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, postapproval, 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 patientrelated 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.

Agreement of Bioluminescence Measurements and Visual Assessment in Monitoring Occlusal Surfaces of Permanent Teeth

“…An active lesion is considered to have a greater likelihood of transition (progress, arrest or regress) than an inactive lesion. However, such changes can normally be observed longitudinally to be sure that the initial assessment was valid [9], such as how it was performed in the present study.…”

“…The recently introduced digital imaging system Calcivis was developed as a bioluminescent marker to illuminate the assessment of dental caries and dental erosion through its binding of calcium ions, known to be released during the process of demineralization. In vitro and clinical studies have already been performed on occlusal and smooth surfaces [6][7][8][9], showing the ability of the bioluminescence method to visualize active demineralization and enamel erosion. However, Drancourt et al [22] concluded in an in vitro study that it was difficult to confirm the ability of a bioluminescence-based camera and a fluorescence-based system for the activity assessment of coronal carious lesions.…”

“…Moreover, the ability of the bioluminescence technology to identify demineralization on smooth surfaces adjacent to orthodontic brackets was shown [8]. In a recently published paper, the bioluminescence system could differentiate tooth surfaces clinically identified as involving active enamel lesions from sound sites [9].…”

“…The assessment of a lesion's true activity status in a single visit remains challenging, and the determination of which initial lesions will progress can normally be validated prospectively by serial monitoring over time [9,12]. It was shown that the bioluminescence method can be used to visualize active demineralization sites in clinically identified enamel lesions [9].…”

“…The assessment of a lesion's true activity status in a single visit remains challenging, and the determination of which initial lesions will progress can normally be validated prospectively by serial monitoring over time [9,12]. It was shown that the bioluminescence method can be used to visualize active demineralization sites in clinically identified enamel lesions [9]. Since the ability of the device for monitoring purposes has not yet been under study, the present study aimed to evaluate the agreement of the bioluminescence method to monitor caries lesions compared with visual findings.…”