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Impact of the expander with differential opening and the conventional Hyrax expander in the pediatric Obstructive Sleep Apnea: a randomized clinical trial

Grant number: 22/11973-9
Support Opportunities:Regular Research Grants
Duration: May 01, 2023 - April 30, 2025
Field of knowledge:Health Sciences - Dentistry - Orthodontics
Principal Investigator:Daniela Gamba Garib Carreira
Grantee:Daniela Gamba Garib Carreira
Host Institution: Faculdade de Odontologia de Bauru (FOB). Universidade de São Paulo (USP). Bauru , SP, Brazil
Associated researchers:Sergio Henrique Kiemle Trindade


The aim of this study is to compare the morphogical and functional effects of the expander with differential opening and the conventional Hyrax expander in patients in the mixed dentition diagnosed with a high risk for sleep-disordered breathing. Methods: The sample will be composed of children of both sexes aged 6 and 11 years of age with uni or bilateral posterior crossbite. Inclusion criteria will be the presence of Class I or II malocclusions with uni or bilateral posterior crossbites and presence of high risk for sleep-disordered breathing according to the Pediatric Sleep Questionnaire (PSQ). Patients who meet the eligibility criteria will be randomized 1:1 into two experimental groups. The EDO group will consist of 12 patients treated with the expander with differential opening. The posterior and anterior expander screws will be activated ½ turn per day until reaching 7 and 10mm expansion, respectively. The HYC group will consist of 12 patients treated with the conventional Hyrax expander with a activation of ½ turn per day reaching 7mm expansion. In both groups, cone-beam computed tomography (CBCT), type III polysomnography, 3D facial photography, Pediatric Sleep Questionnaire (PSQ), Children's Sleep Disorders Scale (EDSC) and Nasal Congestion Scale will be performed before (T1) and 6 months (T2) after rapid maxillary expansion. The transversal dimensions of the maxilla and nasal cavity will be measured in CBCT frontal images. In polysomnography exams, the apnea/hypopnea index and blood oxygen desaturation will be measured. Analysis of results: The interphase and intergroup comparisons will be evaluated using the paired and independent t tests, respectively (p<0.05). Multiple linear regression analysis will be performed to assess the correlation between the increase in nasal cavity and maxillary width and changes in the apnea/hypopnea index. (AU)

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