NCT06864949

Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances

Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances: Prospective Clinical Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Pavia · Academic / Other
• Sex: All
• Age: 7 Years – 13 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-03-15
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2025-03-07
• Last updated: 2025-04-16

Locations

1 site across 1 country: Italy