Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
A randomised controlled trial evaluating the predictability of increasing tooth velocity using Invisalign aligners in a group of teenagers requiring orthodontic treatment
Query!
Secondary ID [1]
282695
0
Nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
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
Query!
Condition category
Condition code
Other
289733
289733
0
0
Query!
Research that is not of generic health relevance and not applicable to specific health categories listed above
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
287356
0
Treatment: Devices
Query!
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
Query!
Control group
Active
Query!
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
Query!
Assessment method [1]
289823
0
Query!
Timepoint [1]
289823
0
Intra oral 3D photo every 6 weeks until orthodontic treatment is finished
Query!
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
Query!
Assessment method [1]
303320
0
Query!
Timepoint [1]
303320
0
Intra oral 3D photo every 6 weeks until treatment finished
Query!
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
Query!
Minimum age
13
Years
Query!
Query!
Maximum age
19
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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
Query!
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.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
Query!
Type of endpoint/s
Query!
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.
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
1/07/2013
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
40
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Funding & Sponsors
Funding source category [1]
287464
0
Commercial sector/Industry
Query!
Name [1]
287464
0
Align Technology
Query!
Address [1]
287464
0
Align Technology, Inc. 2560 Orchard Parkway, San Jose, California 95131
Query!
Country [1]
287464
0
United States of America
Query!
Primary sponsor type
University
Query!
Name
University of Melbourne, School of Dentistry
Query!
Address
720 Swanston Street
Carlton,
VIC 3053
Query!
Country
Australia
Query!
Secondary sponsor category [1]
286208
0
Individual
Query!
Name [1]
286208
0
Dr Vicki Vlaskalic
Query!
Address [1]
286208
0
V Orthodontics, 870 Toorak Rd, Hawthorn East, VIC 3123
Query!
Country [1]
286208
0
Australia
Query!
Ethics approval
Ethics application status
Not yet submitted
Query!
Ethics committee name [1]
289439
0
University of Melbourne - School of Dentistry
Query!
Ethics committee address [1]
289439
0
720 Swanston Street
Carlton
VIC 3053
Query!
Ethics committee country [1]
289439
0
Australia
Query!
Date submitted for ethics approval [1]
289439
0
24/04/2013
Query!
Approval date [1]
289439
0
Query!
Ethics approval number [1]
289439
0
1238666
Query!
Summary
Brief summary
This project will investigate the clinical accuracy of the Invisalign(TM) orthodontic aligner system (Align Technology, California, USA) by comparing computer-proposed tooth movements with actual clinical tooth movement, following an increase in the rate of tooth movement per set of aligners from the default 0.25mm per fortnight to 0.5mm per fortnight.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
40866
0
A/Prof Paul Schneider
Query!
Address
40866
0
University of Melbourne
School of Dentistry, Orthodontic department
720 Swanston Street
Carlton
VIC 3053
Query!
Country
40866
0
Australia
Query!
Phone
40866
0
+61 3 9341 1500
Query!
Fax
40866
0
Query!
Email
40866
0
[email protected]
Query!
Contact person for public queries
Name
40867
0
Dr Margaret Wang
Query!
Address
40867
0
University of Melbourne
School of Dentistry, Orthodontic department
720 Swanston Street
Carlton
VIC 3053
Query!
Country
40867
0
Australia
Query!
Phone
40867
0
+61 3 9341 1073
Query!
Fax
40867
0
Query!
Email
40867
0
[email protected]
Query!
Contact person for scientific queries
Name
40868
0
Dr Margaret Wang
Query!
Address
40868
0
University of Melbourne
School of Dentistry, Orthodontic department
720 Swanston Street
Carlton
VIC 3053
Query!
Country
40868
0
Australia
Query!
Phone
40868
0
+61 3 9341 1073
Query!
Fax
40868
0
Query!
Email
40868
0
[email protected]
Query!
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.
Download to PDF