Effects of Invisalign Palatal Expander System

Palatal Expansion Technique Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06414863
• Other study ID #: 2024-43
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2024
• Est. completion date: May 10, 2034

Study information

• Verified date: May 2024
• Source: University of the Pacific
• Contact: Heeyeon Suh
• Phone: 415-351-7134
• Email: hsuh1[@]pacific.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 10, 2034
• Est. primary completion date: May 10, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

Inclusion criteria:

1. Mixed dentition phase with at least three nonmobile (stable) teeth which have more than 1/4 of primary molar root length left16 in either side

2. Early permanent dentition stage and early permanent dentition but second permanent molars not yet fully erupted in the arch

3. Unilateral or bilateral posterior cross bite patients; or Patients who have been diagnosed with transverse maxillary deficiency (Skeletal transverse discrepancy measured from the estimated center of resistances of the first molars17 = - 3 mm);

4. Patients with Class I or Class II skeletal relationship

5. Subjects willing to consent to the trial

Exclusion Criteria:

1. Any general medical health problems which may influence treatment

2. Any craniofacial anomalies

3. Skeletal Class III patients

4. Mixed dentition patients with more than 2 heavily restored primary second or permanent first molars.

Related Conditions & MeSH terms

• Palatal Expansion Technique

Intervention

Device:
• IPE
Invisalign palatal expander system: The Invisalign® Palatal Expander System (AlignTechnology, inc.) is 3D-printed orthodontic device for maxillary expansion.
• 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

Locations

Country	Name	City	State
United States	University of the Pacific	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of the Pacific

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Width change	Transverse changes on CBCTs	12-18 months
Primary	Arch width change	Arch width change measured on digital study casts	12-18 months
Secondary	Cephalometric changes	Common Cephalometric measurements changes on CBCT analysis	12-18 months