NCT07215598

Split-Mouth Comparison of Invisalign Attachments

Accuracy of Invisalign Attachments: A Split-Mouth Comparative Study of Optimized and Conventional Designs

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Wear, Restoration
• Volume Assessment
• Clear Aligner Appliance

Interventions

Type	Name	Description
DEVICE	Composite Aligner Attachment	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.

Timeline

• Start date: 2025-11-20
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2025-10-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study