The Calcivis story - enamel caries activity assessment from technology to practice.

The Calcivis story is one of innovation and collaboration to deliver new technology capable of helping dentists improve patient care through solving an unmet clinical need in assessing the activity of caries lesions in enamel. Presently, there is no system routinely used in dental practice that can, in a single visit, determine whether a non-cavitated caries lesion is active or not. Calcivis has evolved since 2005, when a potential link between basic science in luminescence and differentiating initial-stage caries lesions that are actively demineralising and likely to progress, from other lesions which are inactive and currently do not need interventive care, was recognised. The 16-year journey has involved clinical academic dentists, scientists and entrepreneurs, general practitioners and their patients, together with serial investors and a core team working to patent, refine, assess and develop products to submit to regulatory approval and take to the international dental market. This journey has been made possible through effective long-term collaborations between disparate groups all sharing a common vision for the possibilities of harnessing new technology to help dental professionals provide better care for their patients.

Clinical validation of a novel bioluminescence imaging technology for aiding the assessment of carious lesion activity status.

OBJECTIVES: Clinical validation of a bioluminescence imaging system (Cis) as measured by the level of agreement between clinician visual and tactile assessment of carious lesion presence and activity and the presence/absence of elevated luminescence on a tooth surface determined from intraoral image mapping. MATERIALS AND METHODS: This was a regulatory clinical study designed in consultation with the FDA. The design was a prospective, five-investigator, nonrandomized, post-approval, clinical study utilizing the Cis to provide images of elevated calcium ion concentration (indicative of active demineralization) on tooth surfaces via use of a photoprotein. Imaged teeth were identified as "sound" or having "active lesions." Images were scored independently for luminescence. RESULTS: A total of 110 participants aged 7-74 years were imaged. Of the 90 teeth assessed as "sound," 88 were deemed to show no luminescence by the reviewing investigator, a negative percentage agreement of 97.8% (significantly >50% agreement [p < .0001]; one-sided 97.5% confidence interval [CI]: 0.9220). Of the 86 teeth initially assessed as having an "active lesion," 78 were deemed to show luminescence by the reviewing investigator, a positive percentage agreement of 90.7% (significantly >50% agreement [p < .0001]; 97.5% CI: 0.8249). There were no patient-related adverse events. CONCLUSIONS: Results show, with a high level of agreement, that Cis can differentiate tooth surfaces clinically identified as involving active enamel lesions (ICDAS code 2/3), from sound sites (biochemically equivalent to inactive lesions) and that the system is safe for clinical use.

Initial investigations of a novel bioluminescence method for imaging dental demineralization.

OBJECTIVES: In this in vitro study, a bioluminescent marker was investigated for its potential to illuminate the assessment of dental caries and dental erosion, which are significant clinical and public health problems, through its binding of those ions, notably Ca2+ , known to be released during the process of demineralization. MATERIALS AND METHODS: The light output from the selected bioluminescent marker was investigated in several experiments, including: (a)contact with a range of Ca2+ ion concentrations; (b) treatment of extracted teeth with solutions of differing pH, followed by application of the bioluminescence marker to assess Ca2+ ion release; and (c) application of the marker to freshly extracted teeth with natural and artificially created caries lesions on occlusal and smooth surfaces to image the Ca2+ ion distribution. RESULTS: The results of: experiment (a) showed that the light output from the marker increases with increasing Ca2+ concentration and of experiment (b) showed increases in light being observed as increasingly acidic solutions were applied. The results of experiment (c) showed the bioluminescence images of the extracted teeth produced "demineralization maps" of the imaged surfaces. CONCLUSIONS: These results demonstrate the ability of a novel bioluminescence technology to image Ca2+ ions on tooth enamel surfaces which has potential in dental caries and dental erosion applications and provides the scientific basis for the ongoing development of that novel technology.