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Clinical Trials/NCT02810353
NCT02810353
Unknown
Not Applicable

Analysis of the Dentoskeletal Effects of the Expander With Differential Opening: a Randomized Clinical Trial

University of Sao Paulo1 site in 1 country50 target enrollmentMay 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Maxillary Constriction
Sponsor
University of Sao Paulo
Enrollment
50
Locations
1
Primary Endpoint
Maxillary and mandibular inter-first permanent molar distances
Last Updated
9 years ago

Overview

Brief Summary

This study evaluates the dentoskeletal effects of the expander with differential opening in orthodontic patients in the mixed dentition. Half of participants will undergo rapid maxillary expansion (RME) using the expander with differential opening, while the other half will undergo RME using the conventional Hyrax expander.

Detailed Description

Recently, a rapid maxillary expander with differential opening was developed aiming to treat maxillary constrictions greater in the anterior region compared to the posterior region of the maxillary dental arch. The aim of this study is to evaluate the dentoskeletal effects of the expander with differential opening in orthodontic patients in the mixed dentition. Material and methods: Fifty patients with maxillary constriction in the mixed dentition will be prospectively and randomly allocated in one of two study groups. The experimental group will comprise 25 patients who will be submitted to rapid maxillary expansion with the expander with differential opening. The control group will be comprised by 25 individuals who will undergo rapid maxillary expander with the Hyrax expander. Digital dental models will be acquired immediately pre-expansion (T1) and six months post-expansion (T2). The Orthoanalyzer™ software will be used to measure maxillary and mandibular widths, arches perimeter, arches lengths, palatal depth, and inclinations of maxillary and mandibular canines and permanent first molars. The intergroup and interphase comparisons will be analyzed using t tests and paired t tests, respectively (p\<0.05).

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
February 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arthur César de Medeiros Alves

University of São Paulo

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • Both sexes;
  • Ages ranging from 7 to 11 years old;
  • Mixed dentition;
  • Maxillary constriction;
  • No previous orthodontic treatment.

Exclusion Criteria

  • Cleft lip and palate and associated syndromes;
  • Systemic and/or neurological diseases.

Outcomes

Primary Outcomes

Maxillary and mandibular inter-first permanent molar distances

Time Frame: 6 months

Maxillary and mandibular inter-second deciduous molar distances

Time Frame: 6 months

Maxillary and mandibular inter-first deciduous molar distances

Time Frame: 6 months

Maxillary and mandibular inter-deciduous canine distances

Time Frame: 6 months

Maxillary and mandibular dental arches perimeters

Time Frame: 6 months

Maxillary and mandibular dental arches lengths

Time Frame: 6 months

Palatal depth

Time Frame: 6 months

Inclination of maxillary and mandibular first permanent molars

Time Frame: 6 months

Inclination of maxillary and mandibular deciduous canines

Time Frame: 6 months

Amount of interincisor diastema

Time Frame: 10 days

Secondary Outcomes

  • Amount of differential expansion on the maxillary and mandibular dental arches(6 months)

Study Sites (1)

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