Trial Outcomes & Findings for BRIUS Vs FFA Efficiency (NCT NCT04347018)
NCT ID: NCT04347018
Last Updated: 2024-10-04
Results Overview
absoluate measurement of extent of movement of teeth
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
18 weeks
Results posted on
2024-10-04
Participant Flow
Participant milestones
| Measure |
BRIUS
BRIUS orthodontic appliance (wire) will be used to treat the patients. BRIUS appliance will be engaged to regular orthodontic brackets intra-orally to initiate orthodontic treatment at the University at Buffalo Orthodontic Clinic.
BRIUS: This is a device that is designed based on movements planned virtually on a computer program. Then all the planned movements are embedded into the wire causing the wire to have the necessary bends to move every tooth into its pre-planned final position. This causes the pre-activated wire to consistently express a low force over a long period of time onto all the teeth. This allows the teeth to move into the final position and treatment progresses towards completion
|
Preadjusted Edgewise Full Fixed Appliance
regular full fixed orthodontic appliance (FFA) appliances will be used to treat patients. These are regular orthodontic brackets with standard orthodontic wires used to treat patients at the University at Buffalo Department of Orthodontics
BRIUS: This is a device that is designed based on movements planned virtually on a computer program. Then all the planned movements are embedded into the wire causing the wire to have the necessary bends to move every tooth into its pre-planned final position. This causes the pre-activated wire to consistently express a low force over a long period of time onto all the teeth. This allows the teeth to move into the final position and treatment progresses towards completion
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
BRIUS
n=7 Participants
BRIUS orthodontic appliance (wire) will be used to treat the patients. BRIUS appliance will be engaged to regular orthodontic brackets intra-orally to initiate orthodontic treatment at the University at Buffalo Orthodontic Clinic.
BRIUS: This is a device that is designed based on movements planned virtually on a computer program. Then all the planned movements are embedded into the wire causing the wire to have the necessary bends to move every tooth into its pre-planned final position. This causes the pre-activated wire to consistently express a low force over a long period of time onto all the teeth. This allows the teeth to move into the final position and treatment progresses towards completion
|
Preadjusted Edgewise Full Fixed Appliance
n=6 Participants
regular full fixed orthodontic appliance (FFA) appliances will be used to treat patients. These are regular orthodontic brackets with standard orthodontic wires used to treat patients at the University at Buffalo Department of Orthodontics
BRIUS: This is a device that is designed based on movements planned virtually on a computer program. Then all the planned movements are embedded into the wire causing the wire to have the necessary bends to move every tooth into its pre-planned final position. This causes the pre-activated wire to consistently express a low force over a long period of time onto all the teeth. This allows the teeth to move into the final position and treatment progresses towards completion
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=7 Participants
|
6 Participants
n=6 Participants
|
13 Participants
n=13 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=13 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=13 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=7 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=7 Participants
|
3 Participants
n=6 Participants
|
8 Participants
n=13 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 18 weeksabsoluate measurement of extent of movement of teeth
Outcome measures
| Measure |
BRIUS
n=7 Participants
BRIUS orthodontic appliance (wire) will be used to treat the patients. BRIUS appliance will be engaged to regular orthodontic brackets intra-orally to initiate orthodontic treatment at the University at Buffalo Orthodontic Clinic.
