Child
Conditions
Interventions
This study will follow a randomized, blinded, placebo-controlled clinical trial design, which will recruit 33 patients diagnosed with transverse maxillary deficiency and adentonsillar hypertrophy. Par
Sponsors
Faculdade de Odontologia de Araçatuba
Faculdade de Odontologia de Araçatuba
Eligibility
Age
7 Years to 11 Years
Inclusion criteria
Inclusion criteria: diagnosis of maxillary atresia, evidenced by negative values in the posterior region of the maxilla based on Korkhaus analysis, which allowed the identification of posterior maxillary constriction; hypertrophy of the palatine tonsils assessed by direct inspection, with only patients presenting grade III or IV hypertrophy being selected; adenoid hypertrophy, evaluated through lateral cephalometric radiographs of the middle and inferior turbinates, as well as the region caudal to the inferior turbinate, which were examined by an otorhinolaryngologist in a single-blind manner; presence of Class II malocclusion with mandibular retrusion; no history of adenoidectomy or tonsillectomy; no systemic disease or use of medication; Gender both sexes; Age between 7 and 11 years
Exclusion criteria
Exclusion criteria: Class I or Class III malocclusion; active dental caries or periodontal disease; craniofacial dimorphisms and/or anomalies; temporomandibular disorders; previous or current history of orthodontic, speech therapy, or otorhinolaryngologic treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome - a significant improvement in transverse maxillary discrepancy is expected in children with adenotonsillar hypertrophy and maxillary atresia, after treatment with the rapid maxillary expansion protocol using the Hyrax device, associated or not with mandibular advancement with the Balters Bionator. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome -bit is expected to verify the improvement in the respiratory pattern, assessed by home polysomnographic analysis, an increase in the dimensions of the upper airways, measured by means of cone beam computed tomography images, an improvement in the quality of life, measured with a validated questionnaire and the effective time of use of the mandibular advancement device, monitored by the TheraMon microsensor, measured through the aforementioned tests carried out initially, after 6 months and after 18 months of treatment | — |
Countries
Brazil
Contacts
Public ContactComitê de Ética em Pesquisa
Faculdade de Odontologia de Araçatuba
Outcome results
None listed