- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06785896
Analysis of the Effect oh the Carriere Motion 3D
January 20, 2025 updated by: Centre Hospitalier Universitaire de Nice
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."
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alpes Maritimes
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Nice, Alpes Maritimes, France, 0600
- CHU Nice
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
The study population consisted of patients treated by Dr. Romain de Papé at his practice in Strasbourg, within the established time frame.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria: None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Angle Class II unilateral, treated by carriere motion appliance
This treatment was unilateral, with dental composite bites ramps behind canines
|
This treatment was unilateral, with dental composite bites ramps behind canines
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Canine Angle class II correction
Time Frame: Up to 6 months
|
Measurement performed between the maxillary canine cusp tip and the inter-dental space between the mandibular canine and premolar in millimeters
|
Up to 6 months
|
|
Extrusion or intrusion
Time Frame: Up to 6 months
|
Extrusion or intrusion of the maxillary canines and molars supporting the orthodontic appliance in millimeters
|
Up to 6 months
|
|
Correction of the Class II canine relationship
Time Frame: Up to 6 months
|
Mesured correction of the Class II canine relationship in millimeters
|
Up to 6 months
|
|
Rotations
Time Frame: Up to 6 months
|
Mesured of the Rotations of the molars and canines supporting the CMA in degrees
|
Up to 6 months
|
|
Inter-incisal variations
Time Frame: Up to 6 months
|
Mesure of the variation in the inter-incisal midline discrepancy in millimeters
|
Up to 6 months
|
|
Arch depth
Time Frame: Up to 6 months
|
Mesure of the variation in arch depth in millimeters
|
Up to 6 months
|
|
Arch width
Time Frame: Up to 6 months
|
Mesure of th variation in canine and molar arch width in millimeters
|
Up to 6 months
|
|
Steiner analysis
Time Frame: Up to 24 months
|
A Steiner analysis was performed on the lateral cephalograms, measurements in millimeters on the X-Ray
|
Up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 11, 2018
Primary Completion (Actual)
November 22, 2023
Study Completion (Actual)
November 22, 2023
Study Registration Dates
First Submitted
December 19, 2024
First Submitted That Met QC Criteria
January 20, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 20, 2025
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24Odonto04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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