RETROSPECTIVE COLLECTION OF SAFETY AND PERFORMANCE DATA - 2023.02

Bioceramed30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Bone Defects Dental Area

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Center Cabinet Dentaire de Stomatologie & Implantologie

Brussels, Belgium

Outcomes

Primary Outcomes

Performance Endpoint

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.

Time frame: follow-up visits, through study completion, an average of 1 year

2. Safety Endpoint

Assessment of Adverse Events (AEs) related to n-IBS® during the follow-up period of patients.

Time frame: Follow-up visits, through study completion, an average of 1 year

Data from ClinicalTrials.gov

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