<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/NCT03773783</url>
  </required_header>
  <id_info>
    <org_study_id>RG_16-204</org_study_id>
    <nct_id>NCT03773783</nct_id>
  </id_info>
  <brief_title>Study to Compare Two Functional Appliances for Class II Malocclusions</brief_title>
  <official_title>Effectiveness of Treatment for Class II Malocclusions With the Button &amp; Bead or Twin-block Functional Appliance: A Single Centre Randomised Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Birmingham</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A randomised controlled clinical trial to compare the effectiveness of two functional&#xD;
      appliances in the correction of a Class II malocclusion. (Class II malocclusions are where&#xD;
      upper front teeth bite significantly further forward in relation to lower front teeth).&#xD;
&#xD;
      Null hypothesis:&#xD;
&#xD;
      There is no significant difference between the Button &amp; bead and Twin-block appliances with&#xD;
      regard to time taken to reduce the overjet&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      A functional appliance is a type of brace used to help correct a 'Class II' malocclusion.&#xD;
      Class II malocclusions are where upper front teeth bite significantly further forward in&#xD;
      relation to lower front teeth. A functional appliance is defined as a brace that engages&#xD;
      upper and lower teeth and works mainly by posturing the lower jaw away from its normal&#xD;
      position1. The functional appliance may either be removable or fixed in nature and of various&#xD;
      designs.&#xD;
&#xD;
      Correction of a class II malocclusion can be commenced early i.e. before the age of 10 or&#xD;
      during early adolescence when the patient is in a late mixed dentition / early permanent&#xD;
      dentition. If correction is commenced early, this results in the need for a two phase&#xD;
      treatment which involves functional appliance treatment in the first phase (age 7-10)&#xD;
      followed by fixed appliances (+/- functional appliances) as an adolescent (age 11-16). If&#xD;
      correction is started in early adolescence only one phase of treatment is required which&#xD;
      involves a combination of functional and fixed appliances (age 11-16).&#xD;
&#xD;
      Early or delayed class II treatment has been studied by various researchers2-10. O'Brien et&#xD;
      al7 concluded that there was no advantage of early treatment with Twin Block as compared to&#xD;
      treatment started in adolescents. In fact, they reported significantly poorer occlusal&#xD;
      outcomes as determined by the objective Peer Assessment Rating (PAR) index in those that had&#xD;
      early treatment. In addition, they found that total duration of treatment, total attendances&#xD;
      and total cost of treatment was significantly higher in the early treatment group. The&#xD;
      average total duration of treatment for those that had early treatment was 968 days (phase 1&#xD;
      = 527 days and phase 2 = 435 days) compared to 744 days for those that had treatment as an&#xD;
      adolescent only.&#xD;
&#xD;
      The most commonly used brace to correct class II malocclusions in the UK is a functional&#xD;
      appliance (Twin Block design) 11.&#xD;
&#xD;
      The Button and Bead functional appliance has been developed and used successfully by Mr Spary&#xD;
      (Consultant Orthodontist) for several years. However, there are no studies to date that have&#xD;
      studied its effectiveness in correcting a class II problem. The Button and bead appliance&#xD;
      appears to be quicker at reducing the overjet and preferred by patients as there is less&#xD;
      mouth opening making the appliance more comfortable to wear. It is also two clear aligners,&#xD;
      which are more aesthetic than the traditional twin block appliance. The button and bead&#xD;
      appliance does not however allow arch expansion. This may necessitate another appliance prior&#xD;
      to fixed appliance treatment or prolong fixed appliance treatment if expansion also needs to&#xD;
      be carried out in that phase.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. Primary objective:&#xD;
&#xD;
           a. To compare the Button-&amp;-bead and Twin-block appliances treatment duration for overjet&#xD;
           reduction&#xD;
&#xD;
        2. Secondary objectives:&#xD;
&#xD;
             1. To compare the Button-&amp;-bead and Twin-block appliances dento-occlusal outcomes as&#xD;
                measured by the Peer Assessment Rating (PAR)&#xD;
&#xD;
             2. To compare patient compliance with the Button-&amp;-bead and Twin-block appliances and&#xD;
                identify causes for failure&#xD;
&#xD;
             3. To compare the health economics of the Button-&amp;-bead and Twin-block appliances&#xD;
                (Cost of appliances, number of visits, number and cost of repairs and/or&#xD;
                replacements)&#xD;
&#xD;
             4. To compare the skeletal changes of the Button-&amp;-bead and Twin-block appliances&#xD;
                based on the Eastman analysis&#xD;
&#xD;
             5. To compare changes in soft tissue profile as assessed by 3D photographs&#xD;
&#xD;
             6. To assess changes in OHRQoL after overjet reduction with the Button-&amp;-bead and&#xD;
                Twin-block appliances&#xD;
&#xD;
             7. To evaluate and compare patient satisfaction with the Button-&amp;-bead and Twin-block&#xD;
                appliances&#xD;
&#xD;
        3. Safety objective&#xD;
&#xD;
             1. To evaluate the safety of the Button-&amp;-Bead appliance relative to the Twin-Block&#xD;
                appliance in terms of the occurrence of any device-related adverse- and&#xD;
                side-effects (soft-tissue trauma, decalcification, dental caries, ingestion or&#xD;
