<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/NCT03004300</url>
  </required_header>
  <id_info>
    <org_study_id>044029</org_study_id>
    <nct_id>NCT03004300</nct_id>
  </id_info>
  <brief_title>Maxillary Expansion Effects in Children With Upper Airway Obstruction</brief_title>
  <official_title>Maxillary Expansion Effects in the Facial Structures of Children With Upper Airway Obstruction: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal de Goias</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal de Goias</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>
      The most frequent causes of mouth breathers are the adenotonsillar hypertrophy.&#xD;
      Adenotonsillectomy is the main choice for the elimination of the obstruction. However, this&#xD;
      surgical treatment does not have its effect well elucidated and apnea has been cited in the&#xD;
      literature as a residual outcome. Other types of supporting treatment may also been involved&#xD;
      such as the use of corticosteroids, physiotherapy and orthodontic-orthopedic treatment, among&#xD;
      them rapid maxillary expansion (RME).&#xD;
&#xD;
      RME corrects the morphological constriction of the upper arch caused by buccal breathing and&#xD;
      also reduce the airway resistance. Despite reports of RME influencing volume enhancement in&#xD;
      pharyngeal airway, there are still few three-dimensional studies following the post-expansion&#xD;
      effects. In addition, these changes are doubtful due postural changes of the tongue during&#xD;
      the tomography exam. Conflicts of results are also present for changes in the nasal septum of&#xD;
      children. The main alteration mentioned is the increase in the length of the lower third of&#xD;
      the septum.&#xD;
&#xD;
      The investigators propose a randomized, prospective, controlled clinical trial in patients&#xD;
      with atresic maxilla with or without adenotonsillar hypertrophy. The patients will be treated&#xD;
      with RME and adenotonsillectomy when the obstruction is present. The purpose of this study is&#xD;
      elucidate if there is different outcomes considering the moment of RME treatment before or&#xD;
      after the adenotonsillectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 13, 2017</start_date>
  <completion_date type="Anticipated">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 30, 2019</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>Airway Volume</measure>
    <time_frame>7 months</time_frame>
    <description>cone beam computed tomography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life before and after maxillary expansion:</measure>
    <time_frame>1 and 7 months</time_frame>
    <description>Obstructive Sleep Apnea-18 questionnaire (OSA-18: scale range 18-126. The impact on quality of life was classified in three groups: a) minor (scores below 60); b) moderate (scores between 60 and 80) and major (scores above 80).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Quality of Life</measure>
    <time_frame>1 and 7 months</time_frame>
    <description>Pediatric Quality of Life Inventory: 0-100 scale range. Higher scores indicate better HRQOL (Health-Related Quality of Life)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Disturbance for Children</measure>
    <time_frame>1 and 7 months</time_frame>
    <description>Sleep Disturbance Scale for Children: scale range 26-130.Scores higher than 39 indicate sleep disturbance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nasal septum morphology</measure>
    <time_frame>7 months</time_frame>
    <description>Linear parameters by lateral tomographic distances</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dental arch distances</measure>
    <time_frame>7 months</time_frame>
    <description>Dental arch growth as described by Mc Namara,2003</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Airway obstruction</measure>
    <time_frame>7 months</time_frame>
    <description>Adenotonsillar hypertrophy by nasal flexible fiberoptic endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bruxism</measure>
    <time_frame>7 months</time_frame>
    <description>Bruxism episodes</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Airway Obstruction</condition>
  <arm_group>
    <arm_group_label>group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with atresic maxilla without upper airway obstruction submitted to rapid maxillary expansion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion before adenotonsillectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion after adenotonsillectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Rapid maxillary expansion</intervention_name>
    <description>Device</description>
    <arm_group_label>group 1</arm_group_label>
    <arm_group_label>group 2</arm_group_label>
    <arm_group_label>group 3</arm_group_label>
    <other_name>maxillary expansion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Adenotonsillectomy</intervention_name>
    <description>Surgery</description>
