Effects of Invisalign Palatal Expander System

University of the Pacific

Status: Enrolling

Conditions: Palatal Expansion Technique

Treatments: Device: HE; Device: IPE

Study type: Interventional

Funder types: Other

Identifiers

NCT06414863

2024-43

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Invisalign® Palatal Expander System

Experimental group

Description:

Invisalign® Palatal Expander System will be delivered.

Treatment:

Device: IPE

Hyrax-type maxillary expander

Active Comparator group

Description:

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

Treatment:

Device: HE