DT News - UK - Caries detection technology close to international market launch

Dental Tribune International

Tue. 4 July 2017

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EDINBURGH, UK: A novel system developed in Scotland for immediate measuring of demineralisation of teeth could soon make its way abroad, as the developer CALCIVIS has recently announced the completion of a premarket approval study that is intended to make the promising technology available to US dentists in addition to clinicians in the UK.

The study was conducted among 111 patients in several dental practices in Edinburgh over the past six months, and the first read-out of data will be available over the next few weeks. If successful, premarket approval by the US Food and Drug Administration for the technology is expected in the second half of 2017. According to CALCIVIS CEO Adam Christie, the US regulatory body has already been consulted on the study design and statistical approach as part of the regulatory pre-submission process.

“Gaining US approval is critical for us to maximise the commercial potential of the CALCIVIS imaging system which we believe will transform the management of enamel demineralisation associated with caries and erosion and support the wider adoption of preventive dentistry,” he said.

The system, which has received over £8 million in funding from the EU and the Scottish Investment Bank, among other institutions, has already gained approval by European regulators and is anticipated to be launched in the UK later this year. Originally developed by researchers at the University of Dundee, the CALCIVIS imaging device allows the real-time detection and visualisation of calcium ions released by demineralising carious lesions in routine dental practice. In order to achieve this, it makes use of bioluminescence with a special solution containing a photoprotein applied to the tooth surface. Photographic mapping with CALCIVIS then provides clinicians with accurate information about the location of active caries or other problems, like acid erosion, in patients.

In addition to helping to detect those conditions in advance, the system is intended to work as a communication tool between patient and dentist, the study’s principal investigator and orthodontist at Downie, Harper and Shanks Dental Practice in Edinburgh, Dr Neil Shanks, explained.

“It will also provide a clear explanation and justification of preventive management approaches to patients, helping to ensure their compliance,” he said.

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