Effects of Invisalign Palatal Expander System

NCT ID: NCT06414863

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-10

Study Completion Date

2034-05-10

Brief Summary

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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.

Detailed Description

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Conditions

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Palatal Expansion Technique

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Invisalign® Palatal Expander System

Invisalign® Palatal Expander System will be delivered.

Group Type EXPERIMENTAL

IPE

Intervention Type DEVICE

Invisalign palatal expander system:

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

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

Group Type ACTIVE_COMPARATOR

HE

Intervention Type DEVICE

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

Interventions

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IPE

Invisalign palatal expander system:

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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of the Pacific

OTHER

Sponsor Role lead

Responsible Party

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Heeyeon Suh

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heeyeon Suh

Role: PRINCIPAL_INVESTIGATOR

University of the Pacific

Locations

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University of the Pacific

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Heeyeon Suh

Role: CONTACT

415-351-7134

Facility Contacts

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Heeyeon Suh

Role: primary

415-351-7134

Other Identifiers

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2024-43

Identifier Type: -

Identifier Source: org_study_id

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