{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T11:21:35Z","timestamp":1785410495858,"version":"3.56.0"},"reference-count":41,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2026,5,6]],"date-time":"2026-05-06T00:00:00Z","timestamp":1778025600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Funda\u00e7\u00e3o para a Ci\u00eancia e Tecnologia","award":["UID\/4585\/2025"],"award-info":[{"award-number":["UID\/4585\/2025"]}]},{"award":["UID\/4585\/2025"],"award-info":[{"award-number":["UID\/4585\/2025"]}],"id":[{"id":"https:\/\/ror.org\/00snfqn58","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JFB"],"abstract":"<jats:p>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 \u03b2-tricalcium phosphate (\u03b2-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 \u00b1 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.<\/jats:p>","DOI":"10.3390\/jfb17050229","type":"journal-article","created":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T09:03:37Z","timestamp":1778144617000},"page":"229","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"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"],"prefix":"10.3390","volume":"17","author":[{"given":"Nuno","family":"Silva","sequence":"first","affiliation":[{"name":"Egas Moniz Center for Interdisciplinary Research (CiiEM), Egas Moniz School of Health & Science, 2829-511 Almada, Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlota","family":"Rodrigues","sequence":"additional","affiliation":[{"name":"Egas Moniz Center for Interdisciplinary Research (CiiEM), Egas Moniz School of Health & Science, 2829-511 Almada, Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-2666-6246","authenticated-orcid":false,"given":"Angel","family":"Lobito","sequence":"additional","affiliation":[{"name":"Egas Moniz Center for Interdisciplinary Research (CiiEM), Egas Moniz School of Health & Science, 2829-511 Almada, Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3682-8155","authenticated-orcid":false,"given":"Ant\u00f3nio Mano","family":"Azul","sequence":"additional","affiliation":[{"name":"Egas Moniz Center for Interdisciplinary Research (CiiEM), Egas Moniz School of Health & Science, 2829-511 Almada, Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8288-5356","authenticated-orcid":false,"given":"Pedro Ferreira","family":"Trancoso","sequence":"additional","affiliation":[{"name":"Egas Moniz Center for Interdisciplinary Research (CiiEM), Egas Moniz School of Health & Science, 2829-511 Almada, Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2503-260X","authenticated-orcid":false,"given":"Vanessa","family":"Machado","sequence":"additional","affiliation":[{"name":"Egas Moniz Center for Interdisciplinary Research (CiiEM), Egas Moniz School of Health & Science, 2829-511 Almada, Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1019-8263","authenticated-orcid":false,"given":"Jo\u00e3o","family":"Botelho","sequence":"additional","affiliation":[{"name":"Egas Moniz Center for Interdisciplinary Research (CiiEM), Egas Moniz School of Health & Science, 2829-511 Almada, Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,5,6]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Duta, L., Dorcioman, G., and Grumezescu, V. (2021). A Review on Biphasic Calcium Phosphate Materials Derived from Fish Discards. Nanomaterials, 11.","DOI":"10.3390\/nano11112856"},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Mishchenko, O., Yanovska, A., Kosinov, O., Maksymov, D., Moskalenko, R., Ramanavicius, A., and Pogorielov, M. (2023). Synthetic Calcium-Phosphate Materials for Bone Grafting. Polymers, 15.","DOI":"10.3390\/polym15183822"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"S1007","DOI":"10.4103\/jpbs.jpbs_1003_23","article-title":"Biphasic Calcium Phosphate in the Extraction Socket Preservation: A Systematic Review","volume":"16","author":"Mohanasatheesh","year":"2024","journal-title":"J. Pharm. Bioallied Sci."