Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment
Primary Purpose
Sleep Apnea Syndrome, Malocclusion
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bioajusta X Orthodontic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea Syndrome focused on measuring Sleep Apnea Syndrome, Orthodontics, Tonsillectomy, Child
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Orthodontic treatment
Control Group
Arm Description
Snoring patients enrolling for tonsil surgery with maxillary constriction, and/or jaw retrognathism
Patients enrolled for tonsils surgery
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Pharyngeal Size
Pharyngeal size was studied with acoustic pharyngometry and data compared between treated and control groups
Full Information
NCT ID
NCT01164631
First Posted
June 30, 2010
Last Updated
June 21, 2012
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01164631
Brief Title
Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment
Official Title
Improvement of Pharyngeal Size in Patients With Obstructive Tonsils Treated With Bioajusta X Orthodontic Appliance - Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndrome, Malocclusion
Keywords
Sleep Apnea Syndrome, Orthodontics, Tonsillectomy, Child
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Orthodontic treatment
Arm Type
Experimental
Arm Description
Snoring patients enrolling for tonsil surgery with maxillary constriction, and/or jaw retrognathism
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients enrolled for tonsils surgery
Intervention Type
Device
Intervention Name(s)
Bioajusta X Orthodontic treatment
Other Intervention Name(s)
Oral appliance, Orthodontic Treatment, Orofacial Orthopedics
Intervention Description
Oral Appliance that promotes semi-rapid maxillary expansion, while corrects tongue positioning and jaws relationship
Primary Outcome Measure Information:
Title
Evaluation of the facial growth
Description
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
Time Frame
six months
Secondary Outcome Measure Information:
Title
Pharyngeal Size
Description
Pharyngeal size was studied with acoustic pharyngometry and data compared between treated and control groups
Time Frame
six month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renata C Di Francesco, Phd
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Walter R Nunes Jr., Ms
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment
We'll reach out to this number within 24 hrs