Maxillary DeficiencyLEAFNCT05135962
Maxillary Expansion: Leaf Expander Versus Hyrax Expander
A study testing orthodontic - rapid maxillary expansion, orthodontic - slow maxillary expansion with leaf expander and orthodontic - slow maxillary expansion with self leaf expander in people with Maxillary Deficiency, run by University of Genova.
Trial summary
The aim of the current study was to evaluate maxillary and mandibular arch widths' response to five different appliances and clinical protocols (Rapid maxillary expander RME, Leaf Expander 450g, Leaf Expander 900g, Self-expander 450g, Self-expander 900g) for the correction of the maxillary deficiency. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Maxillary Deficiency
- What is being tested?
- orthodontic - rapid maxillary expansion, orthodontic - slow maxillary expansion with leaf expander and orthodontic - slow maxillary expansion with self leaf expander
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Nov 2023
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- prepubertal phase of development (cervical stage CS1 or 2 in cervical vertebral maturation or corresponding stage of third Finger middle phalanx maturation index).
- early or intermediate mixed dentition stage with fully erupted upper and lower first permanent molars.
- presence of the second upper deciduous molars available as an anchoring tooth. The second deciduous molar was considered available as anchoring tooth when the root had the same length as the clinical crown at the radiographic examination (Quinzi V, Federici Canova F, Rizzo FA, Marzo G, Rosa M, Primozic J. Factors related to maxillary expander loss due to anchoring deciduous molars exfoliation during treatment in the mixed dentition phase. Eur J Orthod. 2021 Jun 8;43(3):332-337. doi: 10.1093/ejo/cjaa061)
- Posterior transverse interarch discrepancy (PTID) of at least 3 mm. PTID was calculated on dental casts with a caliper as the difference between the maxillary intermolar width (distance between the central fossae of right and left permanent first maxillary molars) and the mandibular intermolar width (distance between the tips of the distobuccal cusps of right and left permanent first mandibular molars) (Tollaro, I., Baccetti, T., Franchi, L. and Tanasescu, C.D. 1996 Role of posterior transverse interarch discrepancy in Class II, Division 1 malocclusion during the mixed dentition phase. AJODO, 110, 417-422).
Who cannot join
- age older than 12 years,
- pubertal or postpubertal stage of development (CS 3-6),
- late deciduous or late mixed dentition, 4. agenesis of upper second premolars (assessed on initial panoramic radiograph),
- Class III malocclusion,
- cleft lip and/or palate and craniofacial syndromes
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Leaf Expander Versus Hyrax Expander. A Multicenter, Prospective, Randomized Trial
The aim of the current study was to evaluate maxillary and mandibular arch widths' response to five different appliances and clinical protocols (Rapid maxillary expander RME, Leaf Expander 450g, Leaf Expander 900g, Self-expander 450g, Self-expander 900g) for the correction of the maxillary deficiency.
Read the detailed description
Maxillary expansion with fixed appliance is a well-known and consolidated practice in clinical orthodontics but current findings of "evidence-based dentistry" have not yet identified a better clinical expansion protocol. This issue is due both to the several expansion screws available on the market and to the different screw activation protocols, which could be grouped in rapid and slow, with several customizations. The comparison between slow and rapid expansion is a hotly debated topic in the literature and a recent systematic review have shown that both rapid and slow expansion protocols are clinically effective on the primary outcome (the resolution of the maxillary deficiency and crossbite with a significant increase of skeletal transversal maxillary dimension). Based on these results, the choice of appliance based on its ability to solve the maxillary constriction may not be any more the main selection criteria. The choice of the orthodontist should also be based on the timing and on a "patient-oriented" device, that minimizes the side effects, such as e.g. appliance breakages, functional impairments, and pain perception.
The aim of the present study is to investigate and analyze five different maxillary expansion appliances to identify an effective and efficient clinical protocol for the maxillary expansion.
