<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/NCT04429113</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0350</org_study_id>
    <nct_id>NCT04429113</nct_id>
  </id_info>
  <brief_title>Quad Helix and Correction of Mandibular Asymmetry</brief_title>
  <official_title>Is the Quad Helix More Efficient to Correct Mandibular Asymmetry Before Age 7? A Retrospective Comparative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      To compare the effectiveness of the Quad Helix, an orthopaedic conventional appliance, in the&#xD;
      correction of skeletal mandibular asymmetry, on frontal x-ray, in subjects treated before or&#xD;
      after 7 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction : Unilateral posterior crossbite (UPCB), often from dysfunctional and&#xD;
      para-functional causes, leads to positional mandibular asymmetries that can develop at a very&#xD;
      young age into skeletal mandibular deviation; hence the interest of early maxillary&#xD;
      expansion. The purpose of this retrospective study was to compare the impact of maxillary&#xD;
      expansion by Quad Helix (QH) on mandibular skeletal asymmetry correction before and after 7&#xD;
      years of age.&#xD;
&#xD;
      Materials and methods : All children with UPCB and skeletal mandibular asymmetry, who were&#xD;
      treated by QH in the orthodontic department between February 2017 and August 2018 and who&#xD;
      have done a radiography file at baseline (T0) and 12 months later (T1) have been included.&#xD;
      The patients were divided into two groups according to age: under 7 years of age (early group&#xD;
      G1) with QH adjusted on second primary molars and over up to 13 years old (late group G2)&#xD;
      with QH adjusted on first permanent molars. The differences between the right and left sides&#xD;
      of the mandible in corpus length L (main eligibility criterion) and ramus height H (secondary&#xD;
      criterion) were compared between groups. X² test, Fisher's exact test and Wilcoxon rank-sum&#xD;
      tests were used for baseline comparisons. A multifactorial analysis allowing adjustment on&#xD;
      possible confounding factors was used with R software at a significance level of 5%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in the mandibular corpus length between the right and left side</measure>
    <time_frame>1 day</time_frame>
    <description>Difference in the mandibular corpus length between the right and left side : △L on conventional frontal x-ray.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in the mandibular ramus height between the right and left side of the mandibule</measure>
    <time_frame>1 day</time_frame>
    <description>Difference in the mandibular ramus height between the right and left side of the mandibule : △H on conventional frontal x-ray.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">67</enrollment>
  <condition>Mandibular Asymmetry</condition>
  <condition>Functional Shift of the Mandible</condition>
  <arm_group>
    <arm_group_label>G1 or Early Group</arm_group_label>
    <description>Patients treated before age 7 (Quad Helix on decidual second molars)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>G2 or Late Group</arm_group_label>
    <description>Patients treated between 7 and 13 years old (Quad Helix on first permanent molars)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Maxillary expansion with conventional Quad Helix bonded on molars.</intervention_name>
    <description>Maxillary expansion with conventional Quad Helix bonded on molars</description>
    <arm_group_label>G1 or Early Group</arm_group_label>
    <arm_group_label>G2 or Late Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of Orthodontic Department of the CHU of Montpellier&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Unilateral Posterior Crossbite (at least one tooth) and skeletal mandibular asymmetry&#xD;
&#xD;
          -  Treated by Quad Helix in the Orthodontic Department of the CHU Montpellier&#xD;
&#xD;
          -  with frontal X-rays available at baseline and 12months later&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Incomplete File&#xD;
&#xD;
          -  Inadequate quality of x-rays&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manon Fourneron</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Early treatment</keyword>
  <keyword>Posterior unilateral cross bite</keyword>
  <keyword>Quad helix</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT04429113
org study id: RECHMPL20_0350
nct id: NCT04429113
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To compare the effectiveness of the Quad Helix, an orthopaedic conventional appliance, in the
      correction of skeletal mandibular asymmetry, on frontal x-ray, in subjects treated before or
      after 7 years.
Introduction : Unilateral posterior crossbite (UPCB), often from dysfunctional and
      para-functional causes, leads to positional mandibular asymmetries that can develop at a very
      young age into skeletal mandibular deviation; hence the interest of early maxillary
      expansion. The purpose of this retrospective study was to compare the impact of maxillary
      expansion by Quad Helix (QH) on mandibular skeletal asymmetry correction before and after 7
      years of age.

      Materials and methods : All children with UPCB and skeletal mandibular asymmetry, who were
      treated by QH in the orthodontic department between February 2017 and August 2018 and who
      have done a radiography file at baseline (T0) and 12 months later (T1) have been included.
      The patients were divided into two groups according to age: under 7 years of age (early group
      G1) with QH adjusted on second primary molars and over up to 13 years old (late group G2)
      with QH adjusted on first permanent molars. The differences between the right and left sides
      of the mandible in corpus length L (main eligibility criterion) and ramus height H (secondary
      criterion) were compared between groups. X² test, Fisher's exact test and Wilcoxon rank-sum
      tests were used for baseline comparisons. A multifactorial analysis allowing adjustment on
      possible confounding factors was used with R software at a significance level of 5%.
observational model: Case-Control
time perspective: Retrospective
measure: Difference in the mandibular corpus length between the right and left side
time frame: 1 day
description: Difference in the mandibular corpus length between the right and left side : △L on conventional frontal x-ray.
measure: Difference in the mandibular ramus height between the right and left side of the mandibule
time frame: 1 day
description: Difference in the mandibular ramus height between the right and left side of the mandibule : △H on conventional frontal x-ray.
arm group label: G1 or Early Group
description: Patients treated before age 7 (Quad Helix on decidual second molars)
arm group label: G2 or Late Group
description: Patients treated between 7 and 13 years old (Quad Helix on first permanent molars)
intervention type: Device
intervention name: Maxillary expansion with conventional Quad Helix bonded on molars.
description: Maxillary expansion with conventional Quad Helix bonded on molars
arm group label: G1 or Early Group
arm group label: G2 or Late Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 13 Years
healthy volunteers: No
last name: Manon Fourneron
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: NC