Analysis of the Dentoskeletal Effects of the Expander With Differential Opening

NCT02810353 | Unknown DMC

• 1 other identifier: Bauru Dental School, USP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (1)

• Amount of differential expansion on the maxillary and mandibular dental arches

  6 months

Study Arms (2)

Expander with differential opening group

EXPERIMENTAL

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).

Device: Differential rapid maxillary expansion

Hyrax group

ACTIVE COMPARATOR

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).

Device: Conventional rapid maxillary expansion

Interventions

Differential rapid maxillary expansion 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.

Also known as: RME with the expander with differential opening

Expander with differential opening group

Conventional rapid maxillary expansion 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.

Also known as: RME with the conventional Hyrax expander

Hyrax group

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of São Paulo

Bauru, São Paulo, 17012059, Brazil

RECRUITING

Study Officials

• Arthur Alves, DDS, MSc

  Bauru Dental School, University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arthur Alves, DDS, MSc

CONTACT

+55 14 981060878; arthurcesar_88@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University of São Paulo

Study Record Dates

• First Submitted: June 18, 2016
• First Posted: June 22, 2016
• Study Start: May 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2018
• Last Updated: June 22, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)