Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances

NCT06864949 | Enrolling By Invitation

• 1 other identifier: 2025-AMCOP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Transverse Maxillary Deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Change in upper intercanine distance on digital casts

  Before treatment (T0) and after 10-12 months of treatment (T1)

• Change in lower intercanine distance on digital casts

  Before treatment (T0) and after 10-12 months of treatment (T1)

• Change in ANB angle

  Before treatment (T0) and after 10-12 months of treatment (T1)

• Change in Wits Index

  Before treatment (T0) and after 10-12 months of treatment (T1)

• Change in Skeletal Class

  Before treatment (T0) and after 10-12 months of treatment (T1)

Study Arms (1)

Treatment with AMCOP First Class appliance

EXPERIMENTAL

Device: AMCOP appliance

Interventions

AMCOP appliance 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.

Treatment with AMCOP First Class appliance

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

Study Officials

• Andrea Scribante, DDS, PhD

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 7, 2025
• Study Start: March 15, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)