RETROSPECTIVE COLLECTION OF SAFETY AND PERFORMANCE DATA - 2023.02

Bioceramed

Status: Completed

Conditions: Dental Area; Bone Defects

Study type: Observational

Funder types: Industry

Identifiers

NCT07084506

2023.02

Details and patient eligibility

About

This study, based on observations of clinical practice, aims to collect clinical data to update information on the performance and safety of the n-IBS® when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence to support the assessment of the device's safety and performance, contributing to the overall clinical evaluation of the product.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult males or females (aged > 18 years old);
• Patients who were implanted with the synthetic bone substitute n-IBS® for the treatment of intrabony defects associated with periodontal disease or for bone augmentation procedures in the alveolar process and maxillary sinus regions.

Exclusion criteria

• Patients with infection at the implantation site;
• Patients with metabolic disorders affecting bone healing;
• Patients with immune system disorders;
• Patients with systemic conditions that impair bone healing.