NCT06814262

Effect of Clear Aligner Attachment Size on Extrusion of Maxillary Lateral Incisors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Orthodontic Appliance Complication

Interventions

Type	Name	Description
DEVICE	Corresponding treatment order in the prescription with Align Technology	Treating orthodontist placing the corresponding order in the prescription with Align Technology.
DEVICE	Superimposition of final and initial positions of lateral incisors: Predicted model	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
DEVICE	Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x3mm aligners	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.
DEVICE	Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x4mm aligners	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.
DEVICE	Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x5mm aligners	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.

Timeline

• Start date: 2025-03-31
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-02-07
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States