Dentoskeletal and upper airway changes after micro-implant-assisted palatal expansion (MARPE) in patients in the final stages of suture fusion: a randomized controlled clinical trial

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2021
INTERVENTION: E06.658.578.458 Two groups of patients with 10 individuals in each one will be evaluated and compared, totaling a sample universe of 20 subjects. Individuals with palatine level of ossification of the maxillary suture will be grouped in the group called “D” (n = 10) and others with maxillary level of ossification in group “E”. Both groups will be submitted to the same intervention only once, the duration of which varies clinically according to the intrinsic characteristics of the patients. The intervention to be carried out in both groups will be the Maxillary Rapid Expansion assisted by mini implants. For this, individuals will receive elastic orthodontic separators in the mesial and distal of the first right and left upper molars. After 5 days of the insertion of the elastics, the first molars will receive orthodontic bands cemented with glass ionomer cement and will be bonded and transfer molding with Hydrogun alginate is carried out (Zhermack®, Badia Polesine, RO, Italy). The plaster models (Durone type IV, Dentsply® Sirona, York, PA, USA) are then sent to the laboratory for the manufacture of MARPE type devices with an expander screw (Peclab®, Belo Horizonte, MG, Brazil). The planning and construction of the device is based on clinical data from the plaster model and from imaging tests obtained during the diagnostic phase. After making the device, and after the clinical test, it will be installed in the patient's mouth and fixed to the palate by means of skeletal anchorage obtained by placing 4 mini implants attached to the expander screw. For this purpose, the mini implants will be installed after intra‐oral asepsis with 0.12% chlorhexidine and infiltrative local anesthesia. After installing the device, the patient must activate the expansion screw following a previously establi Z464 CONDITION: A14.521.645 Developmental disorders of the jaws; maxilla; palate; other specified diseases of the jaws K100 K108 PRIMARY OUTCOME: Improvement in the structural bone ratio, dental and craniofacial soft tissue structures, assessed by conical beam computed tomography exam with an increase of at least 5% in craniometric dimensions. Data collected 1 week before the intervention and 1 weeks after the end of the intervention. Volumetric increase of the upper airway space, verified through tomographic evaluation after multiplanar reconstruction, from the observation of a variation of at least 10% in the pre and post‐intervention measurements. SECONDARY OUTCOME: Secondary outcomes are not expected. INCLUSION CRITERIA: Healthy volunteers; both genders; non smokers; age between 18 and 60 years; presence of maxillary atresia; ossification level of the complete palatal suture.
Epistemonikos ID: 449d49ad36573682d970488c3021baced50504a1
First added on: Aug 24, 2024