Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AMCOP appliance.
- Who it may be relevant to
- Registry conditions: Transverse Maxillary Deficiency. Basic parameters: 7 years — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances: Prospective Clinical Study
Overview
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.
Interventions
- 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 fo
Primary outcome measures
- Change in upper intermolar distance on digital casts [Time frame: Before treatment (T0) and after 10-12 months of treatment (T1)]
Secondary outcome measures (12)
- Change in upper intercanine distance on digital casts [Time frame: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in lower intercanine distance on digital casts [Time frame: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in ANB angle [Time frame: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in Wits Index [Time frame: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in Skeletal Class [Time frame: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in Cranio-Mandibular Angle [Time frame: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in Intermaxillary Angle [Time frame: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in Skeletal Vertical Pattern: [Time frame: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in Articular Angle [Time frame: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in Upper and Lower Goniac Angles [Time frame: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in Mandibular growth pattern [Time frame: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in Upper incisors Inclination [Time frame: Before treatment (T0) and after 10-12 months of treatment (T1)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinic — Pavia
Identifiers
NCT: NCT06864949 · 2025-AMCOP