Recruiting

Invisalign

Sponsor:

University of the Pacific

Code:

NCT06414863

Conditions

Palatal Expansion Technique

Eligibility Criteria

Sex: All

Age: 6 - 14

Healthy Volunteers: Not accepted

Interventions

IPE

HE

Study Details

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

Palatal Expansion Technique

Study ID

NCT06414863

Start date

May 10, 2024

Status verified date

May, 2024

Completion date

May 10, 2034

Anticipated

Primary completion date

May 10, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 14

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Invisalign® Palatal Expander System

Invisalign® Palatal Expander System will be delivered.

active comparator: 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

Interventions

IPE

Invisalign palatal expander system:

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

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

Primary outcome measure

  • Width change [ Time Frame: 12-18 months ]
  • Arch width change [ Time Frame: 12-18 months ]

Central Contacts and Locations

Central contacts

Heeyeon Suh

415-351-7134hsuh1@pacific.edu

Locations

University of the Pacific

Recruiting

San Francisco, California, United States, 94103

Contacts

Heeyeon Suh

415-351-7134hsuh1@pacific.edu

More Information

Sponsor

University of the Pacific

Last update posted

May 16, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of the Pacific on 2024-05-16.