                aspiration of appliance).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 10, 2017</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2019</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in overjet reduction</measure>
    <time_frame>Overjet measurement recorded at the start of treatment and at completion of functional appliance therapy 1 year later.</time_frame>
    <description>How quickly the horizontal discrepancy between upper and lower incisor edges is reduced</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Peer Assessment Rating (PAR)</measure>
    <time_frame>PAR score will be Assessed from the start of treatment models and the end of fixed appliance study models ( 2 years later)</time_frame>
    <description>PAR score change in terms of percentage and actual score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drop out</measure>
    <time_frame>No. of patients at the start of functional appliance therapy that do not wish to continue within the trial or do not finish functional appliance therapy within 18 months</time_frame>
    <description>Percentage of patients dropping out of each arm of the trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skeletal changes</measure>
    <time_frame>Cephalometric x-rays at start of treatment and at the end of treatment 1 year later</time_frame>
    <description>Compare skeletal changes of landmarks in degrees and millimetres using cephalometric x-rays at various time points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3D soft tissue measures</measure>
    <time_frame>3D photographs at start of treatment and at the end of treatment (approx 1 year later)</time_frame>
    <description>Measure changes in soft tissues using 3D photographs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>Patient satisfaction survey at study completion ( 1 year after treament started)</time_frame>
    <description>Use of tailored patient satisfaction questionnaire to assess patient satisfaction with both appliances</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child related Oral health quality of life (OHRQoL) questionnaire</measure>
    <time_frame>The patient ticked the applicable box for the 16 set questions from the standardised qualitative oral health questionairre. This was undertaken at the start of the trial and again at the end of functional appliance therapy ( approximately 1 year later)</time_frame>
    <description>Changes in OHRQoL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Adverse events over the course of functional appliance treatment ( recorded at every visit and reviewed at 1 year)</time_frame>
    <description>Adverse events: decalcification, dental caries, soft tissue trauma, ingestion or aspiration of appliance</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Malocclusion, Angle Class II</condition>
  <arm_group>
    <arm_group_label>Twin Block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Twin Block appliance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Button and Bead</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Button and Bead appliance</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Button and Bead appliance</intervention_name>
    <description>Button and Bead appliance</description>
    <arm_group_label>Button and Bead</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Twin Block appliance</intervention_name>
    <description>Twin Block appliance</description>
    <arm_group_label>Twin Block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  * Overjet ≥ 7mm&#xD;
&#xD;
               -  The normal overjet for a Caucasian population is in the range of 2-4mm. A&#xD;
                  functional appliance is used to allow for overjet reduction without extractions&#xD;
                  and/or to reduce the anchorage demands of the subsequent treatment with the&#xD;
                  Straight Wire Appliance (SWA). Clinically the overjet would need to be&#xD;
                  significantly increased for the treating clinician to consider the use of a&#xD;
                  functional appliance. Other similar studies have used an overjet of &gt;6mm or ≥&#xD;
                  7mm. This study has elected for an initial overjet of ≥ 7mm to improve the&#xD;
                  studies external validity by making it more applicable to day-to-day clinical&#xD;
                  practice.&#xD;
&#xD;
               -  The initial overjet will be used to select patients. The majority of recent high&#xD;
                  level trials and systematic reviews that have provided a significant amount of&#xD;
                  the evidence base in the treatment of Class II malocclusions have defined&#xD;
                  subjects according to their initial overjet.&#xD;
&#xD;
                  * Age 10 to 14 years&#xD;
&#xD;
               -  This has been selected to match other studies relating to functional appliance&#xD;
                  treatment and reflect the most common clinical practice. The literature on&#xD;
                  functional appliance treatment has provided evidence that on average the&#xD;
                  enhancement of growth is small. Some studies on the timing of functional&#xD;
                  appliance treatment have suggested that pubertal growth is not a significant&#xD;
                  factor in the success of functional appliance treatment but it is well know and&#xD;
                  accepted that functional appliance treatment is assisted during periods of more&#xD;
                  rapid growth. Numerous studies have also found better co-operation and completion&#xD;
                  of treatment in younger patients (Banks 2004, KOB 2003a &amp; 2003b)&#xD;
&#xD;
                  * Satisfactory Dental health&#xD;
&#xD;
               -  Patients must be dentally healthy and have a suitable level of oral health that&#xD;
                  would support orthodontic treatment, as per the British Orthodontic Society&#xD;
                  guidelines. They must have good oral hygiene with minimal gingivitis or&#xD;
