Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment

This study has been completed.
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Eduardo Moacyr Krieger, University of Sao Paulo General Hospital Identifier:
First received: June 30, 2010
Last updated: June 21, 2012
Last verified: June 2012
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
Device: Bioajusta X Orthodontic treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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:

Further study details as provided by Eduardo Moacyr Krieger, University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • 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:
  • Pharyngeal Size [ Time Frame: six month ]
    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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT01164631     History of Changes
Other Study ID Numbers: FAPESP - 06/57695-7
Study First Received: June 30, 2010
Last Updated: June 21, 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 processed this record on May 25, 2017