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Trial registered on ANZCTR


Registration number
ACTRN12624001246572p
Ethics application status
Submitted, not yet approved
Date submitted
1/06/2024
Date registered
10/10/2024
Date last updated
10/10/2024
Date data sharing statement initially provided
10/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of the Invisalign Palatal Expander System versus conventional maxillary expander in widening the upper jaw in pre-adolescents
Scientific title
Transverse effects of the Invisalign Palatal Expander System versus rapid maxillary expander for treatment of maxillary transverse deficiency in pre-adolescents: A randomised control trial
Secondary ID [1] 312271 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Maxillary transverse deficiency 333988 0
Condition category
Condition code
Oral and Gastrointestinal 330654 330654 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328730 0
Treatment: Devices
Comparator / control treatment
Conventional rapid maxillary expansion treatment with hrax-type rapid maxillary expander (current gold standard).
This is an appliance that is fixed (cemented) into the mouth with an active component in the form of a jackscrew that is cranked by the parents with a key. The frequency and amount of activation is titrated based on clinical need (i.e. until there is some mild over-correction of the issue, expecting a degree of relapse to ideal).
Control group
Active

Outcomes
Primary outcome [1] 338405 0
Dentoskeletal effects in the transverse dimension
Timepoint [1] 338405 0
Pre-treatment (intraoral scan), after active expansion (approximately 30 days of IPES wear or 1-2 months of RME wear, depending on clinical need and patient compliance - e.g. patients who forget to turn the RME device on some days or incorrectly turn will require a longer period of active wear, and likewise patients who lose or forget to progress their IPES aligners will require longer periods. At this time, an intraoral scan +/- radiograph will be taken), after 3 months of retention (i.e. 90 days after active turning has ceased; the patient will not require any additional follow-up appointments between after active expansion and this 3-month retention check unless it is at the patient's request for review, or the patient is problematic with compliance, where monthly review may be suggested).
Secondary outcome [1] 435807 0
Patient discomfort levels
Timepoint [1] 435807 0
The questionnaire will be given
(1) At the insertion day of the expander appliance (pre-treatment), and
(2) After active expansion period of approximately 1-2 months, depending on clinical need and compliance of patient. This will vary for each patient.
This questionnaire will be given ONCE at each of these time points, and not repeated otherwise.
Secondary outcome [2] 440198 0
Parent anxiety levels
Timepoint [2] 440198 0
After active expansion period of approximately 1-2 months, depending on clinical need and compliance of patient. This will vary for each patient.
This questionnaire will be given ONCE at this time point, and not repeated otherwise.

Eligibility
Key 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
Minimum age
6 Years
Maximum age
10 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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,

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 316658 0
Self funded/Unfunded
Name [1] 316658 0
Country [1] 316658 0
Primary sponsor type
University
Name
Orthodontics Department at the Oral Health Centre of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 318842 0
None
Name [1] 318842 0
Address [1] 318842 0
Country [1] 318842 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315437 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 315437 0
http://www.research.uwa.edu.au/staff/human-research/welcome-to-HREO
Ethics committee country [1] 315437 0
Australia
Date submitted for ethics approval [1] 315437 0
04/10/2024
Approval date [1] 315437 0
Ethics approval number [1] 315437 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134694 0
Dr Richard Tien
Address 134694 0
Orthodontics Department at the Oral Health Centre, 17 Monash Ave, Nedlands WA 6009
Country 134694 0
Australia
Phone 134694 0
+61 8 64577668
Fax 134694 0
Email 134694 0
[email protected]
Contact person for public queries
Name 134695 0
Richard Tien
Address 134695 0
Orthodontics Department at the Oral Health Centre, 17 Monash Ave, Nedlands WA 6009
Country 134695 0
Australia
Phone 134695 0
+61 8 6457 4400
Fax 134695 0
Email 134695 0
[email protected]
Contact person for scientific queries
Name 134696 0
Richard Tien
Address 134696 0
Orthodontics Department at the Oral Health Centre, 17 Monash Ave, Nedlands WA 6009
Country 134696 0
Australia
Phone 134696 0
+61 8 6457 4400
Fax 134696 0
Email 134696 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.