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Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment

U

University of Sao Paulo General Hospital

Status and phase

Completed
Phase 4

Conditions

Sleep Apnea Syndrome
Malocclusion

Treatments

Device: Bioajusta X Orthodontic treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01164631
FAPESP - 06/57695-7

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

6 to 9 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Orthodontic treatment
Experimental group
Description:
Snoring patients enrolling for tonsil surgery with maxillary constriction, and/or jaw retrognathism
Treatment:
Device: Bioajusta X Orthodontic treatment
Control Group
No Intervention group
Description:
Patients enrolled for tonsils surgery

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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