BlueCheck is a liquid which turns porous enamel blue on contact, thus identifying areas that require clinical attention.
The technology has been spun out of research at the University of Melbourne where a team of scientists has been working on improving clinical outcomes for dental patients. The product works by specifically but reversibly binding to regions of porous enamel, such that normal enamel is not labelled. Once porous regions of enamel associated with early caries have been identified, the blue staining is washed off and remineralisation therapy can be applied where it is most needed. This approach can be used to detect early decay and monitor its repair over time.
BlueCheck is a diagnostic tool that enables dental specialists to identify early-stage tooth decay when it is not obvious to the eye or by x-ray. The sensitivity of BlueCheck is very high (lesions ~10-100 microns deep detected) and superior to the sensitivity of the current standard of care, which can detect lesions ~1000 microns deep.
Early diagnosis of tooth decay is key to optimal patient outcomes through the prevention of advanced decay. The earlier that remineralisation treatments are administered to sites of decay, the greater the chance of repair of tooth enamel and lower the likelihood of decay advancing to painful toothaches, which require root-canals and crowns, orextractions.
It is likely that BlueCheck will be classified as a Class II device in the USA.
Incisive is in the process of developing a Quality System consistent with CFR 820 (USA) and ISO 13485 (Australia and Europe), and expects to commence pre-clinical studies by July 2019.
Manufacturing has commenced, and design of the clinical study is underway. The clinical trial is expected to commence in 2019.
Due to its ease of use & sensitivity, BlueCheck is considered a key driver in the evaluation of new and existing remineralisation products.