                  periodontal disease, no dental caries or periapical pathology and no history of&#xD;
                  dento-alveolar trauma. This is judged by the investigator.&#xD;
&#xD;
                    -  Willing to participate in study and provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  * No previous orthodontic treatment or premolar extractions&#xD;
&#xD;
               -  This is aimed at reducing any confounding factors within the study as these may&#xD;
                  affect the success of treatment.&#xD;
&#xD;
                  * No craniofacial syndrome (including Cleft patients)&#xD;
&#xD;
               -  This is aimed at reducing any confounding factors within the study as these&#xD;
                  conditions may affect the success of treatment. The treatment of this subgroup&#xD;
                  requires a multi-disciplinary team and is more complex. Their treatment pathway&#xD;
                  may vary from normal clinical practice.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Dietrich</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Birmingham</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sheena Kotecha, FDS MPhil</last_name>
    <phone>(+44)07940544164</phone>
    <email>drkotecha@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Thomas Dietrich</last_name>
    <email>T.Dietrich@bham.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Birmingham dental hospital</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sheena Kotecha</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Isaacson KG, Reed RT, Stephens CD. Functional orthodontic appliances. Oxford: Blackwell Scientific Publications; 1990.</citation>
  </reference>
  <reference>
    <citation>Tulloch JF, Phillips C, Proffit WR. Benefit of early Class II treatment: progress report of a two-phase randomized clinical trial. Am J Orthod Dentofacial Orthop. 1998 Jan;113(1):62-72, quiz 73-4. doi: 10.1016/S0889-5406(98)70277-X.</citation>
    <PMID>9457020</PMID>
  </reference>
  <reference>
    <citation>Keeling SD, Wheeler TT, King GJ, Garvan CW, Cohen DA, Cabassa S, McGorray SP, Taylor MG. Anteroposterior skeletal and dental changes after early Class II treatment with bionators and headgear. Am J Orthod Dentofacial Orthop. 1998 Jan;113(1):40-50. doi: 10.1016/S0889-5406(98)70275-6.</citation>
    <PMID>9457018</PMID>
  </reference>
  <reference>
    <citation>Ghafari J, Shofer FS, Jacobsson-Hunt U, Markowitz DL, Laster LL. Headgear versus function regulator in the early treatment of Class II, division 1 malocclusion: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 1998 Jan;113(1):51-61. doi: 10.1016/s0889-5406(98)70276-8.</citation>
    <PMID>9457019</PMID>
  </reference>
  <reference>
    <citation>O'Brien K, Wright J, Conboy F, Sanjie Y, Mandall N, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I. Effectiveness of treatment for Class II malocclusion with the Herbst or twin-block appliances: a randomized, controlled trial. Am J Orthod Dentofacial Orthop. 2003 Aug;124(2):128-37. doi: 10.1016/s0889-5406(03)00345-7.</citation>
    <PMID>12923506</PMID>
  </reference>
  <reference>
    <citation>O'Brien K, Wright J, Conboy F, Sanjie Y, Mandall N, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I. Effectiveness of early orthodontic treatment with the Twin-block appliance: a multicenter, randomized, controlled trial. Part 1: Dental and skeletal effects. Am J Orthod Dentofacial Orthop. 2003 Sep;124(3):234-43; quiz 339. doi: 10.1016/S0889540603003524.</citation>
    <PMID>12970656</PMID>
  </reference>
  <reference>
    <citation>O'Brien K, Wright J, Conboy F, Appelbe P, Davies L, Connolly I, Mitchell L, Littlewood S, Mandall N, Lewis D, Sandler J, Hammond M, Chadwick S, O'Neill J, McDade C, Oskouei M, Thiruvenkatachari B, Read M, Robinson S, Birnie D, Murray A, Shaw I, Harradine N, Worthington H. Early treatment for Class II Division 1 malocclusion with the Twin-block appliance: a multi-center, randomized, controlled trial. Am J Orthod Dentofacial Orthop. 2009 May;135(5):573-9. doi: 10.1016/j.ajodo.2007.10.042.</citation>
    <PMID>19409339</PMID>
  </reference>
  <reference>
    <citation>Nelson C, Harkness M, Herbison P. Mandibular changes during functional appliance treatment. Am J Orthod Dentofacial Orthop. 1993 Aug;104(2):153-61. doi: 10.1016/S0889-5406(05)81005-4.</citation>
    <PMID>8338068</PMID>
  </reference>
  <reference>
    <citation>Illing HM, Morris DO, Lee RT. A prospective evaluation of Bass, Bionator and Twin Block appliances. Part I--The hard tissues. Eur J Orthod. 1998 Oct;20(5):501-16. doi: 10.1093/ejo/20.5.501.</citation>
    <PMID>9825553</PMID>
  </reference>
  <reference>
    <citation>Thiruvenkatachari B, Sandler J, Murray A, Walsh T, O'Brien K. Comparison of Twin-block and Dynamax appliances for the treatment of Class II malocclusion in adolescents: a randomized controlled trial. Am J Orthod Dentofacial Orthop. 2010 Aug;138(2):144.e1-9; discussion 144-5. doi: 10.1016/j.ajodo.2010.01.025.</citation>
    <PMID>20691354</PMID>
  </reference>
  <reference>
    <citation>Chadwick SM, Banks P, Wright JL. The use of myofunctional appliances in the UK: a survey of British orthodontists. Dent Update. 1998 Sep;25(7):302-8.</citation>
    <PMID>10478026</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>October 6, 2017</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Myofunctional appliance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malocclusion</mesh_term>
    <mesh_term>Malocclusion, Angle Class II</mesh_term>
    <mesh_term>Overbite</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/NCT03773783
org study id: RG_16-204
nct id: NCT03773783
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A randomised controlled clinical trial to compare the effectiveness of two functional
      appliances in the correction of a Class II malocclusion. (Class II malocclusions are where
      upper front teeth bite significantly further forward in relation to lower front teeth).

