<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/NCT01695928</url>
  </required_header>
  <id_info>
    <org_study_id>ESWT2</org_study_id>
    <nct_id>NCT01695928</nct_id>
  </id_info>
  <brief_title>Effect of Shock Waves on Tooth Movement and Miniscrew Stability</brief_title>
  <official_title>Effect of Low-energy Extracorporeal Shock Waves on Orthodontic Tooth Movement and Miniscrew Stability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The low-energy extracorporal shockwave is a scientifically approved method to activate&#xD;
      respectively increase bone-turnover processes especially in orthopedic medicine. The aim of&#xD;
      this clinical study is to apply this effect in orthodontic dentistry and evaluate the&#xD;
      orthodontic tooth movement respectively miniscrew stability clinically.&#xD;
&#xD;
      This randomized clinical study is carried out in orthodontic patients undergoing space&#xD;
      closure therapy at the university clinic of dentistry. During this period the tooth movement&#xD;
      rate as well as the miniscrew stability are evaluated consecutively chairside.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Orthodontic tooth movement</measure>
    <time_frame>4 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Miniscrew stability</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Periodontal status</measure>
    <time_frame>4 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Mesial Movement of Teeth</condition>
  <condition>Miniscrew Stability</condition>
  <arm_group>
    <arm_group_label>Extracorporeal shockwave therapy (ESWT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ESWT Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>No extracoporeal shockwave therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Extracorporeal shockwave therapy</intervention_name>
    <description>1000 impulses</description>
    <arm_group_label>Extracorporeal shockwave therapy (ESWT)</arm_group_label>
    <other_name>Orthogold 100 MTS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ESWT placebo</intervention_name>
    <description>0 impulses, acoustic effect</description>
    <arm_group_label>ESWT Placebo</arm_group_label>
    <other_name>Orthogold 100 MTS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy patients which don´t fulfill the exclusion criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  disease (syndroms,infections,...) which influence the bone turnover and the oral&#xD;
             health&#xD;
&#xD;
          -  medication, which influences the bone turnover and the oral health&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hans P Bantleon, Prof, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Bernhard Gottlieb University Clinic of Dentistry, Department of Orthodontics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bernhard Gottlieb University clinic of Dentistry</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <results_reference>
    <citation>Sathishkumar S, Meka A, Dawson D, House N, Schaden W, Novak MJ, Ebersole JL, Kesavalu L. Extracorporeal shock wave therapy induces alveolar bone regeneration. J Dent Res. 2008 Jul;87(7):687-91. doi: 10.1177/154405910808700703.</citation>
    <PMID>18573992</PMID>
  </results_reference>
  <results_reference>
    <citation>Martini L, Giavaresi G, Fini M, Torricelli P, de Pretto M, Schaden W, Giardino R. Effect of extracorporeal shock wave therapy on osteoblastlike cells. Clin Orthop Relat Res. 2003 Aug;(413):269-80. doi: 10.1097/01.blo.0000073344.50837.cd.</citation>
    <PMID>12897619</PMID>
  </results_reference>
  <results_reference>
    <citation>Hazan-Molina H, Kaufman H, Reznick ZA, Aizenbud D. [Orthodontic tooth movement under extracorporeal shock wave therapy: the characteristics of the inflammatory reaction--a preliminary study]. Refuat Hapeh Vehashinayim (1993). 2011 Jul;28(3):55-60, 71. Hebrew.</citation>
    <PMID>21939106</PMID>
  </results_reference>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>October 9, 2015</last_update_submitted>
  <last_update_submitted_qc>October 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 12, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Frank Falkensammer, DMD,DMS</investigator_full_name>
    <investigator_title>DMD,DMS</investigator_title>
  </responsible_party>
  <keyword>Velocity</keyword>
  <keyword>Location</keyword>
  <keyword>Periodontal status</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mesial Movement of Teeth</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/NCT01695928
org study id: ESWT2
nct id: NCT01695928
lead sponsor: 
has dmc: Yes
The low-energy extracorporal shockwave is a scientifically approved method to activate
      respectively increase bone-turnover processes especially in orthopedic medicine. The aim of
      this clinical study is to apply this effect in orthodontic dentistry and evaluate the
      orthodontic tooth movement respectively miniscrew stability clinically.

      This randomized clinical study is carried out in orthodontic patients undergoing space
      closure therapy at the university clinic of dentistry. During this period the tooth movement
      rate as well as the miniscrew stability are evaluated consecutively chairside.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Orthodontic tooth movement
time frame: 4 months
measure: Miniscrew stability
time frame: 4 months
measure: Periodontal status
time frame: 4 months
arm group label: Extracorporeal shockwave therapy (ESWT)
arm group type: Active Comparator
description: Active treatment
arm group label: ESWT Placebo
arm group type: Placebo Comparator
description: No extracoporeal shockwave therapy
intervention type: Device
intervention name: Extracorporeal shockwave therapy
description: 1000 impulses
arm group label: Extracorporeal shockwave therapy (ESWT)
other name: Orthogold 100 MTS
intervention type: Device
intervention name: ESWT placebo
description: 0 impulses, acoustic effect
arm group label: ESWT Placebo
other name: Orthogold 100 MTS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hans P Bantleon, Prof, M.D.
role: Study Chair
affiliation: Bernhard Gottlieb University Clinic of Dentistry, Department of Orthodontics
facility: 
country: Austria
citation: Sathishkumar S, Meka A, Dawson D, House N, Schaden W, Novak MJ, Ebersole JL, Kesavalu L. Extracorporeal shock wave therapy induces alveolar bone regeneration. J Dent Res. 2008 Jul;87(7):687-91. doi: 10.1177/154405910808700703.
PMID: 18573992
citation: Martini L, Giavaresi G, Fini M, Torricelli P, de Pretto M, Schaden W, Giardino R. Effect of extracorporeal shock wave therapy on osteoblastlike cells. Clin Orthop Relat Res. 2003 Aug;(413):269-80. doi: 10.1097/01.blo.0000073344.50837.cd.
PMID: 12897619
citation: Hazan-Molina H, Kaufman H, Reznick ZA, Aizenbud D. [Orthodontic tooth movement under extracorporeal shock wave therapy: the characteristics of the inflammatory reaction--a preliminary study]. Refuat Hapeh Vehashinayim (1993). 2011 Jul;28(3):55-60, 71. Hebrew.
PMID: 21939106
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Frank Falkensammer, DMD,DMS
investigator title: DMD,DMS
mesh term: Mesial Movement of Teeth