<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/NCT03308175</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2017-10-04</org_study_id>
    <nct_id>NCT03308175</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effects of Flat and Modified Inclined Fixed Anterior Bite Planes on Mandibular Position in Growing Females With Skeletal Class 2 Malocclusion Due to Mandibular Deficiency and Deep Bite</brief_title>
  <official_title>Evaluation of the Effects of Flat and Modified Inclined Fixed Anterior Bite Planes on Mandibular Position in Growing Females With Skeletal Class 2 Malocclusion Due to Mandibular Deficiency and Deep Bite: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      This study will be conducted to see if unlocking mandible from deep bite in growing females&#xD;
      by flat fixed anterior bite plane will change mandibular position in skeletal mandibular&#xD;
      deficiency and if there is a difference in the change of mandibular position if we assisted&#xD;
      the mandible by holding it in a more forward position by modified inclined fixed anterior&#xD;
      bite plane .These results will be compared to normal mandibular growth from previous records&#xD;
      of a matched control group in the discussion afterthat.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two groups of patients the first for flat fixed anterior bite plane, the second for modified&#xD;
      inclined fixed anterior bite plane.Full records are taken to patients. Then bands selection&#xD;
      for upper first molars,impressions for upper arch with bands fitted and impression to lower&#xD;
      arch, fabrication of either flat/ modified inclined fixed anterior bite planes and&#xD;
      cementation in patient's mouth,evaluation of results after 8 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 30, 2017</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</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>Change in mandibular position</measure>
    <time_frame>8 months</time_frame>
    <description>assessed onCBCT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maxillary anteroposterior and vertical growth change.</measure>
    <time_frame>8 months</time_frame>
    <description>assessed onCBCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anteroposterior and vertical dental changes.</measure>
    <time_frame>8 months</time_frame>
    <description>assessed onCBCT</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Skeletal Class 2</condition>
  <arm_group>
    <arm_group_label>flat fixed anterior bite plane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bands selection will be done for upper 6s. Alginate impressions taken and molar bands are fitted in place into the impressions. Impressions for upper and lower arches are poured with stone plaster. Mounting on simple hinge articulator will be done.&#xD;
Lingual arches (diameter 1 mm) with anterior acrylic bite plates with thickness enough to separate posterior teeth 4mm .&#xD;
The acrylic bite planes were in occlusion with the lower anterior teeth and extended sagittally 2-3mm beyond edges of lower incisors.&#xD;
Finishing ,polishing and cementation into patient's mouth with glass ionomer cement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>modified inclined fixed anterior bite plane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In modified inclined fixed anterior bite plane,the modification is that some indentations will be done in the acrylic part where the lower anteriors will fit such that mandible will be held in a more forward position. These indentations will be relieved lingually to overcome it's flaring effect on mandibular incisors .The inclined plane will be 60 degrees to occlusal plane.&#xD;
Functional bite will be taken to position the mandible in the proper position forward.&#xD;
Bite taken edge-to-edge for appliance construction. Mounting upper and lower casts on simple hinge articulator for construction of modified flat fixed anterior bite plane</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>flat fixed anterior bite plane</intervention_name>
    <description>It causes unlocking mandible from deep bite in growing females</description>
    <arm_group_label>flat fixed anterior bite plane</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>modified inclined fixed anterior bite plane</intervention_name>
    <description>It causes unlocking mandible from deep bite in growing females plus putting the mandible in a more forward position</description>
    <arm_group_label>modified inclined fixed anterior bite plane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1)Growing females aged 10-13 (2)Skeletal maturational stage: stages 3,4 of the&#xD;
             cervical maturational index CVMI.&#xD;
&#xD;
             (3) low-angle/moderate normal growth pattern (4) Overjet of 4-7 mm as measured from&#xD;
             labial surface of upper incisors to labial surface of lower incisors (5)Skeletal class&#xD;
