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Status unknownNCT02810353Updated Jun 22, 2016

Analysis of the Dentoskeletal Effects of the Expander With Differential Opening

An interventional study of Differential rapid maxillary expansion and Conventional rapid maxillary expansion in Maxillary Constriction, Unilateral Posterior Crossbite and Bilateral Posterior Crossbite, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 7 Years to 11 Years. Per ClinicalTrials.gov, last updated 2016-06-22.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
7 Years to 11 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Maxillary Constriction
  • Unilateral Posterior Crossbite
  • Bilateral Posterior Crossbite
  • Mandibular Dental Arch Constriction
03

In context

Malocclusion

457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.

This study's planned enrollment of 50 is above the median of 36 across 371 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Cleft lip and palate and associated syndromes;
  • Systemic and/or neurological diseases.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    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).

    Device: Differential rapid maxillary expansion

  • Active comparator
    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).

    Device: Conventional rapid maxillary expansion

Interventions

  • DeviceDifferential 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.

    Also known as: RME with the expander with differential opening

  • DeviceConventional 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.

    Also known as: RME with the conventional Hyrax expander

06

What researchers measure

Primary outcomes

  1. Maxillary and mandibular inter-first permanent molar distances

    Time frame: 6 months

  2. Maxillary and mandibular inter-second deciduous molar distances

    Time frame: 6 months

  3. Maxillary and mandibular inter-first deciduous molar distances

    Time frame: 6 months

  4. Maxillary and mandibular inter-deciduous canine distances

    Time frame: 6 months

  5. Maxillary and mandibular dental arches perimeters

    Time frame: 6 months

  6. Maxillary and mandibular dental arches lengths

    Time frame: 6 months

  7. Palatal depth

    Time frame: 6 months

  8. Inclination of maxillary and mandibular first permanent molars

    Time frame: 6 months

  9. Inclination of maxillary and mandibular deciduous canines

    Time frame: 6 months

  10. Amount of interincisor diastema

    Time frame: 10 days

Secondary outcomes

  1. Amount of differential expansion on the maxillary and mandibular dental arches

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • University of São Paulo
    Bauru, São Paulo 17012059, Brazil
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02810353
Lead sponsor
University of Sao Paulo
Responsible party
Arthur César de Medeiros Alves (University of São Paulo, University of Sao Paulo) — Principal investigator
First posted
Jun 22, 2016
Start date
May 2015
Primary completion
Dec 2016 (estimated)
Completion
Feb 2018 (estimated)
Last update
Jun 22, 2016

Study contacts

Arthur Alves, DDS, MSc
Contact
arthurcesar_88@hotmail.com
+55 14 981060878
Arthur Alves, DDS, MSc
principal investigator · Bauru Dental School, University of São Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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