<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/NCT04419805</url>
  </required_header>
  <id_info>
    <org_study_id>2-054-19</org_study_id>
    <nct_id>NCT04419805</nct_id>
  </id_info>
  <brief_title>Single Palatal Temporary Anchorage Device for Anterior Open Bite</brief_title>
  <acronym>SPaTAR</acronym>
  <official_title>Single Palatal Temporary Anchorage Device for Anterior Open Bite: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Dundee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Dundee</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>
      Participants are orthodontic patients with anterior open bite (AOB) malocclusion. These&#xD;
      patients will be treated by molar intrusion achieved using one of two interventions, either&#xD;
      orthodontic fixed appliances incorporating a single palatal Temporary Anchorage Device (TAD)&#xD;
      or orthodontic fixed appliances incorporating two buccal TADs&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be recruited from those attending Dundee Dental Hospital Orthodontic&#xD;
      Department and those currently awaiting treatment. Those that meet the inclusion and&#xD;
      exclusion criteria will be invited to participate. After obtaining consent they will be&#xD;
      allocated to receive one of the two interventions. The two interventions represent the&#xD;
      currently available options for treatment of mild - moderate (1-6mm) anterior open bite in&#xD;
      the Orthodontic Department and as such patients will be receiving routine treatment&#xD;
      regardless of the arm they are randomised to. In order to assess the more effective&#xD;
      intervention additional records will be taken during the treatment involving additional&#xD;
      cephalometric radiographs, additional intra-oral scans or dental impressions (See later for&#xD;
      details). Primary outcome is at the end of intrusion with TADs after 9-12 months, but&#xD;
      participants will be followed until completion of treatment for the secondary outcome of&#xD;
      stability of intrusion and overbite correction&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2021</start_date>
  <completion_date type="Anticipated">October 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2023</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>
    <intervention_model_description>Randomised parallel 2 group clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Outcome assessor will be blind to allocation</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Molar intrusion</measure>
    <time_frame>9-12 months after treatment commences</time_frame>
    <description>Amount of upper molar intrusion measured in mms on cephalometric radiograph</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overbite (vertical overlap of anterior teeth)</measure>
    <time_frame>9-12 months after treatment commences</time_frame>
    <description>Change in overbite (vertical overlap of anterior teeth) measured clinically directly from the teeth with a ruler and on 3D dental scans using 3D analysis software, both in mms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Experience</measure>
    <time_frame>9-12 months after treatment commences</time_frame>
    <description>Patient experience with the use of temporary anchorage devices for intrusion by validated questionnaire which uses 3 or 4 point Likert Scales for a range of questions across relevant doamins. Depending on the question the scales are 'Improved/Same/Worse/Much worse' or 'Not at all / A little / A lot' or 'I do more / no difference / I do less' (Yassir et al 2017)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Anterior Openbite</condition>
  <arm_group>
    <arm_group_label>Single Palatal TAD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single Palatal TAD for orthodontic molar intrusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Two buccal TADs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two buccal TADs for orthodontic molar intrusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Single Palatal TAD</intervention_name>
    <description>A single mini-screw inserted in the mid-palate</description>
    <arm_group_label>Single Palatal TAD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Two buccal TADs</intervention_name>
    <description>Two buccal TADs inserted in the upper jaw</description>
    <arm_group_label>Two buccal TADs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with AOB of 1-6mm&#xD;
&#xD;
          -  Aged between (12 and 40 years).&#xD;
&#xD;
          -  Able to consent.&#xD;
&#xD;
          -  Patient due to undergo orthodontic treatment with fixed orthodontic braces.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has previously had upper first permanent molar extraction.&#xD;
&#xD;
          -  Patient with congenital cleft of lip and/or palate or any other craniofacial&#xD;
             anomalies.&#xD;
&#xD;
          -  Patient with bone disease or taking medications that affect the bone quality or&#xD;
             nature.&#xD;
&#xD;
          -  Patient with an active digit sucking habit.&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Mossey, BDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Dundee</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David Bearn, BDS</last_name>
    <phone>01382385024</phone>
