<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/NCT01720797</url>
  </required_header>
  <id_info>
    <org_study_id>20121593</org_study_id>
    <nct_id>NCT01720797</nct_id>
  </id_info>
  <brief_title>Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment</brief_title>
  <acronym>Propel</acronym>
  <official_title>Alveolar Microperforation for Inflammation-Enhanced Tooth Movement During Orthodontic Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AlevoLogic LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to assess the clinical effectiveness of the procedure&#xD;
      of a minimally invasive alveolar microperforation procedure to achieve accelerated tooth&#xD;
      movement in patients undergoing orthodontic treatment. &quot;Accelerated tooth movement&quot; means&#xD;
      that using the PROPEL™ device may help complete your treatment with braces on one side of&#xD;
      your mouth sooner than would be expected if the device were not to be used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following informed consent and satisfying the screening/enrollment assessments, a panoramic&#xD;
      and periapical radiograph of the teeth designated for micro-osteoperforation treatment is to&#xD;
      be taken. Prior to the intervention the subjects will swish 5cc of chlorhexidine for one&#xD;
      minute, twice. Micro-osteoperforation, PROPEL™, is conducted under local or topical&#xD;
      anesthesia AFTER the subject is banded and bonded. The procedure will be randomized to either&#xD;
      the left or right side in each subject. Following the procedure, Chlorhexidine rinses are to&#xD;
      begin twice a day for a week.&#xD;
&#xD;
      The subjects will be advised to take Tylenol only in case of significant pain. Subjects will&#xD;
      be seen four to six weeks after completion of treatment for the first follow-up. Subjects&#xD;
      will be followed up with a telephone consult 24 hours after micro-osteoperforation is&#xD;
      performed. They will be asked if any pain medication was taken after being dismissed from the&#xD;
      research center and if so, they will be asked the name and dose of medication taken.&#xD;
&#xD;
      Study will conclude at the 6 month follow up visit or when space on the treating side is&#xD;
      closed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tooth Movement Between the Groups</measure>
    <time_frame>6 months</time_frame>
    <description>Accelerated tooth movement effectiveness as measured by dental impressions. These impressions at the 6 month follow-up will evaluate the rate of tooth movement by measuring casts.&#xD;
Ortholnsight software was used to measure the millimeters of tooth movement from the dental impressions, and then was converted to a Mean and Standard Deviation measurement.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Malocclusion</condition>
  <arm_group>
    <arm_group_label>Micro-osteoperforation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Minimally invasive micro-osteoperforation (PROPEL™) procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non Micro-osteoperforation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Micro-osteoperforation</intervention_name>
    <description>Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement.</description>
    <arm_group_label>Micro-osteoperforation</arm_group_label>
    <other_name>PROPEL™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anesthestic</intervention_name>
    <description>Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice.</description>
    <arm_group_label>Micro-osteoperforation</arm_group_label>
    <other_name>Topical or local anesthetic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chlorhexidine</intervention_name>
    <description>Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week.</description>
    <arm_group_label>Micro-osteoperforation</arm_group_label>
    <arm_group_label>Non Micro-osteoperforation</arm_group_label>
    <other_name>Peridex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescent and adult subjects ages 18-55 years old, in good general health, with adult&#xD;
             or mixed dentition, regardless of presence of third molars.&#xD;
&#xD;
          -  Subjects are American Society of Anesthesiologists (ASA) class I (ASA class I -&#xD;
             Patients are considered to be normal and healthy).&#xD;
&#xD;
          -  Periodontal or gingivitis diseases must be addressed prior to study enrollments:&#xD;
             Probing Depth(PD)&lt;5mm,Gingival Index (GI)&lt;1,Plaque Index(PI)=1&#xD;
&#xD;
          -  If any caries is present, patient will be referred to dentist for treatment and&#xD;
             maintenance before beginning treatment&#xD;
&#xD;
          -  Able to understand English, follow simple instructions and sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have taken any local or systemic antibiotics, corticosteroids or&#xD;
             periodontal medications in the previous six weeks.&#xD;
&#xD;
          -  Subjects with extreme skeletal class II malocclusion: Overjet&gt;10mm, (Pogonion to&#xD;
             Nasion Perpendicular line)Pg-Nper&gt;18mm, A point Nasion B point (ANB)&gt;7, Sella Nasion&#xD;
             line to Gonion Gnathion Line (SN-GoGN)&gt;38&#xD;
&#xD;
          -  Vulnerable subjects who unable to consent for themselves&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Calogero Dolce, D.D.S, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida, Interim Chair</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida, Department of Orthodontics</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <results_first_submitted>June 2, 2015</results_first_submitted>
  <results_first_submitted_qc>June 2, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 19, 2015</results_first_posted>
  <last_update_submitted>June 2, 2015</last_update_submitted>
  <last_update_submitted_qc>June 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Malocclusion</keyword>
  <keyword>Accelerated tooth movement</keyword>
  <keyword>Braces</keyword>
  <keyword>Orthodontic treatment</keyword>
  <keyword>Propel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malocclusion</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Anesthetics, Local</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Micro-osteoperforation</title>
          <description>Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.&#xD;
Micro-osteoperforation: Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement.&#xD;