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"23","DOI":"10.1186\/s40729-017-0084-4","article-title":"Autogenous Bone Grafts in Oral Implantology-Is It Still a \u201cGold Standard\u201d? A Consecutive Review of 279 Patients with 456 Clinical Procedures","volume":"3","author":"Sakkas","year":"2017","journal-title":"Int. J. Implant. Dent."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"170","DOI":"10.1111\/cid.13242","article-title":"Comparison of Morbidity-related Parameters between Autologous and Allogeneic Bone Grafts for Alveolar Ridge Augmentation from Patients\u2019 Perspective\u2014A Questionnaire-based Cohort Study","volume":"26","author":"Heimes","year":"2024","journal-title":"Clin. Implant. Dent. Relat. Res."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"212","DOI":"10.1111\/j.1600-051X.2005.00642.x","article-title":"Dimensional Ridge Alterations Following Tooth Extraction. An Experimental Study in the Dog","volume":"32","author":"Lindhe","year":"2005","journal-title":"J. Clin. Periodontol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"157","DOI":"10.1111\/clr.14029","article-title":"Influence of Buccal Bone Wall Thickness on the Peri-implant Hard and Soft Tissue Dimensional Changes: A Systematic Review","volume":"34","author":"Monje","year":"2023","journal-title":"Clin. Oral Implant. Res."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"80","DOI":"10.1111\/j.1600-0501.2011.02370.x","article-title":"Evidence-based Knowledge on the Biology and Treatment of Extraction Sockets","volume":"23","author":"Simion","year":"2012","journal-title":"Clin. Oral Implant. Res."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"272","DOI":"10.1111\/clr.12108","article-title":"Ridge Dimensional Changes Following Single-tooth Extraction in the Aesthetic Zone","volume":"25","author":"Farmer","year":"2014","journal-title":"Clin. Oral Implant. Res."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"137","DOI":"10.1111\/jerd.12280","article-title":"The Clinical Effectiveness of Alveolar Ridge Preservation in the Maxillary Anterior Esthetic Zone\u2014A Retrospective Study","volume":"29","author":"Lee","year":"2017","journal-title":"J. Esthet. Restor. Dent."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"48","DOI":"10.1111\/adj.12098","article-title":"Current Perspectives on the Role of Ridge (Socket) Preservation Procedures in Dental Implant Treatment in the Aesthetic Zone","volume":"59","author":"Kassim","year":"2014","journal-title":"Aust. Dent. J."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"107","DOI":"10.11607\/jomi.7259","article-title":"Influence of Facial Bone Thickness After Implant Placement into the Healed Ridges on the Remodeled Facial Bone and Considering Soft Tissue Recession: A Systematic Review","volume":"35","author":"Canullo","year":"2020","journal-title":"Int. J. Oral Maxillofac. Implant."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"282","DOI":"10.1111\/prd.12048","article-title":"Clinical Concepts for Regenerative Therapy in Intrabony Defects","volume":"68","author":"Cortellini","year":"2015","journal-title":"Periodontol. 2000"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"201","DOI":"10.1002\/cap.10254","article-title":"Periodontal Regeneration Risk Assessment in the Treatment of Intrabony Defects","volume":"14","author":"Levine","year":"2024","journal-title":"Clin. Adv. Periodontics"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"341","DOI":"10.1007\/s00784-012-0758-5","article-title":"Alveolar Ridge Preservation. A Systematic Review","volume":"17","author":"Mardas","year":"2013","journal-title":"Clin. Oral Investig."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"14","DOI":"10.1186\/s40902-024-00425-w","article-title":"Advancements in Alveolar Bone Grafting and Ridge Preservation: A Narrative Review on Materials, Techniques, and Clinical Outcomes","volume":"46","author":"Kim","year":"2024","journal-title":"Maxillofac. Plast. Reconstr. Surg."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"195","DOI":"10.1111\/jcpe.13057","article-title":"Effect of Alveolar Ridge Preservation Interventions Following Tooth Extraction: A Systematic Review and Meta-Analysis","volume":"46","author":"Chambrone","year":"2019","journal-title":"J. Clin. Periodontol."