<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/NCT02996292</url>
  </required_header>
  <id_info>
    <org_study_id>UDDS-Ortho-03-2016</org_study_id>
    <nct_id>NCT02996292</nct_id>
  </id_info>
  <brief_title>Treatment of Crowding Without Extraction Using Self Ligating Brackets</brief_title>
  <official_title>Assessment of Dentoalveolar Changes Resulting From Orthodontic Treatment of Crowding With Self-ligating Brackets Using CBCT 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This experimental study will evaluate the effect of active and passive self-ligating brackets&#xD;
      in treatment of crowding, compared with the control group of conventional brackets in class I&#xD;
      malocclusion without extraction.&#xD;
&#xD;
      The study sample will consist of 66 patients with 3-6mm crowding. The sample will be&#xD;
      allocated randomly into two experimental groups, in addition to a control group.&#xD;
&#xD;
      The brackets will be applied using indirect bonding method for all patients. The&#xD;
      dentoalveolar changes occurring after leveling and alignment teeth will be assessed by using&#xD;
      CBCT radiographs; pre and post- treatment changes for each group will be evaluated&#xD;
      individually.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Producing of modern and various brackets systems both self- ligating and conventional make&#xD;
      the 3 dimensional important in order to evaluate the root positions and to investigate EARR&#xD;
      in multi root teeth, so the research will depend on CBCT to carry out these purposes in our&#xD;
      study. Beside to compare the duration of alignment among groups.&#xD;
&#xD;
      Fixed appliances will be applied into three groups as 1. Active self ligating brackets&#xD;
      (ASLB), 2. Passive self ligating brackets (PSLB), 3. Conventional brackets (CB) until reach&#xD;
      to wire 19*25 S.S upper and lower. During leveling, thermal activated wires will be used in&#xD;
      all patients.&#xD;
&#xD;
      CBCT images will be done before and after leveling and alignment of teeth to compare&#xD;
      dentoalveolar changes between study groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">July 19, 2018</completion_date>
  <primary_completion_date type="Actual">November 2017</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Speed of alignment</measure>
    <time_frame>After 9 months</time_frame>
    <description>Speed of alignment will be measured and compared between the groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of the torque and tipping of teeth</measure>
    <time_frame>Evaluation before and after alignment and leveling teeth. (after 9 months)</time_frame>
    <description>The torque and tipping of teeth will be evaluated before and after treatment and compared between the groups using CBCT images.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of widths and depths of the dental arches</measure>
    <time_frame>Evaluation before and after alignment and leveling teeth. (after 9 months)</time_frame>
    <description>Changes of dental arches dimensions will be measured and compared between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>External apical root resorption</measure>
    <time_frame>After 9 months</time_frame>
    <description>External apical root resorption of each tooth on CBCT images (frequencies) after treatment.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Crowding</condition>
  <arm_group>
    <arm_group_label>Traditional brackets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fixed orthodontic appliances will be applied for aligning and leveling of teeth up to 19*25 stainless steel wires using traditional brackets; American Orthodontics Master® MBT 0.022&quot; Brackets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active self-ligating brackets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fixed orthodontic appliances will be applied for aligning and leveling of teeth up to 19*25 stainless steel wires using active self-ligating brackets; American orthodontics active self-ligating Empower® MBT 0.022&quot;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Passive self-ligating brackets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fixed orthodontic appliances will be applied for aligning and leveling of teeth up to 19*25 stainless steel wires using passive self-ligating brackets; American orthodontics passive self-ligating Empower® MBT 0.022&quot;</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Traditional brackets</intervention_name>
    <description>Treating of crowding using traditional brackets</description>
    <arm_group_label>Traditional brackets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active self-ligating brackets</intervention_name>
    <description>Treating of crowding using active self-ligating brackets</description>
    <arm_group_label>Active self-ligating brackets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Passive self-ligating brackets</intervention_name>