Anesthestic: Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice.&#xD;
Chlorhexidine: Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week.</description>
        </group>
        <group group_id="P2">
          <title>Non Micro-osteoperforation</title>
          <description>Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Micro-osteoperforation</title>
          <description>Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.</description>
        </group>
        <group group_id="B2">
          <title>Non Micro-osteoperforation</title>
          <description>Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="21"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Tooth Movement Between the Groups</title>
        <description>Accelerated tooth movement effectiveness as measured by dental impressions. These impressions at the 6 month follow-up will evaluate the rate of tooth movement by measuring casts.&#xD;
Ortholnsight software was used to measure the millimeters of tooth movement from the dental impressions, and then was converted to a Mean and Standard Deviation measurement.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Micro-osteoperforation</title>
            <description>Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.</description>
          </group>
          <group group_id="O2">
            <title>Non Micro-osteoperforation</title>
            <description>Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.</description>
          </group>
        </group_list>
        <measure>
          <title>Tooth Movement Between the Groups</title>
          <description>Accelerated tooth movement effectiveness as measured by dental impressions. These impressions at the 6 month follow-up will evaluate the rate of tooth movement by measuring casts.&#xD;
Ortholnsight software was used to measure the millimeters of tooth movement from the dental impressions, and then was converted to a Mean and Standard Deviation measurement.</description>
          <units>percentage of movement</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.345" spread="1.257"/>
                    <measurement group_id="O2" value="4.04" spread="0.991"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 Months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Micro-osteoperforation</title>
          <description>Minimally invasive micro-osteoperforation (PROPEL™) procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.</description>
        </group>
        <group group_id="E2">
          <title>Non Micro-osteoperforation</title>
          <description>Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.&#xD;
Chlorhexidine: Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Calogero Dolce, DDS, PhD</name_or_title>
      <organization>University of Florida</organization>
      <phone>352-273-5700</phone>
      <email>cdolce@dental.ufl.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01720797
org study id: 20121593
nct id: NCT01720797
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this research study is to assess the clinical effectiveness of the procedure
      of a minimally invasive alveolar microperforation procedure to achieve accelerated tooth
      movement in patients undergoing orthodontic treatment. "Accelerated tooth movement" means
      that using the PROPEL™ device may help complete your treatment with braces on one side of
      your mouth sooner than would be expected if the device were not to be used.
Following informed consent and satisfying the screening/enrollment assessments, a panoramic
      and periapical radiograph of the teeth designated for micro-osteoperforation treatment is to
      be taken. Prior to the intervention the subjects will swish 5cc of chlorhexidine for one
      minute, twice. Micro-osteoperforation, PROPEL™, is conducted under local or topical
      anesthesia AFTER the subject is banded and bonded. The procedure will be randomized to either
      the left or right side in each subject. Following the procedure, Chlorhexidine rinses are to
      begin twice a day for a week.

      The subjects will be advised to take Tylenol only in case of significant pain. Subjects will
      be seen four to six weeks after completion of treatment for the first follow-up. Subjects
      will be followed up with a telephone consult 24 hours after micro-osteoperforation is
      performed. They will be asked if any pain medication was taken after being dismissed from the
      research center and if so, they will be asked the name and dose of medication taken.

      Study will conclude at the 6 month follow up visit or when space on the treating side is
      closed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tooth Movement Between the Groups
time frame: 6 months
description: Accelerated tooth movement effectiveness as measured by dental impressions. These impressions at the 6 month follow-up will evaluate the rate of tooth movement by measuring casts.
Ortholnsight software was used to measure the millimeters of tooth movement from the dental impressions, and then was converted to a Mean and Standard Deviation measurement.
arm group label: Micro-osteoperforation
arm group type: Experimental
description: Minimally invasive micro-osteoperforation (PROPEL™) procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
arm group label: Non Micro-osteoperforation
arm group type: Other
description: Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.
intervention type: Device
intervention name: Micro-osteoperforation
description: Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement.
arm group label: Micro-osteoperforation
other name: PROPEL™
intervention type: Drug
intervention name: Anesthestic
description: Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice.
arm group label: Micro-osteoperforation
other name: Topical or local anesthetic
intervention type: Other
intervention name: Chlorhexidine
description: Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
arm group label: Micro-osteoperforation
arm group label: Non Micro-osteoperforation
other name: Peridex
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Calogero Dolce, D.D.S, PhD
role: Principal Investigator
affiliation: University of Florida, Interim Chair
facility: 
country: United States
responsible party type: Sponsor
mesh term: Malocclusion
mesh term: Inflammation
mesh term: Chlorhexidine
mesh term: Anesthetics
mesh term: Anesthetics, Local
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 