Neocement® Inject P for dental bone augmentation and regeneration.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: info@bioceramed.com
• Phone: 253 573 460

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.