Prospective Pilot Clinical Study of High-Purity Magnesium Plates and Screws for Le Fort I Osteosynthesis

Objectives: This prospective clinical study aimed to evaluate the feasibility, safety, and clinical performance of an innovative high-purity magnesium (HP-Mg) plate and screw system for internal fixation in orthognathic surgery. Materials and methods: Patients indicated for orthognathic surgery fulfilling the study criteria were invited to participate. HP-Mg plates and screws were developed for the first time for Le Fort I fixation in the maxilla, while standard titanium fixation was used in the mandible for comparison. Clinical outcomes, wound healing, neurosensory function, radiographic imaging, systemic complications, and plasma electrolyte levels were assessed over a one-year follow-up. Results: Seven patients were included. HP-Mg plates and screws were systemically safe, with no evidence of hypermagnesemia or related neurosensory impairment. Two patients experienced smooth recovery; 3 developed mild complications (e.g., wound dehiscence, fistula) that were managed conservatively; and 2 required reoperations due to maxillary nonunion. Radiographically, HP-Mg plates and screws were not visible on plain X-rays but were detectable on CBCT, exhibiting reduced radiodensity compared to cortical bone. The complications were attributed to unoptimized plate geometry and rapid in vivo degradation. Conclusions: Although HP-Mg plates and screws represent a promising biodegradable alternative for internal fixation in orthognathic surgery, the observed complications highlight opportunities for further optimization-particularly in enhancing degradation profiles and mechanical strength. With ongoing research and continued improvements, Mg has the potential to become a reliable and effective option for internal fixation in maxillofacial surgery. Clinical relevance: While HP-Mg is a promising biodegradable alternative for internal fixation in orthognathic surgery, further optimization of implant design and degradation profiles is necessary.