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NCT07404488
Comparison of Two Miniscrew Bone-borne Expanders (2 vs 4 Screws) Versus Conventional Hyrax Expander in Adolescents
NA trial testing Miniscrew supported expander application in Orthodontic Appliance in 36 participants. Completed in 1 September 2024.
1 September 2024
Quick facts
| Lead sponsor | University of Roma La Sapienza |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 1 November 2021 |
| Primary completion | 1 September 2024 |
| Estimated completion | 1 September 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Miniscrew supported expander application
- 4 miniscrews supported rapid maxillary expansion application
- Conventional tooth-borne Hyrax expander (comparator)
Conditions studied
- Orthodontic Appliance — all drugs for Orthodontic Appliance →
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:
- PubMed search for NCT07404488
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07404488 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Roma La Sapienza
- Last refreshed: 11 February 2026
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