Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000239460
Ethics application status
Approved
Date submitted
19/11/2024
Date registered
2/04/2025
Date last updated
2/04/2025
Date data sharing statement initially provided
2/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of contemporary expander appliances compared with conventional expander plates.
Scientific title
Efficacy of novel maxillary expansion device compared with rapid maxillary expansion appliances: a randomised clinical controlled trial in participants aged 9-14.
Secondary ID [1] 313314 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Maxillary transverse discrepancy 335797 0
Condition category
Condition code
Oral and Gastrointestinal 332374 332374 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clear aligner expanders are removed and replaced at home with sequentially expanded appliances, oral hygiene practices are not altered when using clear aligners.
The intervention will be delivered by orthodontists and orthodontic registrars. The duration of the intervention is 273 days +/- 3 days from the first visit after enrolment and will take place at Sydney Dental Hospital Orthodontic Department
Clear aligner appliances will not seat if the participant has not adhered to the treatment plan. Participants will be given a self-compliance survey at each visit following the first visit.
Intervention code [1] 329989 0
Treatment: Devices
Comparator / control treatment
Rapid maxillary expansion appliances are cemented to the molar teeth. The rapid maxillary expanders are adjusted at home by the participant using a key which expands the device. Oral hygiene practices continue around the rapid maxillary expanders in situ.
Rapid maxillary expansion appliances are measured to show the expansion progress.
Control group
Active

Outcomes
Primary outcome [1] 339930 0
Dentoskeletal effects of maxillary expander appliances shown as changes in palatal volume.
Timepoint [1] 339930 0
Baseline and 30 weeks following commencement of treatment
Secondary outcome [1] 445498 0
Molar crown tipping between pre- and post-expansion treatment records.
Timepoint [1] 445498 0
Baseline and 30 weeks following commencement of treatment
Secondary outcome [2] 445497 0
Transverse correction achieved between pre- and post-expansion treatment records.
Timepoint [2] 445497 0
Baseline and 30 weeks following commencement of treatment
Secondary outcome [3] 441952 0
Appliance comfort and compliance as composite secondary outcomes.
Timepoint [3] 441952 0
At baseline and 30 weeks after commencement of treatment.

Eligibility
Key inclusion criteria
1. Active and pre-pubertal growth (Cervical maturation stage CS 2-3.)
2. Erupted maxillary first premolars and permanent first molars.
3. Evidence of dental maxillary transverse discrepancy:
a. Md excess >2mm.
b. Unilateral or bilateral transverse crossbite.
c. Medially tipped maxillary clinical crowns.
4. Willingness to provide informed consent (parent/guardian) and comply with the study requirements.
Minimum age
9 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Syndromic individuals (including cleft lip and palate (CLP))
2. Deciduous first molars, severe crowding, hypodontia.
3. Temporomandibular joint disorder signs and symptoms
4. Previous Orthodontic treatment
5. Circumstances/conditions which may interfere with the participant’s ability to give informed consent.

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)
Randomly allocated by an independent biostatistician
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
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
3/04/2025
Actual
Date of last participant enrolment
Anticipated
31/05/2025
Actual
Date of last data collection
Anticipated
19/06/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317760 0
Hospital
Name [1] 317760 0
Sydney Dental Hospital
Country [1] 317760 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ZHEJIANG YINCHILI MEDICAL TECHNOLOGY CO LTD (Shanghai Smartee Denti-Technology Co., Ltd)
Address
Country
China
Secondary sponsor category [1] 320081 0
Commercial sector/Industry
Name [1] 320081 0
Align Technology Inc
Address [1] 320081 0
Country [1] 320081 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316453 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 316453 0
Ethics committee country [1] 316453 0
Australia
Date submitted for ethics approval [1] 316453 0
16/09/2024
Approval date [1] 316453 0
07/03/2025
Ethics approval number [1] 316453 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137934 0
Prof M. Ali Darendeliler
Address 137934 0
Sydney Dental Hospital, 2 Chalmers St, Surry Hills, NSW 2010
Country 137934 0
Australia
Phone 137934 0
+61 2 8336 0625
Fax 137934 0
Email 137934 0
[email protected]
Contact person for public queries
Name 137935 0
Dr Sophie De Casabianca
Address 137935 0
Sydney Dental Hospital, 2 Chalmers St, Surry Hills, NSW 2010
Country 137935 0
Australia
Phone 137935 0
+61 2 8336 0625
Fax 137935 0
Email 137935 0
[email protected]
Contact person for scientific queries
Name 137936 0
Dr Sophie De Casabianca
Address 137936 0
Sydney Dental Hospital, 2 Chalmers St, Surry Hills, NSW 2010
Country 137936 0
Australia
Phone 137936 0
+61 2 8336 0625
Fax 137936 0
Email 137936 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: De-identified data will only be provided in publication, in line with ethics application.



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.