on the post-operative pain
      experience were also studied by means of Logistic regression.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: reduction of pain after low level laser irradiation
time frame: baseline and 4, 8, 12, 24 and 48 hours after the treatment
arm group label: low level laser
arm group type: Active Comparator
description: A single visit Endodontic retreatment was done. After biomechanical preparation, Low Level Laser was irradiated to the buccal and lingual mucosa overlying the apices of the target tooth in the experimental group
arm group label: laser sham
arm group type: Placebo Comparator
description: In the control group patients received placebo laser to eliminate the probable psychological effects of laser.
intervention type: Device
intervention name: low level laser
description: low level laser irradiation
arm group label: low level laser
intervention type: Device
intervention name: laser sham
description: laser without irradiation
arm group label: laser sham
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: mohammad asnaashari
role: Study Chair
affiliation: Shahid Beheshti University of Medical Sciences
last name: saranaz azari-marhabi
phone: 09190129151
email: saranazazari@yahoo.com
facility: 
status: Recruiting
contact: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Shahid Beheshti University
investigator full name: saranaz azari-marhabi
investigator title: assistant professor
sharing ipd: Undecided