BRIUS: This is a device that is designed based on movements planned virtually on a computer program. Then all the planned movements are embedded into the wire causing the wire to have the necessary bends to move every tooth into its pre-planned final position. This causes the pre-activated wire to consistently express a low force over a long period of time onto all the teeth. This allows the teeth to move into the final position and treatment progresses towards completion
|
Preadjusted Edgewise Full Fixed Appliance
n=6 Participants
regular full fixed orthodontic appliance (FFA) appliances will be used to treat patients. These are regular orthodontic brackets with standard orthodontic wires used to treat patients at the University at Buffalo Department of Orthodontics
BRIUS: This is a device that is designed based on movements planned virtually on a computer program. Then all the planned movements are embedded into the wire causing the wire to have the necessary bends to move every tooth into its pre-planned final position. This causes the pre-activated wire to consistently express a low force over a long period of time onto all the teeth. This allows the teeth to move into the final position and treatment progresses towards completion
|
|---|---|---|
|
Overall 3D Movement
|
1.46 mm
Interval 0.16 to 2.0
|
1.41 mm
Interval 0.15 to 2.56
|
PRIMARY outcome
Timeframe: 18 weeksLittle's irregularity index. The index measures the alignment discrepancy in the five contact points of the lower anterior region in millimeteres. The minimum score is zero and the maximum is 10 or above. The greater the score the worse the outcome
Outcome measures
| Measure |
BRIUS
n=7 Participants
BRIUS orthodontic appliance (wire) will be used to treat the patients. BRIUS appliance will be engaged to regular orthodontic brackets intra-orally to initiate orthodontic treatment at the University at Buffalo Orthodontic Clinic.
BRIUS: This is a device that is designed based on movements planned virtually on a computer program. Then all the planned movements are embedded into the wire causing the wire to have the necessary bends to move every tooth into its pre-planned final position. This causes the pre-activated wire to consistently express a low force over a long period of time onto all the teeth. This allows the teeth to move into the final position and treatment progresses towards completion
|
Preadjusted Edgewise Full Fixed Appliance
n=6 Participants
regular full fixed orthodontic appliance (FFA) appliances will be used to treat patients. These are regular orthodontic brackets with standard orthodontic wires used to treat patients at the University at Buffalo Department of Orthodontics
BRIUS: This is a device that is designed based on movements planned virtually on a computer program. Then all the planned movements are embedded into the wire causing the wire to have the necessary bends to move every tooth into its pre-planned final position. This causes the pre-activated wire to consistently express a low force over a long period of time onto all the teeth. This allows the teeth to move into the final position and treatment progresses towards completion
|
|---|---|---|
|
Little's Irregularity Index
|
5.38 Millimeter
Standard Deviation 3.04
|
5.04 Millimeter
Standard Deviation 1.61
|
PRIMARY outcome
Timeframe: 18 weeksOnline survey will evaluate discomfort arising from the orthodontic brackets between patients in the two groups. A visual analog scale from 0-10 millimeter will be applied. The greater the score the worse the discomfort level.
Outcome measures
| Measure |
BRIUS
n=7 Participants
BRIUS orthodontic appliance (wire) will be used to treat the patients. BRIUS appliance will be engaged to regular orthodontic brackets intra-orally to initiate orthodontic treatment at the University at Buffalo Orthodontic Clinic.
BRIUS: This is a device that is designed based on movements planned virtually on a computer program. Then all the planned movements are embedded into the wire causing the wire to have the necessary bends to move every tooth into its pre-planned final position. This causes the pre-activated wire to consistently express a low force over a long period of time onto all the teeth. This allows the teeth to move into the final position and treatment progresses towards completion
|
Preadjusted Edgewise Full Fixed Appliance
n=6 Participants
regular full fixed orthodontic appliance (FFA) appliances will be used to treat patients. These are regular orthodontic brackets with standard orthodontic wires used to treat patients at the University at Buffalo Department of Orthodontics
BRIUS: This is a device that is designed based on movements planned virtually on a computer program. Then all the planned movements are embedded into the wire causing the wire to have the necessary bends to move every tooth into its pre-planned final position. This causes the pre-activated wire to consistently express a low force over a long period of time onto all the teeth. This allows the teeth to move into the final position and treatment progresses towards completion
|
|---|---|---|
|
Discomfort
|
1.57 units on a scale - millimeter
Interval 0.0 to 7.0
|
38.67 units on a scale - millimeter
Interval 21.0 to 59.0
|
Adverse Events
BRIUS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Preadjusted Edgewise Full Fixed 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