<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/NCT02209818</url>
  </required_header>
  <id_info>
    <org_study_id>UDDS-Perio-06-2014</org_study_id>
    <nct_id>NCT02209818</nct_id>
  </id_info>
  <brief_title>Effect of Laser Application in Pain Management Following the Use of Orthodontic Elastomeric Separators</brief_title>
  <official_title>Evaluation of Low Level Laser Therapy (LLLT) Effect on Pain Management Caused by Orthodontic Elastomeric Separators</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Damascus University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Damascus University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the effect of low level laser therapy (LLLT) on pain&#xD;
      management in people commencing orthodontic treatment. The study design is a randomized&#xD;
      controlled trial.&#xD;
&#xD;
      Participants' pain will be dealt with by laser irradiation in one side of the jaw randomly,&#xD;
      and the other side will be treated by a placebo procedure. Pain assessment will be measured&#xD;
      using Visual Analog Scales (VAS).&#xD;
&#xD;
      The hypothesis of this study is that laser irradiation decreases the amount of pain following&#xD;
      the insertion of orthodontic separators.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Here we have two groups:&#xD;
&#xD;
      The first group will undergo one dose of irradiation which is going to be applied on one side&#xD;
      of the mouth whereas the opposing side will serve as a control side (placebo).&#xD;
&#xD;
      The second group will undergo two doses of irradiation which is going to be applied on one&#xD;
      side of the mouth whereas the opposing side will serve as a control side (placebo).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">September 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain Perception</measure>
    <time_frame>Pain will be evaluated at 1, 6, 24, 48, and 72 hours after laser irradiation</time_frame>
    <description>Pain assessment will be performed using a Visual Analog Scale (VAS).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Orthodontic Treatment</condition>
  <arm_group>
    <arm_group_label>Laser Irradiation One Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laser irradiation will be applied in one dose for patients in this group, but only on one side of the jaw. The other side of the jaw will receive a placebo procedure (i.e. a red light beam will be emitted on the gingival tissues as if they are irradiated by a laser beam).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laser Irradiation Two doses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laser irradiation will be applied in two doses for patients in this group, but only on one side of the jaw. The second dose will be given after 24 hour of the first one. The other side of the jaw will receive a placebo procedure (i.e. a red light beam will be emitted on the gingival tissues as if they are irradiated by a laser beam).</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Laser Irradiation One dose</intervention_name>
    <arm_group_label>Laser Irradiation One Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Laser Irradiation Two doses</intervention_name>
    <arm_group_label>Laser Irradiation Two doses</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants should have healthy periodontal structures, healthy teeth.&#xD;
&#xD;
          -  Presence of first molar in both side of the jaw.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic diseases&#xD;
&#xD;
          -  chronic pain or neurological pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mai Almallah, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>MSc student, Department of Periodontics, University of Damascus Dental School, Damascus</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohammad Y Hajeer, DDS MSc PhD</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professor, Orthodontics Department, University of Damascus Dental School, Damascus</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wael Mahdi, DDS MSc PhD</last_name>
    <role>Study Director</role>
    <affiliation>Senior Lecturer in Periodontics, Periodontics Department, University of Damascus Dental School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Periodontics, University of Damascus Dental School</name>
      <address>
        <city>Damascus</city>
        <zip>DM20AM18</zip>
        <country>Syrian Arab Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Syrian Arab Republic</country>
  </location_countries>
  <reference>
    <citation>Abtahi SM, Mousavi SA, Shafaee H, Tanbakuchi B. Effect of low-level laser therapy on dental pain induced by separator force in orthodontic treatment. Dent Res J (Isfahan). 2013 Sep;10(5):647-51.</citation>
    <PMID>24348624</PMID>
  </reference>
  <reference>
    <citation>Eslamian L, Borzabadi-Farahani A, Hassanzadeh-Azhiri A, Badiee MR, Fekrazad R. The effect of 810-nm low-level laser therapy on pain caused by orthodontic elastomeric separators. Lasers Med Sci. 2014 Mar;29(2):559-64. doi: 10.1007/s10103-012-1258-1. Epub 2013 Jan 20.</citation>
    <PMID>23334785</PMID>
  </reference>
  <reference>
    <citation>Nobrega C, da Silva EM, de Macedo CR. Low-level laser therapy for treatment of pain associated with orthodontic elastomeric separator placement: a placebo-controlled randomized double-blind clinical trial. Photomed Laser Surg. 2013 Jan;31(1):10-6. doi: 10.1089/pho.2012.3338. Epub 2012 Nov 15.</citation>
    <PMID>23153291</PMID>
  </reference>
  <reference>
    <citation>Artes-Ribas M, Arnabat-Dominguez J, Puigdollers A. Analgesic effect of a low-level laser therapy (830 nm) in early orthodontic treatment. Lasers Med Sci. 2013 Jan;28(1):335-41. doi: 10.1007/s10103-012-1135-y. Epub 2012 Jul 21.</citation>
    <PMID>22814893</PMID>
  </reference>
  <reference>
    <citation>Huang TH, Liu SL, Chen CL, Shie MY, Kao CT. Low-level laser effects on simulated orthodontic tension side periodontal ligament cells. Photomed Laser Surg. 2013 Feb;31(2):72-7. doi: 10.1089/pho.2012.3359. Epub 2013 Jan 17.</citation>
    <PMID>23327633</PMID>
  </reference>
  <reference>
    <citation>Kim WT, Bayome M, Park JB, Park JH, Baek SH, Kook YA. Effect of frequent laser irradiation on orthodontic pain. A single-blind randomized clinical trial. Angle Orthod. 2013 Jul;83(4):611-6. doi: 10.2319/082012-665.1. Epub 2012 Dec 14.</citation>
    <PMID>23241006</PMID>
  </reference>
  <reference>
    <citation>Fujiyama K, Deguchi T, Murakami T, Fujii A, Kushima K, Takano-Yamamoto T. Clinical effect of CO(2) laser in reducing pain in orthodontics. Angle Orthod. 2008 Mar;78(2):299-303. doi: 10.2319/033007-153.1.</citation>
    <PMID>18251609</PMID>
  </reference>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>March 11, 2016</last_update_submitted>
  <last_update_submitted_qc>March 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Low level laser therapy</keyword>
  <keyword>Elastomeric separator</keyword>
  <keyword>Placebo</keyword>
  <keyword>Visual analog scale</keyword>
  <keyword>Laser irradiation</keyword>
  <!-- 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/NCT02209818
org study id: UDDS-Perio-06-2014
nct id: NCT02209818
lead sponsor: 
has dmc: Yes
The aim of this study is to evaluate the effect of low level laser therapy (LLLT) on pain
      management in people commencing orthodontic treatment. The study design is a randomized
      controlled trial.

