<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/NCT03252782</url>
  </required_header>
  <id_info>
    <org_study_id>2016-TDU-DİŞF-0023</org_study_id>
    <nct_id>NCT03252782</nct_id>
  </id_info>
  <brief_title>Comparison of Distalization and Functional Appliance Therapy</brief_title>
  <official_title>Three Dimensional Stereophotogrammetric Comparison of Intraoral Maxillary Molar Distalization and Functional Mandibular Advancement on Facial Soft Tissues</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Izmir Katip Celebi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Izmir Katip Celebi University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The correction of Class II malocclusion is one of the most common problems facing the&#xD;
      orthodontist, with an estimated one-third of all orthodontic patients treated for this&#xD;
      condition. Many strategies are available for Class II treatment on growing patients, and most&#xD;
      orthodontists tend to choose a treatment protocol based on what part of the craniofacial&#xD;
      deformity they believe the appliance will affect the most. A number of authors have described&#xD;
      the dentoalveolar and skeletal changes induced by the Herbst appliance. The dentoalveolar&#xD;
      effects consist of distalization of the maxillary molars and forward movement of the&#xD;
      mandibular dentition. The main skeletal change &quot;mandibular stimulation&quot; is acceleration of a&#xD;
      patient's inherent mandibular growth rather than increased growth beyond what would occur&#xD;
      without treatment. Maxillary molar distalization, is one of the Class II treatment.&#xD;
      Mini-implants have become popular in recent years, and various kinds of mini-implant-borne&#xD;
      distalization approaches have been described. Because Class II correction appears to be&#xD;
      achievable with either appliance, a follow-up question is whether there is a difference in&#xD;
      the esthetic outcomes. However, because of the complexity of the human face and the&#xD;
      subjectivity of facial beauty, a simple set of measures of lines or angles cannot quantify&#xD;
      facial beauty. With the advances in 3-dimensional imaging, it is now possible to capture and&#xD;
      superimpose digital images and measure the changes in the soft tissues from 3-dimensional&#xD;
      images. Such advances in facial imaging allow a more thorough investigation of changes in 3&#xD;
      dimensions and prevent the inherent loss of information that results from 2-dimensional&#xD;
      imaging. Optical scanners with short shutter speeds are convenient for clinicians and&#xD;
      patients for capturing soft-tissue records. Bearing in mind that the aim of orthodontic&#xD;
      treatment is to achieve facial harmony along with excellent occlusion, one of the most&#xD;
      important objectives of an orthodontist should be the improvement of facial appearance.&#xD;
      Therefore, it is important to gain a better understanding of how or whether orthodontic&#xD;
      procedures affect the appearance of the soft tissues. Thus, the aim of this clinical trial is&#xD;
      three dimensional evaluation of soft tissue facial changes on late mixed dentition patients&#xD;
      following maxillary arch distalization with palatal screws one group and acrylic split herbst&#xD;
      patients on other group and to compare these changes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The correction of Class II malocclusion is one of the most common problems facing the&#xD;
      orthodontist, with an estimated one-third of all orthodontic patients treated for this&#xD;
      condition.&#xD;
&#xD;
      Many strategies are available for Class II treatment on growing patients, and most&#xD;
      orthodontists tend to choose a treatment protocol based on what part of the craniofacial&#xD;
      deformity they believe the appliance will affect the most.&#xD;
&#xD;
      A number of authors have described the dentoalveolar and skeletal changes induced by the&#xD;
      Herbst appliance. The dentoalveolar effects consist of distalization of the maxillary molars&#xD;
      and forward movement of the mandibular dentition. The main skeletal change &quot;mandibular&#xD;
      stimulation&quot; is acceleration of a patient's inherent mandibular growth rather than increased&#xD;
      growth beyond what would occur without treatment.&#xD;
&#xD;
      Maxillary molar distalization, is one of the Class II treatment. Mini-implants have become&#xD;
      popular in recent years, and various kinds of mini-implant-borne distalization approaches&#xD;
      have been described.&#xD;
&#xD;
      Because Class II correction appears to be achievable with either appliance, a follow-up&#xD;
      question is whether there is a difference in the esthetic outcomes. However, because of the&#xD;
      complexity of the human face and the subjectivity of facial beauty, a simple set of measures&#xD;
      of lines or angles cannot quantify facial beauty.&#xD;
&#xD;
      Being the principle quantifiable diagnostic tool, the use of lateral head films lead&#xD;
      orthodontists to have thought primarily in two dimensions. With the advances in 3-dimensional&#xD;
      imaging, it is now possible to capture and superimpose digital images and measure the changes&#xD;
      in the soft tissues from 3-dimensional images. Such advances in facial imaging allow a more&#xD;
      thorough investigation of changes in 3 dimensions and prevent the inherent loss of&#xD;
      information that results from 2-dimensional imaging. Optical scanners with short shutter&#xD;
      speeds are convenient for clinicians and patients for capturing soft-tissue records.&#xD;
&#xD;
