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NCT Number: NCT06414863

Effects of Invisalign Palatal Expander System

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.

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Key information

Conditions

Palatal Expansion Technique

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of the Pacific

San Francisco, California, 94103, United States

Location status: Recruiting

Location contact

Heeyeon Suh

CONTACT

[email protected]

415-351-7134

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Width change

    Time frame: 12-18 months

    Transverse changes on CBCTs

  2. Arch width change

    Time frame: 12-18 months

    Arch width change measured on digital study casts

Secondary outcomes

  1. Cephalometric changes

    Time frame: 12-18 months

    Common Cephalometric measurements changes on CBCT analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Heeyeon Suh

CONTACT

[email protected]

415-351-7134

Sponsors and collaborators

Lead sponsor

University of the Pacific

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2034
First posted
May 16, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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