Angle Class 2 MalocclusionCMANCT05204654
Carriere Motion Appliance* Versus In-office Sectional Appliance
A study testing In-office fabricated appliance and Carriere Motion Appliance in people with Angle Class 2 Malocclusion, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Angle Class 2 Malocclusion
- What is being tested?
- In-office fabricated appliance and Carriere Motion Appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2022to 23 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University at Buffalo School of Dental Medicine
Buffalo, New York, 14214
About this study
Official title: A Comparison of Class II Correction Using the Carriere Motion Appliance Versus an In-Office Sectional Appliance: Treatment Effects and Efficiency
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.
Read the 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.
- Conditions
- Angle Class 2 Malocclusion
- Being tested
- In-office fabricated appliance, Carriere Motion Appliance
- Keywords
- Carriere Motion Appliance, Angle Class 2 Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-office fabricated applianceOther
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
Carriere Motion ApplianceDevice
Also called CMA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Device: Carriere Motion Appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Treatment Time
Months
Measured: 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
Degrees, Millimeters
Measured: 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
Degrees, Millimeters
Measured: 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
Degrees
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start19 Jan 2022
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Why it stopped: Not enough subjects were recruited for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Angle Class 2 MalocclusionStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandria Mary Newton, State University of New York at Buffalo
- Investigators
- David Covell, DDS, PhD, Study chair, Orthodontics Department Chair, University at Buffalo School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204654
- Sponsor's protocol ID
- STUDY00005827
- Acronym
- CMA
- Status last verified
- Mar 2025
- First submitted
- 22 Dec 2021
- Last updated
- 17 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Class II Correction Using the Carriere Motion Appliance Versus an In-Office Sectional Appliance: Treatment Effects and Efficiency
- ClinicalTrials.gov ID
- NCT05204654
- Acronym / sponsor ID
- CMA / STUDY00005827
- Conditions
- Angle Class 2 Malocclusion
- Keywords
- Carriere Motion Appliance, Angle Class 2 Malocclusion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough subjects were recruited for the study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Posted 17 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| In-office fabricated appliance | Experimental | Other: In-office fabricated applianceA 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) |
| Carriere Motion Appliance | Active comparator | Device: Carriere Motion ApplianceThe 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) |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-office fabricated applianceA 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 | Other | In-office fabricated appliance |
| Carriere Motion ApplianceAlso: CMAA 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. | Device | Carriere Motion Appliance |
Primary outcome
Total Treatment Time
Time frame: 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
3 secondary outcomes
Skeletal Changes
Time frame: 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
Time frame: 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
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Covell, DDS, PhD study chair
Orthodontics Department Chair, University at Buffalo School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-office fabricated appliance and Carriere Motion Appliance in people with Angle Class 2 Malocclusion, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Treatment Time (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.