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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01164631
Other study ID # FAPESP - 06/57695-7
Secondary ID
Status Completed
Phase Phase 4
First received June 30, 2010
Last updated June 21, 2012
Start date November 2006
Est. completion date November 2009

Study information

Verified date June 2012
Source University of Sao Paulo General Hospital
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 9 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Bioajusta X Orthodontic treatment
Oral Appliance that promotes semi-rapid maxillary expansion, while corrects tongue positioning and jaws relationship

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital Fundação de Amparo à Pesquisa do Estado de São Paulo

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Pharyngeal Size Pharyngeal size was studied with acoustic pharyngometry and data compared between treated and control groups six month Yes
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