<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/NCT03824574</url>
  </required_header>
  <id_info>
    <org_study_id>AinShamsUOrthodontics</org_study_id>
    <nct_id>NCT03824574</nct_id>
  </id_info>
  <brief_title>Cephalometric Evaluation of a Clear Mandibular Advancement Appliance Based on the Twin-block Design</brief_title>
  <official_title>Cephalometric Evaluation of a Clear Mandibular Advancement Appliance Based on the Twin-block Design</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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 evaluates the cephalometric effects of a clear mandibular advancement appliance&#xD;
      for the treatment of skeletal class II growing patients suffering from mandibular deficiency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Clear mandibular advancement appliance is constructed comprised of a clear dental splint of&#xD;
      1.5 mm thickness adapted on the patient's teeth. This is followed by the construction of&#xD;
      acrylic bite ramps bonded over the splints. The bite ramps are constructed as such when the&#xD;
      patient bites into occlusion, he/she has to advance the mandible to bring the two parts of&#xD;
      the appliance together. Lateral cephalometric radiographs were obtained pre and&#xD;
      post-treatment to evaluate the effects on the patient's maxilla, mandible and dentition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2016</start_date>
  <completion_date type="Actual">March 4, 2018</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effective Mandibular Length</measure>
    <time_frame>12 months</time_frame>
    <description>Condylion-Gnathion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mandible to cranial base</measure>
    <time_frame>12 months</time_frame>
    <description>Sella-Nasion-B point</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effective maxillary length</measure>
    <time_frame>12 months</time_frame>
    <description>Condylion-A point</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maxilla to cranial base</measure>
    <time_frame>12 months</time_frame>
    <description>Sella-Nasion-A point</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lower incisor inclination</measure>
    <time_frame>12 months</time_frame>
    <description>Lower incisor to mandibular plane</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower incisor AP position</measure>
    <time_frame>12 months</time_frame>
    <description>Lower incisor Anteroposterior position</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper incisor inclination</measure>
    <time_frame>12 months</time_frame>
    <description>Upper incisor to palatal plane</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper incisor AP position</measure>
    <time_frame>12 months</time_frame>
    <description>Upper incisor Anteroposterior position</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Profile convexity</measure>
    <time_frame>12 months</time_frame>
    <description>N'Sn/Sn-Pog'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lip protrusion</measure>
    <time_frame>12 months</time_frame>
    <description>Ls-E plane</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chin position</measure>
    <time_frame>12 months</time_frame>
    <description>Soft tissue Pogonion position</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Skeletal Malocclusion</condition>
  <arm_group>
    <arm_group_label>Treatment arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receiving the clear mandibular advancement appliance</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Clear Mandibular Advancement Appliance</intervention_name>
    <description>Clear Mandibular Advancement Appliance for treatment of skeletal class II patients with retrognathic mandible</description>
    <arm_group_label>Treatment arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Gender: Female subjects.&#xD;
&#xD;
          2. Chronological age: All recruited subjects were between the ages of 8-12 years.&#xD;
&#xD;
          3. Anteroposterior skeletal relationship: Subjects with skeletal Class II malocclusion&#xD;
             with normal maxilla and retrognathic mandible were selected. This was confirmed using&#xD;
             lateral cephalometric radiographic analysis with the following parameters: decreased&#xD;
             effective mandibular length (Co-Gn) according to McNamara composite , SNB&lt;78,&#xD;
             SNA=82+2.&#xD;
&#xD;
          4. Dental characteristics:&#xD;
&#xD;
               -  Angle Class II molar relationship ranging from edge to edge to full unit Class&#xD;
                  II.&#xD;
&#xD;
               -  Overjet ranging between 5-10 mm.&#xD;
&#xD;
               -  Absence of posterior crossbite and/or tendency for posterior crossbite.&#xD;
&#xD;
          5. Skeletal maturation stage: The growth stage for all subjects was selected to be before&#xD;
