Trial Outcomes & Findings for Primer Aligner Study (NCT NCT02550938)
NCT ID: NCT02550938
Last Updated: 2021-02-03
Results Overview
Total treatment time was measured in days. The less days a subject was in treatment, the better.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
253 participants
Primary outcome timeframe
Approximately 1 year
Results posted on
2021-02-03
Participant Flow
Participant milestones
| Measure |
7 Aligner Cohort Weartime 1
Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
7 Aligner Cohort Weartime 2
Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
12 Aligner Cohort Weartime 1
Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
12 Aligner Cohort Weartime 2
Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
44
|
85
|
43
|
81
|
|
Overall Study
COMPLETED
|
36
|
78
|
31
|
70
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
12
|
11
|
Reasons for withdrawal
| Measure |
7 Aligner Cohort Weartime 1
Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
7 Aligner Cohort Weartime 2
Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
12 Aligner Cohort Weartime 1
Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
12 Aligner Cohort Weartime 2
Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
7
|
12
|
11
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
7 Aligner Cohort Weartime 1
n=36 Participants
Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
7 Aligner Cohort Weartime 2
n=78 Participants
Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
12 Aligner Cohort Weartime 1
n=31 Participants
Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
12 Aligner Cohort Weartime 2
n=70 Participants
Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=215 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=36 Participants
|
78 Participants
n=78 Participants
|
30 Participants
n=31 Participants
|
66 Participants
n=70 Participants
|
209 Participants
n=215 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=70 Participants
|
6 Participants
n=215 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=36 Participants
|
55 Participants
n=78 Participants
|
27 Participants
n=31 Participants
|
45 Participants
n=70 Participants
|
154 Participants
n=215 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=36 Participants
|
23 Participants
n=78 Participants
|
4 Participants
n=31 Participants
|
25 Participants
n=70 Participants
|
61 Participants
n=215 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
20 participants
n=36 Participants
|
50 participants
n=78 Participants
|
20 participants
n=31 Participants
|
36 participants
n=70 Participants
|
126 participants
n=215 Participants
|
|
Region of Enrollment
United Kingdom
|
16 participants
n=36 Participants
|
28 participants
n=78 Participants
|
11 participants
n=31 Participants
|
34 participants
n=70 Participants
|
89 participants
n=215 Participants
|
PRIMARY outcome
Timeframe: Approximately 1 yearTotal treatment time was measured in days. The less days a subject was in treatment, the better.
Outcome measures
| Measure |
12 Aligner Cohort Weartime 1
n=31 Participants
Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
7 Aligner Cohort Weartime 1
n=36 Participants
Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
7 Aligner Cohort Weartime 2
n=78 Participants
Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
12 Aligner Cohort Weartime 2
n=70 Participants
Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
|---|---|---|---|---|
|
Total Treatment Time
|
326.9355 days
Standard Deviation 151.414
|
197.4167 days
Standard Deviation 102.0774
|
225.7 days
Standard Deviation 108.463
|
294.1111 days
Standard Deviation 181.7863
|
PRIMARY outcome
Timeframe: Approximately 1 yearRate of Refinement was how often subjects in each cohort required additional aligners in (in addition to their originally prescribed aligners) to treat the malocclusion. For example, if a subject was originally prescribed 20 aligners for treatment, but then needed 10 more aligners, the 10 extra aligners would be considered the "refinement." The Rate of Refinement for each cohort was measured as the total number of additional aligners required to complete orthodontic treatment divided by the total number of aligners that were initially prescribed to complete treatment, multiplied by 100. The smaller the rate of refinement (%), the better.
Outcome measures
| Measure |
12 Aligner Cohort Weartime 1
n=31 Participants
Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
7 Aligner Cohort Weartime 1
n=36 Participants
Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
7 Aligner Cohort Weartime 2
n=78 Participants
Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
12 Aligner Cohort Weartime 2
n=70 Participants
Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
|---|---|---|---|---|
|
Rate of Refinement
|
0.419355 percentage of refinement
Standard Deviation 0.50161
|
0.25 percentage of refinement
Standard Deviation 0.439155
|
0.263158 percentage of refinement
Standard Deviation 0.446258
|
0.527778 percentage of refinement
Standard Deviation 0.506309
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 1 year(Observational, not used in data analysis). Subjects filled out a Quality of Life Survey with a scale rating of 1 (very difficult) to 5 (very easy) on how easy the product was to use and their orthodontic experience to date. A higher score on the scale meant a better outcome.
Outcome measures
| Measure |
12 Aligner Cohort Weartime 1
n=31 Participants
Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
7 Aligner Cohort Weartime 1
n=36 Participants
Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
7 Aligner Cohort Weartime 2
n=78 Participants
Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
12 Aligner Cohort Weartime 2
n=70 Participants
Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
|---|---|---|---|---|
|
Subject Satisfaction.
|
4.632 score on a scale
Standard Error 4.499
|
3.499 score on a scale
Standard Error 2.473797384
|
3.156 score on a scale
Standard Error 3.409
|
4.499 score on a scale
Standard Error 3.499
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Approximately 1 year(Observational, not used in data analysis). Doctors filled out a Doctor Survey with a scale rating of 1 (very difficult) to 5 (very easy) on how easy the product was to use and their satisfaction with the product. A higher score on the scale meant a better outcome.
Outcome measures
| Measure |
12 Aligner Cohort Weartime 1
n=31 Participants
Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
7 Aligner Cohort Weartime 1
n=36 Participants
Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
7 Aligner Cohort Weartime 2
n=78 Participants
Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
12 Aligner Cohort Weartime 2
n=70 Participants
Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
Invisalign: The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
|
|---|---|---|---|---|
|
Doctor Survey Results.
|
3.139 score on a scale
Standard Deviation 3.1760840
|
3.139 score on a scale
Standard Deviation 1.4702645
|
2.899 score on a scale
Standard Deviation 1.330019318
|
4.499 score on a scale
Standard Deviation 1.7756956
|
Adverse Events
7 Aligner Cohort Weartime 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
7 Aligner Cohort Weartime 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
12 Aligner Cohort Weartime 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
12 Aligner Cohort Weartime 2
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
Allison Mossing, Sr. Clinical Research Associate
Align Technology, Inc.
Phone: 4084701046
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60