Actively Recruiting
Evaluation of the Safety and Performance of the Neobone ae A Prospective Observational Study in Dental Area
Led by Bioceramed · Updated on 2026-02-03
66
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Bioceramed
Lead Sponsor
E
Egas Moniz - Cooperativa de Ensino Superior, CRL
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to collect real-world clinical data on the performance and safety of Neobone ae, a synthetic, resorbable bone substitute used in reconstructive dental and maxillofacial surgeries. Neobone ae is composed of calcium phosphate ceramics similar to human bone mineral and designed to support natural bone healing. The study will provide clinical evidence for the device's evaluation and help monitor its safety and performance in everyday medical practice. Neobone ae is a single-use, gamma sterilized implantable device intended to fill bone voids or gaps that do not contribute to structural stability. It is used by trained orthopedic surgeons, dentists, and maxillofacial surgeons during surgical procedures. This observational study follows patients undergoing dental reconstructive surgery with Neobone ae according to standard medical practices, without introducing additional interventions or risks. Data will be collected at six visits from before surgery up to 23 months after surgery. Participants will be adults over 18 years undergoing reconstructive dental surgery using Neobone ae and followed for two years. Clinical and radiographic assessments will be performed at scheduled visits, including safety checks shortly after surgery and performance evaluations at 6, 12, and 23 months. Additional measures include quality of life, pain levels, bone density, and bone volume changes. The study monitors outcomes to provide ongoing safety surveillance and support clinical decision-making for this medical device.
CONDITIONS
Brief Title
Evaluation of the Safety and Performance of the Neobone®: A Prospective Observational Study in Dental Area
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult males or females aged over 18 years
- Patients able to sign an informed consent form for data collection
- Patients undergoing reconstructive dental surgery indicated for the use of Neobone�ae
You will not qualify if you...
- Patients unable to understand consent and study objectives
- Presence of local or systemic acute, active, or chronic infections
- Metabolic disorders
- Severe degenerative diseases or conditions unsuitable for general bone grafting
- Implantation sites allowing product migration
- Conditions requiring structural support in the skeletal system
- Unstable implantation sites not rigidly fixated
- Sensitivity or known hypersensitivity to implantable materials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 1 week
Participants undergo reconstructive dental surgery using the Neobone® medical device, with data collected immediately after surgery and during the first week post-surgery.
2 visits (immediately after surgery and 7 ± 1 days post-surgery, in-person)
Duration - Approximately 23 months
Participants are monitored with clinical and radiographic assessments to evaluate the safety and performance of the Neobone® device over time.
3 visits (6 months ±3 weeks, 12 months ±30 days, and 23 months ±30 days, in-person)
Trial Site Locations
Total: 1 location
1
Egas Moniz School of Health and Science Caparica
Lisbon, Portugal
Actively Recruiting
Research Team
A
Alexandre Barros
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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