Clinical Evaluation of an Enhanced White Light and Fluorescence Device for Early Detection of Caries Lesions B.T. Amaechi, BDS, PhD I. Chedjieu, MPH Juanita Lozano-Pineda, DDS, MPH Department of Comprehensive Dentistry University of Texas Health Science Center at San Antonio San Antonio, TX, USA Abstract • Objective: Sensitivity of a device based on Fluorescence Imaging with Reflectance Enhancement (FIRE) in detecting a potential incipient lesion (PIL) was compared with visual examination to demonstrate non-inferiority to it. • Methods: Visual examination (VE) and an investigational device (ID) were used to detect PIL (actual incipient caries [AIC] and hypomineralization). Seventeen subjects satisfied data analysis criteria. Two-hundred and seventy-seven AIC and 367 hypomineralizations reached VE consensus. Ground truth was generated from consensus VE results and image information from enhanced white light (eWL) and FIRE images. Data from VE and ID in Still Image (IDSM) and Video (IDVM) modes were evaluated against ground truth. • Results: Overall sensitivity of VE, IDSM, and IDVM evaluated against ground truth were 0.94, 0.884, and 0.848, respectively, for Actual Incipient Caries (AIC) detection, and 0.95, 0.916, and 0.883, respectively, for PIL detection. Sensitivity of ID in both modes was > 90% that of VE, thus demonstrating non-inferiority of IDSM and IDVM to VE. • Conclusion: The investigated eWL and fluorescence device is clinically effective and at least as good as expert VE in detecting PIL. An enhanced white light device with FIRE technology can be used, in Video or Still Image Detection modes, as an aid to caries diagnosis. (J Clin Dent 2013;24:43–48) Introduction The development of new technologies for the detection and quantitative monitoring of dental decay at its earliest stage of formation could provide health and economic benefits ranging from timely preventive interventions to reduction of the time required for clinical trials of anti-caries agents. 1,2 Thus, as caries management has shifted toward preventive and minimal intervention approaches, interest has grown in the use of technologies to aid in detection, diagnosis, and assessment of early stage caries lesions. However, differences in dental caries presentation, especially at dissimilar anatomical sites, make it unlikely that one diagnostic modality will have adequate sensitivity and specificity of detection at all sites. 3 A combination of diagnostic tools may help the astute practitioner diagnose caries lesions on all tooth surfaces. In the past few years, a variety of devices have been developed and introduced to help practitioners diagnose caries early and treat cases conservatively. 1,4 These technologies utilize a variety of properties, including an alteration in fluorescence, reflectance, electrical conductance/impedance, photothermal, or ultrasound transmittal properties of enamel that occurs when a tooth becomes demineralized, to detect and monitor changes in a caries lesion over time. 1,4 However, most devices detect and monitor demineralization and remineralization based on only one of these properties mentioned, thus limiting their detection sensitivity and specificity. 1,4 A combination of two or more of these properties in one technology may maximize the detection sensitivity and specificity of such a device to provide acceptable compromises between sensitivity and specificity for a wide range of applications for individual patient care, as well as for research purposes. This principle has been applied to the development of a device based on Fluorescence Imaging with Reflectance Enhancement (FIRE) to help detect caries at early stages. The FIRE technology involves capturing both fluorescence and white light reflectance images of the tooth surface, and then compositely processing them to enhance the contrast between demineralized and sound tooth structures. An ex vivo study validating the capability of FIRE for improved detection of actual incipient caries (AIC) had been previously conducted. 5 Since then, the FIRE device has been further optimized for clinical detection of potential incipient lesions (PIL, a combination of AIC and hypomineralization), incorporating a specially developed software tool to automatically generate and display detection results. The objective of the present study was to determine the detection sensitivity of this investigational device in a clinical setting, with the aim of demonstrating non-inferiority in its performance in detecting PIL as compared to conventional visual examination (VE). The investigational device uses intraoral imaging, and is intended for use as an adjunctive device to help identify PIL. Potential incipient lesions here refers to conditions on the tooth surfaces generally referred to as white spot lesions, and includes both early caries lesions (AIC) and developmental hypomineralization. The device performs detection in one of two modes of operation. In Video Detection mode the device illuminates with white LED’s, and displays live video of the tooth with the detected PIL highlighted on the image. In Still Image Detection mode the device makes two image captures of the tooth surface, one with white light LED illumination and one with UV-violet LED illumination. The device then displays the white light still 43