Analysis of the Dentoskeletal Effects of the Expander With Differential Opening

Not Applicable

• Conditions: Maxillary Constriction; Bilateral Posterior Crossbite; Mandibular Dental Arch Constriction; Unilateral Posterior Crossbite
• Interventions: Device: Differential rapid maxillary expansion; Device: Conventional rapid maxillary expansion

• Registration Number: NCT02810353
• Lead Sponsor: University of Sao Paulo

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-05
• Status Verified: 2016-06
• Study First Submitted: 2016-06-18
• Study First Submitted QC: 2016-06-18
• Last Update Submitted: 2016-06-18
• Study First Posted: 2016-06-22
• Last Update Posted: 2016-06-22
• Primary Completion: 2016-12
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Expander with differential opening group	Differential rapid maxillary expansion	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).
Hyrax group	Conventional rapid maxillary expansion	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).

Primary Outcome Measures

Name	Time	Method
Maxillary and mandibular inter-first permanent molar distances	6 months
Maxillary and mandibular inter-second deciduous molar distances	6 months
Maxillary and mandibular inter-first deciduous molar distances	6 months
Maxillary and mandibular inter-deciduous canine distances	6 months
Maxillary and mandibular dental arches perimeters	6 months
Maxillary and mandibular dental arches lengths	6 months
Palatal depth	6 months
Inclination of maxillary and mandibular first permanent molars	6 months
Inclination of maxillary and mandibular deciduous canines	6 months
Amount of interincisor diastema	10 days

Secondary Outcome Measures

Name	Time	Method
Amount of differential expansion on the maxillary and mandibular dental arches	6 months

Trial Locations

Locations (1)

University of São Paulo; 🇧🇷 Bauru, São Paulo, Brazil