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Enrolling by Invitation

NCT Number: NCT06864949

Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances

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.

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Key information

Conditions

Transverse Maxillary Deficiency

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, Lombardy, 27100, Italy

About this study

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:
  • upper and lower intermolar distance (taking as reference the top of the mesiovestibular cusp of the upper first molars)
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in upper intermolar distance on digital casts

    Time frame: 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 outcomes

  1. Change in upper intercanine distance on digital casts

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

    The upper intercanine distance take as reference the top of upper canine cusp.

  2. Change in lower intercanine distance on digital casts

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

    The lower intercanine distance take as reference the top of lower canine cusp.

  3. Change in ANB angle

    Time frame: 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.

  4. Change in Wits Index

    Time frame: 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.

  5. Change in Skeletal Class

    Time frame: 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.

  6. Change in Cranio-Mandibular Angle

    Time frame: 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.

  7. Change in Intermaxillary Angle

    Time frame: 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.

  8. Change in Skeletal Vertical Pattern:

    Time frame: 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.

  9. Change in Articular Angle

    Time frame: 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.

  10. Change in Upper and Lower Goniac Angles

    Time frame: 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.

  11. Change in Mandibular growth pattern

    Time frame: 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.

  12. Change in Upper incisors Inclination

    Time frame: 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.

  13. Change in Lower incisors Inclination

    Time frame: 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.

  14. Change in Dento-alveolar discrepancy

    Time frame: 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

  15. Change in lower intermolar distance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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