Trial Outcomes & Findings for Carriere Motion Appliance* Versus In-office Sectional Appliance (NCT NCT05204654)
NCT ID: NCT05204654
Last Updated: 2025-03-17
Results Overview
Months
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome 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).
Results posted on
2025-03-17
Participant Flow
Participant milestones
| Measure |
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)
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
|
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)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
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)
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
|
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)
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.
|
|---|---|---|
|
Overall Study
Study terminated due to time restraint
|
2
|
2
|
Baseline Characteristics
Carriere Motion Appliance* Versus In-office Sectional Appliance
Baseline characteristics by cohort
| Measure |
In-office Fabricated Appliance
n=2 Participants
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)
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
|
Carriere Motion Appliance
n=2 Participants
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)
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.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
14.5 years
n=5 Participants
|
14.5 years
n=7 Participants
|
14.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
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).Population: Data were not collected, study was terminated due to time constraint and no data on participants was collected.
Months
Outcome measures
Outcome data not reported
SECONDARY outcome
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).Population: Data were not collected, study was terminated due to time constraint and no data on participants was collected.
Degrees, Millimeters
Outcome measures
Outcome data not reported
SECONDARY outcome
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).Population: Data were not collected, study was terminated due to time constraint and no data on participants was collected.
Degrees, Millimeters
Outcome measures
Outcome data not reported
SECONDARY outcome
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).Population: Data were not collected, study was terminated due to time constraint and no data on participants was collected.
Degrees
Outcome measures
Outcome data not reported
Adverse Events
In-office Fabricated Appliance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Carriere Motion Appliance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place