NCT05905224

Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol

A Randomized Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol on the Predictability of Orthodontic Tooth Movement

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

The hypothesis of this project is that replacing the current 7-day wear protocol with a 3-day wear protocol, while integrating less tooth movement per aligner (reduce the amount of activation per aligner) may produce more consistent and continues orthodontic forces, therefore, increase the predictability, accuracy and outcomes achieved for various types of tooth movements and enhance the rate of tooth movement with the Invisalign system

Detailed description

This randomized clinical trial aims to assess the effectiveness of increasing the frequency of change per aligner, within the standard of care, on the efficacy of achieving better treatment outcomes. We will study the influence of reducing the wear scheduled for Invisalign clear aligners, from 7-day change per aligner to 3-day change per aligner, on the predictability and accuracy of different orthodontic tooth movements by comparing the simulated predicted final outcomes to those achieved at the end of treatment between the two change protocols.

Conditions

• Orthodontic Tooth Movement

Interventions

Type	Name	Description
DEVICE	Invisalign 7-day wear protocol	Clear Aligners' (Invisalign, Align technology, San Jose, Calif) 7-day wear protocol
DEVICE	Invisalign 3-day wear protocol	Clear Aligners' (Invisalign, Align technology, San Jose, Calif) 3-day wear protocol

Timeline

• Start date: 2023-10-30
• Primary completion: 2027-12-01
• Completion: 2028-08-01
• First posted: 2023-06-15
• Last updated: 2025-11-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study