Actively Recruiting
Evaluation of the Safety and Performance of the Neocement4 Inject P: 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 to evaluate the performance and safety of Neocement4 Inject P, a synthetic bone substitute used in dental and maxillofacial reconstructive surgeries. The study is observational and focuses on adult patients undergoing reconstructive dental surgery with this device. It seeks to provide clinical evidence to support ongoing evaluation of the device's use and safety in current medical practice. Neocement4 Inject P is a biodegradable medical device composed of calcium phosphates and chitosan, designed to fill bone voids or gaps that do not affect bone stability. It is a single-use, gamma-sterilized device applied by trained surgeons or dentists in operating rooms or dental offices. The study collects data following routine clinical use without introducing new treatments or changes in device design. Participants will be followed for two years with data collected at six visits: before surgery, immediately after surgery, about one week post-surgery, six months, twelve months, and nearly two years later. Researchers will assess clinical and radiographic outcomes, safety, bone density, pain levels, quality of life, and bone volume changes. The study observes standard care practices and aims to monitor long-term performance and safety of the device.
CONDITIONS
Brief Title
Evaluation of the Safety and Performance of the Neocement® Inject P: 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 and indicated for the use of Neocement4 Inject P
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 where bone grafting is not advisable
- Implantation sites allowing product migration
- Conditions requiring structural support in the skeletal system
- Implantation sites that are unstable and not rigidly fixed
- Sensitivity or known hypersensitivity to implantable materials or the device components
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 visit (in-person) before surgery for baseline and enrollment
Duration - Day of surgery and immediately after
Participants undergo reconstructive dental surgery where the Neocement® Inject P device is used, followed by immediate post-operative assessments.
1 visit (in-person) moment after surgery
Duration - Up to 23 months after surgery
Participants are monitored through clinical and radiographic assessments to evaluate safety, pain, quality of life, and bone regeneration over two years.
5 visits (in-person) at 7 days, 6 months, 12 months, and 23 months after surgery
Trial Site Locations
Total: 1 location
1
Egas Moniz School of Health and Science
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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