Split-Mouth Comparison of Invisalign Attachments
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- University of Maryland, Baltimore
- Study ID
- NCT07215598
- Status
- Enrolling By Invitation
Conditions
- Clear Aligner Appliance
- Volume Assessment
- Wear, Restoration
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Composite Aligner Attachment — DEVICEComposite 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.
Study Details
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.
Key Dates
- Start date
- Nov 20, 2025
- Status verified
- Jan 2026
- Primary completion
- Jul 31, 2028
- Completion
- Jul 31, 2028
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Active Comparator: OptimizedOptimized 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.
- Active Comparator: ConventionalConventional 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.
Primary Outcome Measure
Attachment Volume Accuracy [ Time Frame: 1 month ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Maryland School of Dentistry | Baltimore | Maryland | 21201 | - |