A Clinical Trial to Evaluate the Efficacy and Safety of 3D Printed Bioceramic Implants for the Reconstruction of Zygomatic Bone Defects
The purpose of this study was to evaluate the clinical efficacy and safety of patient-specific additive-manufactured CaOSiO2-P2O5-B2O3 glass-ceramic (BGS-7) implants for reconstructing zygomatic bone defects at a 6-month follow-up. A prospective, single-arm, single-center, clinical trial was perform...
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| Veröffentlicht in: | Materials 2020-10, Vol.13 (20), p.4515 |
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| creator | Lee, Ui-Lyong Lim, Jun-Young Park, Sung-Nam Choi, Byoung-Hun Kang, Hyun Choi, Won-Cheul |
| description | The purpose of this study was to evaluate the clinical efficacy and safety of patient-specific additive-manufactured CaOSiO2-P2O5-B2O3 glass-ceramic (BGS-7) implants for reconstructing zygomatic bone defects at a 6-month follow-up. A prospective, single-arm, single-center, clinical trial was performed on patients with obvious zygoma defects who needed and wanted reconstruction. The primary outcome variable was a bone fusion between the implant and the bone evaluated by computed tomography (CT) at 6 months post surgery. Secondary outcomes, including implant immobilization, satisfaction assessment, osteolysis, subsidence of the BGS-7 implant, and safety, were assessed. A total of eight patients were enrolled in the study. Two patients underwent simultaneous reconstruction of the left and right malar defects using a BGS-7 3D printed implant. Cone beam CT analysis showed that bone fusion at 6 months after surgery was 100%. We observed that the average fusion rate was 76.97%. Osteolysis around 3D printed BGS-7 implants was not observed. The mean distance displacement of all 10 implants was 0.4149 mm. Our study showed no adverse event in any of the cases. The visual analog scale score for satisfaction was 9. All patients who enrolled in this trial were aesthetically and functionally satisfied with the surgical results. In conclusion, this study demonstrates the safety and promising value of patient-specific 3D printed BGS-7 implants as a novel facial bone reconstruction method. |
| doi_str_mv | 10.3390/ma13204515 |
| format | Article |
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A prospective, single-arm, single-center, clinical trial was performed on patients with obvious zygoma defects who needed and wanted reconstruction. The primary outcome variable was a bone fusion between the implant and the bone evaluated by computed tomography (CT) at 6 months post surgery. Secondary outcomes, including implant immobilization, satisfaction assessment, osteolysis, subsidence of the BGS-7 implant, and safety, were assessed. A total of eight patients were enrolled in the study. Two patients underwent simultaneous reconstruction of the left and right malar defects using a BGS-7 3D printed implant. Cone beam CT analysis showed that bone fusion at 6 months after surgery was 100%. We observed that the average fusion rate was 76.97%. Osteolysis around 3D printed BGS-7 implants was not observed. The mean distance displacement of all 10 implants was 0.4149 mm. Our study showed no adverse event in any of the cases. The visual analog scale score for satisfaction was 9. All patients who enrolled in this trial were aesthetically and functionally satisfied with the surgical results. In conclusion, this study demonstrates the safety and promising value of patient-specific 3D printed BGS-7 implants as a novel facial bone reconstruction method.</description><identifier>ISSN: 1996-1944</identifier><identifier>EISSN: 1996-1944</identifier><identifier>DOI: 10.3390/ma13204515</identifier><identifier>PMID: 33053855</identifier><language>eng</language><publisher>Basel: MDPI AG</publisher><subject>3-D printers ; Additive manufacturing ; Anesthesia ; Bioceramics ; Biomedical materials ; Boron oxides ; CAD ; CAM ; Clinical outcomes ; Clinical trials ; Computed tomography ; Computer aided design ; Computer aided manufacturing ; Defects ; Evaluation ; FDA approval ; Glass ceramics ; Image reconstruction ; Medical equipment ; Patients ; Phosphorus pentoxide ; Safety ; Sintering ; Surgeons ; Surgery ; Surgical implants ; Three dimensional printing ; Titanium ; Transplants & implants ; Wire</subject><ispartof>Materials, 2020-10, Vol.13 (20), p.4515</ispartof><rights>2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2020 by the authors. 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c383t-17388aea9b76fe574dbc125dfbfae3cf4a3813bb72f82712be1a6d550db8772d3</citedby><cites>FETCH-LOGICAL-c383t-17388aea9b76fe574dbc125dfbfae3cf4a3813bb72f82712be1a6d550db8772d3</cites><orcidid>0000-0002-4786-8734 ; 0000-0003-2844-5880</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7601564/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7601564/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,53791,53793</link.rule.ids></links><search><creatorcontrib>Lee, Ui-Lyong</creatorcontrib><creatorcontrib>Lim, Jun-Young</creatorcontrib><creatorcontrib>Park, Sung-Nam</creatorcontrib><creatorcontrib>Choi, Byoung-Hun</creatorcontrib><creatorcontrib>Kang, Hyun</creatorcontrib><creatorcontrib>Choi, Won-Cheul</creatorcontrib><title>A Clinical Trial to Evaluate the Efficacy and Safety of 3D Printed Bioceramic Implants for the Reconstruction of Zygomatic Bone Defects</title><title>Materials</title><description>The purpose of this study was to evaluate the clinical efficacy and safety of patient-specific additive-manufactured CaOSiO2-P2O5-B2O3 glass-ceramic (BGS-7) implants for reconstructing zygomatic bone defects at a 6-month follow-up. A prospective, single-arm, single-center, clinical trial was performed on patients with obvious zygoma defects who needed and wanted reconstruction. The primary outcome variable was a bone fusion between the implant and the bone evaluated by computed tomography (CT) at 6 months post surgery. Secondary outcomes, including implant immobilization, satisfaction assessment, osteolysis, subsidence of the BGS-7 implant, and safety, were assessed. A total of eight patients were enrolled in the study. Two patients underwent simultaneous reconstruction of the left and right malar defects using a BGS-7 3D printed implant. Cone beam CT analysis showed that bone fusion at 6 months after surgery was 100%. We observed that the average fusion rate was 76.97%. Osteolysis around 3D printed BGS-7 implants was not observed. The mean distance displacement of all 10 implants was 0.4149 mm. Our study showed no adverse event in any of the cases. The visual analog scale score for satisfaction was 9. All patients who enrolled in this trial were aesthetically and functionally satisfied with the surgical results. 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Lim, Jun-Young ; Park, Sung-Nam ; Choi, Byoung-Hun ; Kang, Hyun ; Choi, Won-Cheul</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c383t-17388aea9b76fe574dbc125dfