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Trial registered on ANZCTR


Registration number
ACTRN12613000687796
Ethics application status
Not yet submitted
Date submitted
18/06/2013
Date registered
24/06/2013
Date last updated
24/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Predictability of Increasing Tooth Velocity using Invisalign Aligners in a Group of Teenage Subjects
Scientific title
A randomised controlled trial evaluating the predictability of increasing tooth velocity using Invisalign aligners in a group of teenagers requiring orthodontic treatment
Secondary ID [1] 282695 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accuracy of tooth movement after increasing the velocity of tooth movement from 0.25mm - 0.5mm per fortnight 289408 0
Condition category
Condition code
Other 289733 289733 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clear orthodontic aligners (Invisalign) moving teeth at a rate of either 0.25mm or 0.5mm per fortnight

Test subjects - Aligners will be programmed using Invisalign Clincheck software with activations to move premolars and the anterior dentition at 0.5mm per fortnight per set of aligners. Aligners will be delivered to the patient and expected to be worn 22 hours a day. Appointments will be made every six weeks to deliver the next three sets of aligners. Each set of aligners will be changed sequentially every 2 weeks.
At every six week appointment an intra oral iTero optical scan will be taken of each arch

Participants will be asked to keep a diary of the amount of time spent without aligners in their mouth to monitor adherence to the protocol.

Total duration of study/intervention depends on the individual severity of the case/malocclusion. Typically an orthodontic case takes 18-24 months to treat. This will be the total duration of the study.
Intervention code [1] 287356 0
Treatment: Devices
Comparator / control treatment
Control subjects - Aligners will be programmed using Invisalign Clincheck software with activations to move premolars and the anterior dentition at the current default of 0.25mm per fortnight per set of aligners. Aligners will be delivered to the patient and expected to be worn 22 hours a day. Appointments will be made every six weeks to deliver the next three sets of aligners. At every six week appointment an intra oral iTero optical scan will be taken of each arch
Control group
Active

Outcomes
Primary outcome [1] 289823 0
Clinical accuracy of the Invisalign(TM) orthodontic aligner system (Align Technology, California, USA) when teeth are moved at a rate 0.5mm per fortnight, per set of aligners

The study will assess the amount of tooth movement achieved by superimposing the computer-proposed tooth movements with actual clinical tooth movement
Timepoint [1] 289823 0
Intra oral 3D photo every 6 weeks until orthodontic treatment is finished
Secondary outcome [1] 303320 0
Clinical accuracy of the Invisalign(TM) orthodontic aligner system (Align Technology, California, USA) when teeth are moved at a rate 0.25mm per fortnight, per set of aligners

The study will assess the amount of tooth movement achieved by superimposing the computer-proposed tooth movements with actual clinical tooth movement
Timepoint [1] 303320 0
Intra oral 3D photo every 6 weeks until treatment finished

Eligibility
Key inclusion criteria
Teenage subjects (aged 13-19 years) requiring orthodontic treatment and deemed suitable for Invisalign (i.e. good oral hygiene, compliant and willing to wear aligners for 22 hours a day) will be eligible to participate. To be included, subjects must be in good general health, non-smokers and have a healthy dentition with all permanent teeth present (except third molars). Parents and potential subjects will be advised of the project and given the option to participate in the study
Minimum age
13 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children who are regular users of NSAIDS, steroid medication, or medication that may influence bone metabolism or bone physiology will be excluded. Pregnant patients will also be excluded

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 is not concealed

A sample of 40 consecutive subjects from one specialist orthodontic practice who meet the inclusion/exclusion requirements and consent to the study will be selected
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated sequence will be used to randomly allocate the teenagers into the control or treatment group and will ensure there is the same number of subjects in each group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
A sample of 40 (20 treatment and 20 controls) will be assessed

The minimum sample size for this study was determined using SPSS Sample Power. Calculations were based on the main variable to be tested - a comparison of predicted and actual tooth movement measured from cusp tips of the specific tooth. With a sample of 16 subjects per group the study will have a power of 80% and level of confidence set at 0.05. This means there is an 80% likelihood that the study will yield a statistically significant effect; and hence will determine if the mean dental movement achieved clinically differs from that estimated by ClinCheck. This figure is based on the assumption that the Invisalign system will achieve 80% of predicted dental movement with a standard deviation of 30%. 40 participants will be recruited for the study allowing for four to drop out (a 13% dropout rate).

Multiple measurements will be taken per patient (ten data points per arch, twenty data points per patient), increasing the data available to measure to a sample of 400 points. This will allow for an increase in confidence interval or power levels.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287464 0
Commercial sector/Industry
Name [1] 287464 0
Align Technology
Country [1] 287464 0
United States of America
Primary sponsor type
University
Name
University of Melbourne, School of Dentistry
Address
720 Swanston Street
Carlton,
VIC 3053
Country
Australia
Secondary sponsor category [1] 286208 0
Individual
Name [1] 286208 0
Dr Vicki Vlaskalic
Address [1] 286208 0
V Orthodontics, 870 Toorak Rd, Hawthorn East, VIC 3123
Country [1] 286208 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289439 0
University of Melbourne - School of Dentistry
Ethics committee address [1] 289439 0
Ethics committee country [1] 289439 0
Australia
Date submitted for ethics approval [1] 289439 0
24/04/2013
Approval date [1] 289439 0
Ethics approval number [1] 289439 0
1238666

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

Contacts
Principal investigator
Name 40866 0
A/Prof Paul Schneider
Address 40866 0
University of Melbourne
School of Dentistry, Orthodontic department
720 Swanston Street
Carlton
VIC 3053
Country 40866 0
Australia
Phone 40866 0
+61 3 9341 1500
Fax 40866 0
Email 40866 0
[email protected]
Contact person for public queries
Name 40867 0
Margaret Wang
Address 40867 0
University of Melbourne
School of Dentistry, Orthodontic department
720 Swanston Street
Carlton
VIC 3053
Country 40867 0
Australia
Phone 40867 0
+61 3 9341 1073
Fax 40867 0
Email 40867 0
[email protected]
Contact person for scientific queries
Name 40868 0
Margaret Wang
Address 40868 0
University of Melbourne
School of Dentistry, Orthodontic department
720 Swanston Street
Carlton
VIC 3053
Country 40868 0
Australia
Phone 40868 0
+61 3 9341 1073
Fax 40868 0
Email 40868 0
[email protected]

No information has been provided regarding IPD availability


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.