Standardization and Validation of Digital Volumetric Measurement Methods for Alveolar Cleft Defects Using 3D Imaging.

Background/Objectives: Accurate quantification of alveolar cleft defects for bone grafting remains difficult due to inconsistent anatomical boundaries. This study established an expert consensus on boundary landmarks for alveolar bone graft (ABG) planning and validated the accuracy and reliability of digital volumetric measurement methods. Methods: Three cleft specialists performed repeated simulated graft procedures in seven patient-specific 3D-printed models, first according to the operator's clinical judgment, and subsequently according to panel-derived consensus boundaries. Two radiologists independently conducted digital volumetric assessments in 3D X-ray imaging using four measurement approaches (axial tracing, interpolated axial tracing, landmark-based mirroring, and mesh-based mirroring), generating 56 independent digital segmentations to be evaluated against the consensus-based physical reference standard. Volumes of the defects were recorded, intra- and inter-rater reliabilities were calculated using the intraclass correlation coefficient (ICC), and differences among methods were analyzed. Results: Operator-defined plans showed significant inter-operator differences (p < 0.001) with poor-to-excellent reliability (intra-rater ICC 0.060-0.967; inter-rater ICC 0.300-0.635). Consensus established standardized boundaries: tilted plane from base of anterior nasal spine to hard palate, cemento-enamel junctions, incisive canal, and alveolar contour. Consensus-based filling showed non-significant inter-rater differences (p = 0.139) and substantially improved reliability (intra-rater ICC 0.904-0.988; inter-rater ICC 0.622-0.861). Among the four digital methods evaluated, axial tracing demonstrated excellent reliability (intra-rater ICC 0.971-0.99; inter-rater ICC 0.965) and high accuracy (mean difference 0.001-0.026 cm3), with no significant difference (p = 0.999) from the physical reference standard. Conclusions: These proposed consensus-based boundary definitions and validated volumetric measurement methods improved the accuracy and reproducibility of personalized alveolar bone graft planning.