Scotland-based medical devices firm Calcivis has completed the first clinical study of its Caries Activity Imaging System.
The new system is a sophisticated medical device and consumable combination designed to transform the evaluation and management of dental caries (tooth decay).
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It includes a bioluminescence approach combined with a specialised imaging device, allowing accurate detection and visualisation of demineralisation by imaging free calcium ions at the surface of the tooth.
An actively demineralising caries lesion is more likely to progress and lead to cavitation.
Calcivis said the Calcivis Caries Activity Imaging System was also granted a CE Mark.
The trial was the first to evaluate the system in a full clinical dental setting and was conducted in 39 patients by four general dental practitioners based in three practices in Scotland.
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By GlobalDataPrinciple investigator of the trial Charles Ormond said: “It has been very interesting to be involved with a clinical study of this new technology in Scotland.
“The images have the potential to provide real insights into the ongoing demineralisation disease process.”
According to the company, complete results and analysis from the trial will be completed early in 2015.
Calcivis CEO Adam Christie said: “The completion of our first clinical study is an important step for Calcivis.
“We have previously seen excellent results in ex vivo and the new study has allowed us to gain extremely valuable real world experience in the use of the device and consumable.
“We will be analysing the results over the coming months and using the insights we gain as we continue to prepare for commercialisation.”
The in-clinic device combines a sensitive intraoral camera and application technology to deliver a precise amount of disclosing solution, containing a photoprotein, onto the tooth surface.
Photoprotein binds calcium ions and emits a blue light signal proportional to the amount of calcium present.
The chemiluminescent system produces a demineralisation map of the tooth, which provides a focus for discussion with patients about their caries management programme, and helps to develop a tailored, rational, evidence-based treatment in line with best dental practice.