    <description>Treating of crowding using passive self-ligating brackets</description>
    <arm_group_label>Passive self-ligating brackets</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients permanent dentition stage.&#xD;
&#xD;
          -  crowding up to 6 mm&#xD;
&#xD;
          -  Class I relationship.&#xD;
&#xD;
          -  Good oral hygiene.&#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;
          -  Class II or III skeletal anteroposterior relationship.&#xD;
&#xD;
          -  Crowding less than 3mm and more than 6mm.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>24 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>
        <country>Syrian Arab Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Syrian Arab Republic</country>
  </location_countries>
  <results_reference>
    <citation>Badawi HM, Toogood RW, Carey JP, Heo G, Major PW. Torque expression of self-ligating brackets. Am J Orthod Dentofacial Orthop. 2008 May;133(5):721-8. doi: 10.1016/j.ajodo.2006.01.051.</citation>
    <PMID>18456146</PMID>
  </results_reference>
  <results_reference>
    <citation>Chan EK, Darendeliler MA, Petocz P, Jones AS. A new method for volumetric measurement of orthodontically induced root resorption craters. Eur J Oral Sci. 2004 Apr;112(2):134-9. doi: 10.1111/j.1600-0722.2004.00118.x.</citation>
    <PMID>15056110</PMID>
  </results_reference>
  <results_reference>
    <citation>Chen SS, Greenlee GM, Kim JE, Smith CL, Huang GJ. Systematic review of self-ligating brackets. Am J Orthod Dentofacial Orthop. 2010 Jun;137(6):726.e1-726.e18; discussion 726-7. doi: 10.1016/j.ajodo.2009.11.009.</citation>
    <PMID>20685517</PMID>
  </results_reference>
  <results_reference>
    <citation>Garcia-Figueroa MA, Raboud DW, Lam EW, Heo G, Major PW. Effect of buccolingual root angulation on the mesiodistal angulation shown on panoramic radiographs. Am J Orthod Dentofacial Orthop. 2008 Jul;134(1):93-9. doi: 10.1016/j.ajodo.2006.07.034.</citation>
    <PMID>18617108</PMID>
  </results_reference>
  <results_reference>
    <citation>Lagravere MO, Carey J, Toogood RW, Major PW. Three-dimensional accuracy of measurements made with software on cone-beam computed tomography images. Am J Orthod Dentofacial Orthop. 2008 Jul;134(1):112-6. doi: 10.1016/j.ajodo.2006.08.024.</citation>
    <PMID>18617110</PMID>
  </results_reference>
  <results_reference>
    <citation>Morina E, Eliades T, Pandis N, Jager A, Bourauel C. Torque expression of self-ligating brackets compared with conventional metallic, ceramic, and plastic brackets. Eur J Orthod. 2008 Jun;30(3):233-8. doi: 10.1093/ejo/cjn005.</citation>
    <PMID>18540011</PMID>
  </results_reference>
  <results_reference>
    <citation>Sifakakis I, Pandis N, Makou M, Eliades T, Bourauel C. A comparative assessment of the forces and moments generated at the maxillary incisors between conventional and self-ligating brackets using a reverse curve of Spee NiTi archwire. Aust Orthod J. 2010 Nov;26(2):127-33.</citation>
    <PMID>21175021</PMID>
  </results_reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>July 27, 2018</last_update_submitted>
  <last_update_submitted_qc>July 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Crowding</keyword>
  <keyword>Self ligating</keyword>
  <keyword>CBCT</keyword>
  <keyword>RCT</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will be only available to 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/NCT02996292
org study id: UDDS-Ortho-03-2016
nct id: NCT02996292
lead sponsor: 
has dmc: Yes
This experimental study will evaluate the effect of active and passive self-ligating brackets
      in treatment of crowding, compared with the control group of conventional brackets in class I
      malocclusion without extraction.

      The study sample will consist of 66 patients with 3-6mm crowding. The sample will be
      allocated randomly into two experimental groups, in addition to a control group.

      The brackets will be applied using indirect bonding method for all patients. The
      dentoalveolar changes occurring after leveling and alignment teeth will be assessed by using
      CBCT radiographs; pre and post- treatment changes for each group will be evaluated
      individually.
Producing of modern and various brackets systems both self- ligating and conventional make
      the 3 dimensional important in order to evaluate the root positions and to investigate EARR
      in multi root teeth, so the research will depend on CBCT to carry out these purposes in our
      study. Beside to compare the duration of alignment among groups.

      Fixed appliances will be applied into three groups as 1. Active self ligating brackets
      (ASLB), 2. Passive self ligating brackets (PSLB), 3. Conventional brackets (CB) until reach
      to wire 19*25 S.S upper and lower. During leveling, thermal activated wires will be used in
      all patients.

