Trial Outcomes & Findings for Class II Correction Study Using the Invisalign System (NCT NCT02376829)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

164 participants

Primary outcome timeframe

End of Class II Correction up to 18 months

Results posted on

2023-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	81	83
Overall Study COMPLETED	54	39
Overall Study NOT COMPLETED	27	44

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	27	44

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clinical Study n=81 Participants 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.	Continued Access n=83 Participants 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.	Total n=164 Participants Total of all reporting groups
Age, Continuous	13.24 Years n=81 Participants	13.17 Years n=83 Participants	13.2 Years n=164 Participants
Sex: Female, Male Female	43 Participants n=81 Participants	47 Participants n=83 Participants	90 Participants n=164 Participants
Sex: Female, Male Male	38 Participants n=81 Participants	36 Participants n=83 Participants	74 Participants n=164 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Primary Objective n=42 Participants The primary objective will be met by demonstrating that the velocity of Invisalign with MRF overjet correction is non-inferior to the published rates of Dynamax (0.42mm/month)3.
Rate of Tooth Movement at the End of Class II Correction.	.44 mm/month Interval 0.37 to 0.51

SECONDARY outcome

Timeframe: End of Treatment approximately 2 years

This is the total treatment length of time that subjects took (in days) to complete Invisalign system treatment

Outcome measures

Outcome measures
Measure	Primary Objective n=78 Participants The primary objective will be met by demonstrating that the velocity of Invisalign with MRF overjet correction is non-inferior to the published rates of Dynamax (0.42mm/month)3.
Length of Treatment Time	461 Days Interval 434.0 to 489.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Primary Objective n=164 Participants The primary objective will be met by demonstrating that the velocity of Invisalign with MRF overjet correction is non-inferior to the published rates of Dynamax (0.42mm/month)3.
Patient Quality of Life Questionnaire Throughout Treatment Average Rating of Orthodontic Experience From Subject QOL forms-Initial	4.24 score on a table Interval 4.15 to 4.33
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 Interval 4.18 to 4.38
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 Interval 4.28 to 4.5

SECONDARY outcome

Timeframe: 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).

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 .

Outcome measures

Outcome measures
Measure	Primary Objective n=94 Participants The primary objective will be met by demonstrating that the velocity of Invisalign with MRF overjet correction is non-inferior to the published rates of Dynamax (0.42mm/month)3.
Doctor Survey for Satisfaction With Treatment Outcomes	4.56 score on a scale Interval 4.45 to 4.67

Adverse Events

The Invisalign System

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

Sherri Wilson-Lopes

Align Technology Inc

Phone: 408-470-1032

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place