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MARPE in Patients With Cleft Lip and Palate

NCT04354116 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2020-09-16

No results posted yet for this study

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

Interventions

DEVICE

Rapid maxillary expansion

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.

DEVICE

Maxillary Protraction

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).

Sponsors & Collaborators

  • Pontifícia Universidade Católica de Minas Gerais

    lead OTHER

Principal Investigators

  • Ildeu Andrade Jr., PhD · Pontifícia Universidade Católica de Minas Gerais

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-10
Primary Completion
2021-09-10
Completion
2021-09-10

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04354116 on ClinicalTrials.gov