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To demonstrate that growing teenagers which present up to full cusp Class II malocclusions can be treated using the Invisalign System.
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 about two weeks, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Invisalign System | Experimental | Class II correction of malocclusions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invisalign System | Device | The Invisalign® System is indicated for the alignment of teeth during orthodontic treatment of malocclusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Tooth Movement at the End of Class II Correction. | The primary objective will be met through demonstrating that the velocity of Invisalign with MRF overjet correction is non-inferior to the published rates of Dynamax (0.42mm/month). | End of Class II Correction up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Treatment Time | This is the total treatment length of time that subjects took (in days) to complete Invisalign system treatment | End of Treatment approximately 2 years |
| Patient Quality of Life Questionnaire Throughout Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherri Wilson-Lopes | Align Technology, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Gary Brigham | Scottsdale | Arizona | 85260 | United States | ||
| Dr. Donna Galante |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clinical Study | There were a total of nine (9) Investigators participating in the Clinical Study, seven (7) in the US and two (2) in Canada. |
| FG001 | Continued Access | There were a total of seven (7) Investigators participating in the Continued Access Study, five (5) in the US and two (2) in Canada. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Race and Ethnicity was not captured as part of this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinical Study | There were a total of nine (9) Investigators participating in the Clinical Study, seven (7) in the US and two (2) in Canada. All US Investigators have completed their study participation and have been closed out with the Sponsor and the IRB. Both sites in Canada have completed their study participation and have been closed out with the Sponsor and the IRB. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Tooth Movement at the End of Class II Correction. | The primary objective will be met through demonstrating that the velocity of Invisalign with MRF overjet correction is non-inferior to the published rates of Dynamax (0.42mm/month). | 1. The Continued Access study was created to be able to offer additional Invisalign with Mandibular Advancement to doctors in the Clinical Study after recruitment had completed. The data has been combined for the primary and secondary objectives for pooling and analysis of the data. The data has been provided to FDA to support the IDE and has been 510K cleared for this device. | Posted | Mean | 80% Confidence Interval | mm/month | End of Class II Correction up to 18 months |
|
Adverse event data was collected over the course of Invisalign System Treatment for each subject for the duration of the study. Adverse Events were monitored through study completion, an average of 2 years.
The definitions for adverse events and serious adverse events for the Invisalign System with Mandibular Advancement Feature are described in the Clinical Study Protocol
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | The Invisalign System | Class II correction of malocclusions Invisalign System: The Invisalign® System is indicated for the alignment of teeth during orthodontic treatment of malocclusion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sherri Wilson-Lopes | Align Technology Inc | 408-470-1032 | swilson@aligntech.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2018 | May 2, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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As part of the secondary objective, subject perception was assessed through analysis of case report forms. Case report form analysis of the Quality of Life forms was conducted from the subjects in both the Clinical Study and Continued Access Clinical Study. Subjects were asked to rate their orthodontic experience throughout the course of the study, with options 1(very difficult), 2 (difficult), 3 (average), 4 (easy), and 5 (very easy) as the ratings.
| End of Treatment approximately 2 years |
| Doctor Survey for Satisfaction With Treatment Outcomes | 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 satisfaction experience . | End of Treatment approximately 2 years |
| Rocklin |
| California |
| 95765 |
| United States |
| Dr. Mark Holt | Roseville | California | 95661 | United States |
| Dr. Ray Kubisch and Dr. Drew Ferris | Santa Barbara | California | 93105 | United States |
| Dr. Sandra Selnick | Ellicott City | Maryland | 21042 | United States |
| Dr. Regina Blevins | Inver Grove Heights | Minnesota | 55076 | United States |
| Dr. William Kottemann | Maple Grove | Minnesota | 55369 | United States |
| Dr. Barry Glaser | Cortlandt Manor | New York | 10567 | United States |
| Dr. Sam Daher | Vancouver | British Columbia | Canada |
| Dr. Sandra Tai | Vancouver | British Columbia | Canada |
| BG001 | Continued Access | There were a total of seven (7) Investigators participating in the Continued Access Study, five (5) in the US and two (2) in Canada. As of November 23, 2021, Aall five (5) US Investigators havedve completed their study participation and have been closed with the Sponsor and with the IRB. Both These closed Investigators are: Dr. William Kottemann, Dr. Donna Galante, Dr. Sandra Selnick, Dr. Regina Blevins, and Dr. Raymond Kubisch. As of November 19, 2021, both sites in Canada were closed with the Sponsor and the IRB. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
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| Secondary | Length of Treatment Time | This is the total treatment length of time that subjects took (in days) to complete Invisalign system treatment | Posted | Mean | 80% Confidence Interval | Days | End of Treatment approximately 2 years |
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|
|
| Secondary | Patient Quality of Life Questionnaire Throughout Treatment | As part of the secondary objective, subject perception was assessed through analysis of case report forms. Case report form analysis of the Quality of Life forms was conducted from the subjects in both the Clinical Study and Continued Access Clinical Study. Subjects were asked to rate their orthodontic experience throughout the course of the study, with options 1(very difficult), 2 (difficult), 3 (average), 4 (easy), and 5 (very easy) as the ratings. | The number of participants analyzed in each row is different due to withdrawal and lost to follow up subjects being removed from the study. | Posted | Mean | 80% Confidence Interval | score on a table | End of Treatment approximately 2 years |
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| Secondary | Doctor Survey for Satisfaction With Treatment Outcomes | 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 satisfaction experience . | The average rating of doctor satisfaction with the subject's treatment outcomes, on a scale of 1 (unsatisfied) to 5 (satisfied). | Posted | Mean | 80% Confidence Interval | score on a scale | End of Treatment approximately 2 years |
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| 0 |
| 164 |
| 0 |
| 164 |
| 0 |
| 164 |
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| Average Rating of Orthodontic Experience From Subject QOL forms-End of Treatment |
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