- Conditions
- Maxillary Deficiency
- Being tested
- orthodontic - rapid maxillary expansion, orthodontic - slow maxillary expansion with leaf expander, orthodontic - slow maxillary expansion with self leaf expander
- Keywords
- maxillary expansion, slow expansion, rapid expansion, leaf expander
- Medical subject headings
- Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthodontic - rapid maxillary expansionDevice
Also called orthodontic - rapid palatal expansion
Rapid expansion: when RME was in situ, patients started the screw activation of one-quarter turn a day until overcorrection was achieved and RME was kept on teeth as a passive retainer and removed after one year from its application.
orthodontic - slow maxillary expansion with leaf expanderDevice
Also called orthodontic - slow palatal expansion with leaf expander
Leaf expander: The screw delivers a maximum expansion of 6 or 9 mm by activating (compressing) the spring, which generates a light (450g or 900g) and constant force. The leaves are preactivated in the laboratory to deliver 3mm of expansion. Reactivation is performed in the office by 10 quarter-turns (leaf 450g) or 15 quarter-turns (leaf 900g) of the screw per month until expansion has been completed. After active expansion the Leaf Expander is maintained passively in place for retention period. Leaf expander was kept on teeth as a passive retainer and removed after one year from its application.
orthodontic - slow maxillary expansion with self leaf expanderDevice
Also called orthodontic - slow palatal expansion with self leaf expander
Leaf self expander: similar to Leaf expander with no need for reactivation or patient compliance.
| Study group | Role | What they receive |
|---|---|---|
| RME (rapid expansion) | Active comparator | Intervention orthodontic - maxillary expansion:
maxillary expansion with RME expander anchored on second deciduous molars. Activation: 1/turn day. RME was kept on teeth as a passive retainer and removed after one year from its application. Receives: Device: orthodontic - rapid maxillary expansion |
| Leaf expander 450g (slow expansion) | Experimental | Intervention orthodontic - maxillary expansion: maxillary expansion with Leaf Expander appliance anchored on second deciduous molars Activation: The leaves are preactivated in the laboratory to deliver 3mm of expansion. Reactivation is performed in the office by 10 quarter-turns of the screw per month until expansion has been completed. After active expansion, the Leaf Expander was kept on teeth as a passive retainer and removed after one year from its application. Receives: Device: orthodontic - slow maxillary expansion with leaf expander |
| Leaf self-expander 450g (slow expansion) | Experimental | Intervention orthodontic - maxillary expansion: maxillary expansion with Leaf self Expander appliance anchored on second deciduous molars.
Activation: self activation (preactivated). After active expansion the Leaf self expander was kept on teeth as a passive retainer and removed after one year from its application Receives: Device: orthodontic - slow maxillary expansion with self leaf expander |
| Leaf expander 900g (slow expansion) | Experimental | Intervention orthodontic - maxillary expansion: maxillary expansion with Leaf Leaf Expander appliance anchored on second deciduous molars.
Activation: The leaves are preactivated in the laboratory to deliver 3mm of expansion. Reactivation is performed in the office by 15 quarter-turns of the screw per month until expansion has been completed. After active expansion the Leaf Expander was kept on teeth as a passive retainer and removed after one year from its application. Receives: Device: orthodontic - slow maxillary expansion with leaf expander |
| Leaf self-expander 900g (slow expansion) | Experimental | Intervention orthodontic - maxillary expansion: maxillary expansion with Leaf self Expander appliance anchored on second deciduous molars.
