Maxillary Expansion: Leaf Expander Versus Hyrax Expander

Maxillary Deficiency Clinical Trial

— LEAF  

Official title:

Leaf Expander Versus Hyrax Expander. A Multicenter, Prospective, Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05135962
• Other study ID #: Leaf Expander mRCT
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2021
• Source: University of Genova
• Contact: Alessandro Ugolini, DDS, Phd
• Phone: +390103537309
• Email: alessandro.ugolini[@]unige.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Maxillary Deficiency

Intervention

Device:
• orthodontic - rapid maxillary 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 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 expander
Leaf self expander: similar to Leaf expander with no need for reactivation or patient compliance.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Genova	Università degli Studi di Brescia, University of Milan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crossbite and/or traversal maxillary deficiency correction	Crossbite and/or traversal maxillary deficiency correction	6 months
Secondary	Crossbite correction stability	Crossbite correction stability	1 year
Secondary	Crossbite correction stability	Crossbite correction stability	2 years
Secondary	Canine and molar expansion (upper and lower arch)	Canine and molar millimetres of expansion (upper and lower arch)	6 months
Secondary	Canine and molar angulation (upper and lower arch)	Canine and molar degrees of angulation (upper and lower arch)	6 months
Secondary	Canine and molar expansion (upper and lower arch)	Canine and molar millimetres of expansion (upper and lower arch)	1 year
Secondary	Canine and molar angulation (upper and lower arch)	Canine and molar degrees of angulation (upper and lower arch)	1 year
Secondary	Upper and lower dental arch perimeter modifications	Upper and lower dental arch perimeter modifications (millimetres)	6 months
Secondary	Upper and lower dental arch perimeter modifications	Upper and lower dental arch perimeter modifications (millimetres)	1 year
Secondary	Pain during active expansion phase (VAS scale)	Pain during active expansion phase (VAS scale)	1 month
Secondary	Appliance breakages and detachments	Appliance breakages and detachments	6 months
Secondary	Number of in-office appointments	Number of in-office appointments	6 months
Secondary	Time needed to correct the malocclusion	Time needed to correct the malocclusion	6 months