Monitoring of Caries Lesion Activity in Orthodontic Patients With the Calcivis System

Dental caries (tooth decay) is a significant clinical and public health problem. The development of caries lesions involves a net mineral loss of dental tissue, which can lead to progressive loss of tooth structure and associated pain and disease. Detecting, assessing, diagnosis and treating such lesions are core activities in dentistry. Currently the main detection and diagnosis aids are visual inspection and the used of a probe, together with X-ray images. Determination of the activity status of a lesion (how likely it is to progress) is requires to assess treatment needs. Currently methods are problematic and involve the clinicians' subjective assessment and / or monitoring of lesions progression over a number of visits.

It is generally recognised and reported in the dental literature that patients undergoing orthodontic treatment with fixed appliances find it difficult to maintain meticulous oral hygiene and that, as a result, plaque accumulates adjacent to the orthodontic brackets (which are usually placed on the buccal, Free Smooth, surfaces of teeth, which are readily visible) holding the metal wires which are involved in moving the teeth - thus white spot lesions commonly develop at these sites of plaque stagnation. These lesions are, de facto, actively developing during orthodontic treatment, thus represent 'active lesions'. Once the wires and brackets are removed post-treatment, normal oral hygiene can be resumed, the plaque/biofilm over these lesions is readily removed and they become arrested, i.e. the demineralisation process ceases. Thus during a short period of time - a matter of weeks - there is usually a transition from active to inactive status for these 'orthodontically-induced' white spot lesions. By assessing and monitoring these lesions, using the Calcivis device, at relatively short intervals during this period of lesion status transition immediately post orthodontic treatment it would be possible to monitor the reduction in the demineralisation process as these lesions arrest.

A previous clinical study on the prototype of the Calcivis System has been conducted. The results concluded that the Calcivis System was safe for use and the level of agreement between elevated luminescence and areas of expected activity was above 70% and not due to chance (NCT02098304).

This prospective, single-centre clinical study has been designed to assess the use of the Calcivis System for monitoring the activity levels of post-orthodontic treatment white spot lesions over time. The Dentist will share the images with the patient

The device under evaluation comprises a hand-held customized intra-oral camera which takes both black & white and luminescent images of a lesion on a tooth surface while simultaneously applying a photoprotein solution. The photo-protein detects free calcium ions on the tooth surface and produces a light signal if the caries lesion is active.