Angle Class IINCT06785896
Analysis of the Effect oh the Carriere Motion 3D
An observational study of Angle Class II, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Class II subdivision malocclusions are common and complex to treat due to their asymmetry. The range of orthodontic correction devices is expanding towards systems that are more comfortable for the patient but may not necessarily have scientific evidence to demonstrate their effectiveness. Read more about this study
- Who is it for?
- Ages 28 to 47 years
- Conditions the study is for
- Angle Class II
- What is being tested?
- Angle Class II unilateral, treated by carriere motion appliance
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jul 2018to 22 Nov 2023
- 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 28 to 47 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population consisted of patients treated by Dr. Romain de Papé at his practice in Strasbourg, within the established time frame.
Who may be able to join
- Patients who have completed their growth and present with a Class II subdivision malocclusion.
- Patients who underwent orthodontic treatment with CMA between 07/11/2018 and 11/22/2023.
- Patients who have a complete orthodontic record allowing for pre- and post-treatment measurements with CMA.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Effect oh the Carriere Motion 3D on Patients With Class II Subdivision : a Retrospective Study
Class II subdivision malocclusions are common and complex to treat due to their asymmetry. The range of orthodontic correction devices is expanding towards systems that are more comfortable for the patient but may not necessarily have scientific evidence to demonstrate their effectiveness. The aim of this study was therefore to evaluate, for the first time, the effect of a Class II correction device, namely the Carriere Motion 3D (CMA), on patients with a Class II subdivision malocclusion. Method:this retrospective observational study included all patients presenting with a Class II subdivision malocclusion and treated with CMA between July 2018 and November 2023. Before treatment (T0) and after treatment with CMA (T1), orthodontic data from dental molds and lateral cephalometric radiographs (Steiner analysis) were collected and statistically analyzed to assess dentoalveolar as well as skeletal effects of treatment using CMA."
- Conditions
- Angle Class II
- Being tested
- Angle Class II unilateral, treated by carriere motion appliance
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angle Class II unilateral, treated by carriere motion applianceProcedure or surgery
This treatment was unilateral, with dental composite bites ramps behind canines
| Study group | Role | What they receive |
|---|---|---|
| Angle Class II unilateral, treated by carriere motion appliance | This treatment was unilateral, with dental composite bites ramps behind canines Receives: Procedure: Angle Class II unilateral, treated by carriere motion appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molar Angle class II correction
Measured between the centro vestibular groove of the maxillar fisrt molar and the mesio vestibulair cusp tip of the mandibular molar in millimeters
Measured: Up to 6 months
Secondary outcomes (8)
Canine Angle class II correction
Measurement performed between the maxillary canine cusp tip and the inter-dental space between the mandibular canine and premolar in millimeters
Measured: Up to 6 months
Extrusion or intrusion
Extrusion or intrusion of the maxillary canines and molars supporting the orthodontic appliance in millimeters
Measured: Up to 6 months
Correction of the Class II canine relationship
Mesured correction of the Class II canine relationship in millimeters
Measured: Up to 6 months
Rotations
Mesured of the Rotations of the molars and canines supporting the CMA in degrees
Measured: Up to 6 months
Inter-incisal variations
Mesure of the variation in the inter-incisal midline discrepancy in millimeters
Measured: Up to 6 months
Arch depth
Mesure of the variation in arch depth in millimeters
Measured: Up to 6 months
Arch width
Mesure of th variation in canine and molar arch width in millimeters
Measured: Up to 6 months
Steiner analysis
A Steiner analysis was performed on the lateral cephalograms, measurements in millimeters on the X-Ray
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start11 Jul 2018
- Primary completion22 Nov 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angle Class IIStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785896
- Sponsor's protocol ID
- 24Odonto04
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effect oh the Carriere Motion 3D on Patients With Class II Subdivision : a Retrospective Study
- ClinicalTrials.gov ID
- NCT06785896
- Acronym / sponsor ID
- 24Odonto04
- Conditions
- Angle Class II
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 21 Jan 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.
Class II subdivision malocclusions are common and complex to treat due to their asymmetry. The range of orthodontic correction devices is expanding towards systems that are more comfortable for the patient but may not necessarily have scientific evidence to demonstrate their effectiveness. The aim of this study was therefore to evaluate, for the first time, the effect of a Class II correction device, namely the Carriere Motion 3D (CMA), on patients with a Class II subdivision malocclusion. Method:this retrospective observational study included all patients presenting with a Class II subdivision malocclusion and treated with CMA between July 2018 and November 2023. Before treatment (T0) and after treatment with CMA (T1), orthodontic data from dental molds and lateral cephalometric radiographs (Steiner analysis) were collected and statistically analyzed to assess dentoalveolar as well as skeletal effects of treatment using CMA."
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Angle Class II unilateral, treated by carriere motion appliance | – | Procedure: Angle Class II unilateral, treated by carriere motion applianceThis treatment was unilateral, with dental composite bites ramps behind canines |
Who may qualify
- Ages
- 28 to 47 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consisted of patients treated by Dr. Romain de Papé at his practice in Strasbourg, within the established time frame.
Key inclusion criteria (3 listed)
- Patients who have completed their growth and present with a Class II subdivision malocclusion.
- Patients who underwent orthodontic treatment with CMA between 07/11/2018 and 11/22/2023.
- Patients who have a complete orthodontic record allowing for pre- and post-treatment measurements with CMA.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Angle Class II unilateral, treated by carriere motion applianceThis treatment was unilateral, with dental composite bites ramps behind canines | Procedure or surgery | Angle Class II unilateral, treated by carriere motion appliance |
Primary outcome
Molar Angle class II correction
Time frame: Up to 6 months
Measured between the centro vestibular groove of the maxillar fisrt molar and the mesio vestibulair cusp tip of the mandibular molar in millimeters
8 secondary outcomes
Canine Angle class II correction
Time frame: Up to 6 months
Extrusion or intrusion
Time frame: Up to 6 months
Correction of the Class II canine relationship
Time frame: Up to 6 months
Rotations
Time frame: Up to 6 months
Inter-incisal variations
Time frame: Up to 6 months
Arch depth
Time frame: Up to 6 months
Arch width
Time frame: Up to 6 months
Steiner analysis
Time frame: Up to 24 months
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 21 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Angle Class II, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 0 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 21 Jan 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 France. 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?
Molar Angle class II correction (time frame: Up to 6 months). 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 21 Jan 2025.