Malocclusion
Conditions
Keywords
Orthodontic, Orthodontic Treatment, Clear Aligners, Malocclusion
Brief summary
To demonstrate that growing teenagers which present up to full cusp Class II malocclusions can be treated using the Invisalign System.
Detailed description
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.
Interventions
DEVICEInvisalign System
The Invisalign® System is indicated for the alignment of teeth during orthodontic treatment of malocclusion
Sponsors
Align Technology, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 19 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject must have fully erupted dentition excluding 2nd and 3rd molars * Age range 11-19 years old * Subject that requires bilateral Class II correction and must require at least 3mm of correction as measured by first molar relationship
Exclusion criteria
* Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars) * Subject who has spaces between adjacent teeth larger than 3mm * Subject with active caries * Subject with periodontal disease * Subject does not have at least 1st molar fully captured in PVS (polyvinyl siloxane material ) impression or intraoral scan. * Subject with TMD (Temporomandibular joint dysfunction) symptoms * Subject has undergone pre-treatment with any orthodontic appliance (any previous treatment prior to study) * Subject has known allergy to latex and plastic * Subjects who are pregnant or will become pregnant during treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Tooth Movement at the End of Class II Correction. | End of Class II Correction up to 18 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Treatment Time | End of Treatment approximately 2 years | This is the total treatment length of time that subjects took (in days) to complete Invisalign system treatment |
| Patient Quality of Life Questionnaire Throughout Treatment | End of Treatment approximately 2 years | 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. |
| Doctor Survey for Satisfaction With Treatment Outcomes | End of Treatment approximately 2 years | 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 . |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 81 |
| 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. | 83 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 27 | 44 |
Baseline characteristics
| Characteristic | Clinical Study | Continued Access | Total |
|---|---|---|---|
| Age, Continuous | 13.24 Years | 13.17 Years | 13.2 Years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 43 Participants | 47 Participants | 90 Participants |
| Sex: Female, Male Male | 38 Participants | 36 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 164 |
| other Total, other adverse events | 0 / 164 |
| serious Total, serious adverse events | 0 / 164 |
Outcome results
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).
Time frame: End of Class II Correction up to 18 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Primary Objective | Rate of Tooth Movement at the End of Class II Correction. | .44 mm/month |
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 .
Time frame: End of Treatment approximately 2 years
Population: The average rating of doctor satisfaction with the subject's treatment outcomes, on a scale of 1 (unsatisfied) to 5 (satisfied).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Primary Objective | Doctor Survey for Satisfaction With Treatment Outcomes | 4.56 score on a scale |
Secondary
Length of Treatment Time
This is the total treatment length of time that subjects took (in days) to complete Invisalign system treatment
Time frame: End of Treatment approximately 2 years
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Primary Objective | Length of Treatment Time | 461 Days |
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.
Time frame: End of Treatment approximately 2 years
Population: The number of participants analyzed in each row is different due to withdrawal and lost to follow up subjects being removed from the study.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Primary Objective | Patient Quality of Life Questionnaire Throughout Treatment | Average Rating of Orthodontic Experience From Subject QOL forms-Initial | 4.24 score on a table |
| Primary Objective | Patient Quality of Life Questionnaire Throughout Treatment | Average Rating of Orthodontic Experience From Subject QOL forms-End of MA | 4.28 score on a table |
| Primary Objective | Patient Quality of Life Questionnaire Throughout Treatment | Average Rating of Orthodontic Experience From Subject QOL forms-End of Treatment | 4.39 score on a table |