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Maxillary Expansion: Leaf Expander Versus Hyrax Expander

NCT05135962 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-11-26

No results posted yet for this study

Summary

The aim of the current study was to evaluate maxillary and mandibular arch widths' response to five different appliances and clinical protocols (Rapid maxillary expander RME, Leaf Expander 450g, Leaf Expander 900g, Self-expander 450g, Self-expander 900g) for the correction of the maxillary deficiency.

Conditions

  • Maxillary Deficiency

Interventions

DEVICE

orthodontic - rapid maxillary expansion

Rapid expansion: when RME was in situ, patients started the screw activation of one-quarter turn a day until overcorrection was achieved and RME was kept on teeth as a passive retainer and removed after one year from its application.

DEVICE

orthodontic - slow maxillary expansion with leaf expander

Leaf expander: The screw delivers a maximum expansion of 6 or 9 mm by activating (compressing) the spring, which generates a light (450g or 900g) and constant force. The leaves are preactivated in the laboratory to deliver 3mm of expansion. Reactivation is performed in the office by 10 quarter-turns (leaf 450g) or 15 quarter-turns (leaf 900g) of the screw per month until expansion has been completed. After active expansion the Leaf Expander is maintained passively in place for retention period. Leaf expander was kept on teeth as a passive retainer and removed after one year from its application.

DEVICE

orthodontic - slow maxillary expansion with self leaf expander

Leaf self expander: similar to Leaf expander with no need for reactivation or patient compliance.

Sponsors & Collaborators

  • University of Milan

    collaborator OTHER

  • Università degli Studi di Brescia

    collaborator OTHER

  • University of Genova

    lead OTHER

Principal Investigators

  • Valentina Lanteri, DDS, Phd · University of Milan

  • Domenico Dalessandri, DDS, Phd · Università degli Studi di Brescia

  • Alessandro Ugolini · Universita degli Studi di Genova

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-12-01
Completion
2023-11-01

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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 NCT05135962 on ClinicalTrials.gov