Clinical evaluation of advanced prototype medical device for dental caries assessment

本项目将设计、开发、生产和临床评估Calcivis龋（蛀）活动评估系统的先进原型。在牙科中，鉴别积极脱矿的早期牙病变与不太可能发展为空化的早期牙病变存在显著的未满足需求。Calcivis是独特而创新的，因为它部署了一种光蛋白，在钙离子从主动脱矿的牙齿表面释放出来的情况下产生光。结合定制的口腔内相机，它可以生成牙齿表面的脱矿图。到目前为止，该相机的基本原型已用于展示拔牙的概念证明，但该项目向前迈出了重要一步，因为它使反映牙医详细输入的先进原型能够在诊所中进行改进，生产和评估。

This project will design, develop, produce and clinically evaluate an advanced prototype of the Calcivis dental caries (decay) activity assessment system. There is a significant unmet need in dentistry to differentiate early dental lesions that are actively demineralising from those which are less likely to progress to cavitation. Calcivis is unique and innovative because it deploys a photoprotein which produces light in the presence of the calcium ions being released from an actively demineralising tooth surface. In combination with a customised intra-oral camera it produces a demineralisation map of the tooth surface. To date, a basic prototype of the camera has been used to demonstrate proof of concept in extracted teeth but this project takes a significant step forward as it enables an advanced prototype reflecting detailed input from dentists to be refined, produced and evaluated in the clinic.