title: Clinical evaluation of an enhanced white light and fluorescence device for early detection of caries lesions.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Comprehensive Dentistry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA. amaechi@uthscsa.edu
authors.forename: B T
authors.initials: BT
authors.lastname: Amaechi
authors.forename: I
authors.initials: I
authors.lastname: Chedjieu
authors.forename: Juanita
authors.initials: J
authors.lastname: Lozano-Pineda
mesh_terms: D000328:Adult; D003731:Dental Caries / Q000175:diagnosis* / Q000473:pathology; D042241:Early Diagnosis; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D007091:Image Processing, Computer-Assisted / Q000295:instrumentation / Q000706:statistics & numerical data; D008027:Light; D008029:Lighting / Q000295:instrumentation* / Q000706:statistics & numerical data; D008297:Male; D061848:Optical Imaging / Q000295:instrumentation* / Q000706:statistics & numerical data; D010808:Physical Examination; D012680:Sensitivity and Specificity; D017001:Tooth Demineralization / Q000175:diagnosis / Q000473:pathology; D014466:Ultraviolet Rays; D014741:Video Recording; D055815:Young Adult