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The purpose of this study is to use clear aligners to measure tooth movement and length of treatment.
Orthodontic tooth movement is the result of a force applied to the crown of a tooth and the biological remodeling of the gum and bony tissues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Movement Enhancement Technique | Experimental | Movement Enhancement Technique Clear Aligner |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Movement Enhancement Technique | Device | Conventional Orthodontic treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tooth Movement Change | Participants will be followed for the duration of orthodontic treatment, an expected average of 78 weeks. Tooth movement change will be measured as the number of millimeters of tooth movement per aligner. | Baseline and end of treatment, an average of 78 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Treatment Change | Participants will be followed for the duration of orthodontic treatment, an expected average of 78 weeks. Length of treatment change will be measured as the number of weeks of movement per aligner. | Baseline and end of treatment, an average of 78 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chenin | Principal Investigator | |
| Kottemann | Principal Investigator | |
| Mariani | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Align Technology, Inc. | San Jose | California | 95131 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Movement Enhancement Technique | Movement Enhancement Technique Clear Aligner Movement Enhancement Technique: Conventional Orthodontic treatment Clear Aligner: Orthodontic treatment with Clear Aligner |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Movement Enhancement Technique | Movement Enhancement Technique Clear Aligner Movement Enhancement Technique: Conventional Orthodontic treatment Clear Aligner: Orthodontic treatment with Clear Aligner |
| 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 |
| 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 | Tooth Movement Change | Participants will be followed for the duration of orthodontic treatment, an expected average of 78 weeks. Tooth movement change will be measured as the number of millimeters of tooth movement per aligner. | all completed subjects | Posted | Mean | 95% Confidence Interval | millimeters | Baseline and end of treatment, an average of 78 weeks |
|
|
baseline until end of treatment, an average of 78 weeks
An adverse event (AE) is any unwanted dental occurrence in a clinical investigation subject whether or not the AE is suspected of having a causal relationship with study treatment. Pre-existing events, which increase in frequency or severity or change in nature during or as a consequence of use of an appliance clinical trials, will also be considered as adverse events.
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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 | Movement Enhancement Technique | Movement Enhancement Technique Clear Aligner Movement Enhancement Technique: Conventional Orthodontic treatment Clear Aligner: Orthodontic treatment with Clear Aligner |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allison Mossing | Align Technology | 4084701056 | amossing@aligntech.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 9, 2019 | Feb 8, 2019 | Prot_SAP_000.pdf |
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| 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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| Clear Aligner | Device | Orthodontic treatment with Clear Aligner |
|
| 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 |
|
| Participants |
|
|
| Secondary | Length of Treatment Change | Participants will be followed for the duration of orthodontic treatment, an expected average of 78 weeks. Length of treatment change will be measured as the number of weeks of movement per aligner. | all completed subjects | Posted | Mean | 95% Confidence Interval | days | Baseline and end of treatment, an average of 78 weeks |
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|
| 0 |
| 90 |
| 0 |
| 90 |
| 0 |
| 90 |
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