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OpenTrials
Completed

NCT Number: NCT07084506

RETROSPECTIVE COLLECTION OF SAFETY AND PERFORMANCE DATA - 2023.02

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.

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Key information

Conditions

Bone Defects Dental Area

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center Cabinet Dentaire de Stomatologie & Implantologie

Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Performance Endpoint

    Time frame: 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. 2. Safety Endpoint

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bioceramed

Industry

Registry information

Official study title

RETROSPECTIVE COLLECTION OF SAFETY AND PERFORMANCE DATA

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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