             or at the prepubertal growth spurt. This was confirmed by cervical vertebral&#xD;
             maturation analysis from the lateral cephalometric radiograph. The cervical vertebrae&#xD;
             maturation stage required was Cervical Vertebrae Maturation stage 2-3 according to the&#xD;
             cervical vertebrae maturation index by Baccetti et al. allowing sufficient time before&#xD;
             the end of the growth spurt.&#xD;
&#xD;
          6. No previous history of orthodontic treatment.&#xD;
&#xD;
          7. Absence of systemic diseases affecting growth or craniofacial development. -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Jena AK, Duggal R, Parkash H. Skeletal and dentoalveolar effects of Twin-block and bionator appliances in the treatment of Class II malocclusion: a comparative study. Am J Orthod Dentofacial Orthop. 2006 Nov;130(5):594-602. doi: 10.1016/j.ajodo.2005.02.025.</citation>
    <PMID>17110256</PMID>
  </reference>
  <reference>
    <citation>Teuscher U. A growth-related concept for skeletal class II treatment. Am J Orthod. 1978 Sep;74(3):258-75. doi: 10.1016/0002-9416(78)90202-6.</citation>
    <PMID>281130</PMID>
  </reference>
  <reference>
    <citation>Lv Y, Yan B, Wang L. Two-phase treatment of skeletal class II malocclusion with the combination of the twin-block appliance and high-pull headgear. Am J Orthod Dentofacial Orthop. 2012 Aug;142(2):246-55. doi: 10.1016/j.ajodo.2010.12.024.</citation>
    <PMID>22858335</PMID>
  </reference>
  <reference>
    <citation>O'Brien K, Macfarlane T, Wright J, Conboy F, Appelbe P, Birnie D, Chadwick S, Connolly I, Hammond M, Harradine N, Lewis D, Littlewood S, McDade C, Mitchell L, Murray A, O'Neill J, Sandler J, Read M, Robinson S, Shaw I, Turbill E. Early treatment for Class II malocclusion and perceived improvements in facial profile. Am J Orthod Dentofacial Orthop. 2009 May;135(5):580-5. doi: 10.1016/j.ajodo.2008.02.020.</citation>
    <PMID>19409340</PMID>
  </reference>
  <reference>
    <citation>Tulloch JF, Phillips C, Koch G, Proffit WR. The effect of early intervention on skeletal pattern in Class II malocclusion: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 1997 Apr;111(4):391-400. doi: 10.1016/s0889-5406(97)80021-2.</citation>
    <PMID>9109584</PMID>
  </reference>
  <reference>
    <citation>Cozza P, Baccetti T, Franchi L, De Toffol L, McNamara JA Jr. Mandibular changes produced by functional appliances in Class II malocclusion: a systematic review. Am J Orthod Dentofacial Orthop. 2006 May;129(5):599.e1-12; discussion e1-6. doi: 10.1016/j.ajodo.2005.11.010.</citation>
    <PMID>16679196</PMID>
  </reference>
  <reference>
    <citation>Baccetti T, Franchi L, Toth LR, McNamara JA Jr. Treatment timing for Twin-block therapy. Am J Orthod Dentofacial Orthop. 2000 Aug;118(2):159-70. doi: 10.1067/mod.2000.105571.</citation>
    <PMID>10935956</PMID>
  </reference>
  <reference>
    <citation>Clark WJ. The twin block technique. A functional orthopedic appliance system. Am J Orthod Dentofacial Orthop. 1988 Jan;93(1):1-18. doi: 10.1016/0889-5406(88)90188-6. No abstract available.</citation>
    <PMID>3422118</PMID>
  </reference>
  <reference>
    <citation>Toth LR, McNamara JA Jr. Treatment effects produced by the twin-block appliance and the FR-2 appliance of Frankel compared with an untreated Class II sample. Am J Orthod Dentofacial Orthop. 1999 Dec;116(6):597-609. doi: 10.1016/s0889-5406(99)70193-9.</citation>
    <PMID>10587592</PMID>
  </reference>
  <reference>
    <citation>Trenouth MJ. Cephalometric evaluation of the Twin-block appliance in the treatment of Class II Division 1 malocclusion with matched normative growth data. Am J Orthod Dentofacial Orthop. 2000 Jan;117(1):54-9. doi: 10.1016/s0889-5406(00)70248-4.</citation>
    <PMID>10629520</PMID>
  </reference>
  <reference>
    <citation>Mills CM, McCulloch KJ. Posttreatment changes after successful correction of Class II malocclusions with the twin block appliance. Am J Orthod Dentofacial Orthop. 2000 Jul;118(1):24-33. doi: 10.1067/mod.2000.104902.</citation>
    <PMID>10893470</PMID>
  </reference>
  <reference>
    <citation>Singh GD, Hodge MR. Bimaxillary morphometry of patients with class II division 1 malocclusion treated with twin block appliances. Angle Orthod. 2002 Oct;72(5):402-9. doi: 10.1043/0003-3219(2002)0722.0.CO;2.</citation>
    <PMID>12401048</PMID>
  </reference>
  <reference>
    <citation>Schaefer AT, McNamara JA Jr, Franchi L, Baccetti T. A cephalometric comparison of treatment with the Twin-block and stainless steel crown Herbst appliances followed by fixed appliance therapy. Am J Orthod Dentofacial Orthop. 2004 Jul;126(1):7-15. doi: 10.1016/j.ajodo.2003.06.017.</citation>
    <PMID>15224053</PMID>
  </reference>
  <reference>
