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Dentoskeletal Effects of the Expander With Differential Opening and the Fan-type Expander

Primary Purpose

Malocclusion, Crossbite (Posterior)

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Differential Expansion
Fan-Fype Expander
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring Palatal Expansion Technique, Cone-Beam Computed Tomography, Dental Models

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Both sexes;
  • Mixed dentition;
  • Ages ranging from 7 to 11 years old;
  • Maxillary constriction associated to posterior crossbites;
  • Angle Class I or Angle Class II malocclusions.

Exclusion Criteria:

  • Cleft lip and palate;
  • Craniofacial syndromes;
  • Carious lesions;
  • Angle Class III malocclusion;
  • History of previous orthodontic treatment.

Sites / Locations

  • Bauru Dental School - University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Differential Expansion Group

Fan-Fype Expander Group

Arm Description

The experimental group will be comprised 24 patients treated with a rapid maxillary expansion using the expander with differential opening. The expander is composed by two screws, one posteriorly and the other anteriorly positioned on the palate.

The active comparator group will be comprised by 24 patients treated with rapid maxillary expansion using the the fan-type expander. The expander is composed by one screw anteriorly positioned on the palate.

Outcomes

Primary Outcome Measures

Maxillary and mandibular arch width (mm)
Measurements will be performed in digital dental models
Maxillary and mandibular arch length
Measurements will be performed in digital dental models
Maxillary and mandibular arch perimeter (mm)
Measurements will be performed in digital dental models
Nasal cavity width (mm)
Measurements will be performed in coronal sections of CBCT exams.
Maxillary width (mm)
Measurements will be performed in coronal sections of CBCT exams.
Maxillary molars inclination (°)
Measurement will be performed in CBCT scans.
Maxillary deciduous canines inclination (°)
Measurement be performed CBCT scans.
Amount of interincisor diastema (mm)
Measurement will be assessed in CBCT scans.
Opening of the midpalatal suture (mm)
Measurement be assessed in axial and coronal sections of CBCT scans.

Secondary Outcome Measures

Discomfort evaluation using questionnaires
A Visual Analog Scale will be used from 0 to 10 cm.
Quality of life evaluation using questionnaires
The Child Perceptions Questionnaire (CPQ8-10) will be used to evaluate the quality of life of the patients before and after treatment.
Dentoskeletal displacements by three-dimensional superimposition of CBCT scams.

Full Information

First Posted
October 7, 2018
Last Updated
April 16, 2019
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT03705871
Brief Title
Dentoskeletal Effects of the Expander With Differential Opening and the Fan-type Expander
Official Title
Maxillary Expander With Differential Opening Versus Fan-type Expander: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will assess the dentoskeletal effects of two types of maxillary expanders in orthodontic patients in the mixed dentition, from 7 to 11 years old. Half of participants will be treated using the expander with differential opening, while the other half will undergo rapid maxillary expansion using the fan-type expander. The null hypothesis is that there is no difference between dentoskeletal effects of the two protocols.
Detailed Description
Rapid maxillary expansion (RME) is the orthopedic procedure of choice to treat maxillary constriction and posterior crossbite, and the study of dental, skeletal and periodontal effects of this procedure has been widely discussed in the orthodontic literature. The conventional RME expanders promote a similar expansion in the anterior and posterior regions of the maxillary arch. On the other hand, the fan-type expander allows the expansion concentrated in the intercanine region with little effects the intermolar distance. Finally, the expander with differential opening has two palatal screws and the differential activation protocol promotes a different amount of expansion for the anterior and posterior regions of the maxilla. No clinical study compared dental and skeletal effects of the expander with differential opening with those of the fan-type expander, including a three-dimensional analysis using CBCT exams and digital dental models. So, the aim of the present randomized clinical trial is to compare the skeletal and dentoalveolar effects of the maxillary expander with differential opening and the fan-type expander in the mixed dentition. For this, patients will be recruited at the Orthodontic Clinic of Bauru Dental School, University of São Paulo, Brazil. A sample of 48 patients from 7 to 11 years old with transverse maxillary dental arch constriction will be prospectively and randomly allocated into two study groups. The first group will consist of 24 individuals treated with the expander with differential opening (DEG). The second group will consist of 24 individuals treated with the fan-type expander (FEG). In 12 patients from each group (immediate subgroups), a cone-beam computed tomography (CBCT) will be performed in the beginning of treatment (T1) and immediately after the rapid maxillary expansion (T2). In the other 24 patients, 12 from DEG and 12 from FEG (late subgroups), a CBCT will be obtained at T1 and 6 months after maxillary expansion (T3). Dental models will be obtained for all patients at T1 and T3. In digital dental models, maxillary arch width, perimeter, length and shape will be assessed. Standardized CBCT coronal sections will be used for measuring maxillary transverse dimensions, nasal cavity width and posterior tooth inclinations. Segmentation and superimposition of T1 and T3 CBCT images at the cranial base will be also performed. The opening of the midpalatal suture at the anterior and posterior region and the geometry of the suture opening will be evaluated in axial reconstructions of the CBCT.Discomfort, pain and quality of life will be evaluated by questionnaires. After the normality test, the paired t test will be used in the intragroup comparison, and the independent t test will be used in the intergroup comparison. In the case of lost to follow-up patients, intention to treat analysis will be used. A significance level of 5% will be regarded for all tests. Possible harms that could appear are related to temporary discomfort during the first days after the installation of the expander. Patients and legal guardians will be carefully oriented and they will be able to stop the treatment at any moment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Crossbite (Posterior)
Keywords
Palatal Expansion Technique, Cone-Beam Computed Tomography, Dental Models

