## Protocol Section
### Identification Module
**NCT ID:** NCT06414863

**Brief Title:** Effects of Invisalign Palatal Expander System

**Official Title:** Treatment Effects of Invisalign Palatal Expander System and Hyrax Palatal Expander - A Randomized Controlled Trial

#### Organization Study ID Info
**ID:** 2024-43
#### Organization
**Class:** OTHER
**Full Name:** University of the Pacific
### Status Module
#### Completion Date
**Date:** 2034-05-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2028-05-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-10

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of the Pacific

#### Responsible Party

**Investigator Affiliation:** University of the Pacific

**Investigator Full Name:** Heeyeon Suh

**Investigator Title:** Assistant professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Palatal Expansion Technique

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Invisalign® Palatal Expander System will be delivered.

**Intervention Names:**

- Device: IPE

**Label:** Invisalign® Palatal Expander System

**Type:** EXPERIMENTAL

#### Arm Group 2

**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

**Intervention Names:**

- Device: HE

**Label:** Hyrax-type maxillary expander

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Invisalign® Palatal Expander System

**Description:** Invisalign palatal expander system:

The Invisalign® Palatal Expander System (AlignTechnology, inc.) is 3D-printed orthodontic device for maxillary expansion.

**Name:** IPE

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Hyrax-type maxillary expander

**Description:** 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

**Name:** HE

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Transverse changes on CBCTs

**Measure:** Width change

**Time Frame:** 12-18 months

**Description:** Arch width change measured on digital study casts

**Measure:** Arch width change

**Time Frame:** 12-18 months

#### Secondary Outcomes

**Description:** Common Cephalometric measurements changes on CBCT analysis

**Measure:** Cephalometric changes

**Time Frame:** 12-18 months

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 14 Years

**Minimum Age:** 6 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hsuh1@pacific.edu

**Name:** Heeyeon Suh

**Phone:** 415-351-7134

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** San Francisco

**Contacts:**

***Contact 1:***

- **Email:** hsuh1@pacific.edu

- **Name:** Heeyeon Suh

- **Phone:** 415-351-7134

- **Role:** CONTACT

**Country:** United States

**Facility:** University of the Pacific

**State:** California

**Status:** RECRUITING

**Zip:** 94103

#### Overall Officials

**Official 1:**

**Affiliation:** University of the Pacific

**Name:** Heeyeon Suh

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