      Participants' pain will be dealt with by laser irradiation in one side of the jaw randomly,
      and the other side will be treated by a placebo procedure. Pain assessment will be measured
      using Visual Analog Scales (VAS).

      The hypothesis of this study is that laser irradiation decreases the amount of pain following
      the insertion of orthodontic separators.
Here we have two groups:

      The first group will undergo one dose of irradiation which is going to be applied on one side
      of the mouth whereas the opposing side will serve as a control side (placebo).

      The second group will undergo two doses of irradiation which is going to be applied on one
      side of the mouth whereas the opposing side will serve as a control side (placebo).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in Pain Perception
time frame: Pain will be evaluated at 1, 6, 24, 48, and 72 hours after laser irradiation
description: Pain assessment will be performed using a Visual Analog Scale (VAS).
arm group label: Laser Irradiation One Dose
arm group type: Experimental
description: Laser irradiation will be applied in one dose for patients in this group, but only on one side of the jaw. The other side of the jaw will receive a placebo procedure (i.e. a red light beam will be emitted on the gingival tissues as if they are irradiated by a laser beam).
arm group label: Laser Irradiation Two doses
arm group type: Experimental
description: Laser irradiation will be applied in two doses for patients in this group, but only on one side of the jaw. The second dose will be given after 24 hour of the first one. The other side of the jaw will receive a placebo procedure (i.e. a red light beam will be emitted on the gingival tissues as if they are irradiated by a laser beam).
intervention type: Radiation
intervention name: Laser Irradiation One dose
arm group label: Laser Irradiation One Dose
intervention type: Radiation
intervention name: Laser Irradiation Two doses
arm group label: Laser Irradiation Two doses
criteria: 
gender: All
minimum age: 16 Years
maximum age: 45 Years
healthy volunteers: No
last name: Mai Almallah, DDS
role: Principal Investigator
affiliation: MSc student, Department of Periodontics, University of Damascus Dental School, Damascus
last name: Mohammad Y Hajeer, DDS MSc PhD
role: Study Director
affiliation: Associate Professor, Orthodontics Department, University of Damascus Dental School, Damascus
last name: Wael Mahdi, DDS MSc PhD
role: Study Director
affiliation: Senior Lecturer in Periodontics, Periodontics Department, University of Damascus Dental School
facility: 
country: Syrian Arab Republic
citation: Abtahi SM, Mousavi SA, Shafaee H, Tanbakuchi B. Effect of low-level laser therapy on dental pain induced by separator force in orthodontic treatment. Dent Res J (Isfahan). 2013 Sep;10(5):647-51.
PMID: 24348624
citation: Eslamian L, Borzabadi-Farahani A, Hassanzadeh-Azhiri A, Badiee MR, Fekrazad R. The effect of 810-nm low-level laser therapy on pain caused by orthodontic elastomeric separators. Lasers Med Sci. 2014 Mar;29(2):559-64. doi: 10.1007/s10103-012-1258-1. Epub 2013 Jan 20.
PMID: 23334785
citation: Nobrega C, da Silva EM, de Macedo CR. Low-level laser therapy for treatment of pain associated with orthodontic elastomeric separator placement: a placebo-controlled randomized double-blind clinical trial. Photomed Laser Surg. 2013 Jan;31(1):10-6. doi: 10.1089/pho.2012.3338. Epub 2012 Nov 15.
PMID: 23153291
citation: Artes-Ribas M, Arnabat-Dominguez J, Puigdollers A. Analgesic effect of a low-level laser therapy (830 nm) in early orthodontic treatment. Lasers Med Sci. 2013 Jan;28(1):335-41. doi: 10.1007/s10103-012-1135-y. Epub 2012 Jul 21.
PMID: 22814893
citation: Huang TH, Liu SL, Chen CL, Shie MY, Kao CT. Low-level laser effects on simulated orthodontic tension side periodontal ligament cells. Photomed Laser Surg. 2013 Feb;31(2):72-7. doi: 10.1089/pho.2012.3359. Epub 2013 Jan 17.
PMID: 23327633
citation: Kim WT, Bayome M, Park JB, Park JH, Baek SH, Kook YA. Effect of frequent laser irradiation on orthodontic pain. A single-blind randomized clinical trial. Angle Orthod. 2013 Jul;83(4):611-6. doi: 10.2319/082012-665.1. Epub 2012 Dec 14.
PMID: 23241006
citation: Fujiyama K, Deguchi T, Murakami T, Fujii A, Kushima K, Takano-Yamamoto T. Clinical effect of CO(2) laser in reducing pain in orthodontics. Angle Orthod. 2008 Mar;78(2):299-303. doi: 10.2319/033007-153.1.
PMID: 18251609
responsible party type: Sponsor