<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/NCT03780764</url>
  </required_header>
  <id_info>
    <org_study_id>236/2016</org_study_id>
    <nct_id>NCT03780764</nct_id>
  </id_info>
  <brief_title>Changes in Pulpal Blood Flow Between Conventional and Self-ligating Fixed Orthodontic Brackets During Leveling and Alignment Stage</brief_title>
  <official_title>Changes in Pulpal Blood Flow of Teeth During Leveling and Alignment Stages of Orthodontic Treatment Using 2 Fixed Orthodontic Appliances</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>
      - Evaluate and compare initial changes in PBF between conventional and self-ligating fixed&#xD;
      orthodontic brackets during leveling and alignment stage using 0.016&quot; Nickle titanium (NiTi)&#xD;
      and 0.016X0.022&quot; NiTi archwires at different time intervals (20min, 24h, 72h, 1 week and 1&#xD;
      month) of initial arch wire placement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives: to evaluate and compare the initial changes in pulpal blood flow (PBF) between&#xD;
      conventional and self-ligating fixed orthodontic brackets during leveling and alignment&#xD;
      stage.&#xD;
&#xD;
      Materials and Methods: A total of 22 patients (16 females and 6 males) aged 19± 2.53 years&#xD;
      who presented with mild lower arch crowding were selected to participate in the study. A&#xD;
      split mouth study design was applied for each patient. Two different fixed appliance brackets&#xD;
      were used in the lower arch (self-ligating brackets on one side and conventional brackets on&#xD;
      the other side of the same patients). PBF was measured for the lower right and left sides&#xD;
      using Laser Doppler Flowmetry at different time intervals (20min, 24h, 72h, 1 week and 1&#xD;
      month) after the fitting of 2 alignment archwires; 0.016&quot; NiTi and 0.016X0.022&quot; NiTi. A&#xD;
      repeated measures analysis of variance test and a Bonferroni post-hoc comparison test were&#xD;
      applied to detect differences in PBF between the 2 groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">May 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>A split mouth study design was applied for each patient. Two different fixed appliance brackets were used in the lower arch (self-ligating brackets on one side and conventional brackets on the other side of the same patients).</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</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">22</enrollment>
  <condition>Orthodontic Appliances</condition>
  <arm_group>
    <arm_group_label>Conventional fixed appliance</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A pre-adjusted edgewise fixed appliance (3M Gemini Unitek, 0.022&quot; Roth prescription brackets) on one side of lower arch.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self ligating fixed appliance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Self-ligating brackets (Unitek™ Gemini SL Self-Ligating Brackets, 0.022&quot; Roth prescription brackets) on the other side.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>A Pre-adjusted edgewise brackets: 3M Gemini Unitek, 0.022&quot; Roth prescription brackets</intervention_name>
    <description>A pre-adjusted edgewise fixed appliance (3M Gemini Unitek, 0.022&quot; Roth prescription brackets) on one side of lower arch. The standardized bonding technique was applied according to the manufacturer's instructions. Teeth alignment was initiated using round 0.016&quot; NiTi arch wire until 0.016X0.022&quot; NiTi was reached. The NiTi arch wires were placed into brackets slots and tied with elastomers (figure of 8).</description>
    <arm_group_label>Conventional fixed appliance</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self- ligating brackets: Unitek™ Gemini SL Self-Ligating Brackets, 0.022&quot; Roth prescription brackets</intervention_name>
    <description>Self-ligating brackets (Unitek™ Gemini SL Self-Ligating Brackets, 0.022&quot; Roth prescription brackets) on the other side of lower arch. The standardized bonding technique was applied according to the manufacturer's instructions. Teeth alignment was initiated using round 0.016&quot; NiTi arch wire until 0.016X0.022&quot; NiTi was reached. The NiTi arch wires were placed into brackets slots and held in place by bracket's gate in the self-ligating brackets side.</description>
    <arm_group_label>Self ligating fixed appliance</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both male and female subjects&#xD;
&#xD;
          -  6 or more years old&#xD;
&#xD;
          -  Class I skeletal malocclusion&#xD;
&#xD;
          -  mild lower arch crowding.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poor oral hygiene&#xD;
&#xD;
          -  Previous orthodontic treatment&#xD;
&#xD;
          -  Active periodontal disease&#xD;
&#xD;
          -  Missing teeth, 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 and&#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>
  <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>December 2018</verification_date>
  <study_first_submitted>December 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</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>Proffessor- Main investigator</investigator_title>
  </responsible_party>
  <keyword>Pulpal blood flow</keyword>
  <keyword>self ligating brackets</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/NCT03780764
org study id: 236/2016
nct id: NCT03780764
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
- Evaluate and compare initial changes in PBF between conventional and self-ligating fixed
      orthodontic brackets during leveling and alignment stage using 0.016" Nickle titanium (NiTi)
      and 0.016X0.022" NiTi archwires at different time intervals (20min, 24h, 72h, 1 week and 1
      month) of initial arch wire placement.
