Transverse Maxillary DeficiencyNCT06864949
Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances
A study testing AMCOP appliance in people with Transverse Maxillary Deficiency, run by University of Pavia at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Transverse Maxillary Deficiency
- What is being tested?
- AMCOP appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances: Prospective Clinical Study
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.
Read the 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:
- 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.
- Conditions
- Transverse Maxillary Deficiency
- Being tested
- AMCOP appliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMCOP applianceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with AMCOP First Class appliance | Experimental | Not described Receives: Device: AMCOP appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before treatment (T0) and after 10-12 months of treatment (T1)
Secondary outcomes (15)
Change in upper intercanine distance on digital casts
The upper intercanine distance take as reference the top of upper canine cusp.
Measured: Before treatment (T0) and after 10-12 months of treatment (T1)
Change in lower intercanine distance on digital casts
The lower intercanine distance take as reference the top of lower canine cusp.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Before treatment (T0) and after 10-12 months of treatment (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start15 Mar 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transverse Maxillary DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864949
- Sponsor's protocol ID
- 2025-AMCOP
- Status last verified
- Apr 2025
- First submitted
- 25 Feb 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances: Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06864949
- Acronym / sponsor ID
- 2025-AMCOP
- Conditions
- Transverse Maxillary Deficiency
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with AMCOP First Class appliance | Experimental | Device: AMCOP appliance |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMCOP applianceThe 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. | Device | Treatment with AMCOP First Class appliance |
Primary outcome
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.
15 secondary outcomes
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)
Change in Lower incisors Inclination
Time frame: Before treatment (T0) and after 10-12 months of treatment (T1)
Change in Dento-alveolar discrepancy
Time frame: Before treatment (T0) and after 10-12 months of treatment (T1)
Change in lower intermolar distance
Time frame: Before treatment (T0) and after 10-12 months of treatment (T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the Principal Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Scribante, DDS, PhD principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMCOP appliance in people with Transverse Maxillary Deficiency, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in upper intermolar distance on digital casts (time frame: Before treatment (T0) and after 10-12 months of treatment (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.