    <citation>O'Brien K, Wright J, Conboy F, Sanjie Y, Mandall N, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I. Effectiveness of treatment for Class II malocclusion with the Herbst or twin-block appliances: a randomized, controlled trial. Am J Orthod Dentofacial Orthop. 2003 Aug;124(2):128-37. doi: 10.1016/s0889-5406(03)00345-7.</citation>
    <PMID>12923506</PMID>
  </reference>
  <reference>
    <citation>Flores-Mir C, Major PW. Cephalometric facial soft tissue changes with the twin block appliance in Class II division 1 malocclusion patients. A systematic review. Angle Orthod. 2006 Sep;76(5):876-81. doi: 10.1043/0003-3219(2006)076[0876:CFSTCW]2.0.CO;2.</citation>
    <PMID>17029526</PMID>
  </reference>
  <reference>
    <citation>Khoja A, Fida M, Shaikh A. Cephalometric evaluation of the effects of the Twin Block appliance in subjects with Class II, Division 1 malocclusion amongst different cervical vertebral maturation stages. Dental Press J Orthod. 2016 Jun;21(3):73-84. doi: 10.1590/2177-6709.21.3.073-084.oar.</citation>
    <PMID>27409656</PMID>
  </reference>
  <reference>
    <citation>Mills CM, McCulloch KJ. Treatment effects of the twin block appliance: a cephalometric study. Am J Orthod Dentofacial Orthop. 1998 Jul;114(1):15-24. doi: 10.1016/s0889-5406(98)70232-x.</citation>
    <PMID>9674675</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ahmed Mostafa Zaky</investigator_full_name>
    <investigator_title>Lecturer of Orthodontics</investigator_title>
  </responsible_party>
  <keyword>Functional appliance</keyword>
  <keyword>skeletal class II</keyword>
  <keyword>mandibular deficiency</keyword>
  <keyword>twin-block</keyword>
  <keyword>Growing patients</keyword>
  <keyword>Clear appliance</keyword>
  <keyword>Aligner</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malocclusion</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/NCT03824574
org study id: AinShamsUOrthodontics
nct id: NCT03824574
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the cephalometric effects of a clear mandibular advancement appliance
      for the treatment of skeletal class II growing patients suffering from mandibular deficiency.
A Clear mandibular advancement appliance is constructed comprised of a clear dental splint of
      1.5 mm thickness adapted on the patient's teeth. This is followed by the construction of
      acrylic bite ramps bonded over the splints. The bite ramps are constructed as such when the
      patient bites into occlusion, he/she has to advance the mandible to bring the two parts of
      the appliance together. Lateral cephalometric radiographs were obtained pre and
      post-treatment to evaluate the effects on the patient's maxilla, mandible and dentition.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effective Mandibular Length
time frame: 12 months
description: Condylion-Gnathion
measure: Mandible to cranial base
time frame: 12 months
description: Sella-Nasion-B point
measure: Effective maxillary length
time frame: 12 months
description: Condylion-A point
measure: Maxilla to cranial base
time frame: 12 months
description: Sella-Nasion-A point
measure: Lower incisor inclination
time frame: 12 months
description: Lower incisor to mandibular plane
measure: Lower incisor AP position
time frame: 12 months
description: Lower incisor Anteroposterior position
measure: Upper incisor inclination
time frame: 12 months
description: Upper incisor to palatal plane
measure: Upper incisor AP position
time frame: 12 months
description: Upper incisor Anteroposterior position
measure: Profile convexity
time frame: 12 months
description: N'Sn/Sn-Pog'
measure: Lip protrusion
time frame: 12 months
description: Ls-E plane
measure: Chin position
time frame: 12 months
description: Soft tissue Pogonion position
arm group label: Treatment arm
arm group type: Experimental
description: Subjects receiving the clear mandibular advancement appliance
intervention type: Device
intervention name: Clear Mandibular Advancement Appliance
description: Clear Mandibular Advancement Appliance for treatment of skeletal class II patients with retrognathic mandible
arm group label: Treatment arm
criteria: 
gender: Female
minimum age: 8 Years
maximum age: 12 Years
healthy volunteers: No
citation: Jena AK, Duggal R, Parkash H. Skeletal and dentoalveolar effects of Twin-block and bionator appliances in the treatment of Class II malocclusion: a comparative study. Am J Orthod Dentofacial Orthop. 2006 Nov;130(5):594-602. doi: 10.1016/j.ajodo.2005.02.025.
PMID: 17110256
citation: Teuscher U. A growth-related concept for skeletal class II treatment. Am J Orthod. 1978 Sep;74(3):258-75. doi: 10.1016/0002-9416(78)90202-6.
PMID: 281130
citation: Lv Y, Yan B, Wang L. Two-phase treatment of skeletal class II malocclusion with the combination of the twin-block appliance and high-pull headgear. Am J Orthod Dentofacial Orthop. 2012 Aug;142(2):246-55. doi: 10.1016/j.ajodo.2010.12.024.
