MedTrace Logo

Comparison of Two Miniscrew Bone-borne Expanders (2 vs 4 Screws) Versus Conventional Hyrax Expander in Adolescents

NCT07404488 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-02-11

No results posted yet for this study

Summary

Rapid maxillary expansion (RME) is used to correct transverse deficiencies of the maxilla. This randomized controlled trial compares three RME devices in adolescents (age 10-15) with at least 8 mm maxillary transverse deficiency: (1) bone-borne expander supported by two palatal miniscrews, (2) bone-borne expander supported by four palatal miniscrews, and (3) conventional tooth-borne Hyrax expander. Devices were placed using static computer-guided miniscrew insertion (where applicable). All participants received the same activation protocol to reach 8 mm expansion. Cone-beam CT scans were obtained pre-treatment (T0) and at 6 months post-treatment (T1). The trial assesses skeletal, dentoalveolar, periodontal, and nasal/airway outcomes. Enrollment: 36 subjects. Study sites: Sapienza University of Rome.

Conditions

  • Orthodontic Appliance

Interventions

DEVICE

Miniscrew supported expander application

Two palatal miniscrews with custom bone-borne expansion framework (device transmits forces to palatal bone; no tooth bands).

DEVICE

4 miniscrews supported rapid maxillary expansion application

Four palatal miniscrews with custom bone-borne expansion appliances.

DEVICE

Conventional tooth-borne Hyrax expander (comparator)

Hyrax-type tooth-borne expander with bands cemented on upper first molars (Hyrax click 10 mm).

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2024-09-01
Completion
2024-09-01

Countries

  • Italy

Study Locations

More Related Trials

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 NCT07404488 on ClinicalTrials.gov