Primer Aligner Study

• Sponsor: Align Technology, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02550938
• Collaborator: (none)
• Enrollment: 253
• Locations: 19
• Arms: 4
• Duration (Months): 64.1
• Patients Per Site: 13.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

To demonstrate that a primer aligner product can achieve similar results to the currently marketed product.

Condition or Disease	Intervention/Treatment	Phase
Malocclusion	Device: Invisalign	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 253 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Primer Aligner Study
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Sep 1, 2020
• Actual Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 7 Aligner Cohort weartime 1 Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention.	Device: 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.
Experimental: 7 Aligner Cohort weartime 2 Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention.	Device: 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.
Experimental: 12 aligner cohort weartime 1 Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention.	Device: 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.
Experimental: 12 aligner cohort weartime 2 Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.	Device: 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.

Outcome Measures

Primary Outcome Measures

1. Total Treatment Time [Approximately 1 year]

   Total treatment time was measured in days. The less days a subject was in treatment, the better.

2. Rate of Refinement [Approximately 1 year]

   Rate 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.

Other Outcome Measures

1. Subject Satisfaction. [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.

2. Doctor Survey Results. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subject must have fully erupted dentition

• Age range ≥18 years old (Adult subject)

• Subjects who are indicated for either: 5, 7, 10, or 12 aligner sets

Exclusion Criteria:

• Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars)

• Subject who has mixed dentition

• Subject with periodontal disease

• Subject with active caries

• Subject with Temporomandibular Joint Disorders symptoms

• Subject has undergone pre-treatment with any orthodontic appliance 3 months prior to the start of treatment

• Subject has undergone any accelerated orthodontic treatment prior to or during treatment as part of this study

• Subject has known allergy to latex or plastic

• Subjects who are pregnant or will become pregnant during treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wood Orthodontics	Anthem	Arizona	United States	85086
2	Cooke Orthodontics	Napa	California	United States	94558
3	The Orthodontic Center	Oakland	California	United States	94612
4	Green Dentistry	San Francisco	California	United States	94108
5	Align Technology, Inc.	San Jose	California	United States	95131
6	Posner, Henderson & Goslee Dentistry	Bristol	Connecticut	United States	06010
7	Feldman Orthodontics	Cheshire	Connecticut	United States	06410
8	Comizio Orthodontics	Eastchester	New York	United States	10709
9	Magic Touch Orthodontist	Little Neck	New York	United States	11362
10	Meadowbrook Dental Care	Mineola	New York	United States	11501
11	Wenger Orthodontics	Mayfield Heights	Ohio	United States	44124
12	Dental One Reston	Reston	Virginia	United States	20191
13	DMG Dental Design	Bothell	Washington	United States	98012
14	Anglia Orthdontics	Cambridge	England	United Kingdom	CB3 9PA
15	Bluebell Dental Practice	Chigwell	England	United Kingdom	IG6 2QP
16	Dream Smile Dental Clinic	London	England	United Kingdom	SE13 7FD
17	High Street Dental Care	Melton Mowbray	Leicestershire	United Kingdom	LE13 0TR
18	Brixworth Dental Practice	Brixworth	Northampton	United Kingdom	NN6 9DS
19	Cherrybank Dental Spa	Edinburgh	Scotland	United Kingdom	EH3 5DQ

Sponsors and Collaborators

• Align Technology, Inc.

Investigators

• Principal Investigator: Ahmed Moneim, DDS, Los Gatos Dental Center

Study Documents (Full-Text)

• Study Protocol - Jul 7, 2015

More Information

Publications

None provided.

• Responsible Party: Align Technology, Inc.
• ClinicalTrials.gov Identifier: NCT02550938
• Other Study ID Numbers: CSP-300307-00
• First Posted: Sep 16, 2015
• Last Update Posted: Feb 3, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Malocclusion

Study Results

Participant Flow

Arm/Group Title	7 Aligner Cohort Weartime 1	7 Aligner Cohort Weartime 2	12 Aligner Cohort Weartime 1	12 Aligner Cohort Weartime 2
Arm/Group Description	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.	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.	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.	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.
Period Title: Overall Study
STARTED	44	85	43	81
COMPLETED	36	78	31	70
NOT COMPLETED	8	7	12	11

Baseline Characteristics

Arm/Group Title	7 Aligner Cohort Weartime 1	7 Aligner Cohort Weartime 2	12 Aligner Cohort Weartime 1	12 Aligner Cohort Weartime 2	Total
Arm/Group Description	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.	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.	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.	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 of all reporting groups
Overall Participants	36	78	31	70	215
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	35 97.2%	78 100%	30 96.8%	66 94.3%	209 97.2%
>=65 years	1 2.8%	0 0%	1 3.2%	4 5.7%	6 2.8%
Sex: Female, Male (Count of Participants)
Female	27 75%	55 70.5%	27 87.1%	45 64.3%	154 71.6%
Male	9 25%	23 29.5%	4 12.9%	25 35.7%	61 28.4%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	20 55.6%	50 64.1%	20 64.5%	36 51.4%	126 58.6%
United Kingdom	16 44.4%	28 35.9%	11 35.5%	34 48.6%	89 41.4%

Outcome Measures

1. Primary Outcome

Title	Total Treatment Time
Description	Total treatment time was measured in days. The less days a subject was in treatment, the better.
Time Frame	Approximately 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	7 Aligner Cohort Weartime 1	7 Aligner Cohort Weartime 2	12 Aligner Cohort Weartime 1	12 Aligner Cohort Weartime 2
Arm/Group Description	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.	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.	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.	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.
Measure Participants	36	78	31	70
Mean (Standard Deviation) [days]	197.4167 (102.0774)	225.7 (108.463)	326.9355 (151.414)	294.1111 (181.7863)

2. Primary Outcome

Title	Rate of Refinement
Description	Rate 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.
Time Frame	Approximately 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	7 Aligner Cohort Weartime 1	7 Aligner Cohort Weartime 2	12 Aligner Cohort Weartime 1	12 Aligner Cohort Weartime 2
Arm/Group Description	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.	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.	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.	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.
Measure Participants	36	78	31	70
Mean (Standard Deviation) [percentage of refinement]	0.25 (0.439155)	0.263158 (0.446258)	0.419355 (0.50161)	0.527778 (0.506309)

3. Other Pre-specified Outcome

Title	Subject Satisfaction.
Description	(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.
Time Frame	Approximately 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	7 Aligner Cohort Weartime 1	7 Aligner Cohort Weartime 2	12 Aligner Cohort Weartime 1	12 Aligner Cohort Weartime 2
Arm/Group Description	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.	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.	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.	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.
Measure Participants	36	78	31	70
Mean (Standard Error) [score on a scale]	3.499 (2.473797384)	3.156 (3.409)	4.632 (4.499)	4.499 (3.499)

4. Other Pre-specified Outcome

Title	Doctor Survey Results.
Description	(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.
Time Frame	Approximately 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	7 Aligner Cohort Weartime 1	7 Aligner Cohort Weartime 2	12 Aligner Cohort Weartime 1	12 Aligner Cohort Weartime 2
Arm/Group Description	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.	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.	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.	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.
Measure Participants	36	78	31	70
Mean (Standard Deviation) [score on a scale]	3.139 (1.4702645)	2.899 (1.330019318)	3.139 (3.1760840)	4.499 (1.7756956)

Adverse Events

Time Frame	Adverse events were monitored throughout the entire duration each subjects' participation in the clinical study, from enrollment until completion, an average of 262 days.
Arm/Group Title	7 Aligner Cohort Weartime 1		7 Aligner Cohort Weartime 2		12 Aligner Cohort Weartime 1		12 Aligner Cohort Weartime 2
Arm/Group Description	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.		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.		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.		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.
All Cause Mortality
	7 Aligner Cohort Weartime 1		7 Aligner Cohort Weartime 2		12 Aligner Cohort Weartime 1		12 Aligner Cohort Weartime 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/85 (0%)		0/43 (0%)		0/81 (0%)
Serious Adverse Events
	7 Aligner Cohort Weartime 1		7 Aligner Cohort Weartime 2		12 Aligner Cohort Weartime 1		12 Aligner Cohort Weartime 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/85 (0%)		0/43 (0%)		0/81 (0%)
Other (Not Including Serious) Adverse Events
	7 Aligner Cohort Weartime 1		7 Aligner Cohort Weartime 2		12 Aligner Cohort Weartime 1		12 Aligner Cohort Weartime 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/85 (0%)		0/43 (0%)		0/81 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.