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

Abstract

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 50% agreement [p