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Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01164631
Enrollment
40
Registered
2010-07-16
Start date
2006-11-30
Completion date
2009-11-30
Last updated
2012-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion, Sleep Apnea Syndrome

Keywords

Sleep Apnea Syndrome, Orthodontics, Tonsillectomy, Child

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.

Interventions

DEVICEBioajusta X Orthodontic treatment

Oral Appliance that promotes semi-rapid maxillary expansion, while corrects tongue positioning and jaws relationship

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the facial growthsix monthsFacial 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

MeasureTime frameDescription
Pharyngeal Sizesix monthPharyngeal size was studied with acoustic pharyngometry and data compared between treated and control groups

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026