Bone Defects, Dental Area
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Bioceramed
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance Endpoint | follow-up visits, through study completion, an average of 1 year | Assessment of bone consolidation at the surgical site, based on the quantification of bone gain (mm) as measured through routine X-ray imaging, to evaluate osseous regeneration. |
| 2. Safety Endpoint | Follow-up visits, through study completion, an average of 1 year | Assessment of Adverse Events (AEs) related to n-IBS® during the follow-up period of patients. |
Countries
Belgium
Outcome results
None listed