xml: <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/NCT05993156</url>
    </required_header>
    <id_info>
      <org_study_id>3-3-23</org_study_id>
      <nct_id>NCT05993156</nct_id>
    </id_info>
    <brief_title>Effects of Modified Fixed Twin Block Versus Removable Twin Block on Skeletal Class 2 Growing Patients With Mandibular Deficiency</brief_title>
    <official_title>Effects of Modified Fixed Twin Block Versus Removable Twin Block on Skeletal Class 2 Growing Patients With Mandibular Deficiency</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>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>
        Effects of modified fixed twin block versus removable twin block on skeletal class 2 growing&#xD;
        patients with mandibular deficiency:&#xD;
  &#xD;
        A Randomized Clinical Trial&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The main objective of the study is to evaluate the effects of the modified fixed TB on class&#xD;
        2 growing cases and to compare its effect to the conventional removable TB&#xD;
  &#xD;
        Research question Does the modified fixed twin block have the same effects as removable twin&#xD;
        block during treatment of skeletal class 2 growing patients with mandibular deficiency?&#xD;
  &#xD;
        PICO P: Growing skeletal class 2 patients with deficient mandible I : Modified Fixed Twin&#xD;
        block C: Conventional removable Twin block&#xD;
  &#xD;
        O :&#xD;
  &#xD;
        Primary outcome:&#xD;
  &#xD;
        Overjet&#xD;
  &#xD;
        Secondary outcome:&#xD;
  &#xD;
        Soft tissue Profile Antro-posterior mandibular position Mandibular length Antro-posterior&#xD;
        maxillary position Upper and lower Incisors inclinations Durability of the appliance Patient&#xD;
        Acceptance&#xD;
  &#xD;
        Hypothesis:&#xD;
  &#xD;
        There is no difference between the modified fixed or removable Twin block appliance regarding&#xD;
        overjet reduction, dentoskeletal effects and patient perception.&#xD;
  &#xD;
        8. Trial design: Randomized Clinical Trial Parallel group, two arm, equivalent trial with 1:1&#xD;
        allocation ratio.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 1, 2022</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</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>
      <intervention_model_description>Randomized Clinical Trial Parallel group, two arm, equivalent trial with 1:1 allocation ratio.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Over jet reduction</measure>
      <time_frame>9 months</time_frame>
      <description>the horizontal distance between upper and lower incisors</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Effective mandibular length</measure>
      <time_frame>9 months</time_frame>
      <description>distance from condylon to the Pogonion points</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lower incisor inclination</measure>
      <time_frame>9 months</time_frame>
      <description>inclination of lower incisors on the mandibular plane</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Malocclusion</condition>
    <condition>Angle Class II</condition>
    <condition>Mandible Small</condition>
    <arm_group>
      <arm_group_label>Removable twin block group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>participants would receive conventional removable twin block for correction of class II malocclusion for 9 months</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Fixed twin block group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>participants would receive a modified fixed twin block for correction of class II malocclusion for 9 months</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>modified Fixed twinblock</intervention_name>
      <description>modified fixed twin block functional appliance, with cemented bands on the first molars</description>
      <arm_group_label>Fixed twin block group</arm_group_label>
      <other_name>F.T.B.</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>removable twin block</intervention_name>
      <description>Conventional Removable Clark twin block myofunctional appliance</description>
      <arm_group_label>Removable twin block group</arm_group_label>
      <other_name>R.T.B.</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Skeletal Class 2 malocclusion cases (ANB ≥ 5 degrees)&#xD;
  &#xD;
            -  Overjet ≥ 5 mm&#xD;
  &#xD;
            -  Growing patients (CVMS 3 or 4)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Skeletally mature patients 15 years old or above&#xD;
  &#xD;
            -  Patients with normal mandible and only protruded upper incisors.&#xD;
  &#xD;
