Split-Mouth Comparison of Invisalign Attachments

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07215598
• Lead Sponsor: University of Maryland, Baltimore

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-07
• Study First Submitted QC: 2025-10-08
• Last Update Submitted: 2025-10-08
• Study First Posted: 2025-10-10
• Last Update Posted: 2025-10-10
• Study Start: 2025-11-01
• Primary Completion: 2028-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Attachment Volume Accuracy	1 month	Quantitative comparison of planned versus bonded Invisalign attachment volumes measured using 3D (three dimensional) digital scans. Each bonded attachment will be segmented from intraoral STL (Standard Tessellation Language) files and superimposed onto the corresponding planned ClinCheck model. The absolute difference in attachment volume (in mm³) between planned and bonded models will be calculated to assess bonding accuracy for optimized and conventional designs.
Attachment Active Surface Area Accuracy	1 month	Quantitative difference in attachment active surface area using intraoral 3D scans. STL models obtained at baseline (immediately after bonding) and at 1 month will be superimposed to calculate difference in active surface area (mm²). The mean difference between planned and bonded surface areas will be compared for optimized and conventional attachment designs to evaluate bonding precision.
Positional Accuracy	1 month	Difference between planned and bonded attachment position, measured as centroid displacement (mm) after 3D registration of STL models at baseline and 1 month.

Secondary Outcome Measures

Name	Time	Method
Volume Reduction Over Time	6 months	Quantitative change in attachment volume across follow-up using serial intraoral 3D scans. STL models acquired at baseline (immediately after bonding), 1, 3, and 6 months will be superimposed to calculate absolute loss in attachment volume (mm³) for optimized and conventional designs.
Active Surface Area Change Over Time	6 months	Longitudinal change in the active surface area of bonded attachments measured from serial intraoral 3D scans. Segmented STL models at baseline (immediately after bonding), 1, 3, and 6 months will be registered to compute absolute change in active surface area (mm²) for optimized and conventional designs.
Volume Loss (Percentage)	6 months	Relative change in attachment volume expressed as a percentage of the baseline volume. STL models from baseline, 1, 3, and 6 months will be analyzed to calculate mean percent reduction (%) in attachment volume for optimized and conventional designs.
Active Surface Area Change (Percentage)	6 months	Relative change in attachment active surface area expressed as a percentage of the baseline value. STL models obtained at baseline and at 1, 3, and 6 months will be analyzed to calculate mean percent reduction (%) in active surface area for optimized and conventional attachments.

Trial Locations

Locations (1)

University of Maryland School of Dentistry; 🇺🇸 Baltimore, Maryland, United States