<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/NCT04458506</url>
  </required_header>
  <id_info>
    <org_study_id>260581</org_study_id>
    <nct_id>NCT04458506</nct_id>
  </id_info>
  <brief_title>Treatment of Unilateral Posterior Cross Bite in Children</brief_title>
  <official_title>Treatment of Unilateral Posterior Cross Bite in the Mixed Dentition; a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Örebro County</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region Jönköping County</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Region Örebro County</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>
      Rapid maxillary expansion and quad-helix are two well established appliances in dentistry&#xD;
      used for posterior cross bite treatment. This study aims to compare this two different&#xD;
      appliances in patients in their early mixed dentition, regarding treatment effects of the&#xD;
      extra oral soft tissue but also dental and skeletal effects, if the children experience any&#xD;
      pain and discomfort during treatment and the study also aims to make a cost minimization&#xD;
      analysis. Comparison of these different treatments are barely made and no randomized&#xD;
      controlled trial is yet published. No study has evaluated the difference of subjective&#xD;
      experience during these two treatments. After this study we will know which one of these two&#xD;
      appliances are the most effective, regarding cost minimization and treatment result but we&#xD;
      are also able to put it in relation to the patients subjective experience&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 13, 2019</start_date>
  <completion_date type="Anticipated">April 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2022</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Skeletal expansion at the level of the palatal median suture - the change fram Baseline</measure>
    <time_frame>At baseline, directly after expansion and one year after expansion</time_frame>
    <description>Skeletal expansion evaluated by computed tomography at three time points in both arms. The change in width of the palatal median suture is going to be evaluated and compared to the Baseline values, in both arms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of inclination of teeth and alveolar bone and side effects between the time points</measure>
    <time_frame>At baseline, directly after expansion and one year after expansion</time_frame>
    <description>Dental effects and side effects evaluated by computed tomography at three time points in both arms.The change in degree of angulation and inclination of the dental structures (e.g. tooth inclinations) is going to be evaluated and compared to the Baseline values, in both arms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of the soft tissue changes</measure>
    <time_frame>At baseline, directly after expansion, six months and one year after expansion</time_frame>
    <description>3D assessment of the soft tissue changes during and after treatment by 3D -photography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of pain and discomfort</measure>
    <time_frame>Three times during the first week after inserting the appliances</time_frame>
    <description>Questionnaire The Questionnaire has some questions with Visual Analogue Scale. With the minimum value of &quot;0&quot; and maximum value of &quot;10&quot;. Higher values mean worse outcome.&#xD;
Other questions in the questionnaire have a &quot;yes&quot; and &quot;No&quot; nature.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Temporomandibular Disorder (TMD)</measure>
    <time_frame>Baseline and one year after expansion</time_frame>
    <description>Questionnaire The questionnaire has no scale and the questions have a &quot;Yes&quot; och &quot;No&quot; nature.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness of two treatment modalities in treatment of posterior cross bite</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Evaluation of both the direct and indirect costs of the treatment, number of emergency visits, treatment duration (in total) etc are going to be evaluated.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Malocclusion</condition>
  <condition>Maxillary Expansion</condition>
  <condition>Pain Children</condition>
  <arm_group>
    <arm_group_label>Rapid Maxillary Expander (RME)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>36 patients will be treated with RME in order to correct their unilateral posterior cross bite</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quad Helix (QH)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>36 patients will be treated with QH in order to correct their unilateral posterior cross bite</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Maxillary expansion</intervention_name>
    <description>Correction of the unilateral posterior cross bite in children</description>
    <arm_group_label>Quad Helix (QH)</arm_group_label>
    <arm_group_label>Rapid Maxillary Expander (RME)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children in the early mixed dentition&#xD;
&#xD;
