<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/NCT03833739</url>
  </required_header>
  <id_info>
    <org_study_id>461/2017</org_study_id>
    <nct_id>NCT03833739</nct_id>
  </id_info>
  <brief_title>Comparison Between 2 Protocols for the Treatment of Class II Division 2 Malocclusion</brief_title>
  <official_title>A Prospective Randomized Clinical Trial to Compare Between Two Leveling and Alignment Protocols for the Treatment of Class II Division 2 Malocclusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jordan University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jordan University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</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>
      The aim of this prospective study was to compare between two different treatment modalities&#xD;
      of class II division 2; to start treatment in upper arch first until adequate overjet is&#xD;
      obtained or to start in the lower arch first with removable anterior bite plane in upper&#xD;
      arch.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fifty four subjects with class II division 2 participated in this study. The subjects were&#xD;
      randomly divided into two groups; Group one (28 patients): orthodontic treatment with upper&#xD;
      arch bond up first and lower arch was bonded when 4 mm overjet was reached. The treatment&#xD;
      continued until 0.019 x 0.025 &quot; stainless steel wires were reached in both arches. Group 2&#xD;
      (26 patients): orthodontic treatment with lower arch bond up first with removable anterior&#xD;
      bite plane in upper arch. When 0.019 x 0.025&quot; stainless steel wire was reached, the upper&#xD;
      arch was bonded. The treatment continued until 0.019 x 0.025&quot; stainless steel wires were&#xD;
      reached. Three cephalograms were taken for each patient in both groups; pretreatment (T0) ,&#xD;
      after bonding the other arch (T1) and at the end of leveling and alignment in both arches&#xD;
      (T2). Cephalometric measurements and superimpositions were made. Skeletal and dentoalveolar&#xD;
      treatment changes were compared within and between the 2 groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">November 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 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>
    <intervention_model_description>Randomized clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Upper and lower incisors proclination</measure>
    <time_frame>2 years</time_frame>
    <description>Cephalometric analysis. Treatment changes in the values for upper and lower incisors in degrees, Upper incisor /Maxillary plane in degrees and lower incisors/Mandibular plane in degrees.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of treatment</measure>
    <time_frame>2 years</time_frame>
    <description>Measurements of time of treatment in months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain perception</measure>
    <time_frame>2 years</time_frame>
    <description>Using visual analogue scale. From 0 where is no pain to 10 with severe pain</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Class II Div 2 Incisal Relationship</condition>
  <arm_group>
    <arm_group_label>Upper Arch Treatment First</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention : using fixed orthodontic pre-adjusted edgewise appliance in the upper and lower arches.&#xD;
starting treatment in the upper arch The upper ach was bonded for 28 patients and teeth alignment was started using round 0.014&quot;NiTi arch wire. The 0.014&quot;NiTi arch wire was placed into the slots of the brackets and tied with elastomers by figure of 8. Orthodontic treatment was continued in the upper arch with arch wire sequence of 0.014&quot;NiTi, 0.018&quot;NiTi, 0.016&quot;X0.022&quot;NiTi, 0.019&quot;X0.025&quot;NiTi, and 0.019&quot;X0.025&quot;stainless steel arch wires. The patients were followed up on a monthly basis until sufficient proclination of the upper incisors achieved to establish an overjet of at least 4 mm. After reaching the full working arch wire in lower arch (0.019&quot; X 0.025&quot;stainless steel wire), lateral cephalogram and study models were taken.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lower Arch Treatment First</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention : using fixed orthodontic pre-adjusted edgewise appliance in the lower arch and anterior bite plate in the upper arch.&#xD;
The lower arch was bonded after taking the pretreatment records. At the same appointment an anterior bite plate in the upper arch was delivered to prevent shearing off the mandibular incisor brackets and help in correction of anterior deep bite .After lower arch alignment and leveling in the same arch wire sequence as the other group and 0.019&quot; X 0.025&quot;stainless steel arch wire was reached, the anterior bite plate was removed and the upper arch was bonded. The same arch wire sequence was used in the upper arch as was used in the lower arch. When the full working arch wire (0.019&quot; X 0.025&quot;stainless steel arch wire) was reached in the upper arch, study models and lateral cephalogram were taken.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fixed appliance</intervention_name>
    <arm_group_label>Lower Arch Treatment First</arm_group_label>
    <arm_group_label>Upper Arch Treatment First</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 17 years and ≤ 26 years&#xD;
&#xD;
          -  Class II division 2 malocclusion.&#xD;
&#xD;
          -  Overjet (OJ) &lt; 4 mm.&#xD;
&#xD;
          -  Overbite (OB) covering more than half of the lower incisor height.&#xD;
&#xD;
          -  Mild to moderate crowding with tooth contact displacement no more than 2 mm.&#xD;
&#xD;
          -  Good oral hygiene and healthy periodontium.&#xD;
&#xD;
        Exclusion Criteria:-&#xD;
&#xD;
          -  Systemic health problems and medications were taken.&#xD;
&#xD;
          -  History of previous orthodontic treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan AlKhateeb, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jordan University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jordan University of Science and Technology Dental Teaching Clinics</name>
      <address>
        <city>Irbid</city>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>February 20, 2019</last_update_submitted>
  <last_update_submitted_qc>February 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jordan University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Mahmoud abuaysheh</investigator_full_name>
    <investigator_title>Principal Investigator - Master student</investigator_title>
  </responsible_party>
  <keyword>Class II division 2</keyword>
  <keyword>Alignment</keyword>
  <keyword>Leveling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malocclusion</mesh_term>
  </condition_browse>
  <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/NCT03833739
org study id: 461/2017
nct id: NCT03833739
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this prospective study was to compare between two different treatment modalities
      of class II division 2; to start treatment in upper arch first until adequate overjet is
      obtained or to start in the lower arch first with removable anterior bite plane in upper
      arch.
