CMA: Carriere Motion Appliance* Versus In-office Sectional Appliance

Sponsor

State University of New York at Buffalo (Other)

Overall Status

Recruiting

CT.gov ID

NCT05204654

Collaborator

(none)

Enrollment

Location

Arms

15.3

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Angle Class 2 Malocclusion	Other: In-office fabricated appliance Device: Carriere Motion Appliance	N/A

Detailed Description

The investigators will be recruiting 12 to 17-year 11-month old patients with a Class II molar relationship,who are presenting for comprehensive orthodontic treatment at the Postgraduate orthodontic clinic at University at Buffalo School of Dental Medicine. Recruited subjects will be randomized into one of 2 groups. Both groups will be receiving a method of Class II correction using the Sagittal First approach, which means the Class II molar relationship will be corrected prior to the leveling and aligning phase of orthodontic treatment. Subjects will be treated using either the Carriere Motion Appliance (CMA), or a sectional appliance fabricated with materials that are commonly found in orthodontic practice. Both appliances will be used according to the CMA guidelines. After Class II correction and removal of appliance, and prior to the next stage of treatment, an additional digital scan of the mouth and a lateral cephalometric radiograph will be taken. Dental and skeletal measurements from initial cephalometric radiographs and models will be subtracted from the corresponding measurements taken on radiographs and models obtained after Class II correction, and comparisons will be made between the two treatment treatment groups. Efficiency will be determined by number of months until Class II molar and canine correction was obtained, and efficacy will be determined by the skeletal and dental measurements obtained.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Subjects participating in the study and will then be randomly assigned to one of two treatment interventions: Sagittal first approach using the CMA 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 obtainedSubjects participating in the study and will then be randomly assigned to one of two treatment interventions:Sagittal first approach using the CMA 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

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

A Comparison of Class II Correction Using the Carriere Motion Appliance Versus an In-Office Sectional Appliance: Treatment Effects and Efficiency

Actual Study Start Date :

Jan 19, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: In-office fabricated appliance 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 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
Active Comparator: Carriere Motion Appliance 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 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. Other Names: CMA

Arm

Intervention/Treatment

Experimental: In-office fabricated appliance

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

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

Active Comparator: Carriere Motion Appliance

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

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.

Other Names:

CMA

Outcome Measures

Primary Outcome Measures

Total treatment time [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).]
Months

Secondary Outcome Measures

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).]
Degrees, Millimeters
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).]
Degrees, Millimeters
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).]
Degrees

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University at Buffalo School of Dental Medicine	Buffalo	New York	United States	14214

Sponsors and Collaborators

State University of New York at Buffalo

Investigators

Study Chair: David Covell, DDS, PhD, Orthodontics Department Chair, University at Buffalo School of Dental Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alexandria Mary Newton, Orthodontic Resident, State University of New York at Buffalo

ClinicalTrials.gov Identifier:

NCT05204654

Other Study ID Numbers:

STUDY00005827

First Posted:

Jan 24, 2022

Last Update Posted:

Feb 7, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Alexandria Mary Newton, Orthodontic Resident, State University of New York at Buffalo

Carriere Motion Appliance

Angle Class 2 Malocclusion

Additional relevant MeSH terms:

Malocclusion

Study Results

No Results Posted as of Feb 7, 2022