New dental caries diagnostic device set to move to clinical trials

Consulting October 2019

New dental caries diagnostic device set to move to clinical trials


An innovative diagnostic tool to detect the early stages of tooth decay is moving towards global registration, with clinical trials set to commence in Melbourne this year.

Incisive Technologies has appointed CBE’s Steve Williams and Jeff Davies to develop their manufacturing and quality assurance programs as they move towards the supply of the tool, Bluecheck, to the dental health sector.

Incisive has just met a major milestone, manufacturing their first technical batch of Bluecheck, which is currently undergoing bio-compatibility testing ahead of the clinical trial.

Bluecheck is an innovative dental paint that is highly sensitive in detecting early stage tooth decay. The paint can be easily and painlessly applied with a brush during regular dental check-ups, turning porous enamel blue on contact.

This allows dentists to identify and target areas for clinical attention and helps detect cavities and decay early so that preventive measures can be taken. This approach means patients can avoid painful toothaches and costly surgery later down the track, while assisting dentists to implement best-practice care.

Untreated tooth decay is one of the most common health conditions worldwide, effecting 2.4 billion people. When left untreated tooth decay can lead to white spot lesions, painful toothaches and abscesses, and often requires costly dental treatment such as root canals, crowns and orextractions.

While these conditions are easily preventable through intervention with remineralisation products, this approach has limited efficacy in treating decay that has progressed beyond its early stages.

CBE has helped Incisive to define and implement key strategies during the early stages of manufacturing. The first technical batch of Bluecheck has been shipped to a third party GLP laboratory in Italy and is currently undergoing bio-compatibility testing as a GLP study.

Design of a clinical study is now underway, with clinical trials expected to commence in Melbourne in 2019.

CBE director Jeff Davies said the company was “proud to be associated with a diagnostic that helps with early intervention to prevent tooth decay”.