Activation: self activation (preactivated). After active expansion the Leaf self expander was kept on teeth as a passive retainer and removed after one year from its application Receives: Device: orthodontic - slow maxillary expansion with self leaf expander |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crossbite and/or traversal maxillary deficiency correction
Crossbite and/or traversal maxillary deficiency correction
Measured: 6 months
Secondary outcomes (12)
Crossbite correction stability
Crossbite correction stability
Measured: 1 year
Crossbite correction stability
Crossbite correction stability
Measured: 2 years
Canine and molar expansion (upper and lower arch)
Canine and molar millimetres of expansion (upper and lower arch)
Measured: 6 months
Canine and molar angulation (upper and lower arch)
Canine and molar degrees of angulation (upper and lower arch)
Measured: 6 months
Canine and molar expansion (upper and lower arch)
Canine and molar millimetres of expansion (upper and lower arch)
Measured: 1 year
Canine and molar angulation (upper and lower arch)
Canine and molar degrees of angulation (upper and lower arch)
Measured: 1 year
Upper and lower dental arch perimeter modifications
Upper and lower dental arch perimeter modifications (millimetres)
Measured: 6 months
Upper and lower dental arch perimeter modifications
Upper and lower dental arch perimeter modifications (millimetres)
Measured: 1 year
Pain during active expansion phase (VAS scale)
Pain during active expansion phase (VAS scale)
Measured: 1 month
Appliance breakages and detachments
Appliance breakages and detachments
Measured: 6 months
Number of in-office appointments
Number of in-office appointments
Measured: 6 months
Time needed to correct the malocclusion
Time needed to correct the malocclusion
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maxillary DeficiencyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan, Università degli Studi di Brescia
- Responsible party
- Principal investigator, ALESSANDRO UGOLINI, University of Genova
- Investigators
- Valentina Lanteri, DDS, Phd, Principal investigator, University of MilanDomenico Dalessandri, DDS, Phd, Principal investigator, Università degli Studi di BresciaAlessandro Ugolini, Principal investigator, Universita degli Studi di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135962
- Sponsor's protocol ID
- Leaf Expander mRCT
- Acronym
- LEAF
- Status last verified
- Nov 2021
- First submitted
- 4 Oct 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ugolini A, Bruni A, Abate A, Maspero C, Silvestrini-Biavati F, Lanteri V. Upper arch expansion and spontaneous upper first molar distorotation with Ni-Ti leaf springs and rapid maxillary expander compared to clear aligners : A randomized controlled trial. J Orofac Orthop. 2026 Mar 12. doi: 10.1007/s00056-026-00649-7. Online ahead of print.
PubMed 41817693Abate A, Ugolini A, Bruni A, Quinzi V, Lanteri V. Three-dimensional assessment on digital cast of spontaneous upper first molar distorotation after Ni-ti leaf springs expander and rapid maxillary expander: A two-centre randomized controlled trial. Orthod Craniofac Res. 2025 Feb;28(1):104-115. doi: 10.1111/ocr.12849. Epub 2024 Sep 8.
PubMed 39244736
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leaf Expander Versus Hyrax Expander. A Multicenter, Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT05135962
- Acronym / sponsor ID
- LEAF / Leaf Expander mRCT
- Conditions
- Maxillary Deficiency
- Keywords
- maxillary expansion, slow expansion, rapid expansion, leaf expander
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Collaborators
- University of Milan, Università degli Studi di Brescia
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 26 Nov 2021 (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.
The aim of the current study was to evaluate maxillary and mandibular arch widths' response to five different appliances and clinical protocols (Rapid maxillary expander RME, Leaf Expander 450g, Leaf Expander 900g, Self-expander 450g, Self-expander 900g) for the correction of the maxillary deficiency.
Detailed description
Maxillary expansion with fixed appliance is a well-known and consolidated practice in clinical orthodontics but current findings of "evidence-based dentistry" have not yet identified a better clinical expansion protocol. This issue is due both to the several expansion screws available on the market and to the different screw activation protocols, which could be grouped in rapid and slow, with several customizations. The comparison between slow and rapid expansion is a hotly debated topic in the literature and a recent systematic review have shown that both rapid and slow expansion protocols are clinically effective on the primary outcome (the resolution of the maxillary deficiency and crossbite with a significant increase of skeletal transversal maxillary dimension). Based on these results, the choice of appliance based on its ability to solve the maxillary constriction may not be any more the main selection criteria. The choice of the orthodontist should also be based on the timing and on a "patient-oriented" device, that minimizes the side effects, such as e.g. appliance breakages, functional impairments, and pain perception.
