Carriere Motion Appliance* Versus In-office Sectional Appliance

NCT05204654 | Terminated Results FDA Device

• 1 other identifier: STUDY00005827
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The "sagittal first" approach to Class II correction in orthodontic treatment involves correcting the antero-posterior (AP) relationship of the maxillary and mandibular dentition prior to the leveling and aligning phase of orthodontic treatment. The Carriere Motion Appliance (CMA) was made to provide sagittal correction prior to orthodontic treatment with minimal secondary tooth movements that are typically seen with Class II correction. The aim in this study is to explore the efficacy and efficiency of Class II molar correction in adolescent patients using the sagittal first approach with either a sectional, in-office fabricated appliance or the CMA, by measuring total treatment duration (in months) as well as comparing dental and skeletal measurements taken from lateral cephalometric radiographs obtained prior to Class II correction (T0) and immediately after removal of the appliance (T1). The investigators will also be comparing secondary molar and canine rotational movements after Class II correction by comparing digital dental casts obtained at T0 and T1.

Conditions

Angle Class 2 Malocclusion

Keywords

Carriere Motion Appliance; Angle Class 2 Malocclusion

Outcome Measures

Primary Outcomes (1)

• Total Treatment Time

  Months

  From date of Class II correction appliance delivery to date of removal of Class II correction appliance after Class I molar and canine relationship has been established (approximately 120-180 days).

Secondary Outcomes (3)

• Skeletal Changes

  From date of Class II correction appliance delivery to date of removal of Class II correction appliance after Class I molar and canine relationship has been established (approximately 120-180 days).

• Dental Changes

  From date of Class II correction appliance delivery to date of removal of Class II correction appliance after Class I molar and canine relationship has been established (approximately 120-180 days).

• Maxillary Canine and Maxillary First Molar Rotation

  From date of Class II correction appliance delivery to date of removal of Class II correction appliance after Class I molar and canine relationship has been established (approximately 120-180 days).

Study Arms (2)

In-office fabricated appliance

EXPERIMENTAL

A customized in-office fabricated appliance using the printed digital model of the subject will be used for AP correction. AP correction will be completed following CMA protocol (see model description)

Other: In-office fabricated appliance

Carriere Motion Appliance

ACTIVE COMPARATOR

The appropriate length appliance will be placed as directed in the CMA handbook on the maxillary first molar and canine. AP correction will be completed following CMA protocol (see model description)

Device: Carriere Motion Appliance

Interventions

In-office fabricated appliance OTHER

A 0.022 Slot MBT™ second molar mini tube that has been modified to have a 2 mm length will be placed on the maxillary first molar and a 0.018 slot MBT™ maxillary canine bracket will be placed on the maxillary canine, with a 0.016x0.022 stainless-steel wire spanning from the maxillary first molar to the maxillary canine. A bayonet bend will be placed mesial to the molar tube. A curve will be bent into the wire, so that the wire is able to passively rest on the buccal surface of the maxillary canine. A stainless-steel closed coil will span the molar to canine and lay flush to the mesial portion of the molar tube and the distal portion of the canine bracket. The wire will be cinched mesial to the maxillary canine tie-wing and also 2-3 mm distal to the maxillary first molar to ensure that the molar can rotate during treatment, if needed. A stainless-steel tie will be used to secure the wire into the canine bracket. AP correction will be completed following CMA protocol

In-office fabricated appliance

Carriere Motion Appliance DEVICE

A bar spanning from the maxillary first molar to canine with a ball and socket joint at the molar and a canine pad at the canine. A slight bend is present between the molar and canine bracket. The ball and socket is designed to allow the molar to rotate to -15 degrees along it's longitudinal axis. The appliance claims that it allows for Class II correction with minimal secondary tooth movements when used with mandibular anchorage.

Also known as: CMA

Carriere Motion Appliance

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Males and Females
• Presenting for comprehensive orthodontic treatment at the Postgraduate orthodontic clinic at the University at Buffalo School of Dental Medicine
• Unilateral or bilateral ½-cusp to full-cusp Class II molar and canine relationship
• Growing Patients (\~12-17y 11m)
• Subjects who do not require extractions as part of treatment mechanics
• Mild to moderate crowding

You may not qualify if:

• Patients in mixed dentition
• Any missing teeth up to and including permanent first molars
• Bilateral molar relationship of less than ½ cusp Class II prior to appliance cementation

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

University at Buffalo School of Dental Medicine

Buffalo, New York, 14214, United States

Location

Results Point of Contact

• Title: No Dr. Alexandria Newton
• Organization: University at Buffalo

amnewton@buffalo.edu

716-829-2845

Study Officials

• David Covell, DDS, PhD

  Orthodontics Department Chair, University at Buffalo School of Dental Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Lateral cephalometric radiographs and digital study models will be de-identified prior to landmarking and obtaining measurements. The appliances will not be present on the patient when these records are obtained and therefore, when taking measurements, the outcomes assessor will not know which intervention the subjects received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthodontic Resident

Model Details: Subjects participating in the study and will then be randomly assigned to one of two treatment interventions: 1. Sagittal first approach using the CMA 2. Sagittal first approach using an in-office fabricated custom appliance At the bonding appointment, the appliance will be bonded and AP correction will begin. Both treatment groups will have a button bonded to the mandibular first molars, and Essix retainers with 2 mm thickness will require to be worn at all times for mandibular anchorage during AP correction (only taken out to brush and eat). Both treatment groups will follow the CMA protocol for Class II correction, which consists of wearing Force 1 (1/4, 6 oz) Class II elastics for the first month of treatment, and Force 2 (3/16, 8 oz) Class II elastics for the remainder of Class II correction. Once Class II correction is complete, the appliance will be removed and a lateral cephalometric radiograph and digital model will be obtained

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 24, 2022
• Study Start: January 19, 2022
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: March 17, 2025
• Results First Posted: March 17, 2025

Record last verified: 2025-03

Locations

US (1)