Randomized clinical trial on the effect of an functional ortopedic appliance in childen from 8 to 14 years with OSA

• Grant number: 12/15715-2
• Support Opportunities: Regular Research Grants
• Start date: December 01, 2012
• End date: May 31, 2016
• Field of knowledge: Health Sciences - Dentistry - Orthodontics
• Principal Investigator: Shirley Shizue Nagata Pignatari
• Grantee: Shirley Shizue Nagata Pignatari
• Host Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil
• Associated researchers: Juliana Sato Hermann ; Rosa Carrieri Rossi

Abstract

Functional Orthopedic Appliances have been used for the treatment of Sleep Apnea and Hypopnea. The goal of this research is to demonstrate, by means of a Controled Randomized Trial, the efficiency of The Rossi Orthopedic Appliance is such diseases, in children with restrictions of other approaches or in which that the previous treatments have failed. The mean population consist in children of both sexes from 8 to 14 years of age, (M=11 years) from the UNIFESP Pediatric Ear Nose and Throat Clinic, with the chief concern of sleep disorders associated with previous diagnostic of SAHOS (Sleep Apnea and Hypopnea Syndrome) confirmed by clinical and polysonographic examination, with more than one event of apnea per hour. From this individuals will be selected a consecutive sample of children that have been contraindicated for tonsylectomy by clinical conditions or that have been operated but showed relapse after surgery.The children will be submitted to orthodontic evaluation to access problems with the dental occlusion and for craniofacial disorders and then referred to radiographic and model study. A sample of children with more than 1 sleep apnea/hypopnea event per hour that have skeletal, dental or functional features that could worsen the sleep disorder will be selected for treatment, once most of these orthodontic problems can be successfully treated with orthopedic functional appliances.This group will be evaluated at the beginning (T1) and after 18 months of treatment (T2), when the previous examinations, both orthodontic and polysonographic, will be repeated to access the efficiency of the appliance. (AU)