<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/NCT03240770</url>
  </required_header>
  <id_info>
    <org_study_id>VPro5 + Aligners</org_study_id>
    <nct_id>NCT03240770</nct_id>
  </id_info>
  <brief_title>Effect of VPro5 Therapy on Clear Aligner Therapy</brief_title>
  <official_title>Effect of VPro5 Therapy on Clear Aligner Tracking: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mani Alikhani</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Propel Orthodontics, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Consortium for Translational Orthodontic Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that brief, daily application of HFA will increase the&#xD;
      efficiency of clear aligner treatment by altering PDL metabolism without increasing pain or&#xD;
      discomfort. The investigators will divide subjects into 5 groups changing clear aligners at&#xD;
      different time intervals with or without HFA application for 5 minutes/day to assess the&#xD;
      effect on: time intervals between aligners, cytokine activity, and pain perception.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 3, 2017</start_date>
  <completion_date type="Actual">July 20, 2017</completion_date>
  <primary_completion_date type="Actual">July 20, 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>Average Aligner Tracking Percentage</measure>
    <time_frame>Through study completion, average of 25 days</time_frame>
    <description>Average assessed via measurement of intraoral scan and prediction software</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cytokine Levels</measure>
    <time_frame>Through study completion, average of 25 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Perception via Numerical Rating Scale</measure>
    <time_frame>Day 1 and Day 3 of each aligner</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Malocclusion</condition>
  <arm_group>
    <arm_group_label>14 Day Tray + Sham</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Trays worn at 14 day intervals + Sham</description>
  </arm_group>
  <arm_group>
    <arm_group_label>7 Day Tray + Sham</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trays worn at 7 day intervals (Deviation from Standard Tray Wear Time (14 Days))&#xD;
+ Sham</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5 Day Tray + Sham</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trays worn at 5 day intervals (Deviation from Standard Tray Wear Time (14 Days))&#xD;
+ Sham</description>
  </arm_group>
  <arm_group>
    <arm_group_label>7 Day Tray + VPro5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trays worn at 7 day intervals (Deviation from Standard Tray Wear Time (14 Days))&#xD;
+ HFV with the VPro5 device at 5 min/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5 Day Tray + VPro5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trays worn at 5 day intervals (Deviation from Standard Tray Wear Time (14 Days))&#xD;
+ HFV with the VPro5 device at 5 min/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VPro5 device</intervention_name>
    <description>Use of the VPro5 device for 5 minutes a day</description>
    <arm_group_label>5 Day Tray + VPro5</arm_group_label>
    <arm_group_label>7 Day Tray + VPro5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Deviation from Standard Tray Wear Time (14 Days)</intervention_name>
    <description>Patients reduced Tray Wear Time Interval (14 Days)</description>
    <arm_group_label>5 Day Tray + Sham</arm_group_label>
    <arm_group_label>5 Day Tray + VPro5</arm_group_label>
    <arm_group_label>7 Day Tray + Sham</arm_group_label>
    <arm_group_label>7 Day Tray + VPro5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject must be 18 - 45 years of age&#xD;
&#xD;
          2. Subject is willing and able to comply with all study procedures and sign Informed&#xD;
             consent/HIPAA forms&#xD;
&#xD;
          3. Subject must have complete adult dentition (excluding third molars)&#xD;
&#xD;
          4. Subjects must have class I malocclusion or mild class II/III malocclusions&#xD;
&#xD;
          5. Subject is at least one month into aligner treatment.&#xD;
&#xD;
          6. Subject has history of and current healthy oral hygiene (PD is&lt;4mm, GI&lt;1, and PI=1)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who have received periodontal treatment in the previous 6 months&#xD;
&#xD;
          2. Subjects who are taking medication that could affect the level of inflammation, such&#xD;
             as chronic antibiotics, phenytoin, cyclosporin, ant-inflammatory drugs, systemic&#xD;
