Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances

Not Applicable

• Conditions: Transverse Maxillary Deficiency

• Registration Number: NCT06864949
• Lead Sponsor: University of Pavia

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.

Study Timeline

• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-03-03
• Study First Posted: 2025-03-07
• Study Start: 2025-03-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in upper intercanine distance on digital casts	Before treatment (T0) and after 10-12 months of treatment (T1)	The upper intercanine distance take as reference the top of upper canine cusp.
Change in lower intercanine distance on digital casts	Before treatment (T0) and after 10-12 months of treatment (T1)	The lower intercanine distance take as reference the top of lower canine cusp.
Change in ANB angle	Before treatment (T0) and after 10-12 months of treatment (T1)	ANB angle will be calculated using the pre-treatment and the post-treatment lateral cephalometric radiographs.
Change in Wits Index	Before treatment (T0) and after 10-12 months of treatment (T1)	Wits Index will be calculated using the pre-treatment and the post-treatment lateral cephalometric radiographs.
Change in Skeletal Class	Before treatment (T0) and after 10-12 months of treatment (T1)	Skeletal Class will be assessed combining the ANB angle and Wits Index values using the pre-treatment and the post-treatment lateral cephalometric radiographs.
Change in Cranio-Mandibular Angle	Before treatment (T0) and after 10-12 months of treatment (T1)	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.
Change in Intermaxillary Angle	Before treatment (T0) and after 10-12 months of treatment (T1)	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.
Change in Skeletal Vertical Pattern:	Before treatment (T0) and after 10-12 months of treatment (T1)	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.
Change in Articular Angle	Before treatment (T0) and after 10-12 months of treatment (T1)	Articular Angle will be evaluated between SArGo points following Giannì analysis and using the pre-treatment and the post-treatment lateral cephalometric radiographs.
Change in Upper and Lower Goniac Angles	Before treatment (T0) and after 10-12 months of treatment (T1)	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.
Change in Mandibular growth pattern	Before treatment (T0) and after 10-12 months of treatment (T1)	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.
Change in Upper incisors Inclination	Before treatment (T0) and after 10-12 months of treatment (T1)	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.
Change in Lower incisors Inclination	Before treatment (T0) and after 10-12 months of treatment (T1)	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.
Change in Dento-alveolar discrepancy	Before treatment (T0) and after 10-12 months of treatment (T1)	Dento-alveolar discrepancy will be calculated using the pre-treatment and the post-treatment study models using "Tanaka and Jhonston" space Analysis
Change in lower intermolar distance	Before treatment (T0) and after 10-12 months of treatment (T1)	The lower intermolar distance take as reference the top of the mesiovestibular cusp of the lower first molars.

Trial Locations

Locations (1)

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia; 🇮🇹 Pavia, Lombardy, Italy