      Bearing in mind that the aim of orthodontic treatment is to achieve facial harmony along with&#xD;
      excellent occlusion, one of the most important objectives of an orthodontist should be the&#xD;
      improvement of facial appearance. Therefore, it is important to gain a better understanding&#xD;
      of how or whether orthodontic procedures affect the appearance of the soft tissues. Thus, the&#xD;
      aim of this clinical trial is three dimensional evaluation of soft tissue facial changes on&#xD;
      late mixed dentition patients following maxillary arch distalization with palatal screws one&#xD;
      group and acrylic split herbst patients on other group and to compare these changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Actual">June 1, 2018</completion_date>
  <primary_completion_date type="Actual">March 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>2-arm parallel-group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Soft Tissue Difference</measure>
    <time_frame>Estimated 1 year</time_frame>
    <description>Three-Dimensional Soft Tissue Changes Before and After Treatment</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Mandibular Retrognathism</condition>
  <arm_group>
    <arm_group_label>Functional Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Acrylic Splint Herbst Appliance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Distalization Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mini-implant-borne Distal Jet Appliance</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Herbst Appliance</intervention_name>
    <description>Acrylic Splint Herbst Appliance</description>
    <arm_group_label>Functional Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Distal Jet Appliance</intervention_name>
    <description>Anterior Median Palate Implant Borne Distal Jet Appliance</description>
    <arm_group_label>Distalization Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Angle Class II molar relation, Skeletal Class II depends on mandibular retrognathia ,&#xD;
        Crowding less than 4 mm, Normal growth pattern, No systematic or oral disease, No previous&#xD;
        orthodontic treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Missing teeth, Severe facial asymmetry, Poor oral hygiene&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>February 18, 2019</last_update_submitted>
  <last_update_submitted_qc>February 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Izmir Katip Celebi University</investigator_affiliation>
    <investigator_full_name>Asli Baysal</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Soft Tissue</keyword>
  <keyword>Functional Appliance</keyword>
  <keyword>Maxillary Molar Distalization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retrognathia</mesh_term>
  </condition_browse>
  <!-- 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/NCT03252782
org study id: 2016-TDU-DİŞF-0023
nct id: NCT03252782
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The correction of Class II malocclusion is one of the most common problems facing the
      orthodontist, with an estimated one-third of all orthodontic patients treated for this
      condition. Many strategies are available for Class II treatment on growing patients, and most
      orthodontists tend to choose a treatment protocol based on what part of the craniofacial
      deformity they believe the appliance will affect the most. A number of authors have described
      the dentoalveolar and skeletal changes induced by the Herbst appliance. The dentoalveolar
      effects consist of distalization of the maxillary molars and forward movement of the
      mandibular dentition. The main skeletal change "mandibular stimulation" is acceleration of a
      patient's inherent mandibular growth rather than increased growth beyond what would occur
      without treatment. Maxillary molar distalization, is one of the Class II treatment.
      Mini-implants have become popular in recent years, and various kinds of mini-implant-borne
      distalization approaches have been described. Because Class II correction appears to be
      achievable with either appliance, a follow-up question is whether there is a difference in
      the esthetic outcomes. However, because of the complexity of the human face and the
      subjectivity of facial beauty, a simple set of measures of lines or angles cannot quantify
      facial beauty. With the advances in 3-dimensional imaging, it is now possible to capture and
      superimpose digital images and measure the changes in the soft tissues from 3-dimensional
      images. Such advances in facial imaging allow a more thorough investigation of changes in 3
      dimensions and prevent the inherent loss of information that results from 2-dimensional
      imaging. Optical scanners with short shutter speeds are convenient for clinicians and
      patients for capturing soft-tissue records. Bearing in mind that the aim of orthodontic
      treatment is to achieve facial harmony along with excellent occlusion, one of the most
      important objectives of an orthodontist should be the improvement of facial appearance.
      Therefore, it is important to gain a better understanding of how or whether orthodontic
      procedures affect the appearance of the soft tissues. Thus, the aim of this clinical trial is
      three dimensional evaluation of soft tissue facial changes on late mixed dentition patients
      following maxillary arch distalization with palatal screws one group and acrylic split herbst
      patients on other group and to compare these changes.
The correction of Class II malocclusion is one of the most common problems facing the
      orthodontist, with an estimated one-third of all orthodontic patients treated for this
      condition.

