NCT03705871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

October 7, 2018

Last Update Submit

April 16, 2019

Conditions

MalocclusionCrossbite (Posterior)

Keywords

Palatal Expansion TechniqueCone-Beam Computed TomographyDental Models

Outcome Measures

Primary Outcomes (9)

  • Maxillary and mandibular arch width (mm)

    Measurements will be performed in digital dental models

    6 months

  • Maxillary and mandibular arch length

    Measurements will be performed in digital dental models

    6 months

  • Maxillary and mandibular arch perimeter (mm)

    Measurements will be performed in digital dental models

    6 months

  • Nasal cavity width (mm)

    Measurements will be performed in coronal sections of CBCT exams.

    6 months

  • Maxillary width (mm)

    Measurements will be performed in coronal sections of CBCT exams.

    6 months

  • Maxillary molars inclination (°)

    Measurement will be performed in CBCT scans.

    6 months

  • Maxillary deciduous canines inclination (°)

    Measurement be performed CBCT scans.

    6 months

  • Amount of interincisor diastema (mm)

    Measurement will be assessed in CBCT scans.

    10 days

  • Opening of the midpalatal suture (mm)

    Measurement be assessed in axial and coronal sections of CBCT scans.

    10 days

Secondary Outcomes (3)

  • Discomfort evaluation using questionnaires

    1 month

  • Quality of life evaluation using questionnaires

    6 months

  • Dentoskeletal displacements by three-dimensional superimposition of CBCT scams.

    6 months

Study Arms (2)

Differential Expansion Group

EXPERIMENTAL

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.

Device: Differential Expansion

Fan-Fype Expander Group

ACTIVE COMPARATOR

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.

Device: Fan-Fype Expander

Interventions

Differential ExpansionDEVICE

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.

Differential Expansion Group
Fan-Fype ExpanderDEVICE

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.

Fan-Fype Expander Group

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bauru Dental School - University of São Paulo

Bauru, São Paulo, 17012-901, Brazil

Location

Related Publications (3)

  • Teixeira R, Massaro C, Garib D. Vertical and sagittal changes produced by an expander with differential opening versus a fan-type expander: A post-hoc analysis of a randomised controlled trial. J Orthod. 2024 Dec;51(4):388-396. doi: 10.1177/14653125231208465. Epub 2023 Oct 31.

    PMID: 37905906DERIVED

  • 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.

    PMID: 33580351DERIVED

  • 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.

    PMID: 32840319DERIVED

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

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
DDS, MSc and PhD student

Study Record Dates

First Submitted

October 7, 2018

First Posted

October 15, 2018

Study Start

November 8, 2017

Primary Completion

December 15, 2018

Study Completion

February 1, 2019

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)