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Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment

Primary Purpose

Sleep Apnea Syndrome, Malocclusion

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bioajusta X Orthodontic treatment
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea Syndrome focused on measuring Sleep Apnea Syndrome, Orthodontics, Tonsillectomy, Child

Eligibility Criteria

6 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children 6 to 9 years of age with tonsils degree 3 or 4 ,
  • Sleep snores and narrow maxilla or class II malocclusion.

Exclusion Criteria:

  • Neurological diseases,
  • Tooth missing ,
  • Previous orthodontic treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Orthodontic treatment

    Control Group

    Arm Description

    Snoring patients enrolling for tonsil surgery with maxillary constriction, and/or jaw retrognathism

    Patients enrolled for tonsils surgery

    Outcomes

    Primary Outcome Measures

    Evaluation of the facial growth
    Facial X rays exams were measured from both groups (treatment and control) and compared in a six month interval, in respect to sleep apnea predictors

    Secondary Outcome Measures

    Pharyngeal Size
    Pharyngeal size was studied with acoustic pharyngometry and data compared between treated and control groups

    Full Information

    First Posted
    June 30, 2010
    Last Updated
    June 21, 2012
    Sponsor
    University of Sao Paulo General Hospital
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01164631
    Brief Title
    Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment
    Official Title
    Improvement of Pharyngeal Size in Patients With Obstructive Tonsils Treated With Bioajusta X Orthodontic Appliance - Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2006 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo General Hospital
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Enlarged tonsils and malocclusion have relationship with sleep disturbance in children. The consequences of these features can include deviation of normal craniofacial growth such that this may result in a facial morphology more suitable to the development of sleep apnea later in life. The aim of this study was to compare the growth redirection, the evolution of respiratory symptoms and the pharyngeal size of snoring children with obstructive tonsils from the waiting list for surgery treated with the Bioajusta X orthodontic appliance.This new protocol of orthodontic treatment promotes maxillary expansion, mandibular advancement and proper tongue positioning on swallowing , that together may be helpful on remodeling the upper airways.
    Detailed Description
    Methods-The study population included 40 children, ranging in age from 6 to 9 years old, who were on the waiting list for adenotonsillectomy at the ENT Department of FMUSP. The patients were randomly divided into two groups and were subsequently compared after a six month interval. The first group included 24 patients who where treated with the Bioajusta X appliance and the second group included 16 patients who served as controls, and,thus, did not received any treatment. Cephalometric analysis was used to assess the growth direction by comparing the relationship of the vertical jaw based upon the angle of the palatal plane with the mandibular plane (ANS-PNS/Go-M).Pharyngeal size was measured using acoustic pharyngometry. The parents filled out a questionnaire with respect to the respiratory symptoms of their children.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Apnea Syndrome, Malocclusion
    Keywords
    Sleep Apnea Syndrome, Orthodontics, Tonsillectomy, Child

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Orthodontic treatment
    Arm Type
    Experimental
    Arm Description
    Snoring patients enrolling for tonsil surgery with maxillary constriction, and/or jaw retrognathism
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Patients enrolled for tonsils surgery
    Intervention Type
    Device
    Intervention Name(s)
    Bioajusta X Orthodontic treatment
    Other Intervention Name(s)
    Oral appliance, Orthodontic Treatment, Orofacial Orthopedics
    Intervention Description
    Oral Appliance that promotes semi-rapid maxillary expansion, while corrects tongue positioning and jaws relationship
    Primary Outcome Measure Information:
    Title
    Evaluation of the facial growth
    Description
    Facial X rays exams were measured from both groups (treatment and control) and compared in a six month interval, in respect to sleep apnea predictors
    Time Frame
    six months
    Secondary Outcome Measure Information:
    Title
    Pharyngeal Size
    Description
    Pharyngeal size was studied with acoustic pharyngometry and data compared between treated and control groups
    Time Frame
    six month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children 6 to 9 years of age with tonsils degree 3 or 4 , Sleep snores and narrow maxilla or class II malocclusion. Exclusion Criteria: Neurological diseases, Tooth missing , Previous orthodontic treatment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Renata C Di Francesco, Phd
    Organizational Affiliation
    University of Sao Paulo General Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Walter R Nunes Jr., Ms
    Organizational Affiliation
    University of Sao Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment

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