Efficacy of quantitative digital subtraction radiography using radiographs exposed in a multicenter trial

Digital subtraction radiography (DSR) has been shown to be a sensitive and specific method for the detection of small bony changes in periodontitis. The purpose of this study was to perform a multicenter validation of the DSR in human subjects. Seventeen subjects were enrolled at 3 centers. Feather-edged hydroxyapatite chips (approximately 1, 7 and 10 mg) were used to simulate osseous lesions. Bilateral radiographs were taken with and without chips. Geometry was standardized using a cephalostat and the order of radiographs was determined using a randomization plan. Radiographs were subtracted, lesions isolated, and quantified at a single center without knowledge of the randomization code or location of the chips used in each subject. The overall sensitivity and specificity in detecting 1 mg changes was 87.8% and 100%, respectively. Sensitivity and specificity in detecting 7 mg and 10 mg chips was 100%. A strong linear relationship between actual lesion mass and calculated mass was observed (R2 = 0.94, slope = 0.98, p < 0.0001). No significant differences were observed by center. These data indicate that the DSR is a valid technique for the assessment of alveolar bone changes in multicenter trials.