          -  Unilateral posterior cross bite including the first permanent molar&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No ongoing sucking habits&#xD;
&#xD;
          -  Craniofacial syndroms&#xD;
&#xD;
          -  Earlier Orthodontic treatments&#xD;
&#xD;
          -  Not able to independently understand and answer the questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Farhan Bazargani, DDS, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Örebro University, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Postgraduate Dental Education Center</name>
      <address>
        <city>Örebro</city>
        <zip>SE-70111</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Petren S, Bondemark L, Soderfeldt B. A systematic review concerning early orthodontic treatment of unilateral posterior crossbite. Angle Orthod. 2003 Oct;73(5):588-96. doi: 10.1043/0003-3219(2003)0732.0.CO;2.</citation>
    <PMID>14580028</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</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>
  <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/NCT04458506
org study id: 260581
nct id: NCT04458506
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rapid maxillary expansion and quad-helix are two well established appliances in dentistry
      used for posterior cross bite treatment. This study aims to compare this two different
      appliances in patients in their early mixed dentition, regarding treatment effects of the
      extra oral soft tissue but also dental and skeletal effects, if the children experience any
      pain and discomfort during treatment and the study also aims to make a cost minimization
      analysis. Comparison of these different treatments are barely made and no randomized
      controlled trial is yet published. No study has evaluated the difference of subjective
      experience during these two treatments. After this study we will know which one of these two
      appliances are the most effective, regarding cost minimization and treatment result but we
      are also able to put it in relation to the patients subjective experience
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Skeletal expansion at the level of the palatal median suture - the change fram Baseline
time frame: At baseline, directly after expansion and one year after expansion
description: Skeletal expansion evaluated by computed tomography at three time points in both arms. The change in width of the palatal median suture is going to be evaluated and compared to the Baseline values, in both arms.
measure: The change of inclination of teeth and alveolar bone and side effects between the time points
time frame: At baseline, directly after expansion and one year after expansion
description: Dental effects and side effects evaluated by computed tomography at three time points in both arms.The change in degree of angulation and inclination of the dental structures (e.g. tooth inclinations) is going to be evaluated and compared to the Baseline values, in both arms.
measure: Assessment of the soft tissue changes
time frame: At baseline, directly after expansion, six months and one year after expansion
description: 3D assessment of the soft tissue changes during and after treatment by 3D -photography
measure: Evaluation of pain and discomfort
time frame: Three times during the first week after inserting the appliances
description: Questionnaire The Questionnaire has some questions with Visual Analogue Scale. With the minimum value of "0" and maximum value of "10". Higher values mean worse outcome.
Other questions in the questionnaire have a "yes" and "No" nature.
measure: Evaluation of Temporomandibular Disorder (TMD)
time frame: Baseline and one year after expansion
description: Questionnaire The questionnaire has no scale and the questions have a "Yes" och "No" nature.
measure: Cost-effectiveness of two treatment modalities in treatment of posterior cross bite
time frame: Through study completion, an average of 18 months
description: Evaluation of both the direct and indirect costs of the treatment, number of emergency visits, treatment duration (in total) etc are going to be evaluated.
arm group label: Rapid Maxillary Expander (RME)
arm group type: Experimental
description: 36 patients will be treated with RME in order to correct their unilateral posterior cross bite
arm group label: Quad Helix (QH)
arm group type: Active Comparator
description: 36 patients will be treated with QH in order to correct their unilateral posterior cross bite
intervention type: Procedure
intervention name: Maxillary expansion
description: Correction of the unilateral posterior cross bite in children
arm group label: Quad Helix (QH)
arm group label: Rapid Maxillary Expander (RME)
criteria: 
gender: All
minimum age: 8 Years
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Farhan Bazargani, DDS, PhD
role: Study Director
affiliation: Örebro University, Sweden
facility: 
country: Sweden
citation: Petren S, Bondemark L, Soderfeldt B. A systematic review concerning early orthodontic treatment of unilateral posterior crossbite. Angle Orthod. 2003 Oct;73(5):588-96. doi: 10.1043/0003-3219(2003)0732.0.CO;2.
PMID: 14580028
responsible party type: Sponsor
mesh term: Malocclusion
sharing ipd: No