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

Abstract

ObjectivesClinical 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 MethodsThis 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.ResultsA 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.ConclusionsResults 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.