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"1473","DOI":"10.1016\/S0142-9612(98)00061-1","article-title":"Biphasic Calcium Phosphate Concept Applied to Artificial Bone, Implant Coating and Injectable Bone Substitute","volume":"19","author":"Daculsi","year":"1998","journal-title":"Biomaterials"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"102074","DOI":"10.1016\/j.jebdp.2024.102074","article-title":"Alveolar ridge preservation at molar extraction sites: A systematic review and meta-analysis","volume":"25","author":"Wei","year":"2025","journal-title":"J. Evid. Based Dent. Pract."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"S16","DOI":"10.1016\/j.injury.2011.06.199","article-title":"Allograft Bone Matrix versus Synthetic Bone Graft Substitutes","volume":"42","author":"Zimmermann","year":"2011","journal-title":"Injury"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"323","DOI":"10.1097\/SCS.0b013e318241dcba","article-title":"Autogenous Bone Graft: Basic Science and Clinical Implications","volume":"23","author":"Rogers","year":"2012","journal-title":"J. Craniofac. Surg."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"2493","DOI":"10.1002\/jbm.b.34049","article-title":"Hydoxyapatite\/Beta-tricalcium Phosphate Biphasic Ceramics as Regenerative Material for the Repair of Complex Bone Defects","volume":"106","author":"Dard","year":"2018","journal-title":"J. Biomed. Mater. Res."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"373","DOI":"10.1080\/14740338.2023.2219892","article-title":"An Overview of Methodological Flaws of Real-World Studies Investigating Drug Safety in the Post-Marketing Setting","volume":"22","author":"Crisafulli","year":"2023","journal-title":"Expert Opin. Drug. Saf."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"171","DOI":"10.4103\/picr.picr_62_21","article-title":"Introduction to Real-World Evidence Studies","volume":"12","author":"Chodankar","year":"2021","journal-title":"Perspect. Clin. Res."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"100143","DOI":"10.59717\/j.xinn-med.2025.100143","article-title":"Revisiting Real-World Data Studies: Progress, Value, and Challenges","volume":"3","author":"Yang","year":"2025","journal-title":"Innov. Med."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"361","DOI":"10.2105\/AJPH.94.3.361","article-title":"Improving the Reporting Quality of Nonrandomized Evaluations of Behavioral and Public Health Interventions: The TREND Statement","volume":"94","author":"Lyles","year":"2004","journal-title":"Am. J. Public Health"},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"374","DOI":"10.15309\/17psd180208","article-title":"Oral Health-Related Quality of Life: Portuguese Linguistic and Cultural Adaptation of OHIP-14","volume":"18","author":"Afonso","year":"2017","journal-title":"Psic. Sa\u00fade Doen\u00e7as"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"284","DOI":"10.1111\/j.1600-0528.1997.tb00941.x","article-title":"Derivation and Validation of a Short-Form Oral Health Impact Profile","volume":"25","author":"Slade","year":"1997","journal-title":"Community Dent. Oral Epidemiol."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"399","DOI":"10.1016\/j.oooo.2017.12.010","article-title":"Treatment of Enucleated Odontogenic Jaw Cysts: A Systematic Review","volume":"125","author":"Buchbender","year":"2018","journal-title":"Oral Surg. Oral Med. Oral Pathol. Oral Radiol."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"141","DOI":"10.1590\/0100-69912016003001","article-title":"Cultural Adaptation and the Clavien-Dindo Surgical Complications Classification Translated to Brazilian Portuguese","volume":"43","author":"Moreira","year":"2016","journal-title":"Rev. Col. Bras. Cir."