A novel technique for digitalisation and customisation of reinforced polytetrafluoroethylene meshes: Preliminary results of a clinical trial.

PURPOSE To evaluate the clinical, radiographic and patient-related outcomes of a novel technique for digitalisation and customisation of reinforced polytetrafluoroethylene meshes in vertical ridge augmentation surgery. MATERIALS AND METHODS A total of 10 patients (five men and five women, mean age 54 years) with vertical defects were included in the study. Prior to surgery, digital planning of bone augmentation, manufacturing of 3D printed models and replicas of the meshes and modelling of a customised reinforced polytetrafluoroethylene mesh were carried out. All patients were treated using a 50:50 mixture of xenogeneic and autogenous bone, customised reinforced polytetrafluoroethylene mesh and collagen membrane. After 6 to 9 months, computer-guided surgery was planned, the reinforced polytetrafluoroethylene mesh was removed and implants were placed in augmented sites using a fully guided surgical template. Patient-related outcomes, intraoperative timing, surgical and healing complications, vertical bone gain, bone density, pseudoperiosteum type and number and stability of implants were recorded. RESULTS All 10 patients were treated without surgical complications. Healing was largely uneventful, with the exception of one case of abscess formation without mesh exposure (exposure rate 0%). The mean duration of digital planning was 17.0 minutes, reinforced polytetrafluoroethylene mesh customisation took 9.0 minutes, and the total intraoperative time was 91.3 minutes. The mean planned bone volume was 1.52 cc, vertical bone defect depth was 6.0 ± 1.7 mm and vertical bone gain was 5.5 ± 1.9 mm; most sites showed medium bone density and a Type 1 pseudoperiosteum. All patient-related outcomes were favourable. CONCLUSIONS The preliminary results of this pilot study demonstrated the feasibility and reliability of a fully digital workflow for the customisation of reinforced polytetrafluoroethylene mesh in vertical ridge augmentation.