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Orthodontic treatment has been revolutionized by clear aligner therapy, offering patients a more esthetic and comfortable alternative to traditional braces. In 1999, Align Technology introduced Invisalign. As Invisalign has increased in popularity and demand over the past two decades, clinical trials have shed light on the efficacy of Invisalign treatment. there have been changes in the Invisalign protocol such as introduction of SmartForce features in 2008, such as optimized attachments as well as the implementation of SmartTrack aligner material in 2011. Compared to conventional fixed orthodontic appliances, Invisalign cannot be adjusted on a visit-to visit basis. If ideal tooth movement has not been achieved after completion of the first sequence of aligners, additional trays, known as refinement trays, are required.
There are various expert theories regarding the most effective methods of extrusion and multiple studies performed in vitro to evaluate the efficacy of different attachment types on the extrusion of lateral incisors, however only one in vivo clinical trial exists. There is a need for more randomized clinical trials that evaluate the effectiveness of different attachment designs for achieving optimal extrusion of lateral incisors. By determining the most effective attachment size for maxillary lateral incisor extrusion, this study can help improve treatment outcomes for orthodontic treatment with clear aligners and serve as a guide to assist clinicians in selecting the most effective attachment design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control/optimized for extrusion.aligners | Placebo Comparator | The control will be Invisalign's optimized attachment which will be specifically optimized for extrusion. |
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| Gingivally beveled 1x1x3mm aligners | Experimental | Each set of aligners would be worn for a week/gingivally beveled 1x1x3mm |
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| Gingivally beveled 1x1x4mm aligners | Experimental | Each set of aligners would be worn for a week/gingivally beveled 1x1x4mm |
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| Gingivally beveled 1x1x5mm aligners | Experimental | Each set of aligners would be worn for a week/gingivally beveled 1x1x5mm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corresponding treatment order in the prescription with Align Technology | Device | Treating orthodontist placing the corresponding order in the prescription with Align Technology. |
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| Measure | Description | Time Frame |
|---|---|---|
| Determine which of three different attachment sizes offers more predictable extrusion of maxillary lateral incisors in subjects treated with clear aligners compared | The aim of this prospective, randomized controlled trial is to determine which of three different attachment sizes (gingivally beveled 1x1x3 mm, gingivally beveled 1x1x4 mm, or gingivally beveled 1x1x5 mm) offers more predictable extrusion of maxillary lateral incisors in patients treated with clear aligners compared to control. | baseline until the clear aligner treatment is completed at 20 to 25 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the accuracy of ClinCheck software | To evaluate the accuracy of ClinCheck software in predicting the three-dimensional final position of the lateral incisor following extrusion using the attachment designs tested. | baseline until the clear aligner treatment is completed at 20 to 25 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Lindauer | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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Randomized Controlled Trial
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| Superimposition of final and initial positions of lateral incisors: Predicted model | Device | Superimposition of final and initial positions of lateral incisors, two superimpositions will be completed. The pretreatment model will be superimposed with the predicted final model to establish the predicted movement of the maxillary lateral incisors |
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| Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x3mm aligners | Device | Superimposition of final and initial positions of lateral incisors, two superimpositions will be completed. The pretreatment model (Gingivally beveled 1x1x3mm aligners) will be superimposed with the posttreatment model to establish the actual movement of the maxillary lateral incisor. |
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| Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x4mm aligners | Device | Superimposition of final and initial positions of lateral incisors, two superimpositions will be completed. The pretreatment model (Gingivally beveled 1x1x4mm aligners) will be superimposed with the posttreatment model to establish the actual movement of the maxillary lateral incisor. |
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| Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x5mm aligners | Device | Superimposition of final and initial positions of lateral incisors, two superimpositions will be completed. The pretreatment model (Gingivally beveled 1x1x5mm aligners) will be superimposed with the posttreatment model to establish the actual movement of the maxillary lateral incisor. |
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