<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/NCT02190630</url>
  </required_header>
  <id_info>
    <org_study_id>ReDA Ref: 009038</org_study_id>
    <nct_id>NCT02190630</nct_id>
  </id_info>
  <brief_title>Study to Measure the Effect of Part Time Versus Full Time Orthodontic Appliance Wear</brief_title>
  <official_title>A Prospective Randomised Controlled Trial Investigating the Skeletal and Dental Effects of a Removable Brace That Works on the Upper and Lower Teeth at the Same Time Worn Part Time Versus Full Time</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen Mary University of London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Health Service, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Queen Mary University of London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to assess skeletal (bone) and dental (teeth) changes occurring&#xD;
      following wear of a twin block functional appliance (removable brace which postures the lower&#xD;
      jaw forward to improve a discrepancy between the upper and lower jaw) for differing time&#xD;
      periods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Functional appliances are ordinarily worn full time in adolescence between 11 and 14 years&#xD;
      with a discrepancy between their upper and lower jaws. The reason it is worn between these&#xD;
      ages is to avail of the pre pubertal growth spurt, evidence for full time wear is merely&#xD;
      empirical.If this appliance only had to be worn part time it would have a significant change&#xD;
      in orthodontics in terms of patient acceptance and compliance.The investigators plan on&#xD;
      recruiting 84 patients to the study and these subjects will be referred from hospital&#xD;
      colleagues. The investigators will randomly allocate the subjects into 2 groups, Group 1 will&#xD;
      wear the appliance Full Time(24hours), group 2 will wear the appliance part time(12hours).&#xD;
&#xD;
      The study will be conducted in the Dental Institute at the Royal London Hospital, this&#xD;
      hospital setting will be the sole site.&#xD;
&#xD;
      The study will last for 15 months from the time the last patient is recruited. Participants&#xD;
      will undergo an initial records appointment where a radiograph and clinical measurements will&#xD;
      be taken followed by 12 months of functional appliance treatment where the patient will be&#xD;
      reviewed at 6-8weekly intervals and clinical measurements taken.A final radiograph will be&#xD;
      taken at 15months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>December 2013</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">July 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>remaining overjet measured with an orthodontic ruler</measure>
    <time_frame>outcome measure will be assessed after 12 months appliance wear and after a 3 month relapse period</time_frame>
    <description>the initial overjet will compared to the final overjet following 12 months of appliance treatment, and 3 months of relapse. overjet will be measured with an orthodontic ruler at every review appointment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cephalometric Changes</measure>
    <time_frame>Outcome will be assessed after 12m of appliance wear and after 3 months of settling.</time_frame>
    <description>Both linear and angular cephalometric changes will be assessed over this timeframe.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of subjective and objective measures of appliance wear</measure>
    <time_frame>12 months of appliance wear</time_frame>
    <description>Subjective (patient completed time charts) and objective (theramon micro-sensor) measures of wear will be assessed over 12months of appliance wear.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Class II Division 1 Malocclusion</condition>
  <arm_group>
    <arm_group_label>Part time (12hour) wear</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the' Modified Clark Twin Block' will be worn part time</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Full time (24hour) wear</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the ' Modified Clark Twin Block' will be worn full time</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Modified Clark Twin Block</intervention_name>
    <description>The Modified Clark Twin Block is a type of functional orthodontic appliance used to posture the lower jaw forward to treat discrepancies between the upper and lower jaw bones</description>
    <arm_group_label>Full time (24hour) wear</arm_group_label>
    <arm_group_label>Part time (12hour) wear</arm_group_label>
    <other_name>Clark Twin Block</other_name>
    <other_name>Twin Block</other_name>
    <other_name>Functional Appliance</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Class II div 1 malocclusion(upper front teeth lying more forward than lower front&#xD;
             teeth with upper front teeth proclined),&#xD;
&#xD;
          -  Overjet(horizontal difference between upper and lower front teeth) measuring minimum&#xD;
             of 7mm,&#xD;
&#xD;
          -  Male subjects 12--14 years at the start of treatment,&#xD;
&#xD;
          -  Female subjects 11--13 years at start of treatment,&#xD;
&#xD;
          -  Willingness of the patient and parent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No previous orthodontic treatment&#xD;
&#xD;
          -  No relevant medical history or craniofacial syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kate Counihan, BDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen Mary University of London</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeet Parekh, BDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen Mary University of London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dental Insitiute Royal London Hospital</name>
      <address>
        <city>London</city>
        <zip>E1 1BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>March 12, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malocclusion</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>January 13, 2020</submitted>
    <returned>January 23, 2020</returned>
  </pending_results>
  <!-- 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/NCT02190630
org study id: ReDA Ref: 009038
nct id: NCT02190630
lead sponsor: 
collaborator: 
has dmc: Yes
The aim of this study is to assess skeletal (bone) and dental (teeth) changes occurring
      following wear of a twin block functional appliance (removable brace which postures the lower
      jaw forward to improve a discrepancy between the upper and lower jaw) for differing time
      periods.
