Effects of Invisalign Palatal Expander System

Part of paid clinical trials in San Francisco, California.

Sponsor
University of the Pacific
Study ID
NCT06414863
Status
Recruiting
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Conditions

  • Palatal Expansion Technique

Eligibility Criteria

Sex
ALL
Age
6 Years - 14 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 10, 2024
Status verified
May 2024
Primary completion
May 10, 2028
Completion
May 10, 2034

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Invisalign® Palatal Expander System
    Invisalign® Palatal Expander System will be delivered.
  • Active Comparator: Hyrax-type maxillary expander
    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

Primary Outcome Measure

Width change [ Time Frame: 12-18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of the PacificSan FranciscoCalifornia94103
Heeyeon Suh
[email protected]
415-351-7134

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University of the Pacific· San Francisco, CA