Publicação
Post-market non-controlled study on the clinical safety of a synthetic calcium phosphate ceramic in alveolar bone regeneration : a 6-month prospective study
| datacite.subject.fos | Ciências Médicas::Ciências da Saúde | |
| datacite.subject.sdg | 03:Saúde de Qualidade | |
| dc.contributor.author | Silva, Nuno | |
| dc.contributor.author | Rodrigues, Carlota | |
| dc.contributor.author | Lobito, Angel | |
| dc.contributor.author | Azul, António Mano | |
| dc.contributor.author | Trancoso, Pedro Ferreira | |
| dc.contributor.author | Machado, Vanessa | |
| dc.contributor.author | Botelho, João | |
| dc.date.accessioned | 2026-06-16T14:57:25Z | |
| dc.date.available | 2026-06-16T14:57:25Z | |
| dc.date.issued | 2026-05 | |
| dc.description.abstract | This prospective, single-arm post-market study aimed to evaluate the clinical safety and performance of a synthetic calcium phosphate ceramic used in alveolar bone regeneration procedures. Eighty adult patients requiring bone augmentation were treated with β-tricalcium phosphate (β-TCP) under routine clinical indications. Surgical approaches were adapted to defect morphology. Safety outcomes included adverse events (AEs) and device deficiencies (DDs), while performance outcomes focused on two-dimensional radiographic bone assessment. Radiographic bone consolidation was defined as continuous trabecular radiopacity without radiolucent defects or clinical signs of infection. Patients were followed for six months post-surgery, with clinical and radiographic evaluations, as well as assessment of oral health-related quality of life (OHIP-14). All 80 patients (mean age: 47.2 ± 18.9 years; 51% male) completed the immediate postoperative assessment. Eleven DDs (granule loss) were observed postoperatively (13.8%) and no AEs. At six months, 71 patients (88.8%) completed follow-up. Radiographic bone repair was confirmed in all cases clinically observed and with follow-up X-ray (100%). No AEs or DDs reported (AE-free rate: 100%) at this follow-up. The median OHIP-14 score improved significantly at six months (p = 0.037), indicating better self-reported oral health. Given the observational design, absence of a control group, and partial reliance on non-radiographic follow-up, these findings should be interpreted with caution. Within these limitations, the synthetic calcium phosphate ceramic demonstrated a favorable short-term safety profile and apparent bidimensional radiographic signs of clinical performance under real-world conditions, rather than definitive evidence of effectiveness. Further controlled studies incorporating histological and volumetric analyses are warranted to confirm its regenerative potential. | eng |
| dc.identifier.citation | Silva N, Rodrigues C, Lobito A, Azul AM, Trancoso PF, Machado V, Botelho J. Post-Market Non-Controlled Study on the Clinical Safety of a Synthetic Calcium Phosphate Ceramic in Alveolar Bone Regeneration: A 6-Month Prospective Study. Journal of Functional Biomaterials. 2026; 17(5):229. https://doi.org/10.3390/jfb17050229 | |
| dc.identifier.doi | 10.3390/jfb17050229 | |
| dc.identifier.issn | 2079-4983 | |
| dc.identifier.uri | http://hdl.handle.net/10400.26/63612 | |
| dc.language.iso | eng | |
| dc.peerreviewed | yes | |
| dc.publisher | MDPI | |
| dc.relation.hasversion | https://doi.org/10.3390/jfb17050229 | |
| dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | |
| dc.subject | bioceramics | |
| dc.subject | β-tricalcium phosphate | |
| dc.subject | bone regeneration | |
| dc.subject | oral surgery | |
| dc.subject | prospective study | |
| dc.title | Post-market non-controlled study on the clinical safety of a synthetic calcium phosphate ceramic in alveolar bone regeneration : a 6-month prospective study | eng |
| dc.type | contribution to journal | |
| dspace.entity.type | Publication | |
| oaire.citation.issue | 5 | |
| oaire.citation.startPage | 229 | |
| oaire.citation.title | Journal of Functional Biomaterials | |
| oaire.citation.volume | 17 | |
| oaire.version | http://purl.org/coar/version/c_970fb48d4fbd8a85 |