Clinical trial NCT06864949: Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances
Official title: Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances: Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Transverse Maxillary Deficiency
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in upper intermolar distance on digital casts
timeFrame: Before treatment (T0) and after 10-12 months of treatment (T1)
Secondary outcomes:
measure: Change in upper intercanine distance on digital casts
timeFrame: Before treatment (T0) and after 10-12 months of treatment (T1)
measure: Change in lower intercanine distance on digital casts
timeFrame: Before treatment (T0) and after 10-12 months of treatment (T1)
measure: Change in ANB angle
timeFrame: Before treatment (T0) and after 10-12 months of treatment (T1)
measure: Change in Wits Index
timeFrame: Before treatment (T0) and after 10-12 months of treatment (T1)
measure: Change in Skeletal Class
timeFrame: Before treatment (T0) and after 10-12 months of treatment (T1)
measure: Change in Cranio-Mandibular Angle
timeFrame: Before treatment (T0) and after 10-12 months of treatment (T1)
measure: Change in Intermaxillary Angle
timeFrame: Before treatment (T0) and after 10-12 months of treatment (T1)
measure: Change in Skeletal Vertical Pattern:
timeFrame: Before treatment (T0) and after 10-12 months of treatment (T1)
measure: Change in Articular Angle
timeFrame: Before treatment (T0) and after 10-12 months of treatment (T1)
measure: Change in Upper and Lower Goniac Angles
timeFrame: Before treatment (T0) and after 10-12 months of treatment (T1)
measure: Change in Mandibular growth pattern
timeFrame: Before treatment (T0) and after 10-12 months of treatment (T1)
measure: Change in Upper incisors Inclination
timeFrame: Before treatment (T0) and after 10-12 months of treatment (T1)
measure: Change in Lower incisors Inclination
timeFrame: Before treatment (T0) and after 10-12 months of treatment (T1)
measure: Change in Dento-alveolar discrepancy
timeFrame: Before treatment (T0) and after 10-12 months of treatment (T1)
measure: Change in lower intermolar distance
timeFrame: Before treatment (T0) and after 10-12 months of treatment (T1)
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: