<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/NCT04402164</url>
  </required_header>
  <id_info>
    <org_study_id>AlAzharU-189</org_study_id>
    <nct_id>NCT04402164</nct_id>
  </id_info>
  <brief_title>Skeletally Versus Dentally Anchored Herbst Appliance</brief_title>
  <official_title>Skeletally Versus Dentally Anchored Herbst Appliance During Treatment of Class 2 Mandibular Deficiency in Adolescent Patients; A CBCT Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Al-Azhar University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Al-Azhar University</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>
      The treatment of skeletal Class II malocclusion can be carried out through different&#xD;
      approaches. One of these is the using of Fixed Functional Appliances (FFA), one of main&#xD;
      drawbacks of these appliances is the proclination of the lower anterior teeth limiting the&#xD;
      skeletal effect that is originally addressed in those patients.To overcome these limitations,&#xD;
      miniplates anchored Forsus FRD were introduced, it showed high success rate in achieving a&#xD;
      more skeletal effect with retroclination of lower anterior teeth rather than their&#xD;
      proclination. Although Herbst appliance is categorized as the best FFA with more stable&#xD;
      skeletal and dentoalveolar effects, miniplates had never been tried as an anchorage source&#xD;
      with Herbst appliance in skeletal Class II patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Skeletal Class II malocclusion is one of the most common orthodontic problems, which occurs&#xD;
      in about one third of the population. Although there is many skeletal and dental combination&#xD;
      that can contribute for the creation of Class II, however, mandibular retrusion is considered&#xD;
      as the main contributing factor.&#xD;
&#xD;
      The treatment of skeletal Class II malocclusion can be carried out through three different&#xD;
      time intervals. The first is an early treatment before the pubertal growth spurt through&#xD;
      limiting the maxillary growth and stimulation of mandibular growth by using headgear and/or&#xD;
      functional appliances. The second intervention would be during the maximum growth spurt&#xD;
      through harnessing the spurt time to produce a more favorable skeletal effect by using of&#xD;
      functional appliances either removable or fixed. Once growth had ceased, the third and last&#xD;
      possible intervention would be one of the following treatment options; promoting the&#xD;
      remaining growth through the usage of Fixed Functional Appliances (FFA), camouflage treatment&#xD;
      and orthognathic surgery.&#xD;
&#xD;
      Fixed functional appliances (FFA) are aiming to stimulate mandibular growth by forward&#xD;
      posturing the mandible to correct the skeletal antero-posterior discrepancy. Although there&#xD;
      is always a controversy regarding the effectiveness of these appliances, many studies have&#xD;
      been demonstrated successful correction of skeletal class II in adolescent patients through&#xD;
      their use.&#xD;
&#xD;
      In a way to achieve this, it is recommended to use a rigid type of FFA like Herbst appliance&#xD;
      and the Functional Mandibular Advancer rather than semi-rigid appliances like Forsus Fatigue&#xD;
      Resistant Device (Forsus FRD).&#xD;
&#xD;
      Regardless of the patient's age, one of main drawbacks of these appliances is the&#xD;
      proclination of the lower anterior teeth limiting the skeletal effect that is originally&#xD;
      addressed in those patients.To overcome this limitation, mini screws had been used with both&#xD;
      rigid and semi-rigid types of FFA. Incremental enhancement in the skeletal measurement has&#xD;
      been noted by using them with the rigid type of FFA (e.g. Herbst appliance), however, the&#xD;
      effect was still purely dentoalveolar when it came to semi rigid FFA (e.g. Forsus FRD), never&#xD;
      to say that the success rate of these mini screws in the mandible is very low when compared&#xD;
      with the maxilla which means a more complication and inconsistency in the clinical results.&#xD;
&#xD;
      To overcome these limitations, miniplates anchored Forsus FRD were introduced, it showed high&#xD;
      success rate in achieving a more skeletal effect with retroclination of lower anterior teeth&#xD;
      rather than their proclination. Although Herbst appliance is categorized as the best FFA with&#xD;
      more stable skeletal and dentoalveolar effects,miniplates had never been tried as an&#xD;
      anchorage source with Herbst appliance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</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>Group 1: Dentally anchored Herbst appliance Group 2: Skeletally anchored Herbst appliance</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>another person than the investigators</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>condylar volume changes</measure>
    <time_frame>2 years</time_frame>
    <description>volumetric changes that affects the condylar head when comparing pre and post treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>amount of mandibular advancement</measure>
    <time_frame>2 years</time_frame>
    <description>increase in mandibular length</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in inclination of lower anterior teeth</measure>
    <time_frame>2 years</time_frame>
    <description>angular changes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Angle Class II, Division 1</condition>
  <arm_group>
    <arm_group_label>Dentally anchored Herbst group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Herbst appliance will be anchored on the mandibular dentition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Skeletally anchored Herst group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Herbst appliance will be anchored on mini-plates placed in the para symphesial areas</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Herbst appliance</intervention_name>
    <description>telescopic appliance for mandibular advancement</description>
    <arm_group_label>Dentally anchored Herbst group</arm_group_label>
    <arm_group_label>Skeletally anchored Herst group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Skeletal Class II malocclusion due to mandibular deficiency (SNA=82+4, ANB ≥4o).&#xD;
&#xD;
          2. Overjet ≥5.0 mm.&#xD;
&#xD;
          3. All permanent dentition erupted with exception of the third molars.&#xD;
&#xD;
          4. The patient should be at the maturity stage of MP3-I (where the fusion of the&#xD;
             epiphysis and metaphysis is completed according to the developmental stage of the&#xD;
             middle phalanx).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of any medical problems that may interfere with orthodontic treatment.&#xD;
&#xD;
          2. Previous orthodontic treatment.&#xD;
&#xD;
          3. Clinical signs and symptoms of temporomandibular disorders.&#xD;
&#xD;
          4. Bad oral hygiene.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Al-Dany A. Mohamed, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Al-Azhar University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AlAzharU</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 29, 2018</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Al-Azhar University</investigator_affiliation>
    <investigator_full_name>Ahmed Abdel Salam Mohamed</investigator_full_name>
    <investigator_title>Orthodontist</investigator_title>
  </responsible_party>
  <keyword>Herbst, mini-plates, Skeletal Class 2 malocclusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malocclusion, Angle Class II</mesh_term>
    <mesh_term>Overbite</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04402164
org study id: AlAzharU-189
nct id: NCT04402164
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The treatment of skeletal Class II malocclusion can be carried out through different
      approaches. One of these is the using of Fixed Functional Appliances (FFA), one of main
      drawbacks of these appliances is the proclination of the lower anterior teeth limiting the
      skeletal effect that is originally addressed in those patients.To overcome these limitations,
      miniplates anchored Forsus FRD were introduced, it showed high success rate in achieving a
      more skeletal effect with retroclination of lower anterior teeth rather than their
      proclination. Although Herbst appliance is categorized as the best FFA with more stable
      skeletal and dentoalveolar effects, miniplates had never been tried as an anchorage source
      with Herbst appliance in skeletal Class II patients.
Skeletal Class II malocclusion is one of the most common orthodontic problems, which occurs
      in about one third of the population. Although there is many skeletal and dental combination
      that can contribute for the creation of Class II, however, mandibular retrusion is considered
      as the main contributing factor.

