Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment

June 21, 2012 updated by: Eduardo Moacyr Krieger, University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the facial growth
Time Frame: six months
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
Time Frame: six month
Pharyngeal size was studied with acoustic pharyngometry and data compared between treated and control groups
six month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Study Director: Renata C Di Francesco, Phd, University of Sao Paulo General Hospital
  • Principal Investigator: Walter R Nunes Jr., Ms, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

June 30, 2010

First Submitted That Met QC Criteria

July 15, 2010

First Posted (Estimate)

July 16, 2010

Study Record Updates

Last Update Posted (Estimate)

June 22, 2012

Last Update Submitted That Met QC Criteria

June 21, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAPESP - 06/57695-7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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