Clinical Trial

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

Completed
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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.
Trial Details
NCT Number NCT07404488
Lead Sponsor University of Roma La Sapienza
Conditions Orthodontic Appliance
Enrollment 36 participants
Start Date 2021-11-01
Primary Completion 2024-09-01 (estimated)
Study Completion 2024-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-11