Background: Reconstruction of the maxillary defects following tumor ablation remains to be a challenge for surgeons. Virtual Surgical Planning (VSP), intraoperative cutting guides and stereolithographic models provides the head and neck reconstructive surgeon with powerful tools for complex reconstruction planning. Despite its use in fibular osteocutaneous reconstruction, application to the scapular free flap has not been as widely reported. The aim of this study was to compare aesthetic results and operation time of free scapular flap, with and without computer-aided design and computer-aided manufacturing (CAD/CAM) customized osteotomy guide, for reconstruction of maxillary defects.Methods: In this prospective randomized controlled clinical trial study, we randomly assigned 22 patients with maxillary defects who were scheduled to undergo maxillary reconstruction with either free scapular flap with CAD/CAM customized osteotomy guide; study group (n = 11) or free scapular flap without CAD/CAM customized osteotomy guide; control group (n =11). All patients were followed up for 3 months. The aesthetic outcome, operation and ischemic times were evaluated and compared.Results: Aesthetic outcomes were evaluated objectively by means of differential surface area (sagittal and axial) measurement, which showed improved aesthetic outcome (contour symmetry) in the study group with a mean of (241.39±113.74), compared to patients in control group with a mean of (358.70±143.99). There were significant differences between the two groups (P< 0.05). Aesthetic outcomes were also evaluated subjectively by means of visual analogue scale (VAS) and patient’s satisfaction score (PSS). The postoperative aesthetic appearance was better in the study group with more patients satisfied than that in control group and there were statistically significant differences (P=0.039). The mean total operative time was 678.81 minutes and 777.18 minutes in the study group and control group respectively (P<0.05) and the mean ischemia time was 133.18 minutes and 195.72 minutes for study group and control group respectively (P<0.05).The ischemia time and total operative time were shorter in the study group compared to those in the control group and there were no flap losses in both groups.Conclusion: The use of CAD/CAM prefabricated cutting guides facilitates scapular flap molding and placement, minimizes ischemic time and operating time as well as improves aesthetic outcomes.Trial registration: This trial was registered at ClinicalTrials.gov. Registration number: NCT03757286. Registration date: 28/11/ 2018.
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