Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Transverse Maxillary Deficiency
• Intervention / Treatment: Device: AMCOP appliance

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment with AMCOP First Class appliance

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in upper intermolar distance on digital casts	The upper intermolar distance take as reference the top of the mesiovestibular cusp of the upper first molars.	Before treatment (T0) and after 10-12 months of treatment (T1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in upper intercanine distance on digital casts	The upper intercanine distance take as reference the top of upper canine cusp.	Before treatment (T0) and after 10-12 months of treatment (T1)
Change in lower intercanine distance on digital casts	The lower intercanine distance take as reference the top of lower canine cusp.	Before treatment (T0) and after 10-12 months of treatment (T1)
Change in ANB angle	ANB angle will be calculated using the pre-treatment and the post-treatment lateral cephalometric radiographs.	Before treatment (T0) and after 10-12 months of treatment (T1)
Change in Wits Index	Wits Index will be calculated using the pre-treatment and the post-treatment lateral cephalometric radiographs.	Before treatment (T0) and after 10-12 months of treatment (T1)
Change in Skeletal Class	Skeletal Class will be assessed combining the ANB angle and Wits Index values using the pre-treatment and the post-treatment lateral cephalometric radiographs.	Before treatment (T0) and after 10-12 months of treatment (T1)
Change in Cranio-Mandibular Angle	Cranio-Mandibular Angle will be evaluated between SN and GoGn planes following Giannì analysis and using the pre-treatment and the post-treatment lateral cephalometric radiographs.	Before treatment (T0) and after 10-12 months of treatment (T1)
Change in Intermaxillary Angle	Intermaxillary Angle will be evaluated between bispinal and mandibular planes following Giannì analysis and using the pre-treatment and the post-treatment lateral cephalometric radiographs.	Before treatment (T0) and after 10-12 months of treatment (T1)
Change in Skeletal Vertical Pattern:	Skeletal vertical pattern will be assessed using Cranio-Mandibular and Intermaxillary Angles following Giannì analysis and using the pre-treatment and the post-treatment lateral cephalometric radiographs.	Before treatment (T0) and after 10-12 months of treatment (T1)
Change in Articular Angle	Articular Angle will be evaluated between SArGo points following Giannì analysis and using the pre-treatment and the post-treatment lateral cephalometric radiographs.	Before treatment (T0) and after 10-12 months of treatment (T1)
Change in Upper and Lower Goniac Angles	Upper and Lower goniac angles will be evaluated between respectively Ar-Go-N and N-Go-Gn points following Giannì analysis and using the pre-treatment and the post-treatment lateral cephalometric radiographs.	Before treatment (T0) and after 10-12 months of treatment (T1)
Change in Mandibular growth pattern	Mandibular growth pattern will be assessed using Articular Angle and Upper and Lower Goniac Angles, following Giannì analysis and using the pre-treatment and the post-treatment lateral cephalometric radiographs.	Before treatment (T0) and after 10-12 months of treatment (T1)
Change in Upper incisors Inclination	Upper incisors Inclination will be evaluated between upper incisors Axis and bispinal plane, following Giannì analysis and using the pre-treatment and the post-treatment lateral cephalometric radiographs.	Before treatment (T0) and after 10-12 months of treatment (T1)
Change in Lower incisors Inclination	Upper incisors Inclination will be evaluated between lower incisors Axis and mandibular plane, following Giannì analysis and using the pre-treatment and the post-treatment lateral cephalometric radiographs.	Before treatment (T0) and after 10-12 months of treatment (T1)
Change in Dento-alveolar discrepancy	Dento-alveolar discrepancy will be calculated using the pre-treatment and the post-treatment study models using "Tanaka and Jhonston" space Analysis	Before treatment (T0) and after 10-12 months of treatment (T1)
Change in lower intermolar distance	The lower intermolar distance take as reference the top of the mesiovestibular cusp of the lower first molars.	Before treatment (T0) and after 10-12 months of treatment (T1)

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Principal Investigator: Andrea Scribante, DDS, PhD, University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 7, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2025-AMCOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available upon motivated request to the Principal Investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No