Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment

Study Overview
=================
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.

Official Title
-----------------
Improvement of Pharyngeal Size in Patients With Obstructive Tonsils Treated With Bioajusta X Orthodontic Appliance - Randomized Clinical Trial

Conditions
-----------------
Sleep Apnea Syndrome, Malocclusion

Intervention / Treatment
-----------------
* Device: Bioajusta X Orthodontic treatment


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 9 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orthodontic treatment<br>Snoring patients enrolling for tonsil surgery with maxillary constriction, and/or jaw retrognathism | Device: Bioajusta X Orthodontic treatment<br>* Oral Appliance that promotes semi-rapid maxillary expansion, while corrects tongue positioning and jaws relationship<br>* Other names: Orofacial Orthopedics;|
| No Intervention: Control Group<br>Patients enrolled for tonsils surgery | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the facial growth | 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 | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharyngeal Size | Pharyngeal size was studied with acoustic pharyngometry and data compared between treated and control groups | six month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep Apnea Syndrome, Orthodontics, Tonsillectomy, Child