PMID: 22858335
citation: O'Brien K, Macfarlane T, Wright J, Conboy F, Appelbe P, Birnie D, Chadwick S, Connolly I, Hammond M, Harradine N, Lewis D, Littlewood S, McDade C, Mitchell L, Murray A, O'Neill J, Sandler J, Read M, Robinson S, Shaw I, Turbill E. Early treatment for Class II malocclusion and perceived improvements in facial profile. Am J Orthod Dentofacial Orthop. 2009 May;135(5):580-5. doi: 10.1016/j.ajodo.2008.02.020.
PMID: 19409340
citation: Tulloch JF, Phillips C, Koch G, Proffit WR. The effect of early intervention on skeletal pattern in Class II malocclusion: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 1997 Apr;111(4):391-400. doi: 10.1016/s0889-5406(97)80021-2.
PMID: 9109584
citation: Cozza P, Baccetti T, Franchi L, De Toffol L, McNamara JA Jr. Mandibular changes produced by functional appliances in Class II malocclusion: a systematic review. Am J Orthod Dentofacial Orthop. 2006 May;129(5):599.e1-12; discussion e1-6. doi: 10.1016/j.ajodo.2005.11.010.
PMID: 16679196
citation: Baccetti T, Franchi L, Toth LR, McNamara JA Jr. Treatment timing for Twin-block therapy. Am J Orthod Dentofacial Orthop. 2000 Aug;118(2):159-70. doi: 10.1067/mod.2000.105571.
PMID: 10935956
citation: Clark WJ. The twin block technique. A functional orthopedic appliance system. Am J Orthod Dentofacial Orthop. 1988 Jan;93(1):1-18. doi: 10.1016/0889-5406(88)90188-6. No abstract available.
PMID: 3422118
citation: Toth LR, McNamara JA Jr. Treatment effects produced by the twin-block appliance and the FR-2 appliance of Frankel compared with an untreated Class II sample. Am J Orthod Dentofacial Orthop. 1999 Dec;116(6):597-609. doi: 10.1016/s0889-5406(99)70193-9.
PMID: 10587592
citation: Trenouth MJ. Cephalometric evaluation of the Twin-block appliance in the treatment of Class II Division 1 malocclusion with matched normative growth data. Am J Orthod Dentofacial Orthop. 2000 Jan;117(1):54-9. doi: 10.1016/s0889-5406(00)70248-4.
PMID: 10629520
citation: Mills CM, McCulloch KJ. Posttreatment changes after successful correction of Class II malocclusions with the twin block appliance. Am J Orthod Dentofacial Orthop. 2000 Jul;118(1):24-33. doi: 10.1067/mod.2000.104902.
PMID: 10893470
citation: Singh GD, Hodge MR. Bimaxillary morphometry of patients with class II division 1 malocclusion treated with twin block appliances. Angle Orthod. 2002 Oct;72(5):402-9. doi: 10.1043/0003-3219(2002)0722.0.CO;2.
PMID: 12401048
citation: Schaefer AT, McNamara JA Jr, Franchi L, Baccetti T. A cephalometric comparison of treatment with the Twin-block and stainless steel crown Herbst appliances followed by fixed appliance therapy. Am J Orthod Dentofacial Orthop. 2004 Jul;126(1):7-15. doi: 10.1016/j.ajodo.2003.06.017.
PMID: 15224053
citation: O'Brien K, Wright J, Conboy F, Sanjie Y, Mandall N, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I. Effectiveness of treatment for Class II malocclusion with the Herbst or twin-block appliances: a randomized, controlled trial. Am J Orthod Dentofacial Orthop. 2003 Aug;124(2):128-37. doi: 10.1016/s0889-5406(03)00345-7.
PMID: 12923506
citation: Flores-Mir C, Major PW. Cephalometric facial soft tissue changes with the twin block appliance in Class II division 1 malocclusion patients. A systematic review. Angle Orthod. 2006 Sep;76(5):876-81. doi: 10.1043/0003-3219(2006)076[0876:CFSTCW]2.0.CO;2.
PMID: 17029526
citation: Khoja A, Fida M, Shaikh A. Cephalometric evaluation of the effects of the Twin Block appliance in subjects with Class II, Division 1 malocclusion amongst different cervical vertebral maturation stages. Dental Press J Orthod. 2016 Jun;21(3):73-84. doi: 10.1590/2177-6709.21.3.073-084.oar.
PMID: 27409656
citation: Mills CM, McCulloch KJ. Treatment effects of the twin block appliance: a cephalometric study. Am J Orthod Dentofacial Orthop. 1998 Jul;114(1):15-24. doi: 10.1016/s0889-5406(98)70232-x.
PMID: 9674675
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ahmed Mostafa Zaky
investigator title: Lecturer of Orthodontics
mesh term: Malocclusion
sharing ipd: Undecided