Objectives: to evaluate and compare the initial changes in pulpal blood flow (PBF) between
      conventional and self-ligating fixed orthodontic brackets during leveling and alignment
      stage.

      Materials and Methods: A total of 22 patients (16 females and 6 males) aged 19± 2.53 years
      who presented with mild lower arch crowding were selected to participate in the study. A
      split mouth study design was applied for each patient. Two different fixed appliance brackets
      were used in the lower arch (self-ligating brackets on one side and conventional brackets on
      the other side of the same patients). PBF was measured for the lower right and left sides
      using Laser Doppler Flowmetry at different time intervals (20min, 24h, 72h, 1 week and 1
      month) after the fitting of 2 alignment archwires; 0.016" NiTi and 0.016X0.022" NiTi. A
      repeated measures analysis of variance test and a Bonferroni post-hoc comparison test were
      applied to detect differences in PBF between the 2 groups.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A split mouth study design was applied for each patient. Two different fixed appliance brackets were used in the lower arch (self-ligating brackets on one side and conventional brackets on the other side of the same patients).
primary purpose: Treatment
masking: None (Open Label)
measure: Pulpal blood flow changes by the use of Laser Doppler Flowmeter
time frame: 20 minutes ,48 hours, 72 hours and 1 month
description: millimeter per second
arm group label: Conventional fixed appliance
arm group type: Active Comparator
description: A pre-adjusted edgewise fixed appliance (3M Gemini Unitek, 0.022" Roth prescription brackets) on one side of lower arch.
arm group label: Self ligating fixed appliance
arm group type: Experimental
description: Self-ligating brackets (Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription brackets) on the other side.
intervention type: Other
intervention name: A Pre-adjusted edgewise brackets: 3M Gemini Unitek, 0.022" Roth prescription brackets
description: A pre-adjusted edgewise fixed appliance (3M Gemini Unitek, 0.022" Roth prescription brackets) on one side of lower arch. The standardized bonding technique was applied according to the manufacturer's instructions. Teeth alignment was initiated using round 0.016" NiTi arch wire until 0.016X0.022" NiTi was reached. The NiTi arch wires were placed into brackets slots and tied with elastomers (figure of 8).
arm group label: Conventional fixed appliance
intervention type: Other
intervention name: Self- ligating brackets: Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription brackets
description: Self-ligating brackets (Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription brackets) on the other side of lower arch. The standardized bonding technique was applied according to the manufacturer's instructions. Teeth alignment was initiated using round 0.016" NiTi arch wire until 0.016X0.022" NiTi was reached. The NiTi arch wires were placed into brackets slots and held in place by bracket's gate in the self-ligating brackets side.
arm group label: Self ligating fixed appliance
criteria: 
gender: All
minimum age: 16 Years
maximum age: 22 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Jordan
responsible party type: Principal Investigator
investigator affiliation: Jordan University of Science and Technology
investigator full name: Elham Abu Alhaija
investigator title: Proffessor- Main investigator
sharing ipd: Undecided