Split-Mouth Comparison of Invisalign Attachments

University of Maryland Baltimore (UMB)

Status: Not yet enrolling

Conditions: Wear, Restoration; Volume Assessment; Clear Aligner Appliance

Treatments: Device: Composite Aligner Attachment

Study type: Interventional

Funder types: Other

Identifiers

NCT07215598

HP-00115664

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged18 years or older.
• Patients initiating Invisalign treatment with planned composite attachments.
• Ability to provide written informed consent and agree to additional research intra-oral scans.
• Good oral hygiene and absence of active periodontal disease at enrollment.

Exclusion criteria

• Extensive dental restorations (composites, crowns, veneers) on study teeth that could interfere with attachment bonding.
• Enamel defects or severe wear on study tooth surfaces affecting bonding accuracy.
• Contraindications to digital intraoral scanning (e.g., severe gag reflex, metallic prostheses preventing accurate imaging).
• Severe tooth malposition that would compromise accurate attachment placement.
• Poor oral hygiene or active periodontal disease at enrollment and/or if the patient develops poor oral hygiene or active periodontal disease during treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Optimized

Active Comparator group

Description:

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.

Treatment:

Device: Composite Aligner Attachment

Conventional

Active Comparator group

Description:

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.

Treatment:

Device: Composite Aligner Attachment