             corticosteroids, or calcium channel blockers.&#xD;
&#xD;
          3. Subjects missing adult teeth (except the 3rd molars) or with severe class II or class&#xD;
             III malocclusion.&#xD;
&#xD;
          4. Subjects with skeletal class I but extreme dental malocclusion&#xD;
&#xD;
          5. Severe crowding that require extraction&#xD;
&#xD;
          6. More than 4 mm positive overjet and more than 2 mm negative overjet&#xD;
&#xD;
          7. Extreme deep bite (more than 90%);&#xD;
&#xD;
          8. Severe openbite (more than 2 mm)&#xD;
&#xD;
          9. Pregnant women&#xD;
&#xD;
         10. Subjects do not have any systemic diseases effecting bone metabolism&#xD;
&#xD;
         11. Smoking&#xD;
&#xD;
         12. Vulnerable subjects per IRB definitions&#xD;
&#xD;
         13. Subjects with current caries&#xD;
&#xD;
         14. Subjects that require interproximal reduction or attachments during the study period&#xD;
&#xD;
         15. Subjects who are non-compliant regarding aligner wear or VPro5 recommended daily usage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CTOR</name>
      <address>
        <city>Hoboken</city>
        <state>New Jersey</state>
        <zip>07030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthodontia Studio</name>
      <address>
        <city>Hoboken</city>
        <state>New Jersey</state>
        <zip>07030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>House of Orthodontia</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atique Orthodontics</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Consortium for Translational Orthodontic Research</investigator_affiliation>
    <investigator_full_name>Mani Alikhani</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>HFV</keyword>
  <keyword>HFA</keyword>
  <keyword>High Frequency Vibration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malocclusion</mesh_term>
  </condition_browse>
  <!-- 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/NCT03240770
org study id: VPro5 + Aligners
nct id: NCT03240770
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The investigators hypothesize that brief, daily application of HFA will increase the
      efficiency of clear aligner treatment by altering PDL metabolism without increasing pain or
      discomfort. The investigators will divide subjects into 5 groups changing clear aligners at
      different time intervals with or without HFA application for 5 minutes/day to assess the
      effect on: time intervals between aligners, cytokine activity, and pain perception.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Average Aligner Tracking Percentage
time frame: Through study completion, average of 25 days
description: Average assessed via measurement of intraoral scan and prediction software
measure: Cytokine Levels
time frame: Through study completion, average of 25 days
measure: Pain Perception via Numerical Rating Scale
time frame: Day 1 and Day 3 of each aligner
arm group label: 14 Day Tray + Sham
arm group type: No Intervention
description: Trays worn at 14 day intervals + Sham
arm group label: 7 Day Tray + Sham
arm group type: Experimental
description: Trays worn at 7 day intervals (Deviation from Standard Tray Wear Time (14 Days))
+ Sham
arm group label: 5 Day Tray + Sham
arm group type: Experimental
description: Trays worn at 5 day intervals (Deviation from Standard Tray Wear Time (14 Days))
+ Sham
arm group label: 7 Day Tray + VPro5
arm group type: Experimental
description: Trays worn at 7 day intervals (Deviation from Standard Tray Wear Time (14 Days))
+ HFV with the VPro5 device at 5 min/day
arm group label: 5 Day Tray + VPro5
arm group type: Experimental
description: Trays worn at 5 day intervals (Deviation from Standard Tray Wear Time (14 Days))
+ HFV with the VPro5 device at 5 min/day
intervention type: Device
intervention name: VPro5 device
description: Use of the VPro5 device for 5 minutes a day
arm group label: 5 Day Tray + VPro5
arm group label: 7 Day Tray + VPro5
intervention type: Other
intervention name: Deviation from Standard Tray Wear Time (14 Days)
description: Patients reduced Tray Wear Time Interval (14 Days)
arm group label: 5 Day Tray + Sham
arm group label: 5 Day Tray + VPro5
arm group label: 7 Day Tray + Sham
arm group label: 7 Day Tray + VPro5
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Consortium for Translational Orthodontic Research
investigator full name: Mani Alikhani
investigator title: Director
mesh term: Malocclusion