RETROSPECTIVE COLLECTION OF SAFETY AND PERFORMANCE DATA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-31

Study Completion Date

2023-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Bone Defects Dental Area

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No