Last reviewed · How we verify

NCT07404488

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

Completed NA Last updated 11 February 2026
What this trial tests

NA trial testing Miniscrew supported expander application in Orthodontic Appliance in 36 participants. Completed in 1 September 2024.

Timeline
1 November 2021
Primary endpoint
1 September 2024
1 September 2024

Quick facts

Lead sponsorUniversity of Roma La Sapienza
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment36
Start date1 November 2021
Primary completion1 September 2024
Estimated completion1 September 2024
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

University of Roma La Sapienza

Who can join

Adults 10 to 15, any sex, with Orthodontic Appliance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Orthodontic Appliance

Currently open trials in the same condition.

Other University of Roma La Sapienza trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07404488.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing