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To demonstrate that a primer aligner product can achieve similar results to the currently marketed product.
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 |
|---|---|---|---|
| 7 Aligner Cohort weartime 1 | Experimental | Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention. |
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| 7 Aligner Cohort weartime 2 | Experimental | Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention. |
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| 12 aligner cohort weartime 1 | Experimental | Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention. |
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| 12 aligner cohort weartime 2 | Experimental | Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invisalign | Device | 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 | Description | Time Frame |
|---|---|---|
| Total Treatment Time | Total treatment time was measured in days. The less days a subject was in treatment, the better. | Approximately 1 year |
| Rate of Refinement | 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. | Approximately 1 year |
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| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction. | (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. | Approximately 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Moneim, DDS | Los Gatos Dental Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wood Orthodontics | Anthem | Arizona | 85086 | United States | ||
| Cooke Orthodontics |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2015 | Dec 17, 2020 |
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| Doctor Survey Results. |
(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. |
| Approximately 1 year |
| Napa |
| California |
| 94558 |
| United States |
| The Orthodontic Center | Oakland | California | 94612 | United States |
| Green Dentistry | San Francisco | California | 94108 | United States |
| Align Technology, Inc. | San Jose | California | 95131 | United States |
| Posner, Henderson & Goslee Dentistry | Bristol | Connecticut | 06010 | United States |
| Feldman Orthodontics | Cheshire | Connecticut | 06410 | United States |
| Comizio Orthodontics | Eastchester | New York | 10709 | United States |
| Magic Touch Orthodontist | Little Neck | New York | 11362 | United States |
| Meadowbrook Dental Care | Mineola | New York | 11501 | United States |
| Wenger Orthodontics | Mayfield Heights | Ohio | 44124 | United States |
| Dental One Reston | Reston | Virginia | 20191 | United States |
| DMG Dental Design | Bothell | Washington | 98012 | United States |
| Anglia Orthdontics | Cambridge | England | CB3 9PA | United Kingdom |
| Bluebell Dental Practice | Chigwell | England | IG6 2QP | United Kingdom |
| Dream Smile Dental Clinic | London | England | SE13 7FD | United Kingdom |
| High Street Dental Care | Melton Mowbray | Leicestershire | LE13 0TR | United Kingdom |
| Brixworth Dental Practice | Brixworth | Northampton | NN6 9DS | United Kingdom |
| Cherrybank Dental Spa | Edinburgh | Scotland | EH3 5DQ | United Kingdom |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||
| 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 |
| ||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Total Treatment Time | Total treatment time was measured in days. The less days a subject was in treatment, the better. | Posted | Mean | Standard Deviation | days | Approximately 1 year |
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| |||||||||||||||||||||||||||||||||||
| Primary | Rate of Refinement | 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. | Posted | Mean | Standard Deviation | percentage of refinement | Approximately 1 year |
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| Other Pre-specified | Subject Satisfaction. | (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. | Posted | Mean | Standard Error | score on a scale | Approximately 1 year |
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| Other Pre-specified | Doctor Survey Results. | (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. | Posted | Mean | Standard Deviation | score on a scale | Approximately 1 year |
|
Adverse events were monitored throughout the entire duration each subjects' participation in the clinical study, from enrollment until completion, an average of 262 days.
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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 | 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. | 0 | 44 | 0 | 44 | 0 | 44 |
| EG001 | 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. | 0 | 85 | 0 | 85 | 0 | 85 |
| EG002 | 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. | 0 | 43 | 0 | 43 | 0 | 43 |
| EG003 | 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. | 0 | 81 | 0 | 81 | 0 | 81 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allison Mossing, Sr. Clinical Research Associate | Align Technology, Inc. | 4084701046 | amossing@aligntech.com |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D009968 | Orthodontic Appliances, Removable |
| ID | Term |
|---|---|
| D009967 | Orthodontic Appliances |
| D009970 | Orthodontics |
| D003813 | Dentistry |
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| United Kingdom |
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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. |
| OG002 | 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. |
| OG003 | 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. |
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| OG002 | 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. |
| OG003 | 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. |
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| OG002 | 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. |
| OG003 | 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. |
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