None listed
Conditions
Brief summary
Invisalign has released a new 3D-printed product (Invisalign Palatal Expander System – IPES) to replace traditional jackscrew-based expander plates in children 6-11 years of age. Instead of relying on a jackscrew-type system to open the jaws, it involves sequential wear through a series of 3D-printed removable plates of progressively greater width. It has recently (early 2024) been launched in global markets, with relevant approval granted from regulatory bodies (TGA & FDA). It has been marketed as equally effective but more comfortable and stress-free to use compared to traditional metal jackscrew-based expansion plates. No external studies have validated these claims.
Interventions
Invisalign Palatal Expander System (IPES); a new system introduced by Invisalign in 2024. Treatment with the IPES involves sequentially wearing a series of custom clip-on removable appliances that progressively increase in width.
The patient/parent will remove/insert the device themselves. The participants will ~15 minutes (or more if the patient so requires) of training regarding the use of IPES by the treating orthodontic clinician, which is to the excellent standard that any orthodontic trea
Invisalign Palatal Expander System (IPES); a new system introduced by Invisalign in 2024. Treatment with the IPES involves sequentially wearing a series of custom clip-on removable appliances that progressively increase in width. The patient/parent will remove/insert the device themselves. The participants will ~15 minutes (or more if the patient so requires) of training regarding the use of IPES by the treating orthodontic clinician, which is to the excellent standard that any orthodontic treatment would be conducted. The IPES protocol will involve actively wearing the IPES for up to 1 month (depending on the amount of required expansion, but ~1 month will be the time period for most cases), followed by a period of retention where they will wear the customised retainers made by Align Technology. Removable plates will be changed DAILY as per recommended protocol by Align Technology, during active expansion. The participants will be seen by an orthodontist every 1-2 weeks to review the widening. Adherence will be based on self-report. Poor compliance with the IPES is of interest to study, as it is an inherent limitation of this device versus the gold standard unremovable expander.
Sponsors
Orthodontics Department at the Oral Health Centre of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
6 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
(1) palatal expansion treatment indicated, (2) age 6-11, (3) maxillary first permanent molars and deciduous molars present and stable, (4) maxillary first permanent molars and deciduous molars show greater than or equal to 4 mm clinical crown height, (5) good oral hygiene and healthy periodontal tissues
Exclusion criteria
no major dentofacial anomalies (such as cleft lip or palate or syndromic patients) no stainless steel crowns on second deciduous molars or first permanent molars,
Outcome results
None listed