Neobone® safety and performance in dental bone grafting
Evaluation of the Safety and Performance of the Neobone®: A Prospective Observational Study in Dental Area
This project will collect real-world data to see if Neobone® is safe and helps bone heal in adults having reconstructive dental procedures.
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 | NCT07179497 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (over 18) undergoing reconstructive dental or maxillofacial surgery where the surgeon plans to use Neobone® and who can give informed consent are the intended participants.
Not a fit: Patients who require structural load-bearing support, have active local or systemic infections, metabolic bone disorders, unstable implantation sites, or known hypersensitivity to the implant materials are unlikely to benefit.
Why it matters
Potential benefit: If successful, Neobone® could provide a resorbable synthetic graft that supports bone regeneration and may reduce the need to harvest a patient’s own bone.
How similar studies have performed: Other clinical reports of biphasic hydroxyapatite/β‑TCP bone substitutes have shown positive bone integration in dental augmentation, but long-term device-specific evidence for Neobone® remains limited.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Lisbon
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.