<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/NCT03251807</url>
  </required_header>
  <id_info>
    <org_study_id>UDDS-Ortho-06-2017</org_study_id>
    <nct_id>NCT03251807</nct_id>
  </id_info>
  <brief_title>Effect of Low-Intensity Pulsed Ultrasound on Functional Treatment of Class II Malocclusion</brief_title>
  <official_title>Effect of Low-Intensity Pulsed Ultrasound Applied on Temporomandibular Joint Region on Functional Treatment 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-intensity&#xD;
      pulsed ultrasound (LIPUS) and functional appliances (twin-block) on the correction of class&#xD;
      II malocclusion, compared with the control group treated with functional appliances&#xD;
      (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: control group and experimental group.&#xD;
&#xD;
      The functional appliance (twin-block) will be applied for all patients, while the&#xD;
      low-intensity pulsed ultrasound (LIPUS) will be applied for the experimental group only. The&#xD;
      skeleto-dental changes occurring after functional treatment will be assessed using&#xD;
      cephalometric radiographs; pre and post- treatment changes for each group will be evaluated&#xD;
      individually, and the two groups will be compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies of the etiologic factors of Class II malocclusions recognize that most Class II&#xD;
      malocclusions are a result of mandibular deficiency and not of maxillary excess. For many&#xD;
      patients, especially adults, optimal overall results are best obtained using a combined&#xD;
      orthodontic-surgical approach. However, treating such cases early while the patient is still&#xD;
      growing, using mandibular propulsive functional appliances, can produce satisfactory&#xD;
      improvement in the facial esthetics, and minimizes the need for surgical intervention in many&#xD;
      cases.&#xD;
&#xD;
      Ultrasound (US), a form of mechanical energy that is transmitted through and into biological&#xD;
      tissues as an acoustic pressure wave at frequencies above the limit of human hearing, is used&#xD;
      widely in medicine as a therapeutic, operative and diagnostic tool. Therapeutic US, and some&#xD;
      operative US. Previous studies on animals have found that therapeutic ultrasound (US) can&#xD;
      stimulate and enhance mandibular growth when applied during the active growth period.&#xD;
&#xD;
      This study will evaluate the effect of low-intensity pulsed ultrasound (LIPUS) on the growth&#xD;
      of mandible and the duration of functional treatment.&#xD;
&#xD;
      Twin-block will be applied to the two groups. While the control group will receive the&#xD;
      twin-block only, the experimental group will receive the twin-block combined with&#xD;
      low-intensity pulsed ultrasound (LIPUS) on Temporomandibular joint (TMJ) region.&#xD;
&#xD;
      Cephalometric radiographs will be obtained 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">August 1, 2017</start_date>
  <completion_date type="Actual">March 12, 2019</completion_date>
  <primary_completion_date type="Actual">October 12, 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</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients in this control group will be treated using the Twin-block appliance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Twin-block combined with LIPUS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients in this experimental group will be treated using the Twin-block combined with LIPUS (Low-intensity pulsed ultrasound).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Twin-block</intervention_name>
    <description>Functional treatment will be achieved using the Twinblock appliance</description>
    <arm_group_label>Twin-block</arm_group_label>
    <arm_group_label>Twin-block combined with LIPUS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>LIPUS (Low-intensity pulsed ultrasound)</intervention_name>
    <description>Functional treatment will be combined with LIPUS (Low-intensity pulsed ultrasound )</description>
    <arm_group_label>Twin-block combined with LIPUS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Angle class II malocclusion because of mandibular retrognathia&#xD;
&#xD;
          -  O.J &gt; 5 , SNB &lt; 78&#xD;
&#xD;
          -  Patient during growth spurt&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  TMJ disorders&#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>Ghiath Mahmood, PhD.</last_name>
    <role>Study Director</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>El-Bialy T, El-Shamy I, Graber TM. Growth modification of the rabbit mandible using therapeutic ultrasound: is it possible to enhance functional appliance results? Angle Orthod. 2003 Dec;73(6):631-9. doi: 10.1043/0003-3219(2003)0732.0.CO;2.</citation>
    <PMID>14719726</PMID>
  </reference>
  <reference>
    <citation>El-Bialy T, Hassan A, Albaghdadi T, Fouad HA, Maimani AR. Growth modification of the mandible with ultrasound in baboons: a preliminary report. Am J Orthod Dentofacial Orthop. 2006 Oct;130(4):435.e7-14. doi: 10.1016/j.ajodo.2006.01.025.</citation>
    <PMID>17045140</PMID>
  </reference>
  <reference>
    <citation>Flores-Mir C, Major MP, Major PW. Soft tissue changes with fixed functional appliances in Class II division 1. Angle Orthod. 2006 Jul;76(4):712-20. doi: 10.1043/0003-3219(2006)076[0712:STCWFF]2.0.CO;2.</citation>
    <PMID>16808582</PMID>
  </reference>
  <reference>
    <citation>Jena AK, Duggal R, Parkash H. Skeletal and dentoalveolar effects of Twin-block and bionator appliances in the treatment of Class II malocclusion: a comparative study. Am J Orthod Dentofacial Orthop. 2006 Nov;130(5):594-602. doi: 10.1016/j.ajodo.2005.02.025.</citation>
    <PMID>17110256</PMID>
  </reference>
  <reference>
    <citation>Johns LD, Straub SJ, Howard SM. Analysis of effective radiating area, power, intensity, and field characteristics of ultrasound transducers. Arch Phys Med Rehabil. 2007 Jan;88(1):124-9. doi: 10.1016/j.apmr.2006.09.016.</citation>
    <PMID>17207688</PMID>
  </reference>
  <reference>
    <citation>Sun JS, Hong RC, Chang WH, Chen LT, Lin FH, Liu HC. In vitro effects of low-intensity ultrasound stimulation on the bone cells. J Biomed Mater Res. 2001 Dec 5;57(3):449-56. doi: 10.1002/1097-4636(20011205)57:33.0.co;2-0.</citation>
    <PMID>11523040</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 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-intensity pulsed ultrasound</keyword>
  <keyword>Twin-block</keyword>
  <keyword>Functional treatment</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/NCT03251807
org study id: UDDS-Ortho-06-2017
nct id: NCT03251807
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-intensity
      pulsed ultrasound (LIPUS) 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: control group and experimental group.