The aim of the present study is to investigate and analyze five different maxillary expansion appliances to identify an effective and efficient clinical protocol for the maxillary expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| RME (rapid expansion) | Active comparator | Device: orthodontic - rapid maxillary expansionIntervention orthodontic - maxillary expansion: maxillary expansion with RME expander anchored on second deciduous molars. Activation: 1/turn day. RME was kept on teeth as a passive retainer and removed after one year from its application. |
| Leaf expander 450g (slow expansion) | Experimental | Device: orthodontic - slow maxillary expansion with leaf expanderIntervention orthodontic - maxillary expansion: maxillary expansion with Leaf Expander appliance anchored on second deciduous molars Activation: The leaves are preactivated in the laboratory to deliver 3mm of expansion. Reactivation is performed in the office by 10 quarter-turns of the screw per month until expansion has been completed. After active expansion, the Leaf Expander was kept on teeth as a passive retainer and removed after one year from its application. |
| Leaf self-expander 450g (slow expansion) | Experimental | Device: orthodontic - slow maxillary expansion with self leaf expanderIntervention orthodontic - maxillary expansion: maxillary expansion with Leaf self Expander appliance anchored on second deciduous molars. Activation: self activation (preactivated). After active expansion the Leaf self expander was kept on teeth as a passive retainer and removed after one year from its application |
| Leaf expander 900g (slow expansion) | Experimental | Device: orthodontic - slow maxillary expansion with leaf expanderIntervention orthodontic - maxillary expansion: maxillary expansion with Leaf Leaf Expander appliance anchored on second deciduous molars. Activation: The leaves are preactivated in the laboratory to deliver 3mm of expansion. Reactivation is performed in the office by 15 quarter-turns of the screw per month until expansion has been completed. After active expansion the Leaf Expander was kept on teeth as a passive retainer and removed after one year from its application. |
| Leaf self-expander 900g (slow expansion) | Experimental | Device: orthodontic - slow maxillary expansion with self leaf expanderIntervention orthodontic - maxillary expansion: maxillary expansion with Leaf self Expander appliance anchored on second deciduous molars. Activation: self activation (preactivated). After active expansion the Leaf self expander was kept on teeth as a passive retainer and removed after one year from its application |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- prepubertal phase of development (cervical stage CS1 or 2 in cervical vertebral maturation or corresponding stage of third Finger middle phalanx maturation index).
- early or intermediate mixed dentition stage with fully erupted upper and lower first permanent molars.
- presence of the second upper deciduous molars available as an anchoring tooth. The second deciduous molar was considered available as anchoring tooth when the root had the same length as the clinical crown at the radiographic examination (Quinzi V, Federici Canova F, Rizzo FA, Marzo G, Rosa M, Primozic J. Factors related to maxillary expander loss due to anchoring deciduous molars exfoliation during treatment in the mixed dentition phase. Eur J Orthod. 2021 Jun 8;43(3):332-337. doi: 10.1093/ejo/cjaa061)
- Posterior transverse interarch discrepancy (PTID) of at least 3 mm. PTID was calculated on dental casts with a caliper as the difference between the maxillary intermolar width (distance between the central fossae of right and left permanent first maxillary molars) and the mandibular intermolar width (distance between the tips of the distobuccal cusps of right and left permanent first mandibular molars) (Tollaro, I., Baccetti, T., Franchi, L. and Tanasescu, C.D. 1996 Role of posterior transverse interarch discrepancy in Class II, Division 1 malocclusion during the mixed dentition phase. AJODO, 110, 417-422).
