Post-Market Non-Controlled Study on the Clinical Safety of a Synthetic Calcium Phosphate Ceramic in Alveolar Bone Regeneration: A 6-Month Prospective Study

This prospective, single-arm post-market study aimed to evaluate the clinical safety and performance of a synthetic calcium phosphate ceramic used in alveolar bone regeneration procedures. Eighty adult patients requiring bone augmentation were treated with β-tricalcium phosphate (β-TCP) under routine clinical indications. Surgical approaches were adapted to defect morphology. Safety outcomes included adverse events (AEs) and device deficiencies (DDs), while performance outcomes focused on two-dimensional radiographic bone assessment. Radiographic bone consolidation was defined as continuous trabecular radiopacity without radiolucent defects or clinical signs of infection. Patients were followed for six months post-surgery, with clinical and radiographic evaluations, as well as assessment of oral health-related quality of life (OHIP-14). All 80 patients (mean age: 47.2 ± 18.9 years; 51% male) completed the immediate postoperative assessment. Eleven DDs (granule loss) were observed postoperatively (13.8%) and no AEs. At six months, 71 patients (88.8%) completed follow-up. Radiographic bone repair was confirmed in all cases clinically observed and with follow-up X-ray (100%). No AEs or DDs reported (AE-free rate: 100%) at this follow-up. The median OHIP-14 score improved significantly at six months (p = 0.037), indicating better self-reported oral health. Given the observational design, absence of a control group, and partial reliance on non-radiographic follow-up, these findings should be interpreted with caution. Within these limitations, the synthetic calcium phosphate ceramic demonstrated a favorable short-term safety profile and apparent bidimensional radiographic signs of clinical performance under real-world conditions, rather than definitive evidence of effectiveness. Further controlled studies incorporating histological and volumetric analyses are warranted to confirm its regenerative potential.