Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment

Phase 4

Completed

• Conditions: Sleep Apnea Syndrome; Malocclusion
• Interventions: Device: Bioajusta X Orthodontic treatment

• Registration Number: NCT01164631
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2008-12
• Study Completion: 2009-11
• Study First Submitted: 2010-06-30
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-21
• Last Update Posted: 2012-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orthodontic treatment	Bioajusta X Orthodontic treatment	Snoring patients enrolling for tonsil surgery with maxillary constriction, and/or jaw retrognathism

Primary Outcome Measures

Name	Time	Method
Evaluation of the facial growth	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

Name	Time	Method
Pharyngeal Size	six month	Pharyngeal size was studied with acoustic pharyngometry and data compared between treated and control groups