Early postoperative evaluation of an open-source digital workflow for designing custom-made zirconia membranes in maxillary guided bone regeneration.

Background: Computer-guided surgery has played a crucial role in planning alveolar ridge augmentation. In the last decade, various software programs have been used in computer-guided fabricated nonresorbable membranes, including zirconia membranes, for guided bone regeneration. However, most of these software programs are not free of charge.

Objectives: This study aimed to evaluate clinically and radiographically the accuracy of an open-source digital workflow for designing custom-made zirconia membranes for maxillary guided bone regeneration.

Materials and methods: Twelve custom-made zirconia membranes were designed for 12 patients with maxillary alveolar defects via the integration of two free open-source software programs (Blue Sky Plan^® and Autodesk Meshmixer^®) via a preoperative cone beam computed tomography scan. All patients underwent maxillary alveolar bone augmentation via the designed membranes and particulate mixtures of 1:1 autogenous and xenogenic bone grafts. The membranes were evaluated intraoperatively and radiographically via an immediate postoperative cone beam computed tomography scan, and the collected data were statistically analysed.

Results: All the membranes had accurate intraoperative fits, and there were no significant differences between the virtual and milled (actual) membranes in either the volumetric analysis or the linear horizontal and vertical measurements; the P values were (0.628, 0.226 and 0.239), respectively. The designing time was significantly reduced from 4 h for the first case to 22 min for the final case, while the (mean ± standard deviation) milling time was 28 min ± 11 min, and the (mean ± standard deviation) time of the whole digital workflow including membrane sterilization was 5 h and 20 min ± 1 h and 15 min.

Conclusion: Zirconia membranes can be designed with free open-source software with outstanding clinical fit and promising radiographic results. Further research should be performed with larger sample sizes and other rigid Guided Bone Regeneration membrane materials.

Trial registration number: NCT06227455.

Trial first posted date: 26/1/2024 (Retrospectively registered).