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

Not Applicable

• Conditions: Developmental disorders of the jaws; maxilla; palate; other specified diseases of the jaws; K100; A14.521.645; K108

• Registration Number: RBR-4pgktym
• Lead Sponsor: Centro Universitário da Fundação Hermínio Ometto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-17
• Study Completion: 2021-01-29
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

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.

Exclusion Criteria

Syndromic volunteers; history of orthodontic treatment; history of craniofacial bone fractures; diagnoses of bone or metabolic pathologies.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Secondary outcomes are not expected.;Secondary outcomes are not expected.