Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment

NCT ID: NCT01164631

Last Updated: 2012-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2009-11-30

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.

Conditions

Sleep Apnea Syndrome; Malocclusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Orthodontic treatment

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

Group Type: EXPERIMENTAL

Bioajusta X Orthodontic treatment

Intervention Type: DEVICE

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

Control Group

Patients enrolled for tonsils surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bioajusta X Orthodontic treatment

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

Intervention Type: DEVICE

Other Intervention Names

Oral appliance; Orthodontic Treatment; Orofacial Orthopedics

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eduardo Moacyr Krieger

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renata C Di Francesco, Phd

Role: STUDY_DIRECTOR

University of Sao Paulo General Hospital

Walter R Nunes Jr., Ms

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Other Identifiers

FAPESP - 06/57695-7

Identifier Type: -

Identifier Source: org_study_id