      CBCT images will be done before and after leveling and alignment of teeth to compare
      dentoalveolar changes between study groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Speed of alignment
time frame: After 9 months
description: Speed of alignment will be measured and compared between the groups.
measure: Changes of the torque and tipping of teeth
time frame: Evaluation before and after alignment and leveling teeth. (after 9 months)
description: The torque and tipping of teeth will be evaluated before and after treatment and compared between the groups using CBCT images.
measure: Changes of widths and depths of the dental arches
time frame: Evaluation before and after alignment and leveling teeth. (after 9 months)
description: Changes of dental arches dimensions will be measured and compared between groups.
measure: External apical root resorption
time frame: After 9 months
description: External apical root resorption of each tooth on CBCT images (frequencies) after treatment.
arm group label: Traditional brackets
arm group type: Experimental
description: Fixed orthodontic appliances will be applied for aligning and leveling of teeth up to 19*25 stainless steel wires using traditional brackets; American Orthodontics Master® MBT 0.022" Brackets
arm group label: Active self-ligating brackets
arm group type: Experimental
description: Fixed orthodontic appliances will be applied for aligning and leveling of teeth up to 19*25 stainless steel wires using active self-ligating brackets; American orthodontics active self-ligating Empower® MBT 0.022"
arm group label: Passive self-ligating brackets
arm group type: Experimental
description: Fixed orthodontic appliances will be applied for aligning and leveling of teeth up to 19*25 stainless steel wires using passive self-ligating brackets; American orthodontics passive self-ligating Empower® MBT 0.022"
intervention type: Device
intervention name: Traditional brackets
description: Treating of crowding using traditional brackets
arm group label: Traditional brackets
intervention type: Device
intervention name: Active self-ligating brackets
description: Treating of crowding using active self-ligating brackets
arm group label: Active self-ligating brackets
intervention type: Device
intervention name: Passive self-ligating brackets
description: Treating of crowding using passive self-ligating brackets
arm group label: Passive self-ligating brackets
criteria: 
gender: All
minimum age: 14 Years
maximum age: 24 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: Badawi HM, Toogood RW, Carey JP, Heo G, Major PW. Torque expression of self-ligating brackets. Am J Orthod Dentofacial Orthop. 2008 May;133(5):721-8. doi: 10.1016/j.ajodo.2006.01.051.
PMID: 18456146
citation: Chan EK, Darendeliler MA, Petocz P, Jones AS. A new method for volumetric measurement of orthodontically induced root resorption craters. Eur J Oral Sci. 2004 Apr;112(2):134-9. doi: 10.1111/j.1600-0722.2004.00118.x.
PMID: 15056110
citation: Chen SS, Greenlee GM, Kim JE, Smith CL, Huang GJ. Systematic review of self-ligating brackets. Am J Orthod Dentofacial Orthop. 2010 Jun;137(6):726.e1-726.e18; discussion 726-7. doi: 10.1016/j.ajodo.2009.11.009.
PMID: 20685517
citation: Garcia-Figueroa MA, Raboud DW, Lam EW, Heo G, Major PW. Effect of buccolingual root angulation on the mesiodistal angulation shown on panoramic radiographs. Am J Orthod Dentofacial Orthop. 2008 Jul;134(1):93-9. doi: 10.1016/j.ajodo.2006.07.034.
PMID: 18617108
citation: Lagravere MO, Carey J, Toogood RW, Major PW. Three-dimensional accuracy of measurements made with software on cone-beam computed tomography images. Am J Orthod Dentofacial Orthop. 2008 Jul;134(1):112-6. doi: 10.1016/j.ajodo.2006.08.024.
PMID: 18617110
citation: Morina E, Eliades T, Pandis N, Jager A, Bourauel C. Torque expression of self-ligating brackets compared with conventional metallic, ceramic, and plastic brackets. Eur J Orthod. 2008 Jun;30(3):233-8. doi: 10.1093/ejo/cjn005.
PMID: 18540011
citation: Sifakakis I, Pandis N, Makou M, Eliades T, Bourauel C. A comparative assessment of the forces and moments generated at the maxillary incisors between conventional and self-ligating brackets using a reverse curve of Spee NiTi archwire. Aust Orthod J. 2010 Nov;26(2):127-33.
PMID: 21175021
responsible party type: Sponsor
sharing ipd: No
ipd description: Individual participant data will be only available to the researchers in the department of Orthodontics, Damascus University