RecruitingNot ApplicableNCT06414863

Effects of Invisalign Palatal Expander System

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


Sponsor

University of the Pacific

Enrollment

120 participants

Start Date

May 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 14 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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.

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Interventions

DEVICEIPE

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

DEVICEHE

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(1)

University of the Pacific

San Francisco, California, United States

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NCT06414863


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