Trial Outcomes & Findings for Effect of Clear Aligner Attachment Design on Extrusion of Maxillary Lateral Incisors (NCT NCT04968353)
NCT ID: NCT04968353
Last Updated: 2023-06-28
Results Overview
Percent achieved of the vertical (inciso-gingival) tooth movement will be assessed by comparing the initial ClinCheck software estimate tooth movement required to the amount of tooth movement observed
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
6 months
Results posted on
2023-06-28
Participant Flow
Recruitment began August, 2021 and final data collection was completed in June, 2022. Patients were recruited from 3 orthodontic practices. Units enrolled are counted as numbers of teeth. Potentially, 2 maxillary lateral incisors from each patient could have been enrolled.
Unit of analysis: Teeth
Participant milestones
| Measure |
Horizontal
Use of horizontal (unbeveled) attachment to extrude lateral incisor
Horizontal attachment: Horizontal attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
|
Incisally-beveled
Use of incisally-beveled attachment to extrude lateral incisor
Incisally-beveled attachment: Incisally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
|
Gingivally-beveled
Use of gingivally-beveled attachment to extrude lateral incisor
Gingivally-beveled attachment: Gingivally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
|
Optimized
Use of optimized attachment to extrude lateral incisor
Optimized attachment: Optimized attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20 20
|
15 15
|
16 16
|
22 23
|
|
Overall Study
COMPLETED
|
19 19
|
15 15
|
14 14
|
22 23
|
|
Overall Study
NOT COMPLETED
|
1 1
|
0 0
|
2 2
|
0 0
|
Reasons for withdrawal
| Measure |
Horizontal
Use of horizontal (unbeveled) attachment to extrude lateral incisor
Horizontal attachment: Horizontal attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
|
Incisally-beveled
Use of incisally-beveled attachment to extrude lateral incisor
Incisally-beveled attachment: Incisally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
|
Gingivally-beveled
Use of gingivally-beveled attachment to extrude lateral incisor
Gingivally-beveled attachment: Gingivally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
|
Optimized
Use of optimized attachment to extrude lateral incisor
Optimized attachment: Optimized attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
|
|---|---|---|---|---|
|
Overall Study
Non-compliance
|
1
|
0
|
2
|
0
|
Baseline Characteristics
Effect of Clear Aligner Attachment Design on Extrusion of Maxillary Lateral Incisors
Baseline characteristics by cohort
| Measure |
Incisally-beveled
n=15 Participants
Use of incisally-beveled attachment to extrude lateral incisor
Incisally-beveled attachment: Incisally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
|
Gingivally-beveled
n=14 Participants
Use of gingivally-beveled attachment to extrude lateral incisor
Gingivally-beveled attachment: Gingivally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
|
Optimized
n=22 Participants
Use of optimized attachment to extrude lateral incisor
Optimized attachment: Optimized attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
|
Horizontal
n=19 Participants
Use of horizontal (unbeveled) attachment to extrude lateral incisor
Horizontal attachment: Horizontal attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
31.2 years
STANDARD_DEVIATION 15.6 • n=7 Participants
|
32.1 years
STANDARD_DEVIATION 14.26 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 15.16 • n=4 Participants
|
31.3 years
STANDARD_DEVIATION 15.01 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
22 participants
n=5 Participants
|
20 participants
n=4 Participants
|
73 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPercent achieved of the vertical (inciso-gingival) tooth movement will be assessed by comparing the initial ClinCheck software estimate tooth movement required to the amount of tooth movement observed
Outcome measures
| Measure |
Horizontal
n=19 Teeth
Use of horizontal (unbeveled) attachment to extrude lateral incisor
Horizontal attachment: Horizontal attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
|
Incisally-beveled
n=15 Teeth
Use of incisally-beveled attachment to extrude lateral incisor
Incisally-beveled attachment: Incisally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
|
Gingivally-beveled
n=14 Teeth
Use of gingivally-beveled attachment to extrude lateral incisor
Gingivally-beveled attachment: Gingivally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
|
Optimized
n=23 Teeth
Use of optimized attachment to extrude lateral incisor
Optimized attachment: Optimized attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
|
|---|---|---|---|---|
|
Percent of Vertical Tooth Movement
|
79 percentage of predicted
Interval 58.0 to 100.0
|
78 percentage of predicted
Interval 58.0 to 98.0
|
78 percentage of predicted
Interval 63.0 to 93.0
|
62 percentage of predicted
Interval 40.0 to 84.0
|
Adverse Events
Horizontal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Incisally-beveled
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gingivally-beveled
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Optimized
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
Steven J Lindauer
Virginia Commonwealth University School of Dentistry, Orthodontics
Phone: 8048289326
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place