            -  Syndromic, cleft patients and patients with dental anomalies&#xD;
  &#xD;
            -  Previous orthopaedic or orthodontic treatment&#xD;
  &#xD;
            -  No sex predilection.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>9 Years</minimum_age>
      <maximum_age>15 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Faculty of Dentistry</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>ezat ahmed</last_name>
        <phone>0020223642705</phone>
        <email>rec@dentistry.cu.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Alhammadi MS, Halboub E, Fayed MS, Labib A, El-Saaidi C. Global distribution of malocclusion traits: A systematic review. Dental Press J Orthod. 2018 Nov-Dec;23(6):40.e1-40.e10. doi: 10.1590/2177-6709.23.6.40.e1-10.onl. Erratum In: Dental Press J Orthod. 2019 Aug 01;24(3):113.</citation>
      <PMID>30672991</PMID>
    </reference>
    <reference>
      <citation>Burhan AS, Nawaya FR. Dentoskeletal effects of the Bite-Jumping Appliance and the Twin-Block Appliance in the treatment of skeletal Class II malocclusion: a randomized controlled trial. Eur J Orthod. 2015 Jun;37(3):330-7. doi: 10.1093/ejo/cju052. Epub 2014 Oct 8.</citation>
      <PMID>25296729</PMID>
    </reference>
    <reference>
      <citation>Caldwell S, Cook P. Predicting the outcome of twin block functional appliance treatment: a prospective study. Eur J Orthod. 1999 Oct;21(5):533-9. doi: 10.1093/ejo/21.5.533.</citation>
      <PMID>10565094</PMID>
    </reference>
    <reference>
      <citation>Clark William J., Mahony Derek, 2018. heal talk A journal of clinical dentistry 11.</citation>
    </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>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>Ehsani S, Nebbe B, Normando D, Lagravere MO, Flores-Mir C. Short-term treatment effects produced by the Twin-block appliance: a systematic review and meta-analysis. Eur J Orthod. 2015 Apr;37(2):170-6. doi: 10.1093/ejo/cju030. Epub 2014 Jul 22.</citation>
      <PMID>25052373</PMID>
    </reference>
    <reference>
      <citation>Elfeky HY, Fayed MS, Alhammadi MS, Soliman SAZ, El Boghdadi DM. Three-dimensional skeletal, dentoalveolar and temporomandibular joint changes produced by Twin Block functional appliance. J Orofac Orthop. 2018 Jul;79(4):245-258. doi: 10.1007/s00056-018-0137-1. Epub 2018 Apr 16.</citation>
      <PMID>29663034</PMID>
    </reference>
    <reference>
      <citation>Linjawi AI, Abbassy MA. Dentoskeletal effects of the forsus fatigue resistance device in the treatment of class II malocclusion: A systematic review and meta-analysis. J Orthod Sci. 2018 Feb 15;7:5. doi: 10.4103/jos.JOS_80_17. eCollection 2018.</citation>
      <PMID>29765917</PMID>
    </reference>
    <reference>
      <citation>Matthaios S, Tsolakis AI, Haidich AB, Galanis I, Tsolakis IA. Dental and Skeletal Effects of Herbst Appliance, Forsus Fatigue Resistance Device, and Class II Elastics-A Systematic Review and Meta-Analysis. J Clin Med. 2022 Nov 26;11(23):6995. doi: 10.3390/jcm11236995.</citation>
      <PMID>36498570</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 early orthodontic treatment with the Twin-block appliance: a multicenter, randomized, controlled trial. Part 1: Dental and skeletal effects. Am J Orthod Dentofacial Orthop. 2003 Sep;124(3):234-43; quiz 339. doi: 10.1016/S0889540603003524.</citation>
      <PMID>12970656</PMID>
    </reference>
    <reference>
      <citation>Thiruvenkatachari B, Harrison JE, Worthington HV, O'Brien KD. Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children. Cochrane Database Syst Rev. 2013 Nov 13;(11):CD003452. doi: 10.1002/14651858.CD003452.pub3.</citation>
      <PMID>24226169</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Omar yousry mahmoud mostafa</investigator_full_name>
      <investigator_title>primary investigator, assistant lecturer</investigator_title>
    </responsible_party>
    <keyword>orthodontics</keyword>
    <keyword>orthopedics</keyword>
    <keyword>myofunctional appliance</keyword>
    <keyword>Twinblock</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Micrognathism</mesh_term>
      <mesh_term>Malocclusion</mesh_term>
      <mesh_term>Malocclusion, Angle Class II</mesh_term>
      <mesh_term>Overbite</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>results and statistical data would be published and IPD would be available upon request</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05993156
  org study id: 3-3-23
  nct id: NCT05993156
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Effects of modified fixed twin block versus removable twin block on skeletal class 2 growing
        patients with mandibular deficiency:
  
