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This study evaluates how accurately the attachments used in Invisalign treatment (Align Technology Inc., San Jose, CA, USA) match their planned shapes and sizes in the ClinCheck software (ClinCheck®, Align Technology Inc., San Jose, CA, USA). Attachments are small tooth-colored bumps that help clear aligners grip the teeth and move them effectively.
The investigators are comparing two types of attachments: optimized and conventional, to determine which is bonded to the tooth more accurately and maintains its shape better over time. Participants beginning Invisalign treatment will have attachments placed as part of their normal care. Digital scans will be taken immediately after placement and during follow-up visits to assess attachment accuracy and wear.
The goal is to identify which attachment design provides greater precision and durability to improve the predictability and efficiency of Invisalign treatment planning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimized | Active Comparator | Optimized attachments are small, tooth-colored composite bumps placed on teeth during Invisalign treatment to help aligners deliver controlled forces for tooth movement. These attachments are digitally designed in the ClinCheck software to optimize force direction and retention. In this arm, optimized attachments will be bonded according to the manufacturer's standard template and curing protocols. Their bonded geometry and wear over time will be compared to those of conventional attachments placed on the contralateral teeth. |
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| Conventional | Active Comparator | Conventional attachments are tooth-colored composite bumps placed on teeth during Invisalign treatment to improve aligner retention and control tooth movement. These attachments are designed with standard rectangular or ellipsoid shapes, following established clinical templates. In this arm, conventional attachments will be bonded using manufacturer-recommended materials and curing protocols. Their placement accuracy and wear characteristics will be compared to those of optimized attachments placed on the contralateral teeth within the same participant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Composite Aligner Attachment | Device | Composite aligner attachments are small, tooth-colored resin bumps bonded to specific teeth during Invisalign treatment to enhance aligner retention and force application. These attachments are digitally planned in ClinCheck software and fabricated using manufacturer-provided templates. In this study, two designs: optimized and conventional, will be compared for their accuracy and durability using 3D digital scans at multiple time points. |
| Measure | Description | Time Frame |
|---|---|---|
| Attachment Volume Accuracy | Quantitative comparison of planned versus bonded Invisalign attachment volumes measured using 3D (three dimensional) digital scans. Each bonded attachment will be segmented from intraoral STL (Standard Tessellation Language) files and superimposed onto the corresponding planned ClinCheck model. The absolute difference in attachment volume (in mm³) between planned and bonded models will be calculated to assess bonding accuracy for optimized and conventional designs. | 1 month |
| Attachment Active Surface Area Accuracy | Quantitative difference in attachment active surface area using intraoral 3D scans. STL models obtained at baseline (immediately after bonding) and at 1 month will be superimposed to calculate difference in active surface area (mm²). The mean difference between planned and bonded surface areas will be compared for optimized and conventional attachment designs to evaluate bonding precision. | 1 month |
| Positional Accuracy | Difference between planned and bonded attachment position, measured as centroid displacement (mm) after 3D registration of STL models at baseline and 1 month. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Volume Reduction Over Time | Quantitative change in attachment volume across follow-up using serial intraoral 3D scans. STL models acquired at baseline (immediately after bonding), 1, 3, and 6 months will be superimposed to calculate absolute loss in attachment volume (mm³) for optimized and conventional designs. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland School of Dentistry | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40778386 | Background | Muthuswamy Pandian S, Subramanian AK, Vaiid N. Comparison of efficacy and accuracy of tooth movements in optimized and conventional attachments of clear aligners - A systematic review and meta-analysis. J Oral Biol Craniofac Res. 2025 Sep-Oct;15(5):1123-1133. doi: 10.1016/j.jobcr.2025.07.019. Epub 2025 Jul 29. | |
| 38369617 | Background |
| Label | URL |
|---|---|
| Invisalign Attachments explanation | View source |
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De-identified individual participant data (IPD), including attachment type, attachment volume, surface deviation, and changes in attachment shape and wear over time, will be shared upon reasonable request. Supporting materials such as the data dictionary, study protocol, statistical analysis plan, informed consent form, and computational methods for volumetric evaluation in MeshMixer will also be made available to qualified researchers for further analysis.
November 2025-July 2028
De-identified individual participant data (IPD) and supporting documents will be available to qualified researchers upon reasonable request to the Principal Investigator, following approval under the University of Maryland data governance policy.
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This is a prospective, randomized split-mouth (crossover) study evaluating two types of Invisalign attachments: optimized and conventional. Each participant receives both attachment types on contralateral teeth, allowing within-subject comparison of placement accuracy and wear under identical clinical conditions.
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|
| Volume Loss (Percentage) |
Relative change in attachment volume expressed as a percentage of the baseline volume. STL models from baseline, 1, 3, and 6 months will be analyzed to calculate mean percent reduction (%) in attachment volume for optimized and conventional designs. |
| 6 months |
| Active Surface Area Change Over Time | Longitudinal change in the active surface area of bonded attachments measured from serial intraoral 3D scans. Segmented STL models at baseline (immediately after bonding), 1, 3, and 6 months will be registered to compute absolute change in active surface area (mm²) for optimized and conventional designs. | 6 months |
| Active Surface Area Change (Percentage) | Relative change in attachment active surface area expressed as a percentage of the baseline value. STL models obtained at baseline and at 1, 3, and 6 months will be analyzed to calculate mean percent reduction (%) in active surface area for optimized and conventional attachments. | 6 months |
| Li Q, Yang K. Surface wear of attachments in patients during clear aligner therapy: a prospective clinical study. Prog Orthod. 2024 Feb 19;25(1):7. doi: 10.1186/s40510-023-00506-y. |
| 37314488 | Background | Fausto da Veiga Jardim A, Curado de Freitas J, Estrela C. Surface wear and adhesive failure of resin attachments used in clear aligner orthodontic treatment. J Orofac Orthop. 2024 May;85(Suppl 1):52-62. doi: 10.1007/s00056-023-00471-5. Epub 2023 Jun 14. |
| 37895792 | Background | Bellocchio AM, Portelli M, Ciraolo L, Ciancio E, Militi A, Peditto M, Barbera S, Nucera R. Evaluation of the Clinical Variables Affecting Attachment Reproduction Accuracy during Clear Aligner Therapy. Materials (Basel). 2023 Oct 23;16(20):6811. doi: 10.3390/ma16206811. |