Effectiveness of Virtual Surgical Planning (VSP) in Craniofacial Surgery : A Systematic Review of Randomized Controlled Trials

Abstract

Introduction: Virtual surgical planning (VSP) with computer-aided design and manufacturing (CAD/CAM) has been widely adopted in craniofacial surgery, yet its incremental benefit over conventional planning has been evaluated predominantly in non-randomized cohorts. This systematic review synthesizes evidence exclusively from randomized controlled trials (RCTs) to determine whether VSP improves plan-transfer accuracy, operative efficiency, morphological restoration, patient-reported outcomes, and safety in craniofacial surgery.

Methods: The study strictly adhered to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) 2020 guidelines. Eligible studies were RCTs comparing VSP-based technology with conventional planning in human craniofacial surgery. Risk of bias was appraised using Cochrane RoB 2. A structured synthesis without meta-analysis (SWiM) with direction-of-effect vote counting was performed across thirteen prespecified outcome domains.

Results: Twenty-five reports from twenty-three unique randomized trials comprising 758 participants met eligibility criteria. Statistically significant superiority of VSP-based workflows was demonstrated for linear plan-transfer accuracy, with mean deviations of 0.26 mm, 0.17 mm, and 0.07 mm for CAD/CAM guides versus 1.45 mm, 1.31 mm, and 0.71 mm for conventional wafers (p<0.05); for angular accuracy (SNA p<0.001, SNB p=0.002, ANB p<0.001); for facial symmetry after zygomaticomaxillary complex fracture reduction (bilateral eminence difference 1.24 mm versus 2.22 mm, p<0.001; symmetric-face rate 71.8% versus 35.9%, p=0.001); for orbital volume restoration (0.65 versus 1.67 cm³, p<0.05); for total operative time (126.7 versus 178.3 min, p<0.001); for flap ischaemia time (97.6 versus 172.5 min, p<0.05); and for appearance-related patient satisfaction (p≤0.05). No significant differences were observed for generic health-related quality of life, six-month skeletal stability, or complication rates. VSP consistently increased direct material cost (€884.00 versus €481.80). Risk of bias was low in five reports, of some concern in seventeen, and high in three.

Discussion: The benefit of VSP is conditional on the mechanism of plan transfer: rigid patient-specific hardware or navigation delivers consistent accuracy gains, whereas occlusal wafer transfer confers little measurable advantage. Efficiency gains are largest in free-flap reconstruction, while generic quality of life improves irrespective of planning modality.

Conclusion: Randomized evidence supports VSP as an accurate and operatively efficient alternative to conventional planning, with statistically significant advantages in plan-transfer accuracy, morphological restoration, operative and ischaemia time, and appearance-related satisfaction—especially when combined with patient-specific osteosynthesis, cutting guides, or navigation. Benefits are attenuated when transfer relies on occlusal wafers alone.