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Trial registered on ANZCTR


Registration number
ACTRN12624001461583p
Ethics application status
Submitted, not yet approved
Date submitted
3/12/2024
Date registered
16/12/2024
Date last updated
16/12/2024
Date data sharing statement initially provided
16/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Influence of the clear aligner trimline on incisor tooth movement, and patient experiences during orthodontic treatment
Scientific title
Influence of the clear aligner trimline on incisor tooth movement, and patient experiences in adult patients (18-50 years of age) undergoing non-extraction orthodontic treatment
Secondary ID [1] 313468 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Orthodontic Malocclusion 335873 0
Condition category
Condition code
Oral and Gastrointestinal 332460 332460 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
Adult patients (18-50), receiving non-extraction clear aligner treatment will be prospectively recruited to the study. Patients will be asked to wear the aligners for 22 hours per day, on a 9 day interval. The aligners will be custom manufactured in sets of 3, with each set manufactured to either a straight, or scalloped trimline. The clear aligners utilised are TGA approved, commercially available, and the intended use in this project falls within the described scope and intended purpose of the device (ARTG Entry: 360731), (ClearCorrect TM; Straumann AG, Basel, Switzerland).

The diagnostic and digital treatment planning for the orthodontic tooth movement will be performed for each individual, in line with the therapeutic aims and goals of treatment. Auxiliary features such as bonded tooth attachments may be utilised; these are placed intra-orally at the commencement of treatment by tooth surface preparation with 37% phosphoric acid, bonding agent, and adhesive composite resin.

Block randomisation (n=4) will be done to assign participants to the start with the aligner of either the scalloped or straight aligner. After the initial 3 aligners, the subsequent set of 3 will be of the alternate design (e.g. Scalloped -> Straight -> Scalloped), a continuous manner (e.g. No cessation / break between designs). Patients will be consecutively recruited. The straight trimline aligner will serve as the intervention for this trial.

Participants will be recalled on a monthly basis for a clinical examination to assess the outcome of tooth movement for the particular set of aligners. This will be done by capturing 3D tooth positional data using a intra-oral scanner. The method is non-invasive and does not exposure participants to any ionising radiation. After the tooth position data is captured, patients will then progress to the first aligner of the subsequent design.

Patient comfort and satisfaction with the aligners will be assessed using validated qualify of life measures, including the OHIP-14 Questionnaire, and a visual analogue scale. These questionnaires will be repeated for each aligner design, to assess the patient's acceptance for each set of aligners.

The trial will end after a period of 4 months, or 2 sets of each aligner design. Orthodontic treatment will continue after this time point in a continuous manner, until treatment completion.

Treatment will be administered by specialist orthodontists, and specialist registrars.
Intervention code [1] 330040 0
Treatment: Devices
Comparator / control treatment
The control treatment consists of the same aligner (ClearCorrect), of a scalloped trimline. Participants will wear both the control and intervention aligner design throughout the study in a crossover design.

Control group
Active

Outcomes
Primary outcome [1] 340029 0
Incisor tooth movement outcomes as measured in 3D Intraoral scans of the dentition
Timepoint [1] 340029 0
Baseline (pre-intervention), Monthly scans after each set of 3 aligners
Secondary outcome [1] 442390 0
Patient Comfort and Acceptance of Aligners - This will be assessed as a composite outcome
Timepoint [1] 442390 0
The questionnaire will be completed on the first day of aligner wear, and additionally at the 9 day mark before changing to the next aligner (e.g. on the last day of wearing the first aligner).

This process is repeated when the patient switches to subsequent trimline design, at identical timepoints.

Eligibility
Key inclusion criteria
Adult patients (18-50 years of age) undergoing non-extraction orthodontic treatment with clear aligners
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Untreated periodontal disease
- Orthognathic surgery planned
- Other systemic diseases precluding orthodontic treatment

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)
Allocation concealment will be maintained by a individual not affiliated with the project, who will manage the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation (n=4)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317904 0
Charities/Societies/Foundations
Name [1] 317904 0
The Australian Society of Orthodontists' Foundation for Research and Education
Country [1] 317904 0
Australia
Funding source category [2] 317932 0
Commercial sector/Industry
Name [2] 317932 0
Straumann AG
Country [2] 317932 0
Switzerland
Primary sponsor type
Individual
Name
Professor Marie Cornelis - University of Melbourne, Melbourne Dental School
Address
Country
Australia
Secondary sponsor category [1] 320249 0
None
Name [1] 320249 0
Address [1] 320249 0
Country [1] 320249 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316594 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 316594 0
Ethics committee country [1] 316594 0
Australia
Date submitted for ethics approval [1] 316594 0
03/12/2024
Approval date [1] 316594 0
Ethics approval number [1] 316594 0

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

Contacts
Principal investigator
Name 138350 0
Prof Marie Cornelis
Address 138350 0
University of Melbourne, Melbourne Dental School, Orthodontic Department 720 Swanston Street Carlton VIC 3053
Country 138350 0
Australia
Phone 138350 0
+61 3 9341 1498
Fax 138350 0
Email 138350 0
marie.cornelis@unimelb.edu.au
Contact person for public queries
Name 138351 0
Dr Keishi Barnes
Address 138351 0
University of Melbourne, Melbourne Dental School, Orthodontic Department 720 Swanston Street Carlton VIC 3053
Country 138351 0
Australia
Phone 138351 0
+613 9035 8402
Fax 138351 0
Email 138351 0
kobarnes@student.unimelb.edu.au
Contact person for scientific queries
Name 138352 0
Marie Cornelis
Address 138352 0
University of Melbourne, Melbourne Dental School, Orthodontic Department 720 Swanston Street Carlton VIC 3053
Country 138352 0
Australia
Phone 138352 0
+61 3 9341 1498
Fax 138352 0
Email 138352 0
marie.cornelis@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified individual line-by-line data
When will data be available (start and end dates)?
Immediately following publication, no end date determined
Available to whom?
Researchers who provide a sound proposal
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Contact principal investigator via email marie.cornelis@unimelb.edu.au


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.