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Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Eduardo Moacyr Krieger, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01164631
First received: June 30, 2010
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Sleep Apnea Syndrome
Malocclusion
 Device: Bioajusta X Orthodontic treatment
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improvement of Pharyngeal Size in Patients With Obstructive Tonsils Treated With Bioajusta X Orthodontic Appliance - Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Evaluation of the facial growth [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: six month ] [ Designated as safety issue: Yes ]
    Pharyngeal size was studied with acoustic pharyngometry and data compared between treated and control groups


Enrollment: 40
Study Start Date: November 2006
Study Completion Date: November 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Orthodontic treatment
Snoring patients enrolling for tonsil surgery with maxillary constriction, and/or jaw retrognathism
 Device: Bioajusta X Orthodontic treatment
Oral Appliance that promotes semi-rapid maxillary expansion, while corrects tongue positioning and jaws relationship
Other Names:
  • Oral appliance
  • Orthodontic Treatment
  • Orofacial Orthopedics
No Intervention: Control Group
Patients enrolled for tonsils surgery

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.

  Eligibility

Ages Eligible for Study:   6 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164631

Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Director: Renata C Di Francesco, Phd University of Sao Paulo General Hospital
Principal Investigator: Walter R Nunes Jr., Ms University of Sao Paulo
  More Information

No publications provided

Responsible Party: Eduardo Moacyr Krieger, PhD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01164631     History of Changes
Other Study ID Numbers: FAPESP - 06/57695-7
Study First Received: June 30, 2010
Last Updated: June 21, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
Sleep Apnea Syndrome
Orthodontics
Tonsillectomy
Child

Additional relevant MeSH terms:
Apnea
Malocclusion
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Tooth Diseases
Stomatognathic Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013