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Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01164631
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : June 22, 2012
Information provided by (Responsible Party):

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.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : November 2006
Primary Completion Date : December 2008
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Evaluation of the facial growth [ Time Frame: six months ]
    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 :
  1. Pharyngeal Size [ Time Frame: six month ]
    Pharyngeal size was studied with acoustic pharyngometry and data compared between treated and control groups

Eligibility Criteria

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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164631

Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
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

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
First Posted: July 16, 2010    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012

Keywords provided by Eduardo Moacyr Krieger, University of Sao Paulo General Hospital:
Sleep Apnea Syndrome

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Tooth Diseases
Stomatognathic Diseases