Validity of Soprolife camera and Calcivis device in caries lesion activity assessment.

Aim An ex vivo study was performed to assess (gold standard [GS]: Nyvad criteria) sensitivities (SEs) and specificities (SPs) of Soprolife (fluorescence) and Calcivis (bioluminescence) - indicated, by the manufacturers, for activity assessment of coronal carious lesions (AACCL). We also calculated the positive and negative predictive values, positive and negative log-likelihoods, inter-examiner and intra-examiner variations, and concordance rates (CRs) of both devices compared to GS and to each other.Materials and methods One hundred and twenty-one extracted posterior teeth were included. Within 48 hours after extraction, ICDAS and Nyvad scores were determined and occlusal photographs (Soprolife and Calcivis captures) were taken. Three examiners were asked to score, independently, twice (T0; T0 + 15 days), the caries activity status (active/inactive) for each image.Results Both devices showed modest SEs and SPs. The only statistically significant differences between devices were for SE (p = 0.04) in favour of Soprolife (all ICDAS scores combined) and for SP (p = 0.03) in favour of Calcivis (ICDAS 3, 4). There were higher CRs for Soprolife than for Calcivis (compared to GS). Intra- and inter-examiner variations were 76-86.8% and 71.9-85.1% for Soprolife, and 79.3-89.3% and 72.7-86.8% for Calcivis, respectively.Conclusion In light of the results, it seems difficult to confirm the validation of Soprolife and Calcivis for AACCL.