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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
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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
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Secondary ID [1]
312271
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Maxillary transverse deficiency
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Condition category
Condition code
Oral and Gastrointestinal
330654
330654
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0
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Normal oral and gastrointestinal development and function
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328730
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Treatment: Devices
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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).
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Control group
Active
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Outcomes
Primary outcome [1]
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Dentoskeletal effects in the transverse dimension
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Assessment method [1]
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Clinical (from intra-oral scan) and radiographic (width of split at intermaxillary suture after expansion)
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Timepoint [1]
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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).
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Secondary outcome [1]
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Patient discomfort levels
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Assessment method [1]
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Questionnaire - simple questionnaire designed specifically for this study, not validated
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Timepoint [1]
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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.
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Secondary outcome [2]
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Parent anxiety levels
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Assessment method [2]
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Questionnaire - simple questionnaire designed specifically for this study, not validated
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Timepoint [2]
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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.
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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
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Minimum age
6
Years
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Maximum age
10
Years
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Sex
Males
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Can healthy volunteers participate?
No
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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,
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/fax/computer
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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)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/12/2024
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Actual
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Date of last participant enrolment
Anticipated
28/02/2025
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Actual
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Date of last data collection
Anticipated
1/07/2025
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
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Primary sponsor type
University
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Name
Orthodontics Department at the Oral Health Centre of Western Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
318842
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Country [1]
318842
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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The University of Western Australia Human Research Ethics Committee
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Ethics committee address [1]
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http://www.research.uwa.edu.au/staff/human-research/welcome-to-HREO
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
315437
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04/10/2024
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Approval date [1]
315437
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Ethics approval number [1]
315437
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Richard Tien
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Address
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Orthodontics Department at the Oral Health Centre, 17 Monash Ave, Nedlands WA 6009
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Country
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Australia
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Phone
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+61 8 64577668
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
134695
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Richard Tien
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Address
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Orthodontics Department at the Oral Health Centre, 17 Monash Ave, Nedlands WA 6009
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Country
134695
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Australia
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Phone
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+61 8 6457 4400
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Fax
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Email
134695
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[email protected]
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Contact person for scientific queries
Name
134696
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Richard Tien
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Address
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Orthodontics Department at the Oral Health Centre, 17 Monash Ave, Nedlands WA 6009
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Country
134696
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Australia
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Phone
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+61 8 6457 4400
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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