Observational Study Evaluating Safety and Performance of Neocement Inject P in Dental Bone Reconstruction

What this Trial Is About

This research aims to collect real-world clinical data on the performance and safety of Neocement4 Inject P, a synthetic bone substitute designed to improve bone quality and accelerate regeneration. The study focuses on adult patients undergoing reconstructive dental surgery and seeks to provide clinical evidence to support the devices evaluation and safe use in current medical practice. Neocement4 Inject P is a single-use, biodegradable medical device composed of calcium phosphates and chitosan. It is intended to fill bone voids or gaps in the skeletal system that do not affect structural stability, particularly in dental and maxillofacial surgeries. The device is applied surgically by trained orthopedic surgeons, dentists, or maxillofacial surgeons in operating rooms or dental offices. Participants will be followed according to standard medical practices for two years, with data collected at six time points before surgery baseline, immediately after surgery, 7 days, 6 months, 12 months, and 23 months post-surgery. Assessments include clinical and radiographic performance, safety monitoring, technical success, quality of life, pain levels, bone density, and bone volume changes to understand the devices effects and monitor patient outcomes over time.

Evaluation of the Safety and Performance of the Neocement® Inject P: A Prospective Observational Study in Dental Area