None listed
Conditions
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.
Interventions
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 seque
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.
Sponsors
University of Melbourne, School of Dentistry
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
13 Years to 19 Years
Healthy volunteers
Yes
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
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
Outcome results
None listed