Analysis of the Dentoskeletal Effects of the Expander With Differential Opening

NCT ID: NCT02810353

Last Updated: 2016-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-02-28

Brief Summary

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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

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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).

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Expander with differential opening group

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).

Group Type EXPERIMENTAL

Differential rapid maxillary expansion

Intervention Type DEVICE

Twenty-five patients will be submitted to rapid maxillary expansion using the expander with differential opening. Appliance anchorage will be provided by bands adapted either on the maxillary first permanent molars or on the second deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. If the maxillary second deciduous molars will be banded, a lingual extension wire will be placed in the partially erupted maxillary first permanent molars. Both anterior and posterior screws will be activated with a complete turn a day during 6 days. Then, only the anterior screw will be additionally activated for 4 more days. After the active period of RME, the screws will be fixed with acrylic resin and the appliance will be kept as a retainer for 6 months.

Hyrax group

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).

Group Type ACTIVE_COMPARATOR

Conventional rapid maxillary expansion

Intervention Type DEVICE

Twenty-five patients will undergo rapid maxillary expansion using conventional Hyrax expander. Bands will be adapted either on the maxillary first permanent molars or on second deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. Similarly to the experimental group, a lingual extension wire will be placed in the partially erupted maxillary first permanent molars if the maxillary second deciduous molars will be banded. The expander screw will be activated with a complete turn a day during 6 days. After the expansion active phase, the screw will be fixed with acrylic resin and the appliance will be kept in the dental arch as a retainer for 6 months.

Interventions

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Differential rapid maxillary expansion

Twenty-five patients will be submitted to rapid maxillary expansion using the expander with differential opening. Appliance anchorage will be provided by bands adapted either on the maxillary first permanent molars or on the second deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. If the maxillary second deciduous molars will be banded, a lingual extension wire will be placed in the partially erupted maxillary first permanent molars. Both anterior and posterior screws will be activated with a complete turn a day during 6 days. Then, only the anterior screw will be additionally activated for 4 more days. After the active period of RME, the screws will be fixed with acrylic resin and the appliance will be kept as a retainer for 6 months.

Intervention Type DEVICE

Conventional rapid maxillary expansion

Twenty-five patients will undergo rapid maxillary expansion using conventional Hyrax expander. Bands will be adapted either on the maxillary first permanent molars or on second deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. Similarly to the experimental group, a lingual extension wire will be placed in the partially erupted maxillary first permanent molars if the maxillary second deciduous molars will be banded. The expander screw will be activated with a complete turn a day during 6 days. After the expansion active phase, the screw will be fixed with acrylic resin and the appliance will be kept in the dental arch as a retainer for 6 months.

Intervention Type DEVICE

Other Intervention Names

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RME with the expander with differential opening RME with the conventional Hyrax expander

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Arthur César de Medeiros Alves

University of São Paulo

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arthur Alves, DDS, MSc

Role: PRINCIPAL_INVESTIGATOR

Bauru Dental School, University of São Paulo

Locations

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University of São Paulo

Bauru, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Arthur Alves, DDS, MSc

Role: CONTACT

+55 14 981060878

Facility Contacts

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Arthur Alves, DDS, MSc

Role: primary

+55 14 981060878

Other Identifiers

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Bauru Dental School, USP

Identifier Type: -

Identifier Source: org_study_id

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