Comparison of Two Tooth-borne Expanders in Rapid Maxillary Expansion

NCT03846518 | Completed

• 1 other identifier: hyraxversusminihyrax
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

palatal expansion technique; adolescent; quality of life

Outcome Measures

Primary Outcomes (7)

• Maxillary first molars width. Scale in millimeters and one decimal place.

  Distance between centroid points of maxillary first molars

  6 months

• Maxillary first bicuspid width. Scale in millimeters and one decimal place.

  Distance between centroid points of maxillary first bicuspids

  6 months

• Maxillary second bicuspid width. Scale in millimeters and one decimal place.

  Distance between centroid points of maxillary second bicuspids

  6 months

• Maxillary first molas angulation. Scale in degrees and one decimal place.

  Angulation formed, in occlusal view, by intersection of the lines resulted of the link between mesial-buccal cuspid tip and mesial-palatal cuspid tip of each molar.

  6 months

• Maxillary first bicuspids angulation. Scale in degrees and one decimal place.

  Angulation formed, in occlusal view, by intersection of the lines resulted of the link between buccal cuspid tip and palatal cuspid tip of each bicuspid

  6 months

• Maxillary first molas inclination. Scale in degrees and one decimal place.

  Angulation formed, in coronal view, by intersection of the lines resulted of the link between mesial-buccal cuspid tip and mesial-palatal cuspid tip of each molar

  6 months

• Maxillary first bicuspids inclination. Scale in degrees and one decimal place.

  Angulation formed, in coronal view, by intersection of the lines resulted of the link between buccal cuspid tip and palatal cuspid tip of each bicuspid

  6 months

Secondary Outcomes (2)

• Quality of life evaluation using questionnaires

  2 weeks (2 times: 0 and 2 weeks after insert of device) and 6 months (after removal of device)

• Discomfort evaluation using questionnaires

  24 hours (4 times: 0, 24, 48 and 72 hours after insert of device) and 1 week (2 times: 1 and 2 weeks after insert of device)

Study Arms (2)

Hyrax group

ACTIVE COMPARATOR

Seventeen patients will be submitted to rapid maxillary expansion (RME) using the Hyrax expander. The activation protocol will be 2 turns a day up to obtain transverse overcorrection.

Device: Hyrax

mini Hyrax group

EXPERIMENTAL

Seventeen patients will be submitted to rapid maxillary expansion (RME) using the mini Hyrax expander. The activation protocol will be 2 turns a day up to obtain transverse overcorrection.

Device: mini Hyrax

Interventions

Hyrax DEVICE

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.

Hyrax group

mini Hyrax DEVICE

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.

mini Hyrax group

Eligibility Criteria

• Age: 12 Years - 16 Years
• Gender Eligibility Details: Initially the 34 individuals will be separated by sex, thenceforth the randomization to alocation in the groups will be applied. The objetive of it is avoid major difference in sex between the 2 groups.
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Maxillary permanent dentition, except canines
• Ages ranging from 12 to 16 years old;
• Maxillary constriction associated to posterior crossbite uni or bilateral.

You may not qualify if:

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

Sponsors & Collaborators

• Pontifícia Universidade Católica de Minas Gerais: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Pontifícia Universidade Católica de Minas Gerais

Belo Horizonte, Minas Gerais, 30.535-901, Brazil

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Dauro D Oliveira, PhD

  Associate professor and program director of Orthodontics

  STUDY CHAIR

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: Associate professor and program director of Orthodontics

Model Details: 2 groups: control group (Hyrax) and experimental group (mini Hyrax)

Study Record Dates

• First Submitted: February 17, 2019
• First Posted: February 19, 2019
• Study Start: December 1, 2018
• Primary Completion: September 18, 2019
• Study Completion: February 27, 2020
• Last Updated: March 5, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)