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Analysis of the Dentoskeletal Effects of the Expander With Differential Opening

U

University of Sao Paulo

Status

Unknown

Conditions

Bilateral Posterior Crossbite
Maxillary Constriction
Mandibular Dental Arch Constriction
Unilateral Posterior Crossbite

Treatments

Device: Conventional rapid maxillary expansion
Device: Differential rapid maxillary expansion

Study type

Interventional

Funder types

Other

Identifiers

NCT02810353
Bauru Dental School, USP

Details and patient eligibility

About

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.

Full 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).

Enrollment

50 estimated patients

Sex

All

Ages

7 to 11 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Expander with differential opening group
Experimental group
Description:
The experimental group will comprise 25 patients who will be submitted to rapid maxillary expansion using the expander with differential opening. The expander will be composed by two 11-mm screws, one anteriorly and the other posteriorly positioned on the palate (Great lakes Orthodontics Ltd, NY, EUA).
Treatment:
Device: Differential rapid maxillary expansion
Hyrax group
Active Comparator group
Description:
The control group will be comprised by 25 patients who will undergo rapid maxillary expansion using the conventional Hyrax expander. The expander will be composed by one 11-mm screw centrally positioned on the palate (Dentaurum, Ispringen, Germany).
Treatment:
Device: Conventional rapid maxillary expansion

Trial contacts and locations

1

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Central trial contact

Arthur Alves, DDS, MSc

Data sourced from clinicaltrials.gov

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