    <email>d.bearn@dundee.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vera Nuritova, PhD</last_name>
    <phone>01382383877</phone>
    <email>TASCgovernance@dundee.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dundee Dental Hospital</name>
      <address>
        <city>Dundee</city>
        <zip>DD1 4HR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David R Bearn, BDS</last_name>
      <phone>01382381604</phone>
      <email>d.bearn@dundee.ac.uk</email>
    </contact>
    <contact_backup>
      <last_name>Omar Alshaibi, BDS</last_name>
      <phone>07762379239</phone>
      <email>o.alshaibi@dundee.ac.uk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Yassir YA, McIntyre GT, Bearn DR. Three questionnaires to assess the perception of fixed orthodontic therapy before, during and after treatment: validity and reliability. Eur J Orthod. 2017 Aug 1;39(4):402-410. doi: 10.1093/ejo/cjw076.</citation>
    <PMID>27864320</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Dundee</investigator_affiliation>
    <investigator_full_name>Peter Mossey</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Orthodontics</keyword>
  <keyword>Temporary Anchorage Device</keyword>
  <keyword>Anterior Open Bite</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Open Bite</mesh_term>
  </condition_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/NCT04419805
org study id: 2-054-19
nct id: NCT04419805
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Participants are orthodontic patients with anterior open bite (AOB) malocclusion. These
      patients will be treated by molar intrusion achieved using one of two interventions, either
      orthodontic fixed appliances incorporating a single palatal Temporary Anchorage Device (TAD)
      or orthodontic fixed appliances incorporating two buccal TADs
Participants will be recruited from those attending Dundee Dental Hospital Orthodontic
      Department and those currently awaiting treatment. Those that meet the inclusion and
      exclusion criteria will be invited to participate. After obtaining consent they will be
      allocated to receive one of the two interventions. The two interventions represent the
      currently available options for treatment of mild - moderate (1-6mm) anterior open bite in
      the Orthodontic Department and as such patients will be receiving routine treatment
      regardless of the arm they are randomised to. In order to assess the more effective
      intervention additional records will be taken during the treatment involving additional
      cephalometric radiographs, additional intra-oral scans or dental impressions (See later for
      details). Primary outcome is at the end of intrusion with TADs after 9-12 months, but
      participants will be followed until completion of treatment for the secondary outcome of
      stability of intrusion and overbite correction
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomised parallel 2 group clinical trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Outcome assessor will be blind to allocation
measure: Molar intrusion
time frame: 9-12 months after treatment commences
description: Amount of upper molar intrusion measured in mms on cephalometric radiograph
measure: Overbite (vertical overlap of anterior teeth)
time frame: 9-12 months after treatment commences
description: Change in overbite (vertical overlap of anterior teeth) measured clinically directly from the teeth with a ruler and on 3D dental scans using 3D analysis software, both in mms
measure: Patient Experience
time frame: 9-12 months after treatment commences
description: Patient experience with the use of temporary anchorage devices for intrusion by validated questionnaire which uses 3 or 4 point Likert Scales for a range of questions across relevant doamins. Depending on the question the scales are 'Improved/Same/Worse/Much worse' or 'Not at all / A little / A lot' or 'I do more / no difference / I do less' (Yassir et al 2017)
arm group label: Single Palatal TAD
arm group type: Experimental
description: Single Palatal TAD for orthodontic molar intrusion
arm group label: Two buccal TADs
arm group type: Experimental
description: Two buccal TADs for orthodontic molar intrusion
intervention type: Device
intervention name: Single Palatal TAD
description: A single mini-screw inserted in the mid-palate
arm group label: Single Palatal TAD
intervention type: Device
intervention name: Two buccal TADs
description: Two buccal TADs inserted in the upper jaw
arm group label: Two buccal TADs
criteria: 
gender: All
minimum age: 12 Years
maximum age: 40 Years
healthy volunteers: No
last name: Peter Mossey, BDS
role: Principal Investigator
affiliation: University of Dundee
last name: David Bearn, BDS
phone: 01382385024
email: d.bearn@dundee.ac.uk
last name: Vera Nuritova, PhD
phone: 01382383877
email: TASCgovernance@dundee.ac.uk
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
citation: Yassir YA, McIntyre GT, Bearn DR. Three questionnaires to assess the perception of fixed orthodontic therapy before, during and after treatment: validity and reliability. Eur J Orthod. 2017 Aug 1;39(4):402-410. doi: 10.1093/ejo/cjw076.
PMID: 27864320
responsible party type: Principal Investigator
investigator affiliation: University of Dundee
investigator full name: Peter Mossey
investigator title: Professor
mesh term: Open Bite
sharing ipd: No