<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/NCT03239912</url>
  </required_header>
  <id_info>
    <org_study_id>UDDS-Ortho-05-2017</org_study_id>
    <nct_id>NCT03239912</nct_id>
  </id_info>
  <brief_title>Treatment of Class II Malocclusion Combined With Low-level Laser</brief_title>
  <official_title>The Effects of Combined Treatment With Low-level Laser and Functional Appliances on the Correction of Class II Malocclusion: A Randomized Controlled Trial</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This experimental study will evaluate the effect of combined treatment with low-level laser&#xD;
      and functional appliances (twin-block) on the correction of Class II malocclusion, compared&#xD;
      with the control group treated with functional appliances (twin-block) only.&#xD;
&#xD;
      The study sample will consist of 40 patients with Class II malocclusion. The sample will be&#xD;
      allocated randomly into two groups: a control group and an experimental group.&#xD;
&#xD;
      Functional appliance (twin-block) will be applied for all patients. Low-level laser will be&#xD;
      applied for the experimental group only. The skeleto-dental changes occurring after&#xD;
      functional treatment will be assessed using cephalometric radiographs; pre- and post-&#xD;
      treatment changes for each group will be evaluated individually.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Class II malocclusion is considered as the most common malocclusion between patients.&#xD;
&#xD;
      Recently low-level laser enters the world of dentistry, some studies assessed the effect of&#xD;
      low-level laser on the growth of mandibles and condyles in animals and showed that there is a&#xD;
      good effect of laser on the mandible growth.&#xD;
&#xD;
      This study will evaluate the effect of low-level laser on the growth of the mandible and the&#xD;
      duration of functional treatment.&#xD;
&#xD;
      Twin-block will be applied in two groups: The control group will receive the twin-block only,&#xD;
      and the experimental group will receive the twin-block combined with low-level laser therapy&#xD;
      on the TMG region.&#xD;
&#xD;
      Cephalometric radiographs will be gotten before and after functional treatment to evaluate&#xD;
      the dento-skeletal changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2017</start_date>
  <completion_date type="Actual">February 15, 2019</completion_date>
  <primary_completion_date type="Actual">October 15, 2018</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>The duration of functional treatment</measure>
    <time_frame>After functional treatment which will take approximately 8 months</time_frame>
    <description>The duration of the functional treatment will be measured and compared between groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dentoskeletal effects of the functional treatment</measure>
    <time_frame>Changes will be evaluated before and after functional treatment which will take approximately 8 months</time_frame>
    <description>Dentoskeletal changes before and after functional treatment combined with Low-level Laser compared with those of the control group (SNA, SNB, ANB, Overjet ,…etc) using lateral cephalometric radiographs.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Malocclusion, Angle Class II</condition>
  <arm_group>
    <arm_group_label>Twin-block group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Functional treatment will be applied using the Twin-block appliance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Twin-block combined with low level laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Functional treatment will be applied using the Twin-block appliance combined with low level laser.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Twin-block appliance</intervention_name>
    <description>Functional treatment will be achieved using the Twin-block appliance</description>
    <arm_group_label>Twin-block combined with low level laser</arm_group_label>
    <arm_group_label>Twin-block group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low level laser</intervention_name>
    <description>Functional treatment will be combined with low-level laser therapy on the TMG region</description>
    <arm_group_label>Twin-block combined with low level laser</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Skeletal Class II malocclusion because of mandibular retrognathia&#xD;
&#xD;
          -  ANB &gt; 4&#xD;
&#xD;
          -  Overjet &gt; 5&#xD;
&#xD;
          -  SNB &lt; 78&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poor oral hygiene&#xD;
&#xD;
          -  Previous orthodontic treatment.&#xD;
&#xD;
          -  Patients with syndromes, clefts, or craniofacial abnormalities.&#xD;
&#xD;
          -  Reason of contraindication of functional treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmad S Burhan, PhD.</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Damascus University</name>
      <address>
        <city>Damascus</city>
        <zip>00963</zip>
        <country>Syrian Arab Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Syrian Arab Republic</country>
  </location_countries>
  <reference>
    <citation>Abtahi M, Poosti M, Saghravanian N, Sadeghi K, Shafaee H. The effect of low level laser on condylar growth during mandibular advancement in rabbits. Head Face Med. 2012 Feb 23;8:4. doi: 10.1186/1746-160X-8-4.</citation>
    <PMID>22361310</PMID>
  </reference>
  <reference>
    <citation>Angeletti P, Pereira MD, Gomes HC, Hino CT, Ferreira LM. Effect of low-level laser therapy (GaAlAs) on bone regeneration in midpalatal anterior suture after surgically assisted rapid maxillary expansion. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Mar;109(3):e38-46. doi: 10.1016/j.tripleo.2009.10.043.</citation>
    <PMID>20219584</PMID>
  </reference>
  <reference>
    <citation>Oksayan R, Sokucu O, Ucuncu N. The effects of low-level laser therapy on condylar growth with a mandibular advancement appliance in rats. Photomed Laser Surg. 2015 May;33(5):252-7. doi: 10.1089/pho.2014.3870. Epub 2015 Apr 13.</citation>
    <PMID>25867096</PMID>
  </reference>
  <reference>
    <citation>Seifi M, Maghzi A, Gutknecht N, Mir M, Asna-Ashari M. The effect of 904 nm low level laser on condylar growth in rats. Lasers Med Sci. 2010 Jan;25(1):61-5. doi: 10.1007/s10103-009-0651-x. Epub 2009 Feb 24.</citation>
    <PMID>19238504</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>July 16, 2019</last_update_submitted>
  <last_update_submitted_qc>July 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Low-level laser</keyword>
  <keyword>functional treatment</keyword>
  <keyword>twin-block</keyword>
  <keyword>RCT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malocclusion</mesh_term>
    <mesh_term>Malocclusion, Angle Class II</mesh_term>
    <mesh_term>Overbite</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University</ipd_description>
  </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/NCT03239912
org study id: UDDS-Ortho-05-2017
nct id: NCT03239912
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This experimental study will evaluate the effect of combined treatment with low-level laser
      and functional appliances (twin-block) on the correction of Class II malocclusion, compared
      with the control group treated with functional appliances (twin-block) only.

