Maxillary Expansion: Leaf Expander Versus Hyrax Expander
LEAF
Leaf Expander Versus Hyrax Expander. A Multicenter, Prospective, Randomized Trial
1 other identifier
interventional
200
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2021
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2021
CompletedFirst Posted
Study publicly available on registry
November 26, 2021
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedNovember 26, 2021
November 1, 2021
1 year
October 4, 2021
November 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Crossbite and/or traversal maxillary deficiency correction
Crossbite and/or traversal maxillary deficiency correction
6 months
Secondary Outcomes (12)
Crossbite correction stability
1 year
Crossbite correction stability
2 years
Canine and molar expansion (upper and lower arch)
6 months
Canine and molar angulation (upper and lower arch)
6 months
Canine and molar expansion (upper and lower arch)
1 year
- +7 more secondary outcomes
Study Arms (5)
RME (rapid expansion)
ACTIVE COMPARATORIntervention 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)
EXPERIMENTALIntervention 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)
EXPERIMENTALIntervention 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)
EXPERIMENTALIntervention 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)
EXPERIMENTALIntervention 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
Interventions
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.
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.
Leaf self expander: similar to Leaf expander with no need for reactivation or patient compliance.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Genovalead
- University of Milancollaborator
- Università degli Studi di Bresciacollaborator
Related Publications (1)
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.
PMID: 39244736DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valentina Lanteri, DDS, Phd
University of Milan
- PRINCIPAL INVESTIGATOR
Domenico Dalessandri, DDS, Phd
Università degli Studi di Brescia
- PRINCIPAL INVESTIGATOR
Alessandro Ugolini
Universita degli Studi di Genova
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 4, 2021
First Posted
November 26, 2021
Study Start
December 1, 2021
Primary Completion
December 1, 2022
Study Completion
November 1, 2023
Last Updated
November 26, 2021
Record last verified: 2021-11