RecruitingNCT07179510
Evaluation of the Safety and Performance of the Neocement® Inject P: A Prospective Observational Study in Dental Area
Sponsor
Bioceramed
Enrollment
66 participants
Start Date
Oct 6, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® Inject P when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence for the device's clinical evaluation.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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 Neocement® Inject P;
Exclusion Criteria9
- 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.
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07179510
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