RETROSPECTIVE COLLECTION OF SAFETY AND PERFORMANCE DATA - 2023.02

NCT07084506 | Completed

• 1 other identifier: 2023.02
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Defects; Dental Area

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients (aged \> 18 years old) undergoing reconstructive dental surgeries.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioceramed: lead

Study Sites (1)

Center Cabinet Dentaire de Stomatologie & Implantologie

Brussels, Belgium

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: July 24, 2025
• Study Start: December 31, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)