Clinical trial NCT05204654: Carriere Motion Appliance* Versus In-office Sectional Appliance
Official title: A Comparison of Class II Correction Using the Carriere Motion Appliance Versus an In-Office Sectional Appliance: Treatment Effects and Efficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Angle Class 2 Malocclusion
Keywords: Carriere Motion Appliance
Angle Class 2 Malocclusion
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 4
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Treatment Time
timeFrame: 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:
measure: Skeletal Changes
timeFrame: 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).
measure: Dental Changes
timeFrame: 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).
measure: Maxillary Canine and Maxillary First Molar Rotation
timeFrame: 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).
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo School of Dental Medicine
state: New York
Study officials:
affiliation: Orthodontics Department Chair, University at Buffalo School of Dental Medicine
name: David Covell, DDS, PhD
role: STUDY_CHAIR
References: