Status:
NOT_YET_RECRUITING
Evaluation of the Safety and Performance of the Neobone®: A Prospective Observational Study in Dental Area
Lead Sponsor:
Bioceramed
Collaborating Sponsors:
Egas Moniz - Cooperativa de Ensino Superior, CRL
Conditions:
Bone Augmentation
Eligibility:
All Genders
18+ years
Brief Summary
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neobone® when used according to its intended purpose and current clinical applications. T...
Detailed Description
Neobone® is a synthetic and resorbable implantable synthetic calcium phosphate ceramic bone substitute, composed of hydroxyapatite and beta-tricalcium phosphate. The structures composed of these calci...
Eligibility Criteria
Inclusion
- Adult males or females (age \> 18 years old);
- Patients who are able to sign an informed consent form (for data collection);
- Patients undergoing reconstructive dental surgery and indicated for the use of Neobone®;
Exclusion
- Patients who are unable to understand consent and the objectives of the study;
- Signs of local or systemic acute/ active or chronic infections;
- Metabolic affections;
- Severe degenerative diseases, conditions in which general bone grafting is not advisable;
- Implementation sites that allow product migration;
- Conditions which require structural support in the skeletal system;
- Conditions where the implantation site is unstable and not rigidly fixated;
- Sensibility to the implantable materials;
- Known hypersensitivity to the implant material.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT07179497
Start Date
October 1 2025
End Date
October 1 2027
Last Update
September 17 2025
Active Locations (1)
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1
Egas Moniz School of Health and Science Caparica
Lisbon, Portugal