             2 due to mandibular deficiency 77 degrees &lt;SNB&gt; 73 degrees (6) Normal or slightly&#xD;
             protruded maxillary base (7) All cases had dental deep bite; with the upper incisors&#xD;
             covering more than 50% of the height of the lower incisors.&#xD;
&#xD;
             (8)Only deep bite cases that required extrusion of posterior teeth.&#xD;
&#xD;
        Exclusion Criteria:1- No syndromic or medically compromised patients 2- No growth disorders&#xD;
        3- No use of other appliances before or during the period of functional treatment&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>yomna Elfiky, resident</last_name>
    <phone>01001987078</phone>
    <email>princessyomna7@outlook.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of Dentistry,Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 7, 2017</study_first_submitted>
  <study_first_submitted_qc>October 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>February 2, 2018</last_update_submitted>
  <last_update_submitted_qc>February 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Yomna Elfiky</investigator_full_name>
    <investigator_title>Resident</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Micrognathism</mesh_term>
    <mesh_term>Malocclusion</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/NCT03308175
org study id: CEBD-CU-2017-10-04
nct id: NCT03308175
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will be conducted to see if unlocking mandible from deep bite in growing females
      by flat fixed anterior bite plane will change mandibular position in skeletal mandibular
      deficiency and if there is a difference in the change of mandibular position if we assisted
      the mandible by holding it in a more forward position by modified inclined fixed anterior
      bite plane .These results will be compared to normal mandibular growth from previous records
      of a matched control group in the discussion afterthat.
Two groups of patients the first for flat fixed anterior bite plane, the second for modified
      inclined fixed anterior bite plane.Full records are taken to patients. Then bands selection
      for upper first molars,impressions for upper arch with bands fitted and impression to lower
      arch, fabrication of either flat/ modified inclined fixed anterior bite planes and
      cementation in patient's mouth,evaluation of results after 8 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in mandibular position
time frame: 8 months
description: assessed onCBCT
measure: Maxillary anteroposterior and vertical growth change.
time frame: 8 months
description: assessed onCBCT
measure: Anteroposterior and vertical dental changes.
time frame: 8 months
description: assessed onCBCT
arm group label: flat fixed anterior bite plane
arm group type: Experimental
description: Bands selection will be done for upper 6s. Alginate impressions taken and molar bands are fitted in place into the impressions. Impressions for upper and lower arches are poured with stone plaster. Mounting on simple hinge articulator will be done.
Lingual arches (diameter 1 mm) with anterior acrylic bite plates with thickness enough to separate posterior teeth 4mm .
The acrylic bite planes were in occlusion with the lower anterior teeth and extended sagittally 2-3mm beyond edges of lower incisors.
Finishing ,polishing and cementation into patient's mouth with glass ionomer cement.
arm group label: modified inclined fixed anterior bite plane
arm group type: Experimental
description: In modified inclined fixed anterior bite plane,the modification is that some indentations will be done in the acrylic part where the lower anteriors will fit such that mandible will be held in a more forward position. These indentations will be relieved lingually to overcome it's flaring effect on mandibular incisors .The inclined plane will be 60 degrees to occlusal plane.
Functional bite will be taken to position the mandible in the proper position forward.
Bite taken edge-to-edge for appliance construction. Mounting upper and lower casts on simple hinge articulator for construction of modified flat fixed anterior bite plane
intervention type: Device
intervention name: flat fixed anterior bite plane
description: It causes unlocking mandible from deep bite in growing females
arm group label: flat fixed anterior bite plane
intervention type: Device
intervention name: modified inclined fixed anterior bite plane
description: It causes unlocking mandible from deep bite in growing females plus putting the mandible in a more forward position
arm group label: modified inclined fixed anterior bite plane
criteria: 
gender: Female
minimum age: 10 Years
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
last name: yomna Elfiky, resident
phone: 01001987078
email: princessyomna7@outlook.com
facility: 
status: Recruiting
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Yomna Elfiky
investigator title: Resident
mesh term: Micrognathism
mesh term: Malocclusion