},{"key":"ref_31","doi-asserted-by":"crossref","unstructured":"Bonardi, J.P., Pereira, R.D.S., Mour\u00e3o, C.F., Coelho Mendes, B., Lowenstein, A., Montemezzi, P., Giubilato, F., Okamoto, R., and Hochuli-Vieira, E. (2023). Clinical Assessment of Biphasic Calcium Phosphate in Granules and Paste Forms in Human Maxillary Sinus Bone Augmentation: A Randomized, Split-Mouth Clinical Trial. Materials, 16.","DOI":"10.3390\/ma16031059"},{"key":"ref_32","doi-asserted-by":"crossref","unstructured":"Cheah, C.W., Al-Namnam, N.M., Lau, M.N., Lim, G.S., Raman, R., Fairbairn, P., and Ngeow, W.C. (2021). Synthetic Material for Bone, Periodontal, and Dental Tissue Regeneration: Where Are We Now, and Where Are We Heading Next?. Materials, 14.","DOI":"10.3390\/ma14206123"},{"key":"ref_33","doi-asserted-by":"crossref","unstructured":"Huang, Y., Zhang, Z., Zheng, Y., Zhao, Z., Zhong, Y., Zhang, Q., Xia, D., Ma, N., and Zhang, L. (2021). Effects of Non-Surgical Periodontal Therapy on Periodontal Clinical Data in Periodontitis Patients with Rheumatoid Arthritis: A Meta-Analysis. BMC Oral Health, 21.","DOI":"10.1186\/s12903-021-01695-w"},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"23","DOI":"10.1016\/j.actbio.2020.06.022","article-title":"\u03b2-Tricalcium Phosphate for Bone Substitution: Synthesis and Properties","volume":"113","author":"Bohner","year":"2020","journal-title":"Acta Biomater."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"550","DOI":"10.1007\/s00776-008-1271-1","article-title":"Electron Microscopic Study on Bone Formation and Bioresorption after Implantation of \u03b2-Tricalcium Phosphate in Rabbit Models","volume":"13","author":"Chazono","year":"2008","journal-title":"J. Orthop. Sci."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"9223","DOI":"10.1021\/acsami.8b22041","article-title":"Engineering Porous \u03b2-Tricalcium Phosphate (\u03b2-TCP) Scaffolds with Multiple Channels to Promote Cell Migration, Proliferation, and Angiogenesis","volume":"11","author":"Wang","year":"2019","journal-title":"ACS Appl. Mater. Interfaces"},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"S341","DOI":"10.1098\/rsif.2008.0425.focus","article-title":"Interconnected Porous Hydroxyapatite Ceramics for Bone Tissue Engineering","volume":"6","author":"Yoshikawa","year":"2009","journal-title":"J. R. Soc. Interface"},{"key":"ref_38","doi-asserted-by":"crossref","unstructured":"Roca-Millan, E., Jan\u00e9-Salas, E., Mar\u00ed-Roig, A., Jim\u00e9nez-Guerra, \u00c1., Ortiz-Garc\u00eda, I., Velasco-Ortega, E., L\u00f3pez-L\u00f3pez, J., and Monsalve-Guil, L. (2022). The Application of Beta-Tricalcium Phosphate in Implant Dentistry: A Systematic Evaluation of Clinical Studies. Materials, 15.","DOI":"10.3390\/ma15020655"},{"key":"ref_39","first-page":"588","article-title":"Clinical Evaluation Alveolar Ridge Preservation with a Beta-Tricalcium Phosphate Socket Graft","volume":"30","author":"Horowitz","year":"2009","journal-title":"Compend. Contin. Educ. Dent."},{"key":"ref_40","doi-asserted-by":"crossref","unstructured":"Bozza, B., Pesce, P., Baldi, D., Bagnasco, F., Migliorati, M., and De Angelis, N. (2025). Synthetic Biomaterials for Alveolar Bone Regeneration: A Systematic Review of Clinical Evidence. Materials, 18.","DOI":"10.3390\/ma18235328"},{"key":"ref_41","doi-asserted-by":"crossref","first-page":"72","DOI":"10.1016\/j.ejwf.2023.02.002","article-title":"Oral Health Impact Profile (OHIP)-14 Telephone Interview Reliability to Assess Oral Health-Related Quality of Life (OHRQoL) in Orthosurgical Patients","volume":"12","author":"Holz","year":"2023","journal-title":"J. World Fed. Orthod."}],"container-title":["Journal of Functional Biomaterials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2079-4983\/17\/5\/229\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T09:53:02Z","timestamp":1778147582000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2079-4983\/17\/5\/229"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,6]]},"references-count":41,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2026,5]]}},"alternative-id":["jfb17050229"],"URL":"https:\/\/doi.org\/10.3390\/jfb17050229","relation":{},"ISSN":["2079-4983"],"issn-type":[{"value":"2079-4983","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,6]]}}}