Cleft Lip and Palate Clinical Trial
Official title:
Microimplant-assisted Rapid Palatal Expansion Appliance to Orthopedically Correct Midface Deficiency in Patients With Cleft Lip and Palate: a Randomized Clinical Trial
The objective of this randomized controlled study will be to evaluate the dental and skeletal effects of maxillary protraction with a facemask, associated with MARPE and Class III elastics in patients with unilateral cleft lip and palate (CLP) with maxillary retrusion, compared to HYRAX type maxillary expanders. The investigators will examine differences in treatment times, along with skeletal, dental and soft tissue changes.
Status | Recruiting |
Enrollment | 44 |
Est. completion date | September 10, 2021 |
Est. primary completion date | September 10, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 13 Years |
Eligibility |
Inclusion Criteria: - Patients with cleft lip and palate; - 6 to 13 years before orthodontic treatment, with sagittal deficiency of the facial middle third; - Angle Class III malocclusion, or mesial step of the deciduous second molars, and anterior crossbite; - ANB less than 0°, Wits less than -2 mm and the distance from point A to the perpendicular nasion less than 0 mm. Exclusion Criteria: - Previous orthodontic treatment; - Other craniofacial anomalies; - Inadequate maxillary denture for placement of a expander. |
Country | Name | City | State |
---|---|---|---|
Brazil | Pontifical Catholic University of Minas Gerais | Belo Horizonte | MG |
Lead Sponsor | Collaborator |
---|---|
Pontifícia Universidade Católica de Minas Gerais |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome will be the degree of anterior movement of the maxilla after treatment). | Cone beam computed tomography (CBCT) will be performed at the beginning and at the end of the treatment. Three-dimensional virtual models, built from the CBCT's scans, will allow to measure the changes between T0 and T1. The processing of the TCFC and virtual models will be done using the ITK-SNAP 2.2 software (free software, www.itksnap.org), SLICER CMF 4.0 (free software, www.slicer.org). | 6 months | |
Secondary | Secondary outcomes will be changes in other cephalometric variables and treatment time. | Cone beam computed tomography will be performed at the beginning and at the end of the treatment. Three-dimensional virtual models, built from the CBCT's scans, will allow to measure the changes between T0 and T1. The processing of the TCFC and virtual models will be done using the ITK-SNAP 2.2 software (free software, www.itksnap.org), SLICER CMF 4.0 (free software, www.slicer.org). | 6 months |
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