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Comparison of Two Tooth-borne Expanders in Rapid Maxillary Expansion

NCT03846518 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-03-05

No results posted yet for this study

Summary

This study will assess the dentoalveolar effects and impact on quality of life of two types of maxillary expanders in orthodontic patients with permanent dentition, from 12 to 16 years old. Half of participants will be treated using the Hyrax expander, while the other half will use the mini Hyrax expander. The null hypothesis is that there is no difference between dentoalveolar effects and impact on quality of life of the two protocols.

Conditions

  • Malocclusion
  • Posterior Crossbite

Interventions

DEVICE

Hyrax

Rapid maxillary expansion using the Hyrax expander. Appliance anchorage will be performed by bands adapted to the first maxillary molars and arms of the screw contoured to adapt to palatal faces of the first and second maxillary bicuspids, in wich will be bonded by resin. The screw will be positioned perpendicularly to the palate sagittal midline, between second maxillary bicuspids and first maxillary molars, and 5 mm apically from marginal gingiva of palatal face of the first maxillary molars.The activation protocol will be 2 turns a day up to obtain transverse overcorrection. After the active period of RME, the screws will be fixed with ligature wire and the appliance will be kept as a retainer for 6 months.

DEVICE

mini Hyrax

Rapid maxillary expansion using the mini Hyrax expander. Appliance anchorage will be performed by bands adapted to the first maxillary molars and arms of the screw contoured to adapt to palatal faces of the first and second maxillary bicuspids, in wich will be bonded by resin. The screw will be positioned perpendicularly to the palate sagittal midline, between second maxillary bicuspids and first maxillary molars, and 5 mm apically from marginal gingiva of palatal face of the first maxillary molars. The activation protocol will be 2 turns a day up to obtain transverse overcorrection. After the active period of RME, the screws will be fixed with ligature wire and the appliance will be kept as a retainer for 6 months.

Sponsors & Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    collaborator OTHER_GOV

  • Pontifícia Universidade Católica de Minas Gerais

    lead OTHER

Principal Investigators

  • Dauro D Oliveira, PhD · Associate professor and program director of Orthodontics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2019-09-18
Completion
2020-02-27

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03846518 on ClinicalTrials.gov