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/NCT06024382</url>
    </required_header>
    <id_info>
      <org_study_id>dentist.1995</org_study_id>
      <nct_id>NCT06024382</nct_id>
    </id_info>
    <brief_title>The Effect of Low-level Laser Therapy on Functional Treatment of Skeletal Class II Patients</brief_title>
    <official_title>The Effect of Low-level Laser Therapy on Functional Treatment of Skeletal Class II Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mansoura University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mansoura 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 is a controlled clinical trial with 2 groups of patients of class II skeletal&#xD;
        discrepancy due to mandibular retrusion one group is treated with twin block functional&#xD;
        appliance and the other with twin block combined with low level laser therapy ,the study aims&#xD;
        to detect the effect of low level laser on the skeletal outcomes , dentoalveolar outcomes,&#xD;
        rate of correction and pain during treatment&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 26, 2022</start_date>
    <completion_date type="Anticipated">March 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 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>treatment time</measure>
      <time_frame>8 months</time_frame>
      <description>comparison of treatment between the 2 different groups</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>cephalometric measurements</measure>
      <time_frame>8 months</time_frame>
      <description>digital tracing of pre and post treatment cephalograms of both groups and comparison of linear and angular measurements</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>study cast analysis</measure>
      <time_frame>8 months</time_frame>
      <description>cast analysis of both groups measuring arch perimeter , intercanine wisth and intermolar width</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the short form McGill pain questionnaire</measure>
      <time_frame>1 month</time_frame>
      <description>comparison of questionnaire results between the 2 groups</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Class II Malocclusion</condition>
    <arm_group>
      <arm_group_label>twin block</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>group treated with twin block only</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>group treated with twin block combined with low level laser therapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>twin block</intervention_name>
      <description>2 parallel groups one is treated with twin block and the other is treated with twin block combined with low level laser therapy</description>
      <arm_group_label>twin block</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>twin block combined with low level laser</intervention_name>
      <description>2 parallel groups one is treated with twin block and the other is treated with twin block combined with low level laser therapy</description>
      <arm_group_label>twin block combined with low level laser</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age (early permanent dentition)&#xD;
  &#xD;
            -  Cervical maturation stage CS 3-4&#xD;
  &#xD;
            -  Skeletal class II due to mandibular retrusion.&#xD;
  &#xD;
            -  Overjet more than 4mm.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cleft lip or palate.&#xD;
  &#xD;
            -  Systemic diseases.&#xD;
  &#xD;
            -  Previous orthodontic treatment or abnormal habits.&#xD;
  &#xD;
            -  Congenital craniofacial deformity.&#xD;
  &#xD;
            -  poor oral hygiene&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>9 Years</minimum_age>
      <maximum_age>14 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Nada Gaballah, BDS</last_name>
      <phone>01063632718</phone>
      <phone_ext>002</phone_ext>
      <email>nadaessam@mans.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of Dentistry</name>
        <address>
          <city>Mansoura</city>
          <state>Dakahleya</state>
          <zip>35511</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nada Gaballah, BDS</last_name>
        <phone>01063632718</phone>
        <phone_ext>002</phone_ext>
        <email>nadaessam@mans.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mansoura University</investigator_affiliation>
      <investigator_full_name>Nada Gaballah</investigator_full_name>
      <investigator_title>teaching assistant</investigator_title>
    </responsible_party>
    <keyword>twin block , functional appliance , low level laser , photobiomodulation</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>
    </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/NCT06024382
  org study id: dentist.1995
  nct id: NCT06024382
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  this is a controlled clinical trial with 2 groups of patients of class II skeletal
        discrepancy due to mandibular retrusion one group is treated with twin block functional
        appliance and the other with twin block combined with low level laser therapy ,the study aims
        to detect the effect of low level laser on the skeletal outcomes , dentoalveolar outcomes,
        rate of correction and pain during treatment
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: treatment time
  time frame: 8 months
  description: comparison of treatment between the 2 different groups
  measure: cephalometric measurements
  time frame: 8 months
  description: digital tracing of pre and post treatment cephalograms of both groups and comparison of linear and angular measurements
  measure: study cast analysis
  time frame: 8 months
  description: cast analysis of both groups measuring arch perimeter , intercanine wisth and intermolar width
  measure: the short form McGill pain questionnaire
  time frame: 1 month
  description: comparison of questionnaire results between the 2 groups
  arm group label: twin block
  arm group type: Experimental
  description: group treated with twin block only
  arm group label: twin block combined with low level laser
  arm group type: Experimental
  description: group treated with twin block combined with low level laser therapy
  intervention type: Other
  intervention name: twin block
  description: 2 parallel groups one is treated with twin block and the other is treated with twin block combined with low level laser therapy
  arm group label: twin block
  intervention type: Other
  intervention name: twin block combined with low level laser
  description: 2 parallel groups one is treated with twin block and the other is treated with twin block combined with low level laser therapy
  arm group label: twin block combined with low level laser
  criteria: 
  gender: All
  minimum age: 9 Years
  maximum age: 14 Years
  healthy volunteers: No
  last name: Nada Gaballah, BDS
  phone: 01063632718
  phone ext: 002
  email: nadaessam@mans.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Mansoura University
  investigator full name: Nada Gaballah
  investigator title: teaching assistant
  mesh term: Malocclusion
  mesh term: Malocclusion, Angle Class II
  mesh term: Overbite
  sharing ipd: No