Publication of Calcivis Imaging System pivotal clinical study
Calcivis announces the publication of two key clinical and scientific papers in the journal, Clinical and Experimental Dental Research. Both are available via Open Access on the Wiley Online Library, using
the links below.
The pivotal clinical study was designed in consultation with the FDA, to support the FDA PMA (Premarket Approval) filing.
It evaluated the Calcivis Imaging System in the assessment of active dental demineralisation compared with the current best standard of care.
Results showed a highly significant level of agreement between the clinical assessment of the original dentist and the independent dentist’s assessment using the Calcivis Imaging System for teeth with active lesions (90.7%; p<0.0001) and sound (healthy) teeth (97.8%; p<0.0001).
Clinical validation of a novel bioluminescence imaging technology for aiding the assessment of carious lesion activity status
Initial investigations of a novel bioluminescence method for imaging dental demineralization