      Many strategies are available for Class II treatment on growing patients, and most
      orthodontists tend to choose a treatment protocol based on what part of the craniofacial
      deformity they believe the appliance will affect the most.

      A number of authors have described the dentoalveolar and skeletal changes induced by the
      Herbst appliance. The dentoalveolar effects consist of distalization of the maxillary molars
      and forward movement of the mandibular dentition. The main skeletal change "mandibular
      stimulation" is acceleration of a patient's inherent mandibular growth rather than increased
      growth beyond what would occur without treatment.

      Maxillary molar distalization, is one of the Class II treatment. Mini-implants have become
      popular in recent years, and various kinds of mini-implant-borne distalization approaches
      have been described.

      Because Class II correction appears to be achievable with either appliance, a follow-up
      question is whether there is a difference in the esthetic outcomes. However, because of the
      complexity of the human face and the subjectivity of facial beauty, a simple set of measures
      of lines or angles cannot quantify facial beauty.

      Being the principle quantifiable diagnostic tool, the use of lateral head films lead
      orthodontists to have thought primarily in two dimensions. With the advances in 3-dimensional
      imaging, it is now possible to capture and superimpose digital images and measure the changes
      in the soft tissues from 3-dimensional images. Such advances in facial imaging allow a more
      thorough investigation of changes in 3 dimensions and prevent the inherent loss of
      information that results from 2-dimensional imaging. Optical scanners with short shutter
      speeds are convenient for clinicians and patients for capturing soft-tissue records.

      Bearing in mind that the aim of orthodontic treatment is to achieve facial harmony along with
      excellent occlusion, one of the most important objectives of an orthodontist should be the
      improvement of facial appearance. Therefore, it is important to gain a better understanding
      of how or whether orthodontic procedures affect the appearance of the soft tissues. Thus, the
      aim of this clinical trial is three dimensional evaluation of soft tissue facial changes on
      late mixed dentition patients following maxillary arch distalization with palatal screws one
      group and acrylic split herbst patients on other group and to compare these changes.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: 2-arm parallel-group
primary purpose: Treatment
masking: None (Open Label)
measure: Soft Tissue Difference
time frame: Estimated 1 year
description: Three-Dimensional Soft Tissue Changes Before and After Treatment
arm group label: Functional Treatment
arm group type: Active Comparator
description: Acrylic Splint Herbst Appliance
arm group label: Distalization Treatment
arm group type: Active Comparator
description: Mini-implant-borne Distal Jet Appliance
intervention type: Device
intervention name: Herbst Appliance
description: Acrylic Splint Herbst Appliance
arm group label: Functional Treatment
intervention type: Device
intervention name: Distal Jet Appliance
description: Anterior Median Palate Implant Borne Distal Jet Appliance
arm group label: Distalization Treatment
criteria: 
gender: All
minimum age: 9 Years
maximum age: 14 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Izmir Katip Celebi University
investigator full name: Asli Baysal
investigator title: Associate Professor
mesh term: Retrognathia