{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T05:39:58Z","timestamp":1778823598557,"version":"3.51.4"},"reference-count":19,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2021,4,14]],"date-time":"2021-04-14T00:00:00Z","timestamp":1618358400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Japanese Society for Promotion of Science","award":["19K19070"],"award-info":[{"award-number":["19K19070"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>The purpose of this clinical study is to evaluate the safety and preliminary efficacy of autologous freeze-drying platelet-rich plasma (FD-PRP) on bone regeneration in maxillary sinus floor augmentation as a preliminary pilot study. Five patients that required sinus floor augmentation to facilitate the placement of dental implants participated in this clinical study. The PRP was prepared from the autologous peripheral blood and was lyophilized and stored at \u221220 \u00b0C for 4 weeks before surgery. At surgery, triple-concentrated FD-PRP (x3FD-PRP) mixed with synthetic bone grafting materials was rehydrated following the transplantation into the sinus floor. The primary outcome was a safety verification of x3FD-PRP, evaluated in terms of the clinical course and consecutive blood tests. The secondary outcome was clinical efficacy focused on bone regeneration in sinus floor augmentation evaluated by radiographic examination and implant stability. There were no adverse events, such as systemic complications, excessive inflammatory reactions, severe infection, or local site healing complications, besides those on the usual course associated with surgery. Vertical augmented height was maintained, and the initial stability of implants was achieved post-operatively in 6 months. The results obtained in this study suggest that x3FD-PRP can be used safely for bone engineering in clinical practice. Further studies are required to draw a conclusion concerning the efficacy of x3FD-PRP since this was a pilot study with a single arm and a small sample size.<\/jats:p>","DOI":"10.3390\/jcm10081678","type":"journal-article","created":{"date-parts":[[2021,4,14]],"date-time":"2021-04-14T04:21:08Z","timestamp":1618374068000},"page":"1678","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Clinical Safety Assessment of Autologous Freeze-Drying Platelet-Rich Plasma for Bone Regeneration in Maxillary Sinus Floor Augmentation: A Pilot Study"],"prefix":"10.3390","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9255-186X","authenticated-orcid":false,"given":"Takamitsu","family":"Koga","sequence":"first","affiliation":[{"name":"Department of Regenerative Oral Surgery, Institute of Biomedical Sciences, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8588, Japan"},{"name":"Department of Dentistry and Oral Surgery, Imaki-ire General Hospital, Kagoshima 892-8502, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuya","family":"Nakatani","sequence":"additional","affiliation":[{"name":"Department of Regenerative Oral Surgery, Institute of Biomedical Sciences, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8588, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0639-1714","authenticated-orcid":false,"given":"Seigo","family":"Ohba","sequence":"additional","affiliation":[{"name":"Department of Regenerative Oral Surgery, Institute of Biomedical Sciences, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8588, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masahito","family":"Hara","sequence":"additional","affiliation":[{"name":"Department of Regenerative Oral Surgery, Institute of Biomedical Sciences, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8588, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1247-9763","authenticated-orcid":false,"given":"Yoshinori","family":"Sumita","sequence":"additional","affiliation":[{"name":"Basic and Translational Research Center for Hard Tissue Disease, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8588, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuhiro","family":"Nagai","sequence":"additional","affiliation":[{"name":"Transfusion and Cell Therapy Unit, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki 852-8501, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9448-2001","authenticated-orcid":false,"given":"Izumi","family":"Asahina","sequence":"additional","affiliation":[{"name":"Department of Regenerative Oral Surgery, Institute of Biomedical Sciences, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8588, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2021,4,14]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"489","DOI":"10.1016\/j.joms.2003.12.003","article-title":"Platelet-rich plasma: Evidence to support its use","volume":"62","author":"Marx","year":"2004","journal-title":"J. Oral Maxillofac. Surg."},{"key":"ref_2","first-page":"290","article-title":"The influence of platelet-derived products on angiogenesis and tissue repair: A concise update","volume":"6","author":"Smith","year":"2015","journal-title":"Front. Physiol."