<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/NCT03772795</url>
  </required_header>
  <id_info>
    <org_study_id>262/2016</org_study_id>
    <nct_id>NCT03772795</nct_id>
  </id_info>
  <brief_title>Changes in Pulpal Blood Flow of Teeth During Leveling and Alignment Stages of Orthodontic Treatment Using Clear Aligners</brief_title>
  <official_title>Changes in Pulpal Blood Flow of Teeth During Leveling and Alignment Stages of Orthodontic Treatment Using Clear Aligners</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aims of this study were to: -&#xD;
&#xD;
        -  Evaluate PBF in upper and lower teeth during orthodontic alignment using fixed&#xD;
           appliances (0.014&quot; super elastic NiTi arch wire) at different time intervals (20min,&#xD;
           48h, 72h and 1 month) of initial arch wire placement.&#xD;
&#xD;
        -  Evaluate the PBF in upper and lower teeth during orthodontic teeth alignment using clear&#xD;
           aligners at different time intervals (20min ,48h, 72h and 1 month) of fitting the second&#xD;
           aligner (first active aligner).&#xD;
&#xD;
        -  Compare the PBF changes between the above two different types of orthodontic appliances&#xD;
           (fixed appliances and the clear aligners).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aims: to evaluate the pulpal blood flow (PBF) during orthodontic teeth alignment and leveling&#xD;
      using clear aligners (second aligner) and fixed orthodontic appliance at different time&#xD;
      intervals of orthodontic force application.&#xD;
&#xD;
      Materials and Methods: A total of 45 subjects were subdivided in two groups: group 1: 25&#xD;
      subjects treated with pre-adjusted edgewise fixed appliance with 0.014 inch NiTi as the&#xD;
      alignment arch wire and group 2: 20 subjects treated using clear aligner. In both groups, PBF&#xD;
      was measured for the upper right and the lower left using Laser Doppler Flowmetry at&#xD;
      different time interval (20 minutes, 48 hours, 72 hours, 1 month) after the fitting of the&#xD;
      arch wire in group one and after the delivery of the second aligner in group two.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 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>
    <intervention_model_description>Two groups receiving 2 interventions. In the first group patients received fixed orthodontic appliance and in the second, they received clear aligner orthodontic appliance</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pulpal blood flow changes by the use of Laser Doppler Flowmeter (Moor lab, Moor instruments, UK) with a wavelength of 780 nm and a dental probe MP 13 (Moor instruments, UK; 2 fibers, 0.25 mm diameter, centers 0.5 mm spaced apart).</measure>
    <time_frame>20 minutes ,48 hours, 72 hours and 1 month</time_frame>
    <description>millimeter per second</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Alignment</condition>
  <arm_group>
    <arm_group_label>Group 1- Alignment with fixed appliance</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A pre-adjusted edgewise fixed appliance (3M Gemini Uniteks, 0.022&quot; Roth prescription brackets.Teeth alignment in this group 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. During this stage, only tipping movement was applied.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2- Alignment with clear aligners</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clear aligner orthodontic appliance (EON, Eon Dental NV, Belgium). Teeth alignment with clear aligners.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Orthodontic Alignment</intervention_name>
    <description>Group 1:- Teeth alignment in this group 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. During this stage, only tipping movement was applied.</description>
    <arm_group_label>Group 1- Alignment with fixed appliance</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Orthodontic Alignment</intervention_name>
    <description>Group 2: Teeth alignment using clear aligners.</description>
    <arm_group_label>Group 2- Alignment with clear aligners</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both male and female subjects&#xD;
&#xD;
          -  16 or more years old&#xD;
&#xD;
          -  Class I skeletal malocclusion&#xD;
&#xD;
          -  mild upper and lower arches crowding. Exclusion Criteria:-&#xD;
&#xD;
          -  Poor oral hygiene&#xD;
&#xD;
          -  Previous orthodontic treatment&#xD;
&#xD;
          -  Active periodontal disease&#xD;
&#xD;
          -  Missing teeth&#xD;
&#xD;
          -  Deep carious teeth&#xD;
&#xD;
          -  Teeth with root resorption&#xD;
&#xD;
          -  Endodontically treated teeth&#xD;
&#xD;
          -  History of previous trauma&#xD;
&#xD;
          -  Restoration on measured teeth&#xD;
&#xD;
          -  Medical conditions affecting blood vessels&#xD;
&#xD;
          -  Smoking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>22 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 9, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 28, 2018</last_update_submitted>
  <last_update_submitted_qc>December 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 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>Elham Abu Alhaija</investigator_full_name>
    <investigator_title>Principal Investigator - Main thesis supervisor</investigator_title>
  </responsible_party>
  <keyword>Pulpal blood flow</keyword>
  <keyword>clear aligners</keyword>
  <keyword>orthodontics</keyword>
  <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/NCT03772795
org study id: 262/2016
nct id: NCT03772795
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aims of this study were to: -

