Skeletal MalocclusionNCT06281613
Comparison of AMCOP Bioactivator and High-pull Headgear in Treating Skeletal Class II Hyperdivergent Pediatric Patients
An observational study of Skeletal Malocclusion, run by University of Pavia at 1 site in Italy.
Trial summary
The aim of the present study was to retrospectively compare the clinical use of high-pull headgear versus AMCOP bioactivators for hyperdivergent pediatric patients. Cephalometric radiographs from pediatric patients treated at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of… Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Skeletal Malocclusion
- What is being tested?
- AMCOP group and High-pull headgear
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 3 Mar 2024to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Orthodontic patients
Who may be able to join
- mixed or permanent dentition
- skeletal class II malocclusion diagnosed with ANB angle > 4° from cephalometric radiograph
- skeletal hyperdivergency calculated from AnsPns^GoGn angle > 25°, and at least S-Ar^Go > 149° or Ar-Go^Gn > 137°
Who cannot join
- lack of compliance in the use of the orthodontic appliance
- syndromic patients, cleft lip or cleft palate, severe malformations and asymmetries of the jaws.
Trial locations and contacts
1 site in 1 country.
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: Comparison of AMCOP Bioactivator and High-pull Headgear in Treating Skeletal Class II Hyperdivergent Pediatric Patients: a Retrospective Study
The aim of the present study was to retrospectively compare the clinical use of high-pull headgear versus AMCOP bioactivators for hyperdivergent pediatric patients.
Cephalometric radiographs from pediatric patients treated at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy and at the private practice of Dr. Cardarelli, Isernia, Italy will be collected.
Cephalometric tracing from Giannì analysis will be performed at the baseline (T0) and after 18 months of treatment (T1).
Read the detailed description
The aim of the present study was to retrospectively compare the clinical use of high-pull headgear versus AMCOP bioactivators for hyperdivergent pediatric patients.
Cephalometric radiographs from pediatric patients treated at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy and at the private practice of Dr. Cardarelli, Isernia, Italy will be collected.
Cephalometric tracing from Giannì analysis will be performed at the baseline (T0) and after 18 months of treatment (T1).
- Conditions
- Skeletal Malocclusion
- Being tested
- AMCOP group, High-pull headgear
- Keywords
- hyperdivergency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMCOP groupDevice
Patients were treated with AMCOP for 18 months.
High-pull headgearDevice
Patients were treated with high-pull headgear for 18 months.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Not described Receives: Device: AMCOP group | |
| Control Headgear | Not described Receives: Device: High-pull headgear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cephalometric angular measurements
The following angular measurements will be calculated in cephalometric radiographs:
SNA SNB ANB SN^GoGn AnsPns^GoGn Occl-MP Occl-AnsPns N-S-Ar S-Ar-Go Ar-Go-N N-Go-Gn 11-occl 11-ANSPNS 41-occl 41-GoGn Nasolabial angle Facial angle
Measured: Baseline (T0) and after 18 months (T1)
Linear regressions
Linear regressions among the variables of the study and sex, age, and group of the patients will be performed.
Measured: Baseline (T0) and after 18 months (T1)
Change in cephalometric linear measurements
The following linear measurements will be calculated in cephalometric radiographs:
Anterior cranial base Mandibular body Mandibular ramus Posterior facial height Anterior facial height A0B0
Measured: Baseline (T0) and after 18 months (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start3 Mar 2024
- Primary completion26 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal MalocclusionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
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, Mac, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281613
- Sponsor's protocol ID
- 2024-AMCOPTEO
- Status last verified
- May 2024
- First submitted
- 19 Feb 2024
- Last updated
- 23 May 2024
- Results posted
- 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 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of AMCOP Bioactivator and High-pull Headgear in Treating Skeletal Class II Hyperdivergent Pediatric Patients: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06281613
- Acronym / sponsor ID
- 2024-AMCOPTEO
- Conditions
- Skeletal Malocclusion
- Keywords
- hyperdivergency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 28 Feb 2024 (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 aim of the present study was to retrospectively compare the clinical use of high-pull headgear versus AMCOP bioactivators for hyperdivergent pediatric patients.
Cephalometric radiographs from pediatric patients treated at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy and at the private practice of Dr. Cardarelli, Isernia, Italy will be collected.
Cephalometric tracing from Giannì analysis will be performed at the baseline (T0) and after 18 months of treatment (T1).
Detailed description
The aim of the present study was to retrospectively compare the clinical use of high-pull headgear versus AMCOP bioactivators for hyperdivergent pediatric patients.
Cephalometric radiographs from pediatric patients treated at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy and at the private practice of Dr. Cardarelli, Isernia, Italy will be collected.
Cephalometric tracing from Giannì analysis will be performed at the baseline (T0) and after 18 months of treatment (T1).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Device: AMCOP group |
| Control Headgear | – | Device: High-pull headgear |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Orthodontic patients
Key inclusion criteria (3 listed)
- mixed or permanent dentition
- skeletal class II malocclusion diagnosed with ANB angle > 4° from cephalometric radiograph
- skeletal hyperdivergency calculated from AnsPns^GoGn angle > 25°, and at least S-Ar^Go > 149° or Ar-Go^Gn > 137°
Key exclusion criteria (2 listed)
- lack of compliance in the use of the orthodontic appliance
- syndromic patients, cleft lip or cleft palate, severe malformations and asymmetries of the jaws.
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 groupPatients were treated with AMCOP for 18 months. | Device | Case group |
| High-pull headgearPatients were treated with high-pull headgear for 18 months. | Device | Control Headgear |
Primary outcome
Change in cephalometric angular measurements
Time frame: Baseline (T0) and after 18 months (T1)
The following angular measurements will be calculated in cephalometric radiographs: SNA SNB ANB SN^GoGn AnsPns^GoGn Occl-MP Occl-AnsPns N-S-Ar S-Ar-Go Ar-Go-N N-Go-Gn 11-occl 11-ANSPNS 41-occl 41-GoGn Nasolabial angle Facial angle
Linear regressions
Time frame: Baseline (T0) and after 18 months (T1)
Linear regressions among the variables of the study and sex, age, and group of the patients will be performed.
Change in cephalometric linear measurements
Time frame: Baseline (T0) and after 18 months (T1)
The following linear measurements will be calculated in cephalometric radiographs: Anterior cranial base Mandibular body Mandibular ramus Posterior facial height Anterior facial height A0B0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- 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. This study is not recruiting at the moment.
Andrea Scribante, DDS, PhD, Mac 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?
An observational study of Skeletal Malocclusion, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 23 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 cephalometric angular measurements (time frame: Baseline (T0) and after 18 months (T1)). The study lists 3 primary outcomes in all. 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 23 May 2024.