Fifty four subjects with class II division 2 participated in this study. The subjects were
      randomly divided into two groups; Group one (28 patients): orthodontic treatment with upper
      arch bond up first and lower arch was bonded when 4 mm overjet was reached. The treatment
      continued until 0.019 x 0.025 " stainless steel wires were reached in both arches. Group 2
      (26 patients): orthodontic treatment with lower arch bond up first with removable anterior
      bite plane in upper arch. When 0.019 x 0.025" stainless steel wire was reached, the upper
      arch was bonded. The treatment continued until 0.019 x 0.025" stainless steel wires were
      reached. Three cephalograms were taken for each patient in both groups; pretreatment (T0) ,
      after bonding the other arch (T1) and at the end of leveling and alignment in both arches
      (T2). Cephalometric measurements and superimpositions were made. Skeletal and dentoalveolar
      treatment changes were compared within and between the 2 groups.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized clinical trial
primary purpose: Treatment
measure: Upper and lower incisors proclination
time frame: 2 years
description: Cephalometric analysis. Treatment changes in the values for upper and lower incisors in degrees, Upper incisor /Maxillary plane in degrees and lower incisors/Mandibular plane in degrees.
measure: Duration of treatment
time frame: 2 years
description: Measurements of time of treatment in months
measure: Pain perception
time frame: 2 years
description: Using visual analogue scale. From 0 where is no pain to 10 with severe pain
arm group label: Upper Arch Treatment First
arm group type: Experimental
description: Intervention : using fixed orthodontic pre-adjusted edgewise appliance in the upper and lower arches.
starting treatment in the upper arch The upper ach was bonded for 28 patients and teeth alignment was started using round 0.014"NiTi arch wire. The 0.014"NiTi arch wire was placed into the slots of the brackets and tied with elastomers by figure of 8. Orthodontic treatment was continued in the upper arch with arch wire sequence of 0.014"NiTi, 0.018"NiTi, 0.016"X0.022"NiTi, 0.019"X0.025"NiTi, and 0.019"X0.025"stainless steel arch wires. The patients were followed up on a monthly basis until sufficient proclination of the upper incisors achieved to establish an overjet of at least 4 mm. After reaching the full working arch wire in lower arch (0.019" X 0.025"stainless steel wire), lateral cephalogram and study models were taken.
arm group label: Lower Arch Treatment First
arm group type: Experimental
description: Intervention : using fixed orthodontic pre-adjusted edgewise appliance in the lower arch and anterior bite plate in the upper arch.
The lower arch was bonded after taking the pretreatment records. At the same appointment an anterior bite plate in the upper arch was delivered to prevent shearing off the mandibular incisor brackets and help in correction of anterior deep bite .After lower arch alignment and leveling in the same arch wire sequence as the other group and 0.019" X 0.025"stainless steel arch wire was reached, the anterior bite plate was removed and the upper arch was bonded. The same arch wire sequence was used in the upper arch as was used in the lower arch. When the full working arch wire (0.019" X 0.025"stainless steel arch wire) was reached in the upper arch, study models and lateral cephalogram were taken.
intervention type: Device
intervention name: Fixed appliance
arm group label: Lower Arch Treatment First
arm group label: Upper Arch Treatment First
criteria: 
gender: All
minimum age: 17 Years
maximum age: 26 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Susan AlKhateeb, PhD
role: Principal Investigator
affiliation: Jordan University of Science and Technology
facility: 
country: Jordan
responsible party type: Principal Investigator
investigator affiliation: Jordan University of Science and Technology
investigator full name: Mahmoud abuaysheh
investigator title: Principal Investigator - Master student
mesh term: Malocclusion
sharing ipd: Undecided