RecruitingNot ApplicableNCT06814262

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


Sponsor

Virginia Commonwealth University

Enrollment

40 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 Years

Inclusion Criteria6

  • 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

Exclusion Criteria9

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICECorresponding treatment order in the prescription with Align Technology

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

DEVICESuperimposition of final and initial positions of lateral incisors: Predicted model

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

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

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.

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

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.

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

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.


Locations(1)

Virginia Commonwealth University

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06814262


Related Trials