},{"key":"ref_3","first-page":"345","article-title":"Localized ridge augmentation using GBR and platelet-rich plasma: Case reports","volume":"21","author":"Shanaman","year":"2001","journal-title":"Int. J. Periodontics Restor. Dent."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"157","DOI":"10.1053\/joms.2003.50041","article-title":"Maxillary sinus augmentation with deproteinated bovine bone and platelet rich plasma with simultaneous inser-tion of endosseous implants","volume":"61","author":"Rodriguez","year":"2003","journal-title":"J. Oral Maxillofac. Surg."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"573","DOI":"10.1111\/j.1743-6109.2006.00164.x","article-title":"Freeze-dried platelet-rich plasma shows beneficial healing properties in chronic wounds","volume":"14","author":"Pietramaggiori","year":"2006","journal-title":"Wound Repair Regen."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"329","DOI":"10.4184\/asj.2017.11.3.329","article-title":"Freeze-Dried Human Platelet-Rich Plasma Retains Activation and Growth Factor Expression after an Eight-Week Preservation Period","volume":"11","author":"Shiga","year":"2017","journal-title":"Asian Spine J."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"223","DOI":"10.1016\/j.cryobiol.2013.01.006","article-title":"An improved freeze-dried PRP-coated biodegradable material suitable for connective tissue regenerative therapy","volume":"66","author":"Horimizu","year":"2013","journal-title":"Cryobiology"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"594","DOI":"10.3109\/09537104.2011.645923","article-title":"Bioactivity of freeze-dried platelet-rich plasma in an adsorbed form on a biodegradable polymer material","volume":"23","author":"Nakajima","year":"2012","journal-title":"Platelets"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"172","DOI":"10.1016\/j.archoralbio.2016.10.006","article-title":"Efficacy of freeze-dried platelet-rich plasma in bone engineering","volume":"73","author":"Nakatani","year":"2017","journal-title":"Arch. Oral Biol."},{"key":"ref_10","doi-asserted-by":"crossref","unstructured":"Andia, I., Perez-Valle, A., Del Amo, C., and Maffulli, N. (2020). Freeze-Drying of Platelet-Rich Plasma: The Quest for Standardization. Int. J. Mol. Sci., 21.","DOI":"10.3390\/ijms21186904"},{"key":"ref_11","first-page":"e22","article-title":"Easy-to-Use Preservation and application of platelet-rich plasma in combination wound therapy with a gela-tin sheet and freeze-dried platelet-rich plasma: A case report","volume":"16","author":"Morimoto","year":"2016","journal-title":"Eplasty"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"466","DOI":"10.1111\/cid.12473","article-title":"Clinical and immunohistochemical performance of lyophilized platelet-rich fibrin (Ly-PRF) on tissue regeneration","volume":"19","author":"Zhang","year":"2017","journal-title":"Clin. Implant. Dent. Relat. Res."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"36715","DOI":"10.1038\/srep36715","article-title":"Freeze-Dried Platelet-Rich Plasma Accelerates Bone Union with Adequate Rigidity in Posterolateral Lumbar Fusion Surgery Model in Rats","volume":"6","author":"Shiga","year":"2016","journal-title":"Sci. Rep."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"1","DOI":"10.31616\/asj.2019.0048","article-title":"Freeze-dried platelet-rich plasma induces osteoblast proliferation via platelet-derived growth factor recep-tor-mediated signal transduction","volume":"14","author":"Kinoshita","year":"2020","journal-title":"Asian Spine J."},{"key":"ref_15","doi-asserted-by":"crossref","unstructured":"Li, J., Chen, M., Wei, X., Hao, Y., and Wang, J. (2017). Evaluation of 3D-Printed Polycaprolactone Scaffolds Coated with Freeze-Dried Platelet-Rich Plasma for Bone Regenera-tion. Materials, 10.","DOI":"10.3390\/ma10070831"},{"key":"ref_16","first-page":"15","article-title":"In vitro effects of different concentration of PRP on primary bone and gingival cell lines. Preliminary results","volume":"54","author":"Graziani","year":"2005","journal-title":"Minerva Stomatol."},{"key":"ref_17","first-page":"7","article-title":"Effectiveness of sinus lift procedures for dental implant rehabilitation: A Cochrane systematic review","volume":"3","author":"Esposito","year":"2010","journal-title":"Eur. J. Oral Implant."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"959","DOI":"10.1111\/cid.12522","article-title":"Histologic and histomorphometric assessment of sinus-floor augmentation with beta-tricalcium phosphate alone or in combination with pure-platelet-rich plasma or platelet-rich fibrin: A randomized clinical trial","volume":"19","author":"Parlak","year":"2017","journal-title":"Clin. Implant. Dent. Relat. Res."},{"key":"ref_19","first-page":"7267062","article-title":"Effectiveness of platelet-rich fibrin as an adjunctive material to bone graft in maxillary sinus augmentation: A meta-analysis of randomized controlled trails","volume":"2019","author":"Liu","year":"2019","journal-title":"BioMed Res. 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