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Procedure

Invisalign Expander for Palate Expansion

N/A
Recruiting
Led By Heeyeon Suh
Research Sponsored by University of the Pacific
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Mixed dentition phase with at least three nonmobile (stable) teeth which have more than 1/4 of primary molar root length left in either side
Patients diagnosed with transverse maxillary deficiency (Skeletal transverse discrepancy measured from the estimated center of resistances of the first molars ≤ - 3 mm)
Must not have
Mixed dentition patients with more than 2 heavily restored primary second or permanent first molars
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-18 months
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to see if the Invisalign Palatal Expander system works well for growing patients. They will compare how well this system works to traditional treatments in a randomized controlled trial."

Who is the study for?
This trial is for patients with a narrow upper jaw presenting as unilateral or bilateral posterior crossbite, who are in the mixed or early permanent dentition phase without fully erupted second molars. Participants must have stable teeth and be willing to consent. Those with craniofacial anomalies, Class III skeletal profile, or significant health issues affecting treatment are excluded.
What is being tested?
The study evaluates the Invisalign Palatal Expander system's effectiveness in growing patients compared to conventional palatal expansion techniques. It's a randomized controlled trial which means participants will be randomly assigned to receive either the new Invisalign system or standard treatment.
What are the potential side effects?
While specific side effects aren't detailed here, orthodontic treatments like palatal expanders can cause discomfort, pressure sensation on teeth and jaws, minor speech alterations, and may affect eating habits temporarily.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least three stable teeth with enough root left.
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I have been diagnosed with a narrow upper jaw.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have more than two heavily filled baby or adult molars.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Arch width change
Width change
Secondary study objectives
Cephalometric changes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Invisalign® Palatal Expander SystemExperimental Treatment1 Intervention
Invisalign® Palatal Expander System will be delivered.
Group II: Hyrax-type maxillary expanderActive Control1 Intervention
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

Find a Location

Who is running the clinical trial?

University of the PacificLead Sponsor
15 Previous Clinical Trials
886 Total Patients Enrolled
Heeyeon SuhPrincipal InvestigatorUniversity of the Pacific
~80 spots leftby May 2028
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