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

NCT06814262 | Recruiting

• 1 other identifier: HM20031880
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orthodontic Appliance Complication

Keywords

Extrusion of Maxillary Lateral Incisors; Clear Aligner Attachment

Outcome Measures

Primary Outcomes (1)

• Determine which of three different attachment sizes offers more predictable extrusion of maxillary lateral incisors in subjects treated with clear aligners compared

  The aim of this prospective, randomized controlled trial is to determine which of three different attachment sizes (gingivally beveled 1x1x3 mm, gingivally beveled 1x1x4 mm, or gingivally beveled 1x1x5 mm) offers more predictable extrusion of maxillary lateral incisors in patients treated with clear aligners compared to control.

  baseline until the clear aligner treatment is completed at 20 to 25 weeks

Secondary Outcomes (1)

• Evaluate the accuracy of ClinCheck software

  baseline until the clear aligner treatment is completed at 20 to 25 weeks

Study Arms (4)

Control/optimized for extrusion.aligners

PLACEBO COMPARATOR

The control will be Invisalign's optimized attachment which will be specifically optimized for extrusion.

Device: Corresponding treatment order in the prescription with Align Technology; Device: Superimposition of final and initial positions of lateral incisors: Predicted model

Gingivally beveled 1x1x3mm aligners

EXPERIMENTAL

Each set of aligners would be worn for a week/gingivally beveled 1x1x3mm

Device: Corresponding treatment order in the prescription with Align Technology; Device: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x3mm aligners

Gingivally beveled 1x1x4mm aligners

EXPERIMENTAL

Each set of aligners would be worn for a week/gingivally beveled 1x1x4mm

Device: Corresponding treatment order in the prescription with Align Technology; Device: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x4mm aligners

Gingivally beveled 1x1x5mm aligners

EXPERIMENTAL

Each set of aligners would be worn for a week/gingivally beveled 1x1x5mm

Device: Corresponding treatment order in the prescription with Align Technology; Device: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x5mm aligners

Interventions

Corresponding treatment order in the prescription with Align Technology DEVICE

Treating orthodontist placing the corresponding order in the prescription with Align Technology.

Control/optimized for extrusion.aligners; Gingivally beveled 1x1x3mm aligners; Gingivally beveled 1x1x4mm aligners; Gingivally beveled 1x1x5mm aligners

Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x4mm aligners DEVICE

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.

Gingivally beveled 1x1x4mm aligners

Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x5mm aligners DEVICE

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.

Gingivally beveled 1x1x5mm aligners

Superimposition of final and initial positions of lateral incisors: Predicted model DEVICE

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

Control/optimized for extrusion.aligners

Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x3mm aligners DEVICE

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.

Gingivally beveled 1x1x3mm aligners

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients treated with either Comprehensive Invisalign or Invisalign Teen treatment
• The maxillary arch has less than 6 mm of crowding or spacing
• Maxillary lateral incisors have a minimum of 0.3 mm of extrusion prescribed in the Tooth Movement Table on the Invisalign ClinCheck for the first set of aligners
• Maxillary lateral incisors within a normal range of bucco-lingual inclination
• Patients 12 years of age or older and either the patient or legal guardian are able to give consent
• Patients confirm good compliance throughout the study period

You may not qualify if:

• Patients do not complete all aligners in the first phase as prescribed
• Poor compliance recorded for aligner wear
• Restorations placed or oral surgery completed prior to final scan
• Midcourse intervention to improve tracking such as a bootstrap
• Maxillary lateral incisors not tracking and noted by minimum of 1 mm of aligner material incisally displaced when aligner fully seated
• Treatment plans include surgery or extractions
• Maxillary lateral incisors with pathology and restorations
• Missing teeth other than third molars
• Patients with anterior crossbite

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Study Officials

• Steven Lindauer

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexis Catalano

CONTACT

(202) 560-0496; catalanoam2@vcu.edu

Steven Lindauer

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: March 31, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)