Randomized Clinical Trial of the Accuracy of Patient-Specific Implants versus CAD/CAM Splints in Orthognathic Surgery

Abstract

Background: The maxilla position is essential for the aesthetic and functional outcomes of orthognathic surgery. Previous studies demonstrated the advantages of patient-specific implants in orthognathic surgery. However, more data are needed to confirm the superiority of patient-specific implants over surgical splints created with computer-aided design/computer-aided manufacturing (CAD/CAM). This randomized controlled trial aimed to compare the accuracy of patient-specific implants and CAD/CAM splints for maxilla repositioning in orthognathic surgery. Methods: Patients ( n = 64) who required orthognathic surgery were randomly assigned to use either patient-specific implants (patient-specific implant group) or CAD/CAM surgical splints (splint group) to reposition the maxilla. The outcome evaluation was completed by comparing virtual plans with actual results. The primary outcome was the discrepancies of the centroid position of the maxilla. Other translation and orientation discrepancies of the maxilla were also assessed. Results: The authors analyzed 27 patients in the patient-specific implant group and 31 in the splint group. The maxilla position discrepancy was 1.41 ± 0.58 mm in the patient-specific implant group and 2.20 ± 0.94 mm in the splint group; the between-group difference was significant ( p < 0.001). For the patient-specific implant group, the largest translation discrepancy was 1.02 ± 0.66 mm in the anteroposterior direction, and the largest orientation discrepancy was 1.85 ± 1.42 degrees in pitch. For the splint group, the largest translation discrepancy was 1.23 ± 0.93 mm in the mediolateral direction, and the largest orientation discrepancy was 1.72 ± 1.56 degrees in pitch. Conclusion: The result showed that using patient-specific implants in orthognathic surgery resulted in a more accurate maxilla position than CAD/CAM surgical splints. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Three-Dimensional Accuracy and Stability of Personalized Implants in Orthognathic Surgery: A Systematic Review and a Meta-Analysis

“…A total of 566 patients from 21 articles were included for this systematic review. Eleven articles had a prospective study design [ 13 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 ], of which five were randomized [ 31 , 34 , 36 , 37 , 38 ], four were clinical trials [ 31 , 34 , 36 , 38 ] and two were multi-center [ 34 , 38 ]. The study characteristics are presented in Table 1 .…”

“…Sixteen records evaluated the accuracy of PSI for the maxilla [ 13 , 31 , 32 , 33 , 34 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 ], out of which eight exclusively focused on non-segmental Le Fort I procedures [ 31 , 32 , 34 , 36 , 38 , 43 , 45 , 46 ] and two on non-segmental Le Fort I procedures in conjunction with the accuracy of PSI for mandibular osteotomies [ 13 , 39 ]. Six studies included mixed single and segmental Le Fort I osteotomies [ 33 , 37 , 40 , 41 , 42 ].…”

“…The only subset that had sufficient data for a meta-analysis comprised those studies employing single Le Fort I osteotomies exclusively. The studies reporting absolute values were analyzed [ 32 , 34 , 36 , 39 , 43 , 45 ]. A stratification of the meta-analysis on absolute and signed values was done to allow correct interpretation of the estimates on two studies [ 13 , 46 ].…”

“…The outcome variables and the antero-posterior, transversal and vertical error measurements were registered. An analysis was also conducted on the subset of studies that included pitch, roll and yaw error measurements [ 34 , 36 , 39 , 43 , 45 , 46 ]. This analysis was also stratified, with a stratum for the studies reporting signed values separate from the rest.…”

Simultaneous PSI-Based Orthognathic and PEEK Bone Augmentation Surgery Leads to Improved Symmetric Facial Appearance in Craniofacial Malformations

“…Since the invention of 3D printing in 1984 [ 8 ], computer-aided design (CAD) and computer-aided manufacturing (CAM) have opened up new opportunities for modern medicine to improve the surgical outcome for each individual patient [ 9 , 10 ]. Many studies have already demonstrated the higher accuracy of CAD/CAM technology for intraoperative splints in orthognathic surgery [ 11 , 12 , 13 , 14 , 15 , 16 ]. Even more, patient-specific implants (PSI) have revolutionized orthognathic surgery in recent years by allowing accurate preoperative planning and by assisting the surgeon in proper positioning [ 17 , 18 , 19 ].…”