Effects of Invisalign Palatal Expander System

NCT06414863 | Recruiting FDA Device

• 1 other identifier: 2024-43
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Width change

  Transverse changes on CBCTs

  12-18 months

• Arch width change

  Arch width change measured on digital study casts

  12-18 months

Secondary Outcomes (1)

• Cephalometric changes

  12-18 months

Study Arms (2)

Invisalign® Palatal Expander System

EXPERIMENTAL

Invisalign® Palatal Expander System will be delivered.

Device: IPE

Hyrax-type maxillary expander

ACTIVE COMPARATOR

Hyrax-type maxillary expander will be delivered. The Hyrax-type maxillary expander will include a midline self-locking screw, which 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

Device: HE

Interventions

IPE DEVICE

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

Invisalign® Palatal Expander System

HE DEVICE

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

Hyrax-type maxillary expander

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Early permanent dentition stage and early permanent dentition but second permanent molars not yet fully erupted in the arch
• 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);
• Patients with Class I or Class II skeletal relationship
• Subjects willing to consent to the trial

You may not qualify if:

• Any general medical health problems which may influence treatment
• Any craniofacial anomalies
• Skeletal Class III patients
• Mixed dentition patients with more than 2 heavily restored primary second or permanent first molars.

Sponsors & Collaborators

• University of the Pacific: lead

Study Sites (1)

University of the Pacific

San Francisco, California, 94103, United States

RECRUITING

Study Officials

• Heeyeon Suh

  University of the Pacific

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heeyeon Suh

CONTACT

415-351-7134; hsuh1@pacific.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 16, 2024
• Study Start: May 10, 2024
• Primary Completion (Estimated): May 10, 2028
• Study Completion (Estimated): May 10, 2034
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

US (1)