Abstract

<h3>Objective</h3> To evaluate a novel dual-energy cone beam computed tomography (DE-CBCT) device for jaw bone density assessment. <h3>Study Design</h3> An ongoing clinical trial has enrolled 19 subjects with a target enrollment of 24 subjects. All subjects were 21 years and older and required a maxillofacial CT scan for standard-of-care diagnosis. Each subject received 2 examinations: one with a 64-slice multi-detector CT (MDCT) scanner and the second with the experimental DE-CBCT device (RCT720, Ray Co. Seoul, Korea). Asynchronous scanning of a custom hydroxyapatite phantom (concentrations of 0.8, 1.0 and 1.2 g/cc) provided calibration for bone density measurement. DICOM data from both CT examinations were imported into a custom version of OnDemand software<i>.</i> Calibration curves were generated from the MDCT and DE-CBCT scans of the hydroxyapatite phantoms. The MDCT and DE-CBCT scans of study subjects were superimposed and custom tools allowed calculation of bone density within a specified region of interest (ROI). Concordance between the MDCT- and DE-CBCT-derived bone densities was examined. <h3>Results</h3> In our preliminary assessments of data from current subjects, the mean calculated bone density in all the ROIs measured was 0.51 ± 0.27 g/cc for MDCT imaging and 0.50 ± 0.32 for DE-CBCT imaging. The range of the calculated bone densities was 0.06 to 1.1 g/cc for MDCT and 0.04 to 1.3 g/cc for DE-CBCT. Overall, there was strong correlation between bone densities calculated from MDCT scans with those calculated from DE-CBCT scans (r = 0.96, p <0.0001). Bland-Altman analysis identified a bias of 0.01 ± 0.1, and 95% limits of agreement range was -0.19 to 0.21. <h3>Conclusion</h3> The RCT720, a newly-developed DE-CBCT device, produced measurement of bone density equivalent to MDCT and overcomes the inaccuracies of bone density assessment using conventional CBCT scans. <b>Statement of Ethical Review</b> Human/Animal subjects were used and this study was approved by an institutional ethics panel

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