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The purpose of this research is to test which of four clear aligner attachment types is more efficient in extruding (erupting) maxillary lateral incisors vertically into correct position during orthodontic treatment.
Attachments are small tooth-colored shapes that are bonded (attached) to teeth before or during treatment with clear aligners. They are like handles, giving aligners something to gently push teeth into correct positions. There are 4 different shapes of attachments that are commonly used to extrude lateral incisors (incisally-beveled, gingivally-beveled, optimized and horizontal). All 4 of these attachments are successful in extruding lateral incisors but there is not enough research evidence to know for sure which attachment would be ideal for a specific circumstance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Incisally-beveled | Active Comparator | Use of incisally-beveled attachment to extrude lateral incisor |
|
| Gingivally-beveled | Active Comparator | Use of gingivally-beveled attachment to extrude lateral incisor |
|
| Optimized | Active Comparator | Use of optimized attachment to extrude lateral incisor |
|
| Horizontal | Active Comparator | Use of horizontal (unbeveled) attachment to extrude lateral incisor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incisally-beveled attachment | Device | Incisally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Vertical Tooth Movement | Percent achieved of the vertical (inciso-gingival) tooth movement will be assessed by comparing the initial ClinCheck software estimate tooth movement required to the amount of tooth movement observed | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Lindauer, DDS | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37610383 | Derived | Groody JT, Lindauer SJ, Kravitz ND, Carrico CK, Madurantakam P, Shroff B, Darkazanli M, Gardner WG. Effect of clear aligner attachment design on extrusion of maxillary lateral incisors: A multicenter, single-blind randomized clinical trial. Am J Orthod Dentofacial Orthop. 2023 Nov;164(5):618-627. doi: 10.1016/j.ajodo.2023.07.011. Epub 2023 Aug 21. |
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Recruitment began August, 2021 and final data collection was completed in June, 2022. Patients were recruited from 3 orthodontic practices. Units enrolled are counted as numbers of teeth. Potentially, 2 maxillary lateral incisors from each patient could have been enrolled.
| ID | Title | Description |
|---|---|---|
| FG000 | Horizontal | Use of horizontal (unbeveled) attachment to extrude lateral incisor Horizontal attachment: Horizontal attachments will be bonded to teeth before or during orthodontal treatment with clear aligners |
| FG001 | Incisally-beveled | Use of incisally-beveled attachment to extrude lateral incisor Incisally-beveled attachment: Incisally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners |
| FG002 | Gingivally-beveled | Use of gingivally-beveled attachment to extrude lateral incisor Gingivally-beveled attachment: Gingivally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners |
| FG003 | Optimized | Use of optimized attachment to extrude lateral incisor Optimized attachment: Optimized attachments will be bonded to teeth before or during orthodontal treatment with clear aligners |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Incisally-beveled | Use of incisally-beveled attachment to extrude lateral incisor Incisally-beveled attachment: Incisally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners |
| BG001 | Gingivally-beveled |
| 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 | Percent of Vertical Tooth Movement | Percent achieved of the vertical (inciso-gingival) tooth movement will be assessed by comparing the initial ClinCheck software estimate tooth movement required to the amount of tooth movement observed | Posted | Mean | 95% Confidence Interval | percentage of predicted | 6 months | Teeth | Teeth |
|
1 year
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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 | Horizontal | Use of horizontal (unbeveled) attachment to extrude lateral incisor Horizontal attachment: Horizontal attachments will be bonded to teeth before or during orthodontal treatment with clear aligners |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven J Lindauer | Virginia Commonwealth University School of Dentistry, Orthodontics | 8048289326 | sjlindau@vcu.edu |
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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 | Jun 8, 2021 | Jun 2, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 8, 2021 | Jun 2, 2023 | ICF_001.pdf |
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| Gingivally-beveled attachment | Device | Gingivally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners |
|
| Optimized attachment | Device | Optimized attachments will be bonded to teeth before or during orthodontal treatment with clear aligners |
|
| Horizontal attachment | Device | Horizontal attachments will be bonded to teeth before or during orthodontal treatment with clear aligners |
|
Use of gingivally-beveled attachment to extrude lateral incisor Gingivally-beveled attachment: Gingivally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners |
| BG002 | Optimized | Use of optimized attachment to extrude lateral incisor Optimized attachment: Optimized attachments will be bonded to teeth before or during orthodontal treatment with clear aligners |
| BG003 | Horizontal | Use of horizontal (unbeveled) attachment to extrude lateral incisor Horizontal attachment: Horizontal attachments will be bonded to teeth before or during orthodontal treatment with clear aligners |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Gingivally-beveled | Use of gingivally-beveled attachment to extrude lateral incisor Gingivally-beveled attachment: Gingivally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners |
| OG003 | Optimized | Use of optimized attachment to extrude lateral incisor Optimized attachment: Optimized attachments will be bonded to teeth before or during orthodontal treatment with clear aligners |
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Incisally-beveled | Use of incisally-beveled attachment to extrude lateral incisor Incisally-beveled attachment: Incisally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Gingivally-beveled | Use of gingivally-beveled attachment to extrude lateral incisor Gingivally-beveled attachment: Gingivally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners | 0 | 14 | 0 | 14 | 0 | 14 |
| EG003 | Optimized | Use of optimized attachment to extrude lateral incisor Optimized attachment: Optimized attachments will be bonded to teeth before or during orthodontal treatment with clear aligners | 0 | 22 | 0 | 22 | 0 | 22 |
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