        -  Evaluate PBF in upper and lower teeth during orthodontic alignment using fixed
           appliances (0.014" super elastic NiTi arch wire) at different time intervals (20min,
           48h, 72h and 1 month) of initial arch wire placement.

        -  Evaluate the PBF in upper and lower teeth during orthodontic teeth alignment using clear
           aligners at different time intervals (20min ,48h, 72h and 1 month) of fitting the second
           aligner (first active aligner).

        -  Compare the PBF changes between the above two different types of orthodontic appliances
           (fixed appliances and the clear aligners).
Aims: to evaluate the pulpal blood flow (PBF) during orthodontic teeth alignment and leveling
      using clear aligners (second aligner) and fixed orthodontic appliance at different time
      intervals of orthodontic force application.

      Materials and Methods: A total of 45 subjects were subdivided in two groups: group 1: 25
      subjects treated with pre-adjusted edgewise fixed appliance with 0.014 inch NiTi as the
      alignment arch wire and group 2: 20 subjects treated using clear aligner. In both groups, PBF
      was measured for the upper right and the lower left using Laser Doppler Flowmetry at
      different time interval (20 minutes, 48 hours, 72 hours, 1 month) after the fitting of the
      arch wire in group one and after the delivery of the second aligner in group two.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two groups receiving 2 interventions. In the first group patients received fixed orthodontic appliance and in the second, they received clear aligner orthodontic appliance
primary purpose: Treatment
masking: None (Open Label)
measure: Pulpal blood flow changes by the use of Laser Doppler Flowmeter (Moor lab, Moor instruments, UK) with a wavelength of 780 nm and a dental probe MP 13 (Moor instruments, UK; 2 fibers, 0.25 mm diameter, centers 0.5 mm spaced apart).
time frame: 20 minutes ,48 hours, 72 hours and 1 month
description: millimeter per second
arm group label: Group 1- Alignment with fixed appliance
arm group type: Active Comparator
description: A pre-adjusted edgewise fixed appliance (3M Gemini Uniteks, 0.022" Roth prescription brackets.Teeth alignment in this group 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. During this stage, only tipping movement was applied.
arm group label: Group 2- Alignment with clear aligners
arm group type: Experimental
description: Clear aligner orthodontic appliance (EON, Eon Dental NV, Belgium). Teeth alignment with clear aligners.
intervention type: Other
intervention name: Orthodontic Alignment
description: Group 1:- Teeth alignment in this group 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. During this stage, only tipping movement was applied.
arm group label: Group 1- Alignment with fixed appliance
intervention type: Other
intervention name: Orthodontic Alignment
description: Group 2: Teeth alignment using clear aligners.
arm group label: Group 2- Alignment with clear aligners
criteria: 
gender: All
minimum age: 16 Years
maximum age: 22 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Jordan University of Science and Technology
investigator full name: Elham Abu Alhaija
investigator title: Principal Investigator - Main thesis supervisor
sharing ipd: Undecided