      The treatment of skeletal Class II malocclusion can be carried out through three different
      time intervals. The first is an early treatment before the pubertal growth spurt through
      limiting the maxillary growth and stimulation of mandibular growth by using headgear and/or
      functional appliances. The second intervention would be during the maximum growth spurt
      through harnessing the spurt time to produce a more favorable skeletal effect by using of
      functional appliances either removable or fixed. Once growth had ceased, the third and last
      possible intervention would be one of the following treatment options; promoting the
      remaining growth through the usage of Fixed Functional Appliances (FFA), camouflage treatment
      and orthognathic surgery.

      Fixed functional appliances (FFA) are aiming to stimulate mandibular growth by forward
      posturing the mandible to correct the skeletal antero-posterior discrepancy. Although there
      is always a controversy regarding the effectiveness of these appliances, many studies have
      been demonstrated successful correction of skeletal class II in adolescent patients through
      their use.

      In a way to achieve this, it is recommended to use a rigid type of FFA like Herbst appliance
      and the Functional Mandibular Advancer rather than semi-rigid appliances like Forsus Fatigue
      Resistant Device (Forsus FRD).

      Regardless of the patient's age, one of main drawbacks of these appliances is the
      proclination of the lower anterior teeth limiting the skeletal effect that is originally
      addressed in those patients.To overcome this limitation, mini screws had been used with both
      rigid and semi-rigid types of FFA. Incremental enhancement in the skeletal measurement has
      been noted by using them with the rigid type of FFA (e.g. Herbst appliance), however, the
      effect was still purely dentoalveolar when it came to semi rigid FFA (e.g. Forsus FRD), never
      to say that the success rate of these mini screws in the mandible is very low when compared
      with the maxilla which means a more complication and inconsistency in the clinical results.

      To overcome these limitations, miniplates anchored Forsus FRD were introduced, it showed high
      success rate in achieving a more skeletal effect with retroclination of lower anterior teeth
      rather than their proclination. Although Herbst appliance is categorized as the best FFA with
      more stable skeletal and dentoalveolar effects,miniplates had never been tried as an
      anchorage source with Herbst appliance.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Group 1: Dentally anchored Herbst appliance Group 2: Skeletally anchored Herbst appliance
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: another person than the investigators
measure: condylar volume changes
time frame: 2 years
description: volumetric changes that affects the condylar head when comparing pre and post treatment
measure: amount of mandibular advancement
time frame: 2 years
description: increase in mandibular length
measure: changes in inclination of lower anterior teeth
time frame: 2 years
description: angular changes
arm group label: Dentally anchored Herbst group
arm group type: Active Comparator
description: Herbst appliance will be anchored on the mandibular dentition
arm group label: Skeletally anchored Herst group
arm group type: Active Comparator
description: Herbst appliance will be anchored on mini-plates placed in the para symphesial areas
intervention type: Device
intervention name: Herbst appliance
description: telescopic appliance for mandibular advancement
arm group label: Dentally anchored Herbst group
arm group label: Skeletally anchored Herst group
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 20 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Al-Dany A. Mohamed, Prof
role: Study Director
affiliation: Al-Azhar University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Al-Azhar University
investigator full name: Ahmed Abdel Salam Mohamed
investigator title: Orthodontist
mesh term: Malocclusion, Angle Class II
mesh term: Overbite
sharing ipd: Undecided