Neocement® Inject P for dental bone augmentation and regeneration.

Evaluation of the Safety and Performance of the Neocement® Inject P: A Prospective Observational Study in Dental Area

This study will try Neocement® Inject P, an injectable calcium‑phosphate bone substitute, in adults having reconstructive dental or maxillofacial surgery to see if it is safe and helps bone heal.

Quick facts

• Study type: Observational
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bioceramed (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Lisbon)
• Trial ID: NCT07179510 on ClinicalTrials.gov

What this trial studies

This is a prospective observational study collecting real‑world clinical data on the performance and safety of Neocement® Inject P when used according to its intended indications in dental and maxillofacial procedures. The device is an injectable, single‑use calcium phosphate and chitosan bone substitute delivered as a two‑part system intended to fill non‑load‑bearing bony voids and support bone regeneration. Adult patients undergoing reconstructive dental surgery who provide informed consent will have device handling, clinical outcomes, and adverse events recorded under a predefined observational protocol. The collected data will serve as clinical evidence to inform the device's clinical evaluation.

Who should consider this trial

Good fit: Adults (≥18 years) scheduled for reconstructive dental or maxillofacial surgery with non‑load‑bearing bone defects and no active infection, metabolic contraindication, or known material hypersensitivity.

Not a fit: Patients with active local or systemic infection, metabolic bone disease, unstable or load‑bearing implantation sites, or known hypersensitivity to the implant materials are unlikely to benefit from this device.

Why it matters

Potential benefit: If successful, Neocement® Inject P could improve bone quality and accelerate bone healing after dental reconstructive procedures.

How similar studies have performed: Injectable calcium‑phosphate bone substitutes similar to Neocement® Inject P have clinical precedent with documented bone healing and acceptable safety profiles in comparable indications.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Lisbon

• Egas Moniz School of Health and Science — Lisbon, Portugal (Recruiting)

Study contacts

• Principal investigator: João Botelho — Egas Moniz School of Health and Science Caparica, Lisboa, Portugal
• Study coordinator: Alexandre Barros

Conditions Bone Augmentation; prospective observational clinical study; bone substitute; bone defects; real-world clinical data; safety; performance; medical device