NCT06785896

Brief 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. 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."

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2018

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 21, 2025

Completed
Last Updated

January 21, 2025

Status Verified

December 1, 2024

Enrollment Period

5.4 years

First QC Date

December 19, 2024

Last Update Submit

January 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Up to 6 months

Secondary Outcomes (8)

  • Canine Angle class II correction

    Up to 6 months

  • Extrusion or intrusion

    Up to 6 months

  • Correction of the Class II canine relationship

    Up to 6 months

  • Rotations

    Up to 6 months

  • Inter-incisal variations

    Up to 6 months

  • +3 more secondary outcomes

Study Arms (1)

Angle Class II unilateral, treated by carriere motion appliance

This treatment was unilateral, with dental composite bites ramps behind canines

Procedure: Angle Class II unilateral, treated by carriere motion appliance

Interventions

This treatment was unilateral, with dental composite bites ramps behind canines

Angle Class II unilateral, treated by carriere motion appliance

Eligibility Criteria

Age28 Years - 47 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU NICE

Nice, Alpes Maritimes, 0600, France

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2024

First Posted

January 21, 2025

Study Start

July 11, 2018

Primary Completion

November 22, 2023

Study Completion

November 22, 2023

Last Updated

January 21, 2025

Record last verified: 2024-12

Locations