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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.
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with AMCOP First Class appliance | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in upper intercanine distance on digital casts | The upper intercanine distance take as reference the top of upper canine cusp. | Before treatment (T0) and after 10-12 months of treatment (T1) |
| Change in lower intercanine distance on digital casts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Scribante, DDS, PhD | University of Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia | Pavia | Lombardy | 27100 | Italy |
Data will be available upon motivated request to the Principal Investigator.
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|
The lower intercanine distance take as reference the top of lower canine cusp. |
| Before treatment (T0) and after 10-12 months of treatment (T1) |
| Change in ANB angle | ANB angle will be calculated using the pre-treatment and the post-treatment lateral cephalometric radiographs. | Before treatment (T0) and after 10-12 months of treatment (T1) |
| Change in Wits Index | Wits Index will be calculated using the pre-treatment and the post-treatment lateral cephalometric radiographs. | Before treatment (T0) and after 10-12 months of treatment (T1) |
| Change in Skeletal Class | Skeletal Class will be assessed combining the ANB angle and Wits Index values using the pre-treatment and the post-treatment lateral cephalometric radiographs. | Before treatment (T0) and after 10-12 months of treatment (T1) |
| Change in Cranio-Mandibular Angle | 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. | Before treatment (T0) and after 10-12 months of treatment (T1) |
| Change in Intermaxillary Angle | 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. | Before treatment (T0) and after 10-12 months of treatment (T1) |
| Change in Skeletal Vertical Pattern: | 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. | Before treatment (T0) and after 10-12 months of treatment (T1) |
| Change in Articular Angle | Articular Angle will be evaluated between SArGo points following Giannì analysis and using the pre-treatment and the post-treatment lateral cephalometric radiographs. | Before treatment (T0) and after 10-12 months of treatment (T1) |
| Change in Upper and Lower Goniac Angles | 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. | Before treatment (T0) and after 10-12 months of treatment (T1) |
| Change in Mandibular growth pattern | 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. | Before treatment (T0) and after 10-12 months of treatment (T1) |
| Change in Upper incisors Inclination | 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. | Before treatment (T0) and after 10-12 months of treatment (T1) |
| Change in Lower incisors Inclination | 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. | Before treatment (T0) and after 10-12 months of treatment (T1) |
| Change in Dento-alveolar discrepancy | Dento-alveolar discrepancy will be calculated using the pre-treatment and the post-treatment study models using "Tanaka and Jhonston" space Analysis | Before treatment (T0) and after 10-12 months of treatment (T1) |
| Change in lower intermolar distance | The lower intermolar distance take as reference the top of the mesiovestibular cusp of the lower first molars. | Before treatment (T0) and after 10-12 months of treatment (T1) |