    <arm_group_label>group 2</arm_group_label>
    <arm_group_label>group 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children (boys and girls) between 5 and 9 years of age.&#xD;
&#xD;
          -  Atresic maxilla.&#xD;
&#xD;
          -  Skeletal Class I&#xD;
&#xD;
          -  With or without Adenotonsillar hypertrophy&#xD;
&#xD;
          -  Parents or tutors sign Informed Consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Craniofacial syndromes or neurologic disease diagnosis.&#xD;
&#xD;
          -  History of adenotonsillectomy and orthodontic treatment&#xD;
&#xD;
          -  History of facial trauma&#xD;
&#xD;
          -  Morbid obesity&#xD;
&#xD;
          -  Premature loss of posterior teeth&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose Valladares Neto, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal de Goiás</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculdade de Odontologia</name>
      <address>
        <city>Goias</city>
        <state>Goiás</state>
        <zip>74.605-220</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Guilleminault C, Monteyrol PJ, Huynh NT, Pirelli P, Quo S, Li K. Adeno-tonsillectomy and rapid maxillary distraction in pre-pubertal children, a pilot study. Sleep Breath. 2011 May;15(2):173-7. doi: 10.1007/s11325-010-0419-3. Epub 2010 Sep 17.</citation>
    <PMID>20848317</PMID>
  </reference>
  <reference>
    <citation>de Castilho LS, Abreu MH, de Oliveira RB, Souza E Silva ME, Resende VL. Factors associated with mouth breathing in children with -developmental -disabilities. Spec Care Dentist. 2016 Mar-Apr;36(2):75-9. doi: 10.1111/scd.12157. Epub 2016 Jan 13.</citation>
    <PMID>26763202</PMID>
  </reference>
  <reference>
    <citation>Caprioglio A, Meneghel M, Fastuca R, Zecca PA, Nucera R, Nosetti L. Rapid maxillary expansion in growing patients: correspondence between 3-dimensional airway changes and polysomnography. Int J Pediatr Otorhinolaryngol. 2014 Jan;78(1):23-7. doi: 10.1016/j.ijporl.2013.10.011. Epub 2013 Oct 25.</citation>
    <PMID>24231036</PMID>
  </reference>
  <reference>
    <citation>Chang Y, Koenig LJ, Pruszynski JE, Bradley TG, Bosio JA, Liu D. Dimensional changes of upper airway after rapid maxillary expansion: a prospective cone-beam computed tomography study. Am J Orthod Dentofacial Orthop. 2013 Apr;143(4):462-70. doi: 10.1016/j.ajodo.2012.11.019.</citation>
    <PMID>23561406</PMID>
  </reference>
  <reference>
    <citation>Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.</citation>
    <PMID>11468499</PMID>
  </reference>
  <reference>
    <citation>Bruni O, Ottaviano S, Guidetti V, Romoli M, Innocenzi M, Cortesi F, Giannotti F. The Sleep Disturbance Scale for Children (SDSC). Construction and validation of an instrument to evaluate sleep disturbances in childhood and adolescence. J Sleep Res. 1996 Dec;5(4):251-61. doi: 10.1111/j.1365-2869.1996.00251.x.</citation>
    <PMID>9065877</PMID>
  </reference>
  <reference>
    <citation>Fernandes FM, Teles Rda C. Application of the Portuguese version of the Obstructive Sleep Apnea-18 survey to children. Braz J Otorhinolaryngol. 2013 Nov-Dec;79(6):720-6. doi: 10.5935/1808-8694.20130132.</citation>
    <PMID>24474484</PMID>
  </reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>October 14, 2019</last_update_submitted>
  <last_update_submitted_qc>October 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Goias</investigator_affiliation>
    <investigator_full_name>José Valladares Neto</investigator_full_name>
    <investigator_title>PHD Professor</investigator_title>
  </responsible_party>
  <keyword>maxillary expansion</keyword>
  <keyword>adenotonsillar hypertrophy</keyword>
  <keyword>airway volume</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Airway Obstruction</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/NCT03004300
org study id: 044029
nct id: NCT03004300
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The most frequent causes of mouth breathers are the adenotonsillar hypertrophy.
      Adenotonsillectomy is the main choice for the elimination of the obstruction. However, this
      surgical treatment does not have its effect well elucidated and apnea has been cited in the
      literature as a residual outcome. Other types of supporting treatment may also been involved
      such as the use of corticosteroids, physiotherapy and orthodontic-orthopedic treatment, among
      them rapid maxillary expansion (RME).

      RME corrects the morphological constriction of the upper arch caused by buccal breathing and
      also reduce the airway resistance. Despite reports of RME influencing volume enhancement in
      pharyngeal airway, there are still few three-dimensional studies following the post-expansion
      effects. In addition, these changes are doubtful due postural changes of the tongue during
      the tomography exam. Conflicts of results are also present for changes in the nasal septum of
      children. The main alteration mentioned is the increase in the length of the lower third of
      the septum.

