Clinical Studies
Align Technology conducted a number of private and university-based clinical studies across the U.S. prior to commercially releasing Invisalign. Align has launched new clinical studies to expand applicability and determine specific Aligner properties. As a result of these clinical studies, the range of applicability demonstrated by Invisalign has expanded significantly. A sample of on-going studies is listed below.
University of the Pacific School of Dentistry: Align is working with the University of Pacific to study a range of mild to severe malocclusions including bicuspid extractions, anterior open bites, and severe rotations. As a result, one article has already been published in the December 2001 issue of Seminars in Orthodontics titled, "Three-dimensional diagnosis and orthodontic treatment of complex malocclusions with the Invisalign appliance."
University of Washington: Align is working with the University of Washington to conduct a randomized clinical trial to study the effectiveness of different materials and different treatment times for Invisalign. An abstract on the frequency of activation and stiffness of Invisalign Appliances was presented at the 2003 AADR/IADR meeting.
University of Florida: Align is working with the University of Florida to conduct a randomized clinical trial to study various attachment designs for extrusion, rotation, and intrusion of teeth to be used with the Invisalign appliance. A secondary goal of the study is to obtain descriptive data regarding the incidence of side-effects such as caries incidence, gingival inflammation, root resorption, and temporomandibular joint changes, associated with wearing ALIGN appliances. An abstract on the effect of Invisalign Aligners on periodontal tissues was presented at the 2003 AADR/IADR meeting.
University of Ferrara, Italy: Align is conducting a randomized clinical trial with the University of Ferrara to study the effectiveness of using an aligner material, Exceed 40 (EX40) in the Invisalign treatment process and its prevalence on case refinements and mid-course corrections. Descriptive data related to potential risk factors associated with wearing Ex40 on oral hygiene, tooth sensitivity, root resorption, and temporamandibular joint discomfort will be examined.
Tel Aviv University: Align is conducting a clinical trial at Tel Aviv University to measure strain changes over time in Aligners as they are worn and determine the forces produced by these strains, and then correlate the strains and forces with the movements and speeds programmed into the appliance.
Adolescent Study: Align is working with a number of doctors to conduct a randomized clinical trial to evaluate the outcome of treating Class I crowding and spacing malocclusions in adolescent patients, aged 12-18, using Invisalign.
Bicuspid Extraction Combination Study: Align is working with an Orthodontist to conduct a randomized clinical trial to evaluate the outcome of treating bicuspid extraction cases using Invisalign in combination with braces.
Case Refinement Study: Align is working with a couple of orthodontists to evaluate the use of a thicker material at the end of treatment and the use of automated overcorrection to reduce case refinement. A secondary goal of this study is to obtain data regarding the types of tooth positions that require overcorrection and the amount of overcorrection required to achieve the results shown at the final stage on Clincheck.
Virtual vs. Actual Treatment Study: Align is conducting a preliminary case study with an orthodontist on the comparison of Invisalign's virtual treatment to that of actual treatment results at every Aligner stage. The goals will be to measure teeth location differences between the virtual and real representations and analyze tooth dynamics throughout the treatment.
New Attachment Study: Align is working with a number of doctors to conduct a clinical trial to evaluate a new attachment concept and design for extrusions of incisors, canines, and premolars, and rotations of canines and premolars.