Trial Outcomes & Findings for Evaluation of Clear Aligner Trays to Straighten Teeth (NCT NCT03141788)
NCT ID: NCT03141788
Last Updated: 2024-12-02
Results Overview
Achievement of target setup per treatment plan as determined by Orthodontist.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.
Results posted on
2024-12-02
Participant Flow
Screen failures because they did not meet Inclusion/Exclusion criteria
Participant milestones
| Measure |
3M Clear Aligner
3M Clear Aligner for Orthodontic Treatment
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
3M Clear Aligner
3M Clear Aligner for Orthodontic Treatment
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
Evaluation of Clear Aligner Trays to Straighten Teeth
Baseline characteristics by cohort
| Measure |
3M Clear Aligner
n=52 Participants
Clear Aligner Treatment
Clear Aligner: Clear Aligner used to straighten teeth to desired outcome
|
|---|---|
|
Age, Continuous
|
34.1 years
STANDARD_DEVIATION 10.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
|
Class type of malocclusion
Class I Malocclusion
|
39 Participants
n=5 Participants
|
|
Class type of malocclusion
Class II Malocclusion
|
12 Participants
n=5 Participants
|
|
Class type of malocclusion
Class III Malocclusion
|
1 Participants
n=5 Participants
|
|
Previous orthodontic treatments
Yes
|
32 Participants
n=5 Participants
|
|
Previous orthodontic treatments
No
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.Achievement of target setup per treatment plan as determined by Orthodontist.
Outcome measures
| Measure |
3M Clear Aligner
n=52 Participants
Clear Aligner Orthodontic Treatment for malocclusion
|
|---|---|
|
Successful Correction of Malocclusion
Reached Target Set Up
|
32 Participants
|
|
Successful Correction of Malocclusion
Did Not Reach Target Set Up
|
20 Participants
|
SECONDARY outcome
Timeframe: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.Population: Not obtained due to technical difficulties including warped and insufficient dental scans
Achievement of individual tooth movement measured per treatment plan and digital scan
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.Achievement of individual tooth movement measured per treatment plan
Outcome measures
| Measure |
3M Clear Aligner
n=52 Participants
Clear Aligner Orthodontic Treatment for malocclusion
|
|---|---|
|
Treatment Time for Tooth Movement
|
443 days
Interval 14.0 to 853.0
|
SECONDARY outcome
Timeframe: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.Effective use of attachment by tracking attachment bond failures by visual assessment
Outcome measures
| Measure |
3M Clear Aligner
n=52 Participants
Clear Aligner Orthodontic Treatment for malocclusion
|
|---|---|
|
Effective Use of Attachments
|
5.4 Percentage of Attachment Bond Failure
Standard Deviation 14.58
|
SECONDARY outcome
Timeframe: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.Orthodontist satisfaction with treatment outcome
Outcome measures
| Measure |
3M Clear Aligner
n=52 Participants
Clear Aligner Orthodontic Treatment for malocclusion
|
|---|---|
|
Orthodontist Satisfaction
Very Satisfied
|
5 Participants
|
|
Orthodontist Satisfaction
Satisfied
|
33 Participants
|
|
Orthodontist Satisfaction
Neutral
|
7 Participants
|
|
Orthodontist Satisfaction
Dissatisfied
|
2 Participants
|
|
Orthodontist Satisfaction
Not Applicable
|
5 Participants
|
SECONDARY outcome
Timeframe: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.Population: The ordering software was updated during treatment and therefore not analyzed.
Orthodontist satisfaction with treatment management software -Ease of use in ordering products
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.Aligner comfortable to wear
Outcome measures
| Measure |
3M Clear Aligner
n=479 study visits
Clear Aligner Orthodontic Treatment for malocclusion
|
|---|---|
|
Aligner Comfort
Comfortable
|
390 study visits
|
|
Aligner Comfort
Tolerable
|
41 study visits
|
|
Aligner Comfort
Somewhat Uncomfortable
|
22 study visits
|
|
Aligner Comfort
Not at all Comfortable
|
2 study visits
|
|
Aligner Comfort
Extremely Comfortable
|
24 study visits
|
SECONDARY outcome
Timeframe: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.Subject satisfaction with appearance during treatment
Outcome measures
| Measure |
3M Clear Aligner
n=479 study visits
Clear Aligner Orthodontic Treatment for malocclusion
|
|---|---|
|
Appearance Satisfaction
Satisfied
|
470 study visits
|
|
Appearance Satisfaction
Not Satisfied
|
9 study visits
|
SECONDARY outcome
Timeframe: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.Subject satisfaction with ease of cleaning during treatment
Outcome measures
| Measure |
3M Clear Aligner
n=479 study visits
Clear Aligner Orthodontic Treatment for malocclusion
|
|---|---|
|
Aligner Ease of Cleaning
Easy to Keep Clean
|
436 study visits
|
|
Aligner Ease of Cleaning
Not Easy to Keep Clean
|
43 study visits
|
SECONDARY outcome
Timeframe: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.Subject satisfaction with treatment; specifically aligners easy to insert
Outcome measures
| Measure |
3M Clear Aligner
n=479 study visits
Clear Aligner Orthodontic Treatment for malocclusion
|
|---|---|
|
Ease of Insertion
Easy
|
364 study visits
|
|
Ease of Insertion
Somewhat Easy
|
97 study visits
|
|
Ease of Insertion
Somewhat Difficult
|
15 study visits
|
|
Ease of Insertion
Difficult
|
3 study visits
|
SECONDARY outcome
Timeframe: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.Number of mid course refinements or corrections
Outcome measures
| Measure |
3M Clear Aligner
n=52 Participants
Clear Aligner Orthodontic Treatment for malocclusion
|
|---|---|
|
Mid Course Corrections/Refinements Needed
No Corrections/Refinements
|
21 Participants
|
|
Mid Course Corrections/Refinements Needed
1 Corrections/Refinements
|
19 Participants
|
|
Mid Course Corrections/Refinements Needed
2 Corrections/Refinements
|
8 Participants
|
|
Mid Course Corrections/Refinements Needed
3 Corrections/Refinements
|
4 Participants
|
SECONDARY outcome
Timeframe: The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months.Subject satisfaction with treatment; specifically with aligner removal
Outcome measures
| Measure |
3M Clear Aligner
n=479 study visit
Clear Aligner Orthodontic Treatment for malocclusion
|
|---|---|
|
Ease of Aligner Removal
Easy
|
308 study visit
|
|
Ease of Aligner Removal
Somewhat Easy
|
136 study visit
|
|
Ease of Aligner Removal
Somewhat Difficult
|
32 study visit
|
|
Ease of Aligner Removal
Difficult
|
3 study visit
|
Adverse Events
3M Clear Aligner
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
3M Clear Aligner
n=52 participants at risk
3M Clear Aligner for Orthodontic Treatment
|
|---|---|
|
Gastrointestinal disorders
Bleeding Gums
|
1.9%
1/52 • Number of events 1 • Up to 28 months
|
|
Product Issues
Filling Fell Off Tooth
|
1.9%
1/52 • Number of events 2 • Up to 28 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place