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| Name | Class |
|---|---|
| University of Milan | OTHER |
| Università degli Studi di Brescia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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 |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| orthodontic - rapid maxillary expansion | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Crossbite and/or traversal maxillary deficiency correction | Crossbite and/or traversal maxillary deficiency correction | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Crossbite correction stability | Crossbite correction stability | 1 year |
| Crossbite correction stability | Crossbite correction stability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandro Ugolini, DDS, Phd | Contact | +390103537309 | alessandro.ugolini@unige.it |
| Name | Affiliation | Role |
|---|---|---|
| Valentina Lanteri, DDS, Phd | University of Milan | Principal Investigator |
| Domenico Dalessandri, DDS, Phd | Università degli Studi di Brescia | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41817693 | Derived | 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. | |
| 39244736 |
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| ID | Term |
|---|---|
| D063173 | Retrognathia |
| ID | Term |
|---|---|
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
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| 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 |
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|
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| orthodontic - slow maxillary expansion with leaf expander | Device | 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. |
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| orthodontic - slow maxillary expansion with self leaf expander | Device | Leaf self expander: similar to Leaf expander with no need for reactivation or patient compliance. |
|
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| 2 years |
| Canine and molar expansion (upper and lower arch) | Canine and molar millimetres of expansion (upper and lower arch) | 6 months |
| Canine and molar angulation (upper and lower arch) | Canine and molar degrees of angulation (upper and lower arch) | 6 months |
| Canine and molar expansion (upper and lower arch) | Canine and molar millimetres of expansion (upper and lower arch) | 1 year |
| Canine and molar angulation (upper and lower arch) | Canine and molar degrees of angulation (upper and lower arch) | 1 year |
| Upper and lower dental arch perimeter modifications | Upper and lower dental arch perimeter modifications (millimetres) | 6 months |
| Upper and lower dental arch perimeter modifications | Upper and lower dental arch perimeter modifications (millimetres) | 1 year |
| Pain during active expansion phase (VAS scale) | Pain during active expansion phase (VAS scale) | 1 month |
| Appliance breakages and detachments | Appliance breakages and detachments | 6 months |
| Number of in-office appointments | Number of in-office appointments | 6 months |
| Time needed to correct the malocclusion | Time needed to correct the malocclusion | 6 months |
| Alessandro Ugolini |
| Universita degli Studi di Genova |
| Principal Investigator |
| Abate 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. |
| D019465 |
| Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D008336 | Mandibular Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |