Aesthetic Reconstruction of Onco-surgical Mandibular Defects Using Free Fibular Flap with and without CAD/CAM Customized Osteotomy Guide: A Randomized Controlled Clinical Trial

BACKGROUND: Reconstruction of mandibular defects following ablative surgery remains a challenge even for experienced surgeons. Virtual planning and guided surgery, including computer-aided design/computer-aided manufacturing (CAD/CAM), afford optimized ways by which to plan complex surgery. This study aimed to evaluate and compare aesthetic outcome and surgical efficiency of free fibular flap (FFF) with and without CAD/CAM customized osteotomy guide (COG) for reconstruction of onco-surgical mandibular defects. METHODS: Twenty-two patients indicated for segmental mandibulectomy were randomly assigned to either CAD/CAM with COG group or that without COG- Model based reconstruction (MB group) at a 1:1 ratio. Aesthetic outcomes were evaluated by means of morphometric assessment and comparison for each differential area (DAr) and angle (DAn) in the affected side to the contralateral side of the mandible using computerized digital imaging analysis (CDIA) based on the post-operative 3D CT-scan. Subjective evaluation was performed using the Visual Analogue Scale (VAS) and Patient’s Satisfaction Score (PSS). Surgical efficiency was a secondary outcome and evaluated as total operative time and ischemia time. RESULTS: The mean sagittal DAr was significantly lower in the COG group (277.28 ± 127.05 vs. 398.67 ± 139.10 mm(2), P = 0.045). Although there was an improvement in the axial DAr (147.61 ± 55.42 vs. 183.68 ± 72.85 mm(2)), the difference was not statistically significant (P = 0.206). The mean differences (Δ) in both sagittal and coronal DAn were significantly lower in the COG group than in the MB group (6.11 ± 3.46 and 1.77 ± 1.12° vs. 9.53 ± 4.17 and 3.44 ± 2.34°), respectively. There were no statistically significant differences in the axial DAn between the two groups (P = 0.386). The PSS was significantly higher in the COG group, reflecting better aesthetic satisfaction than in the MB group (P = 0.041). The total operation and ischemia time were significantly shorter in favor of the COG group with a mean of (562.91 ± 51.22, 97.55 ± 16.80 min vs. 663.55 ± 53.43, 172.45 ± 21.87 min), respectively. CONCLUSION: The CAD/CAM with COG is more reliable and highly valuable in enhancing aesthetic outcomes and surgical efficiency of mandibular reconstruction by FFF compared to that without COG (MB reconstruction). TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov. Registration number: NCT03757273. Registration date: 28/11/2018.