Health TrialsbyHealthPanel

Effects of Invisalign Palatal Expander System

ConditionPalatal Expansion Technique
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-14
SponsorUniversity of the Pacific

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Any general medical health problems which may influence treatment

Any craniofacial anomalies

Skeletal Class III patients

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • IPE

    Device

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

  • HE

    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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Invisalign® Palatal Expander SystemExperimental treatment 1 intervention
Group B: Hyrax-type maxillary expanderActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Width change

Transverse changes on CBCTs

Time frame
12-18 months
2

Arch width change

Arch width change measured on digital study casts

Time frame
12-18 months

Secondary outcomes

1

Cephalometric changes

Common Cephalometric measurements changes on CBCT analysis

Time frame
12-18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of the Pacific

Lead sponsor

Source ClinicalTrials.gov
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