<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/NCT02983084</url>
  </required_header>
  <id_info>
    <org_study_id>1608063565</org_study_id>
    <nct_id>NCT02983084</nct_id>
  </id_info>
  <brief_title>Orthodontic Archwire Comparison Trial</brief_title>
  <official_title>SmartWire Multiforce Archwire Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ormco Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ormco Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this randomized clinical trial (RCT) is to compare traditional CuNiTi&#xD;
      archwires and a recently marketed multiforce version of the same material for the initial&#xD;
      alignment and leveling of dental arches, as well as the expression of EARR in adult&#xD;
      orthodontic patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized clinical trial utilizing multiforce and CuNiTi orthodontic archwires to&#xD;
      align and level dental arches and compare their results. A three group double blind parallel&#xD;
      single site study at IUSD will be used.&#xD;
&#xD;
      Patients that meet the inclusion and exclusion criteria will be recruited from the IUSD&#xD;
      orthodontic clinic. The subjects will be randomly assigned to one of the three groups by the&#xD;
      study statistician. Subjects, examiners providing subject treatment, and examiners measuring&#xD;
      study outcomes will be blinded to treatment assignment.&#xD;
&#xD;
      Study population indicates a sample size of 105 subjects, each group containing 35 clinical&#xD;
      subjects.&#xD;
&#xD;
      Patients will be treated with Ormco Titanium Orthos fixed appliances and defined archwire&#xD;
      sequence according to a clinical protocol. During the six-month study period, subjects will&#xD;
      be seen approximately every 4 (four) weeks for regular standard of care appointments that&#xD;
      will include archwire monitoring, photography and questionnaire completions. Final study&#xD;
      records will be taken at the end of the study period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Anticipated">March 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alignment of dental arches</measure>
    <time_frame>Initial six months of treatment</time_frame>
    <description>Tooth alignment rate in response to force from archwire measured in mm on dental models</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Leveling of dental arches</measure>
    <time_frame>Initial six months of treatment</time_frame>
    <description>Depth of the Curve of Spee (CoS): percent correction during the six month initial alignment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expression of external apical root resorption (EARR)</measure>
    <time_frame>Initial six months of treatment</time_frame>
    <description>Amount of root resorption in response to force from archwire calculated in 3D from the CBCT</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">105</enrollment>
  <condition>Malocclusion</condition>
  <arm_group>
    <arm_group_label>Multiforce</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Variable modulus version of a current orthodontic archwire</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CuNiTi A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>.016&quot; current orthodontic archwire</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CuNiTi B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0.014&quot; and 0.018&quot; current orthodontic archwire sequence</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Orthodontic archwire</intervention_name>
    <description>Archwire used to align teeth in an orthodontic fixed appliance</description>
    <arm_group_label>CuNiTi A</arm_group_label>
    <arm_group_label>CuNiTi B</arm_group_label>
    <arm_group_label>Multiforce</arm_group_label>
    <other_name>Multiforce CuNiTi</other_name>
    <other_name>CuNiTi</other_name>
    <other_name>Copper Nickel Titanium</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult &gt;14yrs of age&#xD;
&#xD;
          -  Amenable to treatment with metal brackets&#xD;
&#xD;
          -  Crowding of 3-8mm in one or both arches (non-extraction treatment)&#xD;
&#xD;
          -  Overbite &gt;3mm&#xD;
&#xD;
          -  Read and speak English without a translator&#xD;
&#xD;
          -  Individuals in good general health at the discretion of the investigator(s)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical/Dental History (Hx):&#xD;
&#xD;
               -  Documented metabolic disorder(s)&#xD;
&#xD;
               -  Nickel allergy&#xD;
&#xD;
               -  Bisphosphonate treatment&#xD;
&#xD;
               -  Amelogenesis, dentinogenesis or osteogenesis imperfect&#xD;
&#xD;
               -  Active caries or periodontal disease&#xD;
&#xD;
               -  Root resorption (moderate to severe)&#xD;
&#xD;
               -  Patients who are pregnant or breast feeding or plan to be pregnant during the&#xD;
                  study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kelton T Stewart, DDS, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana Unversity</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IUSD Orthodontic Clinic</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Orthodontic wires</keyword>
  <keyword>Root resorption</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malocclusion</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Copper</mesh_term>
    <mesh_term>Nickel</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02983084
org study id: 1608063565
nct id: NCT02983084
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this randomized clinical trial (RCT) is to compare traditional CuNiTi
      archwires and a recently marketed multiforce version of the same material for the initial
      alignment and leveling of dental arches, as well as the expression of EARR in adult
      orthodontic patients.
This is a randomized clinical trial utilizing multiforce and CuNiTi orthodontic archwires to
      align and level dental arches and compare their results. A three group double blind parallel
      single site study at IUSD will be used.

      Patients that meet the inclusion and exclusion criteria will be recruited from the IUSD
      orthodontic clinic. The subjects will be randomly assigned to one of the three groups by the
      study statistician. Subjects, examiners providing subject treatment, and examiners measuring
      study outcomes will be blinded to treatment assignment.

      Study population indicates a sample size of 105 subjects, each group containing 35 clinical
      subjects.

      Patients will be treated with Ormco Titanium Orthos fixed appliances and defined archwire
      sequence according to a clinical protocol. During the six-month study period, subjects will
      be seen approximately every 4 (four) weeks for regular standard of care appointments that
      will include archwire monitoring, photography and questionnaire completions. Final study
      records will be taken at the end of the study period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Alignment of dental arches
time frame: Initial six months of treatment
description: Tooth alignment rate in response to force from archwire measured in mm on dental models
measure: Leveling of dental arches
time frame: Initial six months of treatment
description: Depth of the Curve of Spee (CoS): percent correction during the six month initial alignment
measure: Expression of external apical root resorption (EARR)
time frame: Initial six months of treatment
description: Amount of root resorption in response to force from archwire calculated in 3D from the CBCT
arm group label: Multiforce
arm group type: Experimental
description: Variable modulus version of a current orthodontic archwire
arm group label: CuNiTi A
arm group type: Active Comparator
description: .016" current orthodontic archwire
arm group label: CuNiTi B
arm group type: Active Comparator
description: 0.014" and 0.018" current orthodontic archwire sequence
intervention type: Device
intervention name: Orthodontic archwire
description: Archwire used to align teeth in an orthodontic fixed appliance
arm group label: CuNiTi A
arm group label: CuNiTi B
arm group label: Multiforce
other name: Multiforce CuNiTi
other name: CuNiTi
other name: Copper Nickel Titanium
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kelton T Stewart, DDS, MS
role: Principal Investigator
affiliation: Indiana Unversity
facility: 
country: United States
responsible party type: Sponsor
mesh term: Malocclusion
mesh term: Copper
mesh term: Nickel
sharing ipd: No