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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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The objective of this study is to evaluate the efficacy of Clear Aligners to correct tooth malocclusions with the use of attachments and/or buttons, as determined by the amount of teeth movement and overall achievement goals of the treatment plan.
This is a prospective, multi-center study with a maximum duration of 24 months or longer depending on refinements, to assess the safety and efficacy of 3M Clear Aligners, with the use of attachments to correct teeth malocclusions.
The subject population for this study will be male and female subjects ≥ 14 years of age. Subjects who meet the inclusion and exclusion criteria will be asked to participate in the study. Up to a total of 180 subjects may be enrolled at up to 12 different clinical research sites, (up to 15 subjects per site).
The subjects will undergo a target of up to 24 months (or longer depending on refinements) of treatment to align the teeth to the planned target. Subjects will wear the Clear Aligners for at least 22 hours per day, with the exception of consumption of meals and beverages, with the exception of water, which can be consumed while wearing the aligners. During each 6-week period between follow up visits, subjects will wear each set of Clear Aligners for 2 weeks, in the order indicated per the Orthodontists treatment plan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3M Clear Aligner | Other | Clear Aligner for Orthodontic Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clear Aligner | Device | Clear Aligner used to straighten teeth to desired outcome |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful Correction of Malocclusion | Achievement of target setup per treatment plan as determined by Orthodontist. | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Individual Tooth Movement | Achievement of individual tooth movement measured per treatment plan and digital scan | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. |
| Treatment Time for Tooth Movement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail E Maxey, BA, CCRA | 3M Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benson Orthodontics | Denver | Colorado | 80209-3244 | United States | ||
| Depew Orthodontics |
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Screen failures because they did not meet Inclusion/Exclusion criteria
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| ID | Title | Description |
|---|---|---|
| FG000 | 3M Clear Aligner | 3M Clear Aligner for Orthodontic Treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3M Clear Aligner | Clear Aligner Treatment Clear Aligner: Clear Aligner used to straighten teeth to desired outcome |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Successful Correction of Malocclusion | Achievement of target setup per treatment plan as determined by Orthodontist. | Posted | Count of Participants | Participants | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. |
|
|
Up to 28 months
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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 | 3M Clear Aligner | 3M Clear Aligner for Orthodontic Treatment | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding Gums | Gastrointestinal disorders | Not Coded | Systematic Assessment | Bleeding Gums |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elaine Egging | 3M | 651-737-0263 | eegging@mmm.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 | Apr 19, 2017 | Sep 14, 2020 | 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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Achievement of individual tooth movement measured per treatment plan |
| The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. |
| Effective Use of Attachments | Effective use of attachment by tracking attachment bond failures by visual assessment | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. |
| Orthodontist Satisfaction | Orthodontist satisfaction with treatment outcome | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. |
| Software Satisfaction | Orthodontist satisfaction with treatment management software -Ease of use in ordering products | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. |
| Aligner Comfort | Aligner comfortable to wear | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. |
| Appearance Satisfaction | Subject satisfaction with appearance during treatment | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. |
| Aligner Ease of Cleaning | Subject satisfaction with ease of cleaning during treatment | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. |
| Ease of Insertion | Subject satisfaction with treatment; specifically aligners easy to insert | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. |
| Mid Course Corrections/Refinements Needed | Number of mid course refinements or corrections | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. |
| Ease of Aligner Removal | Subject satisfaction with treatment; specifically with aligner removal | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. |
| Kennesaw |
| Georgia |
| 30144 |
| United States |
| Orthodontics Associates | Catonsville | Maryland | 21228 | United States |
| Henseler Orthodontics | Woodbury | Minnesota | 55125 | United States |
| Horton Orthodontics | Woodbury | Minnesota | 55125 | United States |
| Mellion Orthodontics | Fairlawn | Ohio | 44333 | United States |
| Wolf/Chhibber Orthodontics | Norwalk | Ohio | 44857 | United States |
| Simply Smiles Orthodontics | McKinney | Texas | 75070 | United States |
| Riolo Orthodontics | Seattle | Washington | 98101 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Class type of malocclusion | Class I Malocclusion - the bite is normal but the upper teeth slightly overlap the lower teeth Class II Malocclusion - the upper jaw and teeth severely overlap the bottom jaw and teeth (overbite) Class III Malocclusion - the lower jaw is advanced forward or the upper jaw is held back (underbite) | Count of Participants | Participants |
|
| Previous orthodontic treatments | Count of Participants | Participants |
|
|
| Secondary | Individual Tooth Movement | Achievement of individual tooth movement measured per treatment plan and digital scan | Not obtained due to technical difficulties including warped and insufficient dental scans | Posted | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. |
|
|
| Secondary | Treatment Time for Tooth Movement | Achievement of individual tooth movement measured per treatment plan | Posted | Median | Full Range | days | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. |
|
|
|
| Secondary | Effective Use of Attachments | Effective use of attachment by tracking attachment bond failures by visual assessment | Posted | Mean | Standard Deviation | Percentage of Attachment Bond Failure | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. |
|
|
|
| Secondary | Orthodontist Satisfaction | Orthodontist satisfaction with treatment outcome | Posted | Count of Participants | Participants | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. |
|
|
|
| Secondary | Software Satisfaction | Orthodontist satisfaction with treatment management software -Ease of use in ordering products | The ordering software was updated during treatment and therefore not analyzed. | Posted | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. |
|
|
| Secondary | Aligner Comfort | Aligner comfortable to wear | Posted | Count of Units | study visits | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. | study visits | study visits |
|
|
|
| Secondary | Appearance Satisfaction | Subject satisfaction with appearance during treatment | Posted | Count of Units | study visits | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. | study visits | study visits |
|
|
|
| Secondary | Aligner Ease of Cleaning | Subject satisfaction with ease of cleaning during treatment | Posted | Count of Units | study visits | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. | study visits | study visits |
|
|
|
| Secondary | Ease of Insertion | Subject satisfaction with treatment; specifically aligners easy to insert | Posted | Count of Units | study visits | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. | study visits | study visits |
|
|
|
| Secondary | Mid Course Corrections/Refinements Needed | Number of mid course refinements or corrections | Posted | Count of Participants | Participants | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. |
|
|
|
| Secondary | Ease of Aligner Removal | Subject satisfaction with treatment; specifically with aligner removal | Posted | Count of Units | study visit | The expected duration of subject participation was to be 6 to 24 months. Due to additional time needed for orthodontic refinements, the actual longest duration was approximately 28 months. | study visit | study visit |
|
|
|
| 52 |
| 0 |
| 52 |
| 2 |
| 52 |
| Filling Fell Off Tooth | Product Issues | Not Coded | Systematic Assessment | Filling Fell Out of Tooth |
|
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|
| Not Applicable |
|
| Somewhat Uncomfortable |
|
| Not at all Comfortable |
|
| Difficult |
|
| 3 Corrections/Refinements |
|
| Difficult |
|