Post-Approval Clinical Study to Evaluate the Safety and Performance of the Calcivis Caries Activity Imaging System in a Clinical Setting

Detailed Summary

This is a prospective, multi-centre, post-approval clinical study to assess the safety and the performance of the Calcivis Caries Activity Imaging System in aiding the identification of active caries lesions on the occlusal surfaces of human teeth. Following the identification of potential caries lesions by oral examination under ICDAS (International Caries Detection and Assessment System) guidelines, a disclosing solution will be applied which will cause areas of active demineralization (loss of calcium ions) to luminesce - these will be captured with an intra-oral camera to produce mapping images of the tooth surface. For the purposes of this study the presence / absence of luminescence will be used as an indicator of lesion activity / inactivity. The study will be deemed a success if the level of agreement between elevated luminescence with the Calcivis System, and areas of expected lesion activity as rated by the Investigators ICDAS staging, is above 70%, is not due to chance and correlates well with published data on active non-cavitated lesions in molars at various stages of eruption.

Study Details

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Interventions