MARPE in Patients With Cleft Lip and Palate

NCT04354116 | Unknown DMC

• 1 other identifier: MARPE Class III cleft patients
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Palatal Expansion Technique; Cleft Lip and Palate; Class III Malocclusion; Skeletal Malocclusion

Keywords

palatal expansion technique; Cleft Lip; Cleft Palate; Maxillary retroposition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary outcomes will be changes in other cephalometric variables and treatment time.

  6 months

Study Arms (2)

MARPE

EXPERIMENTAL

Maxillary expander anchored in mini-implants (MARPE)

Device: Rapid maxillary expansion; Device: Maxillary Protraction

Hyrax

ACTIVE COMPARATOR

Tooth-born anchored maxillary expanders, without mini-implants

Device: Rapid maxillary expansion; Device: Maxillary Protraction

Interventions

Rapid maxillary expansion DEVICE

Palatal expanders of the HYRAX type, with bands on the first permanent molars will be used for patients in both groups. In the experimental group, the expander will be anchored mesially and bilaterally in mini-implants, in a technique known as rapid maxillary expansion assisted by mini-implants (MARPE). The control active group will be with conventional HYRAX expanders. The maxillary expansion protocol will be once a day for 2 weeks.

Hyrax; MARPE

Maxillary Protraction DEVICE

Protraction hooks will be projected around the upper canine area. In the experimental group (MARPE), the appliance will be anchored mesially and bilaterally in mini-implants. The control active group will be anchored with conventional HYRAX expanders. Both groups will be treated with maxillary protraction with a Petit-type face mask at night (12 hours a day).

Hyrax; MARPE

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients with cleft lip and palate;
• 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.

You may not qualify if:

• Previous orthodontic treatment;
• Other craniofacial anomalies;
• Inadequate maxillary denture for placement of a expander.

Sponsors & Collaborators

• Pontifícia Universidade Católica de Minas Gerais: lead

Study Sites (1)

Pontifical Catholic University of Minas Gerais

Belo Horizonte, Minas Gerais, 30535-901, Brazil

RECRUITING

MeSH Terms

Conditions

Cleft Lip; Malocclusion, Angle Class III; Cleft Palate; Retrognathia

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malocclusion; Tooth Diseases; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases

Study Officials

• Ildeu Andrade Jr., PhD

  Pontifícia Universidade Católica de Minas Gerais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vitor Eto, DDS

CONTACT

55(31)99822-5804; ildeu_andrade@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 21, 2020
• Study Start: January 10, 2020
• Primary Completion: September 10, 2021
• Study Completion: September 10, 2021
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)