Palatal Expansion Technique
Conditions
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.
Interventions
DEVICEIPE
Invisalign palatal expander system: The Invisalign® Palatal Expander System (AlignTechnology, inc.) is 3D-printed orthodontic device for maxillary expansion.
DEVICEHE
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
Sponsors
University of the Pacific
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Width change | 12-18 months | Transverse changes on CBCTs |
| Arch width change | 12-18 months | Arch width change measured on digital study casts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cephalometric changes | 12-18 months | Common Cephalometric measurements changes on CBCT analysis |
Countries
United States
Contacts
Primary ContactHeeyeon Suh
Outcome results
None listed