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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 6 Years and 14 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 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 2. Early permanent dentition stage and early permanent dentition but second permanent molars not yet fully erupted in the arch 3. 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); 4. Patients with Class I or Class II skeletal relationship 5. Subjects willing to consent to the trial

Exclusion Criteria

  1. Any general medical health problems which may influence treatment 2. Any craniofacial anomalies 3. Skeletal Class III patients 4. Mixed dentition patients with more than 2 heavily restored primary second or permanent first molars.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Invisalign® Palatal Expander System 		Invisalign® Palatal Expander System will be delivered.
  • Device: IPE
    Invisalign palatal expander system: The Invisalign® Palatal Expander System (AlignTechnology, inc.) is 3D-printed orthodontic device for maxillary expansion.
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
  • 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

Recruiting Locations

University of the Pacific
San Francisco, California 94103
Contact:
Heeyeon Suh
415-351-7134
hsuh1@pacific.edu

More Details

Status
Recruiting
Sponsor
University of the Pacific

Study Contact

Heeyeon Suh
415-351-7134
hsuh1@pacific.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.