Key exclusion criteria (5 listed)
- age older than 12 years,
- pubertal or postpubertal stage of development (CS 3-6),
- late deciduous or late mixed dentition, 4. agenesis of upper second premolars (assessed on initial panoramic radiograph),
- Class III malocclusion,
- cleft lip and/or palate and craniofacial syndromes
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 |
|---|---|---|
| orthodontic - rapid maxillary expansionAlso: orthodontic - rapid palatal expansionRapid expansion: when RME was in situ, patients started the screw activation of one-quarter turn a day until overcorrection was achieved and RME was kept on teeth as a passive retainer and removed after one year from its application. | Device | RME (rapid expansion) |
| orthodontic - slow maxillary expansion with leaf expanderAlso: orthodontic - slow palatal expansion with leaf expanderLeaf expander: The screw delivers a maximum expansion of 6 or 9 mm by activating (compressing) the spring, which generates a light (450g or 900g) and constant force. The leaves are preactivated in the laboratory to deliver 3mm of expansion. Reactivation is performed in the office by 10 quarter-turns (leaf 450g) or 15 quarter-turns (leaf 900g) of the screw per month until expansion has been completed. After active expansion the Leaf Expander is maintained passively in place for retention period. Leaf expander was kept on teeth as a passive retainer and removed after one year from its application. | Device | Leaf expander 450g (slow expansion), Leaf expander 900g (slow expansion) |
| orthodontic - slow maxillary expansion with self leaf expanderAlso: orthodontic - slow palatal expansion with self leaf expanderLeaf self expander: similar to Leaf expander with no need for reactivation or patient compliance. | Device | Leaf self-expander 450g (slow expansion), Leaf self-expander 900g (slow expansion) |
Primary outcome
Crossbite and/or traversal maxillary deficiency correction
Time frame: 6 months
Crossbite and/or traversal maxillary deficiency correction
12 secondary outcomes
Crossbite correction stability
Time frame: 1 year
Crossbite correction stability
Time frame: 2 years
Canine and molar expansion (upper and lower arch)
Time frame: 6 months
Canine and molar angulation (upper and lower arch)
Time frame: 6 months
Canine and molar expansion (upper and lower arch)
Time frame: 1 year
Canine and molar angulation (upper and lower arch)
Time frame: 1 year
Upper and lower dental arch perimeter modifications
Time frame: 6 months
Upper and lower dental arch perimeter modifications
Time frame: 1 year
Pain during active expansion phase (VAS scale)
Time frame: 1 month
Appliance breakages and detachments
Time frame: 6 months
Number of in-office appointments
Time frame: 6 months
Time needed to correct the malocclusion
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Derived from this study: PubMed 41817693Ugolini A, Bruni A, Abate A, Maspero C, Silvestrini-Biavati F, Lanteri V. Upper arch expansion and spontaneous upper first molar distorotation with Ni-Ti leaf springs and rapid maxillary expander compared to clear aligners : A randomized controlled trial. J Orofac Orthop. 2026 Mar 12. doi: 10.1007/s00056-026-00649-7. Online ahead of print.
- Derived from this study: PubMed 39244736Abate A, Ugolini A, Bruni A, Quinzi V, Lanteri V. Three-dimensional assessment on digital cast of spontaneous upper first molar distorotation after Ni-ti leaf springs expander and rapid maxillary expander: A two-centre randomized controlled trial. Orthod Craniofac Res. 2025 Feb;28(1):104-115. doi: 10.1111/ocr.12849. Epub 2024 Sep 8.
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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.
Valentina Lanteri, DDS, Phd principal investigator
University of Milan
Domenico Dalessandri, DDS, Phd principal investigator
Università degli Studi di Brescia
Alessandro Ugolini principal investigator
Universita degli Studi di Genova
Questions about this trial
What is this clinical trial studying?
A study testing orthodontic - rapid maxillary expansion, orthodontic - slow maxillary expansion with leaf expander and orthodontic - slow maxillary expansion with self leaf expander in people with Maxillary Deficiency, run by University of Genova.
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 5 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: status not confirmed, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Ugolini, DDS, Phd (+390103537309, alessandro.ugolini@unige.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crossbite and/or traversal maxillary deficiency correction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05135962, which also lists 2 linked publications.
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 26 Nov 2021.