Malocclusion
Conditions
Brief summary
To demonstrate that a primer aligner product can achieve similar results to the currently marketed product.
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
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.
Sponsors
Align Technology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Treatment Time | Approximately 1 year | Total treatment time was measured in days. The less days a subject was in treatment, the better. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| 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. | 78 |
| 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. | 31 |
| 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. | 70 |
| Total | 215 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 7 | 12 | 11 |
Baseline characteristics
| Characteristic | Total | 7 Aligner Cohort Weartime 2 | 12 Aligner Cohort Weartime 1 | 12 Aligner Cohort Weartime 2 | 7 Aligner Cohort Weartime 1 |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 0 Participants | 1 Participants | 4 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 209 Participants | 78 Participants | 30 Participants | 66 Participants | 35 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — |
| Region of Enrollment United Kingdom | 89 participants | 28 participants | 11 participants | 34 participants | 16 participants |
| Region of Enrollment United States | 126 participants | 50 participants | 20 participants | 36 participants | 20 participants |
| Sex: Female, Male Female | 154 Participants | 55 Participants | 27 Participants | 45 Participants | 27 Participants |
| Sex: Female, Male Male | 61 Participants | 23 Participants | 4 Participants | 25 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 85 | 0 / 43 | 0 / 81 |
| other Total, other adverse events | 0 / 44 | 0 / 85 | 0 / 43 | 0 / 81 |
| serious Total, serious adverse events | 0 / 44 | 0 / 85 | 0 / 43 | 0 / 81 |
Outcome results
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.
Time frame: Approximately 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 7 Aligner Cohort Weartime 1 | Rate of Refinement | 0.25 percentage of refinement | Standard Deviation 0.439155 |
| 7 Aligner Cohort Weartime 2 | Rate of Refinement | 0.263158 percentage of refinement | Standard Deviation 0.446258 |
| 12 Aligner Cohort Weartime 1 | Rate of Refinement | 0.419355 percentage of refinement | Standard Deviation 0.50161 |
| 12 Aligner Cohort Weartime 2 | Rate of Refinement | 0.527778 percentage of refinement | Standard Deviation 0.506309 |
Primary
Total Treatment Time
Total treatment time was measured in days. The less days a subject was in treatment, the better.
Time frame: Approximately 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 7 Aligner Cohort Weartime 1 | Total Treatment Time | 197.4167 days | Standard Deviation 102.0774 |
| 7 Aligner Cohort Weartime 2 | Total Treatment Time | 225.7 days | Standard Deviation 108.463 |
| 12 Aligner Cohort Weartime 1 | Total Treatment Time | 326.9355 days | Standard Deviation 151.414 |
| 12 Aligner Cohort Weartime 2 | Total Treatment Time | 294.1111 days | Standard Deviation 181.7863 |
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.
Time frame: Approximately 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 7 Aligner Cohort Weartime 1 | Doctor Survey Results. | 3.139 score on a scale | Standard Deviation 1.4702645 |
| 7 Aligner Cohort Weartime 2 | Doctor Survey Results. | 2.899 score on a scale | Standard Deviation 1.330019318 |
| 12 Aligner Cohort Weartime 1 | Doctor Survey Results. | 3.139 score on a scale | Standard Deviation 3.176084 |
| 12 Aligner Cohort Weartime 2 | Doctor Survey Results. | 4.499 score on a scale | Standard Deviation 1.7756956 |
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.
Time frame: Approximately 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 7 Aligner Cohort Weartime 1 | Subject Satisfaction. | 3.499 score on a scale | Standard Error 2.473797384 |
| 7 Aligner Cohort Weartime 2 | Subject Satisfaction. | 3.156 score on a scale | Standard Error 3.409 |
| 12 Aligner Cohort Weartime 1 | Subject Satisfaction. | 4.632 score on a scale | Standard Error 4.499 |
| 12 Aligner Cohort Weartime 2 | Subject Satisfaction. | 4.499 score on a scale | Standard Error 3.499 |