Direct digital acquisition of intra-oral radiographs has been possible only in the last decade. Several studies have shown that, theoretically, there are a number of advantages of direct digital radiography compared with conventional film. Laboratory as well as controlled clinical studies are needed to determine whether new digital imaging systems alter diagnosis, treatment and prognosis compared with conventional methods. Most studies so far have evaluated their diagnostic performance only in laboratory settings. This review concentrates on what evidence we have for the diagnostic efficacy of digital systems for caries detection. Digital systems are compared with film and those studies which have evaluated the effects on diagnostic accuracy of contrast and edge enhancement, image size, variations in radiation dose and image compression are reviewed together with the use of automated image analysis for caries diagnosis. Digital intra-oral radiographic systems seem to be as accurate as the currently available dental films for the detection of caries. Sensitivities are relatively high (0.6-0.8) for detection of occlusal lesions into dentine with false positive fractions of 5-10%. A radiolucency in dentine is recognised as a good predictor for demineralisation. Radiography is of no value for the detection of initial (enamel) occlusal lesions. For detection of approximal dentinal lesions, sensitivities, specificities as well as the predictive values are fair, but are very poor for lesions known to be confined to enamel. Very little documented information exists, however, on the utilization of digital systems in the clinic. It is not known whether dose is actually reduced with the storage phosphor system, or whether collimator size is adjusted to fit sensor size in the CCD-based systems. There is no evidence that the number of retakes have been reduced. It is not known how many images are needed with the various CCD systems when compared with a conventional bitewing, nor how stable these systems are in the daily clinical use or whether proper cross-infection control can be maintained in relation to scanning the storage phosphor plates and the sensors and the cable. There is only sparse evidence that the enhancement facilities are used when interpreting images, and none that this has changed working practices or treatment decisions. The economic consequences for the patient, dentist and society require examination.