Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances

University of Pavia

Status: Invitation-only

Conditions: Transverse Maxillary Deficiency

Treatments: Device: AMCOP appliance

Study type: Interventional

Funder types: Other

Identifiers

NCT06864949

2025-AMCOP

Details and patient eligibility

About

The present study aimed to investigate the cross-sectional effect of Class I AMCOP devices in patients of all possible skeletal types from both vertical skeletal pattern (normodivergent, hyperdivergent, hypodivergent) and sagittal skeletal pattern (skeletal Class I, skeletal Class II, skeletal Class III).

The criterion for choosing patients was determined by the protocol of using these devices, which is to always perform an AMCOP First Class phase with the aim of improving transverse coordination of the arches, Spee's Curve and Wilson's Curve.

Full description

This prospective clinical study will investigate the cross-sectional effect of Class I AMCOP (Cranium Occluded Postural Multifunctional Harmonizers, Micerium spa) devices in patients of all possible skeletal types from both vertical skeletal pattern (normodivergent, hyperdivergent, hypodivergent) and sagittal skeletal pattern (skeletal Class I, skeletal Class II, skeletal Class III).

Patients willing to start AMCOP therapy and recruited for the study will be asked to sign the informed consent. Parents will sign the consent for underage patients.

We will recruit patients by following specific inclusion and exclusion criteria during an orthodontic examination.

Diagnostic records will be recorded before treatment (T0) and after 10-12 months of treatment (T1) and included:

• Intraoral and extraoral photographs
• Impressions of the dental arches with digital scanner
• Orthopantomography
• Lateral teleradiography

Changes will be evaluated at T0 and T1 as follows:

• cross-sectional effects will be analyzed on digital models of the upper and lower arch, taking the following linear measurements with OrthoCad program:

  1. upper and lower intermolar distance (taking as reference the top of the mesiovestibular cusp of the upper first molars)
  2. upper and lower intercanine distance (taking as reference the top of the cusp)

• skeletal changes in latero-lateral teleradiography will be analyzed by using "Giannì cephalometric analysis" The expected duration of the first phase of therapy is averaged 10-12 months. During this time, every month patients will be visited and the devices will be activated.

Enrollment: 30 estimated patients

Sex: All

Ages: 7 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients presenting maxillary transverse deficits (that includes: posterior crossbite monolateral or bilateral; end-to-end occlusal relationships; excessive linguoinclination of lower posterior teeth due to the contraction of maxillary arch; limited permutation space of permanent elements)
• patients with all sagittal and vertical skeletal patterns

Exclusion criteria

• syndromic patterns, cleft lip or cleft palate, severe malformations of the maxillae, severe skeletal asymmetry
• physical or psychological limitations
• presence of metallic restorations
• previous orthodontic treatments

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Treatment with AMCOP First Class appliance

Experimental group

Treatment:

Device: AMCOP appliance