      Null hypothesis:

      There is no significant difference between the Button & bead and Twin-block appliances with
      regard to time taken to reduce the overjet
Background:

      A functional appliance is a type of brace used to help correct a 'Class II' malocclusion.
      Class II malocclusions are where upper front teeth bite significantly further forward in
      relation to lower front teeth. A functional appliance is defined as a brace that engages
      upper and lower teeth and works mainly by posturing the lower jaw away from its normal
      position1. The functional appliance may either be removable or fixed in nature and of various
      designs.

      Correction of a class II malocclusion can be commenced early i.e. before the age of 10 or
      during early adolescence when the patient is in a late mixed dentition / early permanent
      dentition. If correction is commenced early, this results in the need for a two phase
      treatment which involves functional appliance treatment in the first phase (age 7-10)
      followed by fixed appliances (+/- functional appliances) as an adolescent (age 11-16). If
      correction is started in early adolescence only one phase of treatment is required which
      involves a combination of functional and fixed appliances (age 11-16).

      Early or delayed class II treatment has been studied by various researchers2-10. O'Brien et
      al7 concluded that there was no advantage of early treatment with Twin Block as compared to
      treatment started in adolescents. In fact, they reported significantly poorer occlusal
      outcomes as determined by the objective Peer Assessment Rating (PAR) index in those that had
      early treatment. In addition, they found that total duration of treatment, total attendances
      and total cost of treatment was significantly higher in the early treatment group. The
      average total duration of treatment for those that had early treatment was 968 days (phase 1
      = 527 days and phase 2 = 435 days) compared to 744 days for those that had treatment as an
      adolescent only.

      The most commonly used brace to correct class II malocclusions in the UK is a functional
      appliance (Twin Block design) 11.