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Differential Expansion Group
Arm Type
Experimental
Arm Description
The experimental group will be comprised 24 patients treated with a rapid maxillary expansion using the expander with differential opening. The expander is composed by two screws, one posteriorly and the other anteriorly positioned on the palate.
Arm Title
Fan-Fype Expander Group
Arm Type
Active Comparator
Arm Description
The active comparator group will be comprised by 24 patients treated with rapid maxillary expansion using the the fan-type expander. The expander is composed by one screw anteriorly positioned on the palate.
Intervention Type
Device
Intervention Name(s)
Differential Expansion
Intervention Description
Twenty-four patients will be treated with a rapid maxillary expansion using the expander with differential opening. Appliance anchorage will be performed by bands adapted in the second maxillary deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. The activation protocols will totalize an opening of 8mm in the anterior screw of the expander. 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)
Fan-Fype Expander
Intervention Description
Twenty-four patients will be treated with a rapid maxillary expansion using the fan-type expander. Appliance anchorage will be performed by bands adapted in the second maxillary deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. The activation protocols will totalize an opening of 8mm screw of the expander. 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.
Primary Outcome Measure Information:
Title
Maxillary and mandibular arch width (mm)
Description
Measurements will be performed in digital dental models
Time Frame
6 months
Title
Maxillary and mandibular arch length
Description
Measurements will be performed in digital dental models
Time Frame
6 months
Title
Maxillary and mandibular arch perimeter (mm)
Description
Measurements will be performed in digital dental models
Time Frame
6 months
Title
Nasal cavity width (mm)
Description
Measurements will be performed in coronal sections of CBCT exams.
Time Frame
6 months
Title
Maxillary width (mm)
Description
Measurements will be performed in coronal sections of CBCT exams.
Time Frame
6 months
Title
Maxillary molars inclination (°)
Description
Measurement will be performed in CBCT scans.
Time Frame
6 months
Title
Maxillary deciduous canines inclination (°)
Description
Measurement be performed CBCT scans.
Time Frame
6 months
Title
Amount of interincisor diastema (mm)
Description
Measurement will be assessed in CBCT scans.
Time Frame
10 days
Title
Opening of the midpalatal suture (mm)
Description
Measurement be assessed in axial and coronal sections of CBCT scans.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Discomfort evaluation using questionnaires
Description
A Visual Analog Scale will be used from 0 to 10 cm.
Time Frame
1 month
Title
Quality of life evaluation using questionnaires
Description
The Child Perceptions Questionnaire (CPQ8-10) will be used to evaluate the quality of life of the patients before and after treatment.
Time Frame
6 months
Title
Dentoskeletal displacements by three-dimensional superimposition of CBCT scams.
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; Mixed dentition; Ages ranging from 7 to 11 years old; Maxillary constriction associated to posterior crossbites; Angle Class I or Angle Class II malocclusions. Exclusion Criteria: Cleft lip and palate; Craniofacial syndromes; Carious lesions; Angle Class III malocclusion; History of previous orthodontic treatment.
Facility Information:
Facility Name
Bauru Dental School - University of São Paulo
City
Bauru
State/Province
São Paulo
ZIP/Postal Code
17012-901
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33580351
Citation
Massaro C, Garib D, Cevidanes L, Janson G, Yatabe M, Lauris JRP, Ruellas AC. Maxillary dentoskeletal outcomes of the expander with differential opening and the fan-type expander: a randomized controlled trial. Clin Oral Investig. 2021 Sep;25(9):5247-5256. doi: 10.1007/s00784-021-03832-9. Epub 2021 Feb 12.
Results Reference
derived
PubMed Identifier
32840319
Citation
Massaro C, Janson G, Miranda F, Aliaga-Del Castillo A, Pugliese F, Lauris JRP, Garib D. Dental arch changes comparison between expander with differential opening and fan-type expander: a randomized controlled trial. Eur J Orthod. 2021 Jun 8;43(3):265-273. doi: 10.1093/ejo/cjaa050.
Results Reference
derived

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Dentoskeletal Effects of the Expander With Differential Opening and the Fan-type Expander

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