<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/NCT04422093</url>
  </required_header>
  <id_info>
    <org_study_id>OrthoKontrol</org_study_id>
    <nct_id>NCT04422093</nct_id>
  </id_info>
  <brief_title>Monitoring System for the Wearing of Orthodontic Elastics</brief_title>
  <acronym>OK</acronym>
  <official_title>OrthoKontrol - System Zur Überwachung Der Tragedauer Von kieferorthopädischen Gummizügen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      The aim of the study is to validate a novel sensor intended to measure the wearing time of&#xD;
      orthodontic elastics in patients with multibracket appliances. The newly developped sensor&#xD;
      will be tested in 42 patients over a period of 6 months&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fixed multibracket appliances are used to correct tooth and jaw malocclusions. Usually,&#xD;
      elastics are inserted between the upper and lower jaws to adjust the position of the jaws in&#xD;
      relation to each other. The wearing time of the elastics determines the duration of the&#xD;
      treatment and the quality of the treatment results. While micro-sensors are increasingly used&#xD;
      for removable appliances to monitor patient compliance, there is still no such possibility&#xD;
      for fixed appliances. This gap is to be closed with the planned 'OrthoKontrol' (intraoral&#xD;
      mini-sensor). This is intended to measure and record the wearing time of the elastics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 15, 2021</start_date>
  <completion_date type="Anticipated">September 15, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 15, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>comfort of the device</measure>
    <time_frame>6 months</time_frame>
    <description>The wearing comfort for the patient is ok/not ok</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Handling of the device</measure>
    <time_frame>6 months</time_frame>
    <description>The handling for the therapist is ok/not ok</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cooperation</measure>
    <time_frame>6 months</time_frame>
    <description>read on the sensors how long the patients followed the instructions</description>
  </secondary_outcome>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Medical Device Complication</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OrthoKontrol</intervention_name>
    <description>Fixing OrthoKontrol Sensor on multibracket appliance to measure cooperation</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with class II malocclusion in treatment with fixed appliances&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Multibracket appliances (fixed braces) in both jaws&#xD;
&#xD;
          -  Need for intermaxillary elastics on at least one side&#xD;
&#xD;
          -  Minimum motor skills&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with general diseases&#xD;
&#xD;
          -  Patients with inflammatory oral diseases&#xD;
&#xD;
          -  Patients with physical disabilities, which make it impossible to cooperate&#xD;
&#xD;
          -  Independent insertion of the elastics is not possible&#xD;
&#xD;
          -  Patients with impaired judgment Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Carlalberta Verna</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Center for Dental Medicine, Basel, Switzerland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carlalberta Verna</last_name>
    <phone>+410612672641</phone>
    <email>carlalberta.verna@unibas.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Center for Dental Medicine UZB</name>
      <address>
        <city>Basel</city>
        <state>Basel Stadt</state>
        <zip>4056</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>carlalberta verna</last_name>
      <email>carlalberta.verna@unibas.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Mizrahi E. Risk management in clinical practice. Part 7. Dento-legal aspects of orthodontic practice. Br Dent J. 2010 Oct 23;209(8):381-90. doi: 10.1038/sj.bdj.2010.926.</citation>
    <PMID>20966997</PMID>
  </reference>
  <reference>
    <citation>Al-Moghrabi D, Salazar FC, Pandis N, Fleming PS. Compliance with removable orthodontic appliances and adjuncts: A systematic review and meta-analysis. Am J Orthod Dentofacial Orthop. 2017 Jul;152(1):17-32. doi: 10.1016/j.ajodo.2017.03.019.</citation>
    <PMID>28651764</PMID>
  </reference>
  <reference>
    <citation>Huanca Ghislanzoni L, Ameur S, Antonarakis GS, Kiliaridis S. Headgear compliance as assessed by a temperature-sensitive recording device: a prospective clinical study. Eur J Orthod. 2019 Nov 15;41(6):641-645. doi: 10.1093/ejo/cjz036.</citation>
    <PMID>31143922</PMID>
  </reference>
  <reference>
    <citation>Schott TC, Goz G. Applicative characteristics of new microelectronic sensors Smart Retainer(R) and TheraMon(R) for measuring wear time. J Orofac Orthop. 2010 Sep;71(5):339-47. doi: 10.1007/s00056-010-1019-3. Epub 2010 Oct 21. English, German.</citation>
    <PMID>20963543</PMID>
  </reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>December 7, 2022</last_update_submitted>
  <last_update_submitted_qc>December 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04422093
org study id: OrthoKontrol
nct id: NCT04422093
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to validate a novel sensor intended to measure the wearing time of
      orthodontic elastics in patients with multibracket appliances. The newly developped sensor
      will be tested in 42 patients over a period of 6 months
Fixed multibracket appliances are used to correct tooth and jaw malocclusions. Usually,
      elastics are inserted between the upper and lower jaws to adjust the position of the jaws in
      relation to each other. The wearing time of the elastics determines the duration of the
      treatment and the quality of the treatment results. While micro-sensors are increasingly used
      for removable appliances to monitor patient compliance, there is still no such possibility
      for fixed appliances. This gap is to be closed with the planned 'OrthoKontrol' (intraoral
      mini-sensor). This is intended to measure and record the wearing time of the elastics.
observational model: Case-Control
time perspective: Prospective
measure: comfort of the device
time frame: 6 months
description: The wearing comfort for the patient is ok/not ok
measure: Handling of the device
time frame: 6 months
description: The handling for the therapist is ok/not ok
measure: cooperation
time frame: 6 months
description: read on the sensors how long the patients followed the instructions
intervention type: Device
intervention name: OrthoKontrol
description: Fixing OrthoKontrol Sensor on multibracket appliance to measure cooperation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 11 Years
maximum age: N/A
last name: Carlalberta Verna
role: Principal Investigator
affiliation: University Center for Dental Medicine, Basel, Switzerland
last name: Carlalberta Verna
phone: +410612672641
email: carlalberta.verna@unibas.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
citation: Mizrahi E. Risk management in clinical practice. Part 7. Dento-legal aspects of orthodontic practice. Br Dent J. 2010 Oct 23;209(8):381-90. doi: 10.1038/sj.bdj.2010.926.
PMID: 20966997
citation: Al-Moghrabi D, Salazar FC, Pandis N, Fleming PS. Compliance with removable orthodontic appliances and adjuncts: A systematic review and meta-analysis. Am J Orthod Dentofacial Orthop. 2017 Jul;152(1):17-32. doi: 10.1016/j.ajodo.2017.03.019.
PMID: 28651764
citation: Huanca Ghislanzoni L, Ameur S, Antonarakis GS, Kiliaridis S. Headgear compliance as assessed by a temperature-sensitive recording device: a prospective clinical study. Eur J Orthod. 2019 Nov 15;41(6):641-645. doi: 10.1093/ejo/cjz036.
PMID: 31143922
citation: Schott TC, Goz G. Applicative characteristics of new microelectronic sensors Smart Retainer(R) and TheraMon(R) for measuring wear time. J Orofac Orthop. 2010 Sep;71(5):339-47. doi: 10.1007/s00056-010-1019-3. Epub 2010 Oct 21. English, German.
PMID: 20963543
responsible party type: Sponsor