Neobone® safety and performance in dental bone grafting

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

Neobone® is a synthetic, resorbable biphasic calcium phosphate (hydroxyapatite and beta‑tricalcium phosphate) bone substitute intended for use in dental and maxillofacial grafting. This prospective observational study will gather clinical and safety data from adults who receive Neobone® during reconstructive dental surgery at the participating center. Collected information will include handling, wound healing, radiographic and clinical signs of bone integration, and any adverse events during follow-up. The results are intended to provide clinical evidence to support the device's performance and safety profile.

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 Neobone®;

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 Caparica
  Lisbon, Portugal Recruiting

Study contacts

• Principal investigator: João Botelho — Egas Moniz School of Health and Science Caparica
• 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.