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Recruiting NCT06414863

Effects of Invisalign Palatal Expander System

No phase Interventional Palatal Expansion Technique

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IPE, HE.
Who it may be relevant to
Registry conditions: Palatal Expansion Technique. Basic parameters: 6 years — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Width change [Time frame: 12-18 months]
  • Arch width change [Time frame: 12-18 months]
Secondary outcome measures (1)
  • Cephalometric changes [Time frame: 12-18 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of the Pacific — San Francisco

Identifiers

NCT: NCT06414863 · 2024-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