Orthodontic Appliance
Conditions
Brief 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.
Detailed description
This is a prospective, randomized, parallel-group clinical trial performed at the Department of Oral and Maxillofacial Sciences, Sapienza University of Rome (Nov 2021 - Sep 2024). Inclusion criteria included age under 16 years, late mixed or permanent dentition, and maxillary transverse deficiency ≥ 8 mm. Exclusion: poor oral hygiene; previous orthodontic treatment; craniofacial syndromes; cleft lip/palate; genetic/congenital diseases. After consent, eligible participants (N=36) were randomized (1:1:1) to: Group A - two-miniscrew bone-borne expander (paramedian screws near 1st-2nd premolar region); Group B - four-miniscrew bone-borne expander (two paramedian + two parapalatine); Group C - Hyrax tooth-borne expander banded to upper first molars. Miniscrews (Benefit system; PSM Medical Solutions) were placed using a CAD-CAM surgical guide planned from CBCT and digital models (Easy Driver). Activation: Hyrax click 10 mm screw; four quarter-turns at insertion then three quarter-turns/day for 12 days (0.20 mm/turn; \ 0.6 mm/day) until 8 mm achieved. CBCT scan acquisition: Scanora 3Dx (Soredex). Measurements performed on Simplant v17 on defined landmarks (MaxBas, MaxAlv, MaxAlvPre, Ns, ZigMax, IntermCo, IntermoAp, molar angles, periodontal bone thickness measures, nasopalatine foramen width). Primary outcome: change in maxillary basal width (MaxBas) T0 to T1 measured on CBCT.
Interventions
DEVICEMiniscrew supported expander application
Two palatal miniscrews with custom bone-borne expansion framework (device transmits forces to palatal bone; no tooth bands).
DEVICE4 miniscrews supported rapid maxillary expansion application
Four palatal miniscrews with custom bone-borne expansion appliances.
DEVICEConventional tooth-borne Hyrax expander (comparator)
Hyrax-type tooth-borne expander with bands cemented on upper first molars (Hyrax click 10 mm).
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Age 10 to 15 years (under 16 at enrollment). * Late mixed or permanent dentition. * Maxillary transverse deficiency ≥ 8 mm (unilateral or bilateral). * Parent/guardian able to provide written informed consent; participant assent where applicable.
Exclusion criteria
* Poor oral hygiene. * Prior orthodontic treatment. * Craniofacial syndromes. * Cleft lip and/or palate. * Genetic or congenital diseases likely to affect craniofacial growth or bone quality. * Inability/unwillingness to attend scheduled follow-up visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in maxillary basal width (MaxBas) from baseline (T0) to 6 months post-treatment (T1) | at 6 months | Measurement method: CBCT (Simplant software) distance between alveolar/basal points (points 5-6 as per Podesser/Garib protocol). |
Countries
Italy
Outcome results
None listed