      The functional appliance (twin-block) will be applied for all patients, while the
      low-intensity pulsed ultrasound (LIPUS) 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, and the two groups will be compared.
Studies of the etiologic factors of Class II malocclusions recognize that most Class II
      malocclusions are a result of mandibular deficiency and not of maxillary excess. For many
      patients, especially adults, optimal overall results are best obtained using a combined
      orthodontic-surgical approach. However, treating such cases early while the patient is still
      growing, using mandibular propulsive functional appliances, can produce satisfactory
      improvement in the facial esthetics, and minimizes the need for surgical intervention in many
      cases.

      Ultrasound (US), a form of mechanical energy that is transmitted through and into biological
      tissues as an acoustic pressure wave at frequencies above the limit of human hearing, is used
      widely in medicine as a therapeutic, operative and diagnostic tool. Therapeutic US, and some
      operative US. Previous studies on animals have found that therapeutic ultrasound (US) can
      stimulate and enhance mandibular growth when applied during the active growth period.

      This study will evaluate the effect of low-intensity pulsed ultrasound (LIPUS) on the growth
      of mandible and the duration of functional treatment.

      Twin-block will be applied to the two groups. While the control group will receive the
      twin-block only, the experimental group will receive the twin-block combined with
      low-intensity pulsed ultrasound (LIPUS) on Temporomandibular joint (TMJ) region.

      Cephalometric radiographs will be obtained 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
arm group type: Experimental
description: The patients in this control group will be treated using the Twin-block appliance.
arm group label: Twin-block combined with LIPUS
arm group type: Experimental
description: The patients in this experimental group will be treated using the Twin-block combined with LIPUS (Low-intensity pulsed ultrasound).
intervention type: Device
intervention name: Twin-block
description: Functional treatment will be achieved using the Twinblock appliance
arm group label: Twin-block
arm group label: Twin-block combined with LIPUS
intervention type: Other
intervention name: LIPUS (Low-intensity pulsed ultrasound)
description: Functional treatment will be combined with LIPUS (Low-intensity pulsed ultrasound )
arm group label: Twin-block combined with LIPUS
criteria: 
gender: All
minimum age: 11 Years
maximum age: 14 Years
healthy volunteers: No
last name: Ghiath Mahmood, PhD.
role: Study Director
affiliation: Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
facility: 
country: Syrian Arab Republic
citation: El-Bialy T, El-Shamy I, Graber TM. Growth modification of the rabbit mandible using therapeutic ultrasound: is it possible to enhance functional appliance results? Angle Orthod. 2003 Dec;73(6):631-9. doi: 10.1043/0003-3219(2003)0732.0.CO;2.
PMID: 14719726
citation: El-Bialy T, Hassan A, Albaghdadi T, Fouad HA, Maimani AR. Growth modification of the mandible with ultrasound in baboons: a preliminary report. Am J Orthod Dentofacial Orthop. 2006 Oct;130(4):435.e7-14. doi: 10.1016/j.ajodo.2006.01.025.
PMID: 17045140
citation: Flores-Mir C, Major MP, Major PW. Soft tissue changes with fixed functional appliances in Class II division 1. Angle Orthod. 2006 Jul;76(4):712-20. doi: 10.1043/0003-3219(2006)076[0712:STCWFF]2.0.CO;2.
PMID: 16808582
citation: Jena AK, Duggal R, Parkash H. Skeletal and dentoalveolar effects of Twin-block and bionator appliances in the treatment of Class II malocclusion: a comparative study. Am J Orthod Dentofacial Orthop. 2006 Nov;130(5):594-602. doi: 10.1016/j.ajodo.2005.02.025.
PMID: 17110256
citation: Johns LD, Straub SJ, Howard SM. Analysis of effective radiating area, power, intensity, and field characteristics of ultrasound transducers. Arch Phys Med Rehabil. 2007 Jan;88(1):124-9. doi: 10.1016/j.apmr.2006.09.016.
PMID: 17207688
citation: Sun JS, Hong RC, Chang WH, Chen LT, Lin FH, Liu HC. In vitro effects of low-intensity ultrasound stimulation on the bone cells. J Biomed Mater Res. 2001 Dec 5;57(3):449-56. doi: 10.1002/1097-4636(20011205)57:33.0.co;2-0.
PMID: 11523040
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