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Analysis of the Dentoskeletal Effects of the Expander With Differential Opening

Primary Purpose

Maxillary Constriction, Unilateral Posterior Crossbite, Bilateral Posterior Crossbite

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Differential rapid maxillary expansion
Conventional rapid maxillary expansion
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maxillary Constriction

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • University of São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Expander with differential opening group

Hyrax group

Arm 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).

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).

Outcomes

Primary Outcome Measures

Maxillary and mandibular inter-first permanent molar distances
Maxillary and mandibular inter-second deciduous molar distances
Maxillary and mandibular inter-first deciduous molar distances
Maxillary and mandibular inter-deciduous canine distances
Maxillary and mandibular dental arches perimeters
Maxillary and mandibular dental arches lengths
Palatal depth
Inclination of maxillary and mandibular first permanent molars
Inclination of maxillary and mandibular deciduous canines
Amount of interincisor diastema

Secondary Outcome Measures

Amount of differential expansion on the maxillary and mandibular dental arches

Full Information

First Posted
June 18, 2016
Last Updated
June 18, 2016
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02810353
Brief Title
Analysis of the Dentoskeletal Effects of the Expander With Differential Opening
Official Title
Analysis of the Dentoskeletal Effects of the Expander With Differential Opening: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillary Constriction, Unilateral Posterior Crossbite, Bilateral Posterior Crossbite, Mandibular Dental Arch Constriction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Expander with differential opening group
Arm Type
Experimental
Arm 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).
Arm Title
Hyrax group
Arm Type
Active Comparator
Arm 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).
Intervention Type
Device
Intervention Name(s)
Differential rapid maxillary expansion
Other Intervention Name(s)
RME with the expander with differential opening
Intervention Description
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
Intervention Name(s)
Conventional rapid maxillary expansion
Other Intervention Name(s)
RME with the conventional Hyrax expander
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maxillary and mandibular inter-first permanent molar distances
Time Frame
6 months
Title
Maxillary and mandibular inter-second deciduous molar distances
Time Frame
6 months
Title
Maxillary and mandibular inter-first deciduous molar distances
Time Frame
6 months
Title
Maxillary and mandibular inter-deciduous canine distances
Time Frame
6 months
Title
Maxillary and mandibular dental arches perimeters
Time Frame
6 months
Title
Maxillary and mandibular dental arches lengths
Time Frame
6 months
Title
Palatal depth
Time Frame
6 months
Title
Inclination of maxillary and mandibular first permanent molars
Time Frame
6 months
Title
Inclination of maxillary and mandibular deciduous canines
Time Frame
6 months
Title
Amount of interincisor diastema
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Amount of differential expansion on the maxillary and mandibular dental arches
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arthur Alves, DDS, MSc
Phone
+55 14 981060878
Email
arthurcesar_88@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur Alves, DDS, MSc
Organizational Affiliation
Bauru Dental School, University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of São Paulo
City
Bauru
State/Province
São Paulo
ZIP/Postal Code
17012059
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arthur Alves, DDS, MSc
Phone
+55 14 981060878
Email
arthurcesar_88@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Analysis of the Dentoskeletal Effects of the Expander With Differential Opening

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