Functional appliances are ordinarily worn full time in adolescence between 11 and 14 years
      with a discrepancy between their upper and lower jaws. The reason it is worn between these
      ages is to avail of the pre pubertal growth spurt, evidence for full time wear is merely
      empirical.If this appliance only had to be worn part time it would have a significant change
      in orthodontics in terms of patient acceptance and compliance.The investigators plan on
      recruiting 84 patients to the study and these subjects will be referred from hospital
      colleagues. The investigators will randomly allocate the subjects into 2 groups, Group 1 will
      wear the appliance Full Time(24hours), group 2 will wear the appliance part time(12hours).

      The study will be conducted in the Dental Institute at the Royal London Hospital, this
      hospital setting will be the sole site.

      The study will last for 15 months from the time the last patient is recruited. Participants
      will undergo an initial records appointment where a radiograph and clinical measurements will
      be taken followed by 12 months of functional appliance treatment where the patient will be
      reviewed at 6-8weekly intervals and clinical measurements taken.A final radiograph will be
      taken at 15months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: remaining overjet measured with an orthodontic ruler
time frame: outcome measure will be assessed after 12 months appliance wear and after a 3 month relapse period
description: the initial overjet will compared to the final overjet following 12 months of appliance treatment, and 3 months of relapse. overjet will be measured with an orthodontic ruler at every review appointment
measure: Cephalometric Changes
time frame: Outcome will be assessed after 12m of appliance wear and after 3 months of settling.
description: Both linear and angular cephalometric changes will be assessed over this timeframe.
measure: Comparison of subjective and objective measures of appliance wear
time frame: 12 months of appliance wear
description: Subjective (patient completed time charts) and objective (theramon micro-sensor) measures of wear will be assessed over 12months of appliance wear.
arm group label: Part time (12hour) wear
arm group type: Active Comparator
description: the' Modified Clark Twin Block' will be worn part time
arm group label: Full time (24hour) wear
arm group type: Active Comparator
description: the ' Modified Clark Twin Block' will be worn full time
intervention type: Device
intervention name: Modified Clark Twin Block
description: The Modified Clark Twin Block is a type of functional orthodontic appliance used to posture the lower jaw forward to treat discrepancies between the upper and lower jaw bones
arm group label: Full time (24hour) wear
arm group label: Part time (12hour) wear
other name: Clark Twin Block
other name: Twin Block
other name: Functional Appliance
criteria: 
gender: All
minimum age: 11 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kate Counihan, BDS
role: Principal Investigator
affiliation: Queen Mary University of London
last name: Jeet Parekh, BDS
role: Principal Investigator
affiliation: Queen Mary University of London
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Malocclusion
submitted: January 13, 2020
returned: January 23, 2020