NCT06414863

Effects of Invisalign Palatal Expander System

Treatment Effects of Invisalign Palatal Expander System and Hyrax Palatal Expander - A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of the Pacific · Academic / Other
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the effectiveness of Invisalign Palatal Expander system ingrowing patients. This study compares the treatment outcomes of Invisalign Palatal Expander system to conventional treatments through randomized controlled trial.

Conditions

• Palatal Expansion Technique

Interventions

Type	Name	Description
DEVICE	IPE	Invisalign palatal expander system: The Invisalign® Palatal Expander System (AlignTechnology, inc.) is 3D-printed orthodontic device for maxillary expansion.
DEVICE	HE	Hyrax expander: The Hyrax-type maxillary expander will include a midline self-locking screw. The expansion screw is connected to the conventional molar bands or printed clasps, which are cemented on the maxillary first molars (or on the maxillary primary second molars), via 0.9 mm stainless-steel wire. The framework is soldered to the bands and extends on the palatal side to the primary canines or canines. The expander will be fabricated by a qualified laboratory technician

Timeline

• Start date: 2024-05-10
• Primary completion: 2028-05-10
• Completion: 2034-05-10
• First posted: 2024-05-16
• Last updated: 2024-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study