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

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What is being tested

IPE

+ HE

Device
Who is being recruted

From 6 to 14 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2024
See protocol details

Summary

Principal SponsorUniversity of the Pacific
Study ContactHeeyeon Suh
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 10, 2024

Actual date on which the first participant was enrolled.

This study focuses on understanding how well the Invisalign Palatal Expander system works for growing patients, compared to more traditional methods like the Hyrax Palatal Expander. The goal is to see if Invisalign can effectively help with expanding the palate in young people who are still growing. This research is important because it could offer a more comfortable and potentially more effective option for children who need palate expansion as part of their dental care. Participants in the study are randomly assigned to receive either the Invisalign Palatal Expander or the traditional Hyrax Palatal Expander. The treatment involves using these devices to expand the palate, a common procedure in orthodontics. The study evaluates how each system affects the growth and alignment of the palate over time, although specific outcomes measured are not detailed. By comparing the results, researchers aim to determine which method provides better outcomes for patients. The study is designed to ensure fairness and accuracy by randomly assigning treatments to participants.

Official TitleTreatment Effects of Invisalign Palatal Expander System and Hyrax Palatal Expander - A Randomized Controlled Trial
Principal SponsorUniversity of the Pacific
Study ContactHeeyeon Suh
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 to 14 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
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

Show More Criteria

4 exclusion criteria prevent from participating
Any craniofacial anomalies

Any general medical health problems which may influence treatment

Skeletal Class III patients

Mixed dentition patients with more than 2 heavily restored primary second or permanent first molars.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Invisalign® Palatal Expander System will be delivered.

Group II

Active Comparator
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of the Pacific

San Francisco, United StatesOpen University of the Pacific in Google Maps
Recruiting
One Study Center
Treatment Effects of Invisalign Palatal Expander System and Hyrax Palatal Expander - A Randomized Controlled Trial | PatLynk