      The investigators propose a randomized, prospective, controlled clinical trial in patients
      with atresic maxilla with or without adenotonsillar hypertrophy. The patients will be treated
      with RME and adenotonsillectomy when the obstruction is present. The purpose of this study is
      elucidate if there is different outcomes considering the moment of RME treatment before or
      after the adenotonsillectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Airway Volume
time frame: 7 months
description: cone beam computed tomography
measure: Quality of life before and after maxillary expansion:
time frame: 1 and 7 months
description: Obstructive Sleep Apnea-18 questionnaire (OSA-18: scale range 18-126. The impact on quality of life was classified in three groups: a) minor (scores below 60); b) moderate (scores between 60 and 80) and major (scores above 80).
measure: Pediatric Quality of Life
time frame: 1 and 7 months
description: Pediatric Quality of Life Inventory: 0-100 scale range. Higher scores indicate better HRQOL (Health-Related Quality of Life)
measure: Sleep Disturbance for Children
time frame: 1 and 7 months
description: Sleep Disturbance Scale for Children: scale range 26-130.Scores higher than 39 indicate sleep disturbance
measure: Nasal septum morphology
time frame: 7 months
description: Linear parameters by lateral tomographic distances
measure: Dental arch distances
time frame: 7 months
description: Dental arch growth as described by Mc Namara,2003
measure: Airway obstruction
time frame: 7 months
description: Adenotonsillar hypertrophy by nasal flexible fiberoptic endoscopy
measure: Bruxism
time frame: 7 months
description: Bruxism episodes
arm group label: group 1
arm group type: Active Comparator
description: Patients with atresic maxilla without upper airway obstruction submitted to rapid maxillary expansion
arm group label: group 2
arm group type: Experimental
description: Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion before adenotonsillectomy
arm group label: group 3
arm group type: Experimental
description: Patients with atresic maxilla and adenotonsillar hypertrophy submitted to rapid maxillary expansion after adenotonsillectomy
intervention type: Procedure
intervention name: Rapid maxillary expansion
description: Device
arm group label: group 1
arm group label: group 2
arm group label: group 3
other name: maxillary expansion
intervention type: Procedure
intervention name: Adenotonsillectomy
description: Surgery
arm group label: group 2
arm group label: group 3
criteria: 
gender: All
minimum age: 5 Years
maximum age: 9 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jose Valladares Neto, PHD
role: Principal Investigator
affiliation: Universidade Federal de Goiás
facility: 
country: Brazil
citation: Guilleminault C, Monteyrol PJ, Huynh NT, Pirelli P, Quo S, Li K. Adeno-tonsillectomy and rapid maxillary distraction in pre-pubertal children, a pilot study. Sleep Breath. 2011 May;15(2):173-7. doi: 10.1007/s11325-010-0419-3. Epub 2010 Sep 17.
PMID: 20848317
citation: de Castilho LS, Abreu MH, de Oliveira RB, Souza E Silva ME, Resende VL. Factors associated with mouth breathing in children with -developmental -disabilities. Spec Care Dentist. 2016 Mar-Apr;36(2):75-9. doi: 10.1111/scd.12157. Epub 2016 Jan 13.
PMID: 26763202
citation: Caprioglio A, Meneghel M, Fastuca R, Zecca PA, Nucera R, Nosetti L. Rapid maxillary expansion in growing patients: correspondence between 3-dimensional airway changes and polysomnography. Int J Pediatr Otorhinolaryngol. 2014 Jan;78(1):23-7. doi: 10.1016/j.ijporl.2013.10.011. Epub 2013 Oct 25.
PMID: 24231036
citation: Chang Y, Koenig LJ, Pruszynski JE, Bradley TG, Bosio JA, Liu D. Dimensional changes of upper airway after rapid maxillary expansion: a prospective cone-beam computed tomography study. Am J Orthod Dentofacial Orthop. 2013 Apr;143(4):462-70. doi: 10.1016/j.ajodo.2012.11.019.
PMID: 23561406
citation: Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
PMID: 11468499
citation: Bruni O, Ottaviano S, Guidetti V, Romoli M, Innocenzi M, Cortesi F, Giannotti F. The Sleep Disturbance Scale for Children (SDSC). Construction and validation of an instrument to evaluate sleep disturbances in childhood and adolescence. J Sleep Res. 1996 Dec;5(4):251-61. doi: 10.1111/j.1365-2869.1996.00251.x.
PMID: 9065877
citation: Fernandes FM, Teles Rda C. Application of the Portuguese version of the Obstructive Sleep Apnea-18 survey to children. Braz J Otorhinolaryngol. 2013 Nov-Dec;79(6):720-6. doi: 10.5935/1808-8694.20130132.
PMID: 24474484
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal de Goias
investigator full name: José Valladares Neto
investigator title: PHD Professor
mesh term: Airway Obstruction
sharing ipd: Undecided