Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances

NCT ID: NCT06864949

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2026-02-28

Brief Summary

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.

Detailed 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.

Conditions

Transverse Maxillary Deficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment with AMCOP First Class appliance

Group Type: EXPERIMENTAL

AMCOP appliance

Intervention Type: DEVICE

The device measure will be determined with OrthoCad program on digital models, taking the distance between the vestibular cusps of the upper first molars, at the level of the most prominent point. AMCOPs are preformed devices and there are five different measures based on transverse diameter: 1 (45mm), 2 (50mm), 3 (55mm), 4 (60mm), 5 (65mm).

Requiring expansion, we will choose an higher AMCOP measure than the transverse distance measured on the digital models at T0.

The clinical indications for use of the AMCOP device will be as follow:

• in the first week, wear the appliance during the night and for 30 minutes during the day
• from the second week onward, wear the appliance for one hour during the day and throughout the night During this time, every month we will visit patients and we will expand the device by soaking it in hot water at about 70 °C for 30 s and then in cold water to stabilize it in its new shape.

Interventions

AMCOP appliance

The device measure will be determined with OrthoCad program on digital models, taking the distance between the vestibular cusps of the upper first molars, at the level of the most prominent point. AMCOPs are preformed devices and there are five different measures based on transverse diameter: 1 (45mm), 2 (50mm), 3 (55mm), 4 (60mm), 5 (65mm).

Requiring expansion, we will choose an higher AMCOP measure than the transverse distance measured on the digital models at T0.

The clinical indications for use of the AMCOP device will be as follow:

• in the first week, wear the appliance during the night and for 30 minutes during the day
• from the second week onward, wear the appliance for one hour during the day and throughout the night During this time, every month we will visit patients and we will expand the device by soaking it in hot water at about 70 °C for 30 s and then in cold water to stabilize it in its new shape.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pavia

OTHER

Sponsor Role: lead

Responsible Party

Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Scribante, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, Italy

Countries

Italy

Other Identifiers

2025-AMCOP

Identifier Type: -

Identifier Source: org_study_id