Observational Study on Safety and Performance of Neobone4 in Adult Dental Bone Reconstruction

What this Trial Is About

Researchers are collecting real-world clinical data to evaluate the safety and performance of Neobone4, a synthetic, resorbable bone substitute used in dental and maxillofacial reconstructive surgeries. Neobone4 is made of calcium phosphate ceramics similar to human bone and is designed to promote bone integration and gradual resorption. The study aims to provide clinical evidence supporting the medical devices long-term use and monitor any emerging risks or misuse. Neobone4 is a single-use, gamma-sterilized implant intended for filling bone voids that do not affect structural stability. It is used by trained surgeons or dentists through surgical procedures. This observational post-market study will document standard medical practices without imposing additional risks or benefits to participants. Data collection occurs at six time points before surgery, immediately after surgery, 7 days, 6 months, 12 months, and 23 months post-surgery. Participants are adult patients undergoing reconstructive dental surgery with Neobone4 and will be followed according to local standard care for 2 years. Clinical evaluations include radiographic assessments, safety monitoring at multiple visits, quality of life and pain questionnaires, and measurement of bone density and volume changes. The study seeks to maintain up-to-date information on device performance and safety to support regulatory requirements and patient protection.

Evaluation of the Safety and Performance of the Neobone®: A Prospective Observational Study in Dental Area