Orthodontic ApplianceNCT07404488
Comparison of Two Miniscrew Bone-borne Expanders (2 vs 4 Screws) Versus Conventional Hyrax Expander in Adolescents
A study testing Miniscrew supported expander application, 4 miniscrews supported rapid maxillary expansion application and Conventional tooth-borne Hyrax expander (comparator) in people with Orthodontic Appliance, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Orthodontic Appliance
- What is being tested?
- Miniscrew supported expander application, 4 miniscrews supported rapid maxillary expansion application and Conventional tooth-borne Hyrax expander (comparator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2021to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled Study Comparing Dentoalveolar, Skeletal, Periodontal and Nasal/Airway Effects of a Two-miniscrew Bone-borne Expander, a Four-miniscrew Bone-borne Expander, and a Conventional Tooth-borne Hyrax Expander in Adolescents.
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.
Read the 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.
- Conditions
- Orthodontic Appliance
- Being tested
- Miniscrew supported expander application, 4 miniscrews supported rapid maxillary expansion application, Conventional tooth-borne Hyrax expander (comparator)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miniscrew supported expander applicationDevice
Two palatal miniscrews with custom bone-borne expansion framework (device transmits forces to palatal bone; no tooth bands).
4 miniscrews supported rapid maxillary expansion applicationDevice
Four palatal miniscrews with custom bone-borne expansion appliances.
Conventional tooth-borne Hyrax expander (comparator)Device
Hyrax-type tooth-borne expander with bands cemented on upper first molars (Hyrax click 10 mm).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Group A) - Two-miniscrew bone-borne expander | Experimental | one-borne rapid maxillary expander anchored on two palatal miniscrews inserted in paramedian palatal vault (near first-second premolar area). Miniscrews: self-tapping titanium (Benefit system; PSM Medical Solutions). Placement planned via CBCT-guided CAD/CAM surgical guide (Easy Driver). Activation protocol: Hyrax click 10 mm screw: 4 quarter-turns at placement then 3 quarter-turns/day for 12 days (0.20 mm/turn) until ~8 mm expansion. Receives: Device: Miniscrew supported expander application |
| Arm 2 (Group B) - Four-miniscrew bone-borne expander | Experimental | Bone-borne rapid maxillary expander anchored on four palatal miniscrews (two paramedian + two parapalatine). Same guided insertion workflow and activation protocol as Group A. Receives: Device: 4 miniscrews supported rapid maxillary expansion application |
| Arm 3 (Group C) - Conventional tooth-borne Hyrax expander | Active comparator | Tooth-borne Hyrax expander banded on upper first permanent molars (conventional Hyrax). Same activation protocol as Groups A/B. Receives: Device: Conventional tooth-borne Hyrax expander (comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maxillary basal width (MaxBas) from baseline (T0) to 6 months post-treatment (T1)
Measurement method: CBCT (Simplant software) distance between alveolar/basal points (points 5-6 as per Podesser/Garib protocol).
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Nov 2021
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic ApplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Cassetta, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404488
- Sponsor's protocol ID
- URomLS_RME
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Study Comparing Dentoalveolar, Skeletal, Periodontal and Nasal/Airway Effects of a Two-miniscrew Bone-borne Expander, a Four-miniscrew Bone-borne Expander, and a Conventional Tooth-borne Hyrax Expander in Adolescents.
- ClinicalTrials.gov ID
- NCT07404488
- Acronym / sponsor ID
- URomLS_RME
- Conditions
- Orthodontic Appliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Group A) - Two-miniscrew bone-borne expander | Experimental | Device: Miniscrew supported expander applicationone-borne rapid maxillary expander anchored on two palatal miniscrews inserted in paramedian palatal vault (near first-second premolar area). Miniscrews: self-tapping titanium (Benefit system; PSM Medical Solutions). Placement planned via CBCT-guided CAD/CAM surgical guide (Easy Driver). Activation protocol: Hyrax click 10 mm screw: 4 quarter-turns at placement then 3 quarter-turns/day for 12 days (0.20 mm/turn) until ~8 mm expansion. |
| Arm 2 (Group B) - Four-miniscrew bone-borne expander | Experimental | Device: 4 miniscrews supported rapid maxillary expansion applicationBone-borne rapid maxillary expander anchored on four palatal miniscrews (two paramedian + two parapalatine). Same guided insertion workflow and activation protocol as Group A. |
| Arm 3 (Group C) - Conventional tooth-borne Hyrax expander | Active comparator | Device: Conventional tooth-borne Hyrax expander (comparator)Tooth-borne Hyrax expander banded on upper first permanent molars (conventional Hyrax). Same activation protocol as Groups A/B. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Miniscrew supported expander applicationTwo palatal miniscrews with custom bone-borne expansion framework (device transmits forces to palatal bone; no tooth bands). | Device | Arm 1 (Group A) - Two-miniscrew bone-borne expander |
| 4 miniscrews supported rapid maxillary expansion applicationFour palatal miniscrews with custom bone-borne expansion appliances. | Device | Arm 2 (Group B) - Four-miniscrew bone-borne expander |
| Conventional tooth-borne Hyrax expander (comparator)Hyrax-type tooth-borne expander with bands cemented on upper first molars (Hyrax click 10 mm). | Device | Arm 3 (Group C) - Conventional tooth-borne Hyrax expander |
Primary outcome
Change in maxillary basal width (MaxBas) from baseline (T0) to 6 months post-treatment (T1)
Time frame: at 6 months
Measurement method: CBCT (Simplant software) distance between alveolar/basal points (points 5-6 as per Podesser/Garib protocol).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miniscrew supported expander application, 4 miniscrews supported rapid maxillary expansion application and Conventional tooth-borne Hyrax expander (comparator) in people with Orthodontic Appliance, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maxillary basal width (MaxBas) from baseline (T0) to 6 months post-treatment (T1) (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.