      The study sample will consist of 40 patients with Class II malocclusion. The sample will be
      allocated randomly into two groups: a control group and an experimental group.

      Functional appliance (twin-block) will be applied for all patients. Low-level laser will be
      applied for the experimental group only. The skeleto-dental changes occurring after
      functional treatment will be assessed using cephalometric radiographs; pre- and post-
      treatment changes for each group will be evaluated individually.
Class II malocclusion is considered as the most common malocclusion between patients.

      Recently low-level laser enters the world of dentistry, some studies assessed the effect of
      low-level laser on the growth of mandibles and condyles in animals and showed that there is a
      good effect of laser on the mandible growth.

      This study will evaluate the effect of low-level laser on the growth of the mandible and the
      duration of functional treatment.

      Twin-block will be applied in two groups: The control group will receive the twin-block only,
      and the experimental group will receive the twin-block combined with low-level laser therapy
      on the TMG region.

      Cephalometric radiographs will be gotten before and after functional treatment to evaluate
      the dento-skeletal changes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: The duration of functional treatment
time frame: After functional treatment which will take approximately 8 months
description: The duration of the functional treatment will be measured and compared between groups.
measure: Dentoskeletal effects of the functional treatment
time frame: Changes will be evaluated before and after functional treatment which will take approximately 8 months
description: Dentoskeletal changes before and after functional treatment combined with Low-level Laser compared with those of the control group (SNA, SNB, ANB, Overjet ,…etc) using lateral cephalometric radiographs.
arm group label: Twin-block group
arm group type: Experimental
description: Functional treatment will be applied using the Twin-block appliance.
arm group label: Twin-block combined with low level laser
arm group type: Experimental
description: Functional treatment will be applied using the Twin-block appliance combined with low level laser.
intervention type: Device
intervention name: Twin-block appliance
description: Functional treatment will be achieved using the Twin-block appliance
arm group label: Twin-block combined with low level laser
arm group label: Twin-block group
intervention type: Other
intervention name: Low level laser
description: Functional treatment will be combined with low-level laser therapy on the TMG region
arm group label: Twin-block combined with low level laser
criteria: 
gender: All
minimum age: 11 Years
maximum age: 14 Years
healthy volunteers: No
last name: Ahmad S Burhan, PhD.
role: Study Chair
affiliation: Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
facility: 
country: Syrian Arab Republic
citation: Abtahi M, Poosti M, Saghravanian N, Sadeghi K, Shafaee H. The effect of low level laser on condylar growth during mandibular advancement in rabbits. Head Face Med. 2012 Feb 23;8:4. doi: 10.1186/1746-160X-8-4.
PMID: 22361310
citation: Angeletti P, Pereira MD, Gomes HC, Hino CT, Ferreira LM. Effect of low-level laser therapy (GaAlAs) on bone regeneration in midpalatal anterior suture after surgically assisted rapid maxillary expansion. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Mar;109(3):e38-46. doi: 10.1016/j.tripleo.2009.10.043.
PMID: 20219584
citation: Oksayan R, Sokucu O, Ucuncu N. The effects of low-level laser therapy on condylar growth with a mandibular advancement appliance in rats. Photomed Laser Surg. 2015 May;33(5):252-7. doi: 10.1089/pho.2014.3870. Epub 2015 Apr 13.
PMID: 25867096
citation: Seifi M, Maghzi A, Gutknecht N, Mir M, Asna-Ashari M. The effect of 904 nm low level laser on condylar growth in rats. Lasers Med Sci. 2010 Jan;25(1):61-5. doi: 10.1007/s10103-009-0651-x. Epub 2009 Feb 24.
PMID: 19238504
responsible party type: Sponsor
mesh term: Malocclusion
mesh term: Malocclusion, Angle Class II
mesh term: Overbite
sharing ipd: No
ipd description: The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University