      The Button and Bead functional appliance has been developed and used successfully by Mr Spary
      (Consultant Orthodontist) for several years. However, there are no studies to date that have
      studied its effectiveness in correcting a class II problem. The Button and bead appliance
      appears to be quicker at reducing the overjet and preferred by patients as there is less
      mouth opening making the appliance more comfortable to wear. It is also two clear aligners,
      which are more aesthetic than the traditional twin block appliance. The button and bead
      appliance does not however allow arch expansion. This may necessitate another appliance prior
      to fixed appliance treatment or prolong fixed appliance treatment if expansion also needs to
      be carried out in that phase.

      Objectives:

        1. Primary objective:

           a. To compare the Button-&-bead and Twin-block appliances treatment duration for overjet
           reduction

        2. Secondary objectives:

             1. To compare the Button-&-bead and Twin-block appliances dento-occlusal outcomes as
                measured by the Peer Assessment Rating (PAR)

             2. To compare patient compliance with the Button-&-bead and Twin-block appliances and
                identify causes for failure

             3. To compare the health economics of the Button-&-bead and Twin-block appliances
                (Cost of appliances, number of visits, number and cost of repairs and/or
                replacements)

             4. To compare the skeletal changes of the Button-&-bead and Twin-block appliances
                based on the Eastman analysis

             5. To compare changes in soft tissue profile as assessed by 3D photographs

             6. To assess changes in OHRQoL after overjet reduction with the Button-&-bead and
                Twin-block appliances

             7. To evaluate and compare patient satisfaction with the Button-&-bead and Twin-block
                appliances

        3. Safety objective

             1. To evaluate the safety of the Button-&-Bead appliance relative to the Twin-Block
                appliance in terms of the occurrence of any device-related adverse- and
                side-effects (soft-tissue trauma, decalcification, dental caries, ingestion or
                aspiration of appliance).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in overjet reduction
time frame: Overjet measurement recorded at the start of treatment and at completion of functional appliance therapy 1 year later.
description: How quickly the horizontal discrepancy between upper and lower incisor edges is reduced
measure: Change in Peer Assessment Rating (PAR)
time frame: PAR score will be Assessed from the start of treatment models and the end of fixed appliance study models ( 2 years later)
description: PAR score change in terms of percentage and actual score
measure: Drop out
time frame: No. of patients at the start of functional appliance therapy that do not wish to continue within the trial or do not finish functional appliance therapy within 18 months
description: Percentage of patients dropping out of each arm of the trial
measure: Skeletal changes
time frame: Cephalometric x-rays at start of treatment and at the end of treatment 1 year later
description: Compare skeletal changes of landmarks in degrees and millimetres using cephalometric x-rays at various time points
measure: 3D soft tissue measures
time frame: 3D photographs at start of treatment and at the end of treatment (approx 1 year later)
description: Measure changes in soft tissues using 3D photographs
measure: Patient satisfaction
time frame: Patient satisfaction survey at study completion ( 1 year after treament started)
description: Use of tailored patient satisfaction questionnaire to assess patient satisfaction with both appliances
measure: Child related Oral health quality of life (OHRQoL) questionnaire
time frame: The patient ticked the applicable box for the 16 set questions from the standardised qualitative oral health questionairre. This was undertaken at the start of the trial and again at the end of functional appliance therapy ( approximately 1 year later)
description: Changes in OHRQoL
measure: Adverse events
time frame: Adverse events over the course of functional appliance treatment ( recorded at every visit and reviewed at 1 year)
description: Adverse events: decalcification, dental caries, soft tissue trauma, ingestion or aspiration of appliance
arm group label: Twin Block
arm group type: Active Comparator
description: Twin Block appliance
arm group label: Button and Bead
arm group type: Experimental
description: Button and Bead appliance
intervention type: Device
intervention name: Button and Bead appliance
description: Button and Bead appliance
arm group label: Button and Bead
intervention type: Device
intervention name: Twin Block appliance
description: Twin Block appliance
arm group label: Twin Block
criteria: 
gender: All
minimum age: 10 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas Dietrich
role: Principal Investigator
affiliation: University of Birmingham
last name: Sheena Kotecha, FDS MPhil
phone: (+44)07940544164
email: drkotecha@gmail.com
last name: Thomas Dietrich
email: T.Dietrich@bham.ac.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
citation: Isaacson KG, Reed RT, Stephens CD. Functional orthodontic appliances. Oxford: Blackwell Scientific Publications; 1990.
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PMID: 10478026
responsible party type: Sponsor
mesh term: Malocclusion
mesh term: Malocclusion, Angle Class II
mesh term: Overbite
sharing ipd: No