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Short-term Stability of Tooth-borne vs Bone-borne Maxillary Expansion: A Parallel Cohort Study

NCT06916299 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-04-08

No results posted yet for this study

Summary

This prospective parallel cohort study aimed to compare the short-term stability of maxillary expansion achieved with tooth-borne (Hyrax) and bone-borne expanders.

A total of 36 patients (mean age: 12.3 ± 0.6 years) with transverse maxillary deficiency (≥8 mm) were randomly assigned to two groups: Group A (tooth-borne Hyrax) and Group B (bone-borne expander with four mini-screws). Both groups followed the same activation protocol and underwent an 8-month retention period. After this period, the expansion devices were removed, and relapse was assessed at 12 months post-expansion (T2), corresponding to 4 months after device removal. Digital dental models were analyzed using linear measurements, and statistical analysis was conducted using t-tests (p ≤ 0.05).

Conditions

  • Orthodontic Appliance
  • Orthodontic Appliances
  • Orthodontic Relapse

Interventions

DIAGNOSTIC_TEST

dental casts

At the end of the planned expansion, an 8-month retention period was expected. At this time, the expansion device was removed, and impressions were taken in both groups (T1). At 12-month follow-up (T2), new impressions were taken in both groups to evaluate, at dental level, the relapse in the short term. Fig 1

DEVICE

tooth-borne expander insertion

tooth-borne expander delivery.

PROCEDURE

miniscrew and bone-borne expander insertion

Insertion of the paramedian miniscrews in a totally guided procedure, and after was delivered the tooth-borne expander

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-10-01
Completion
2024-12-01

Countries

  • Italy

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 NCT06916299 on ClinicalTrials.gov