Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment

NCT01164631 | Completed Phase 4 DMC

• 1 other identifier: FAPESP - 06/57695-7
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep Apnea Syndrome; Malocclusion

Keywords

Sleep Apnea Syndrome; Orthodontics; Tonsillectomy; Child

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pharyngeal Size

  six month

Study Arms (2)

Orthodontic treatment

EXPERIMENTAL

Snoring patients enrolling for tonsil surgery with maxillary constriction, and/or jaw retrognathism

Device: Bioajusta X Orthodontic treatment

Control Group

NO INTERVENTION

Patients enrolled for tonsils surgery

Interventions

Bioajusta X Orthodontic treatment DEVICE

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

Also known as: Oral appliance, Orthodontic Treatment, Orofacial Orthopedics

Orthodontic treatment

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 6 to 9 years of age with tonsils degree 3 or 4 ,
• Sleep snores and narrow maxilla or class II malocclusion.

You may not qualify if:

• Neurological diseases,
• Tooth missing ,
• Previous orthodontic treatment.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

MeSH Terms

Conditions

Sleep Apnea Syndromes; Malocclusion

Interventions

Orthodontics

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Renata C Di Francesco, Phd

  University of Sao Paulo General Hospital

  STUDY DIRECTOR

• Walter R Nunes Jr., Ms

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: July 16, 2010
• Study Start: November 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: November 1, 2009
• Last Updated: June 22, 2012

Record last verified: 2012-06