Clinical validation of a new subtraction radiography technique for periodontal bone loss detection.

BACKGROUND Diagnostic subtraction radiography (DSR) is a new digital radiographic image subtraction method designed to enhance detection of crestal or periapical bone density changes and to help evaluate caries progression in teeth. In this clinical study, the performance of the DSR method was evaluated for its ability to detect periodontal bone loss and was compared with that of conventional evaluation of radiographs and the standardized cephalostat-guided image acquisition and subtraction technique (LRA) which served as the "gold standard." METHODS In each of 25 subjects with alveolar crestal bone loss created by periodontal surgery, one set of DSR radiographs and one set of LRA radiographs were obtained before and after the surgery. Subtraction images were then generated by both the proprietary DSR and the LRA techniques. Four viewers evaluated the paired film sets and both subtraction image sets using a 5 point confidence scale to determine the presence or absence of crestal bone loss. Receiver operating characteristics (ROC) statistical procedures were applied to analyze the diagnostic accuracy and statistical differences between the three imaging modalities. RESULTS The DSR subtraction viewing generated an ROC area of 0.882. For 2 of the viewers this represented a statistically significant gain (P <0.05) over the conventional viewing of the radiographs which had an average ROC area of 0.730. In comparison, the LRA method achieved an area of 0.954. The differences between the LRA and the DSR subtraction methods were not statistically significant, but the statistical power for claiming equality was low ranging from 0.2 to 0.6. CONCLUSIONS The use of the DSR technique in clinical radiographic image acquisition and subsequent subtraction analysis clearly enhanced the accuracy of alveolar crestal bone loss detection when compared to conventional film viewing. Because this methodology is less resource demanding than LRA and the film exposure techniques and computer-based image analysis skills may be acquired with only a few hours of training, the DSR has potential in clinical practice.