        A Randomized Clinical Trial
  The main objective of the study is to evaluate the effects of the modified fixed TB on class
        2 growing cases and to compare its effect to the conventional removable TB
  
        Research question Does the modified fixed twin block have the same effects as removable twin
        block during treatment of skeletal class 2 growing patients with mandibular deficiency?
  
        PICO P: Growing skeletal class 2 patients with deficient mandible I : Modified Fixed Twin
        block C: Conventional removable Twin block
  
        O :
  
        Primary outcome:
  
        Overjet
  
        Secondary outcome:
  
        Soft tissue Profile Antro-posterior mandibular position Mandibular length Antro-posterior
        maxillary position Upper and lower Incisors inclinations Durability of the appliance Patient
        Acceptance
  
        Hypothesis:
  
        There is no difference between the modified fixed or removable Twin block appliance regarding
        overjet reduction, dentoskeletal effects and patient perception.
  
        8. Trial design: Randomized Clinical Trial Parallel group, two arm, equivalent trial with 1:1
        allocation ratio.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized Clinical Trial Parallel group, two arm, equivalent trial with 1:1 allocation ratio.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Over jet reduction
  time frame: 9 months
  description: the horizontal distance between upper and lower incisors
  measure: Effective mandibular length
  time frame: 9 months
  description: distance from condylon to the Pogonion points
  measure: lower incisor inclination
  time frame: 9 months
  description: inclination of lower incisors on the mandibular plane
  arm group label: Removable twin block group
  arm group type: Active Comparator
  description: participants would receive conventional removable twin block for correction of class II malocclusion for 9 months
  arm group label: Fixed twin block group
  arm group type: Experimental
  description: participants would receive a modified fixed twin block for correction of class II malocclusion for 9 months
  intervention type: Device
  intervention name: modified Fixed twinblock
  description: modified fixed twin block functional appliance, with cemented bands on the first molars
  arm group label: Fixed twin block group
  other name: F.T.B.
  intervention type: Device
  intervention name: removable twin block
  description: Conventional Removable Clark twin block myofunctional appliance
  arm group label: Removable twin block group
  other name: R.T.B.
  criteria: 
  gender: Female
  minimum age: 9 Years
  maximum age: 15 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  citation: Alhammadi MS, Halboub E, Fayed MS, Labib A, El-Saaidi C. Global distribution of malocclusion traits: A systematic review. Dental Press J Orthod. 2018 Nov-Dec;23(6):40.e1-40.e10. doi: 10.1590/2177-6709.23.6.40.e1-10.onl. Erratum In: Dental Press J Orthod. 2019 Aug 01;24(3):113.
  PMID: 30672991
  citation: Burhan AS, Nawaya FR. Dentoskeletal effects of the Bite-Jumping Appliance and the Twin-Block Appliance in the treatment of skeletal Class II malocclusion: a randomized controlled trial. Eur J Orthod. 2015 Jun;37(3):330-7. doi: 10.1093/ejo/cju052. Epub 2014 Oct 8.
  PMID: 25296729
  citation: Caldwell S, Cook P. Predicting the outcome of twin block functional appliance treatment: a prospective study. Eur J Orthod. 1999 Oct;21(5):533-9. doi: 10.1093/ejo/21.5.533.
  PMID: 10565094
  citation: Clark William J., Mahony Derek, 2018. heal talk A journal of clinical dentistry 11.
  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: 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: Ehsani S, Nebbe B, Normando D, Lagravere MO, Flores-Mir C. Short-term treatment effects produced by the Twin-block appliance: a systematic review and meta-analysis. Eur J Orthod. 2015 Apr;37(2):170-6. doi: 10.1093/ejo/cju030. Epub 2014 Jul 22.
  PMID: 25052373
  citation: Elfeky HY, Fayed MS, Alhammadi MS, Soliman SAZ, El Boghdadi DM. Three-dimensional skeletal, dentoalveolar and temporomandibular joint changes produced by Twin Block functional appliance. J Orofac Orthop. 2018 Jul;79(4):245-258. doi: 10.1007/s00056-018-0137-1. Epub 2018 Apr 16.
  PMID: 29663034
  citation: Linjawi AI, Abbassy MA. Dentoskeletal effects of the forsus fatigue resistance device in the treatment of class II malocclusion: A systematic review and meta-analysis. J Orthod Sci. 2018 Feb 15;7:5. doi: 10.4103/jos.JOS_80_17. eCollection 2018.
  PMID: 29765917
  citation: Matthaios S, Tsolakis AI, Haidich AB, Galanis I, Tsolakis IA. Dental and Skeletal Effects of Herbst Appliance, Forsus Fatigue Resistance Device, and Class II Elastics-A Systematic Review and Meta-Analysis. J Clin Med. 2022 Nov 26;11(23):6995. doi: 10.3390/jcm11236995.
  PMID: 36498570
  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 early orthodontic treatment with the Twin-block appliance: a multicenter, randomized, controlled trial. Part 1: Dental and skeletal effects. Am J Orthod Dentofacial Orthop. 2003 Sep;124(3):234-43; quiz 339. doi: 10.1016/S0889540603003524.
  PMID: 12970656
  citation: Thiruvenkatachari B, Harrison JE, Worthington HV, O'Brien KD. Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children. Cochrane Database Syst Rev. 2013 Nov 13;(11):CD003452. doi: 10.1002/14651858.CD003452.pub3.
  PMID: 24226169
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Omar yousry mahmoud mostafa
  investigator title: primary investigator, assistant lecturer
  mesh term: Micrognathism
  mesh term: Malocclusion
  mesh term: Malocclusion, Angle Class II
  mesh term: Overbite
  sharing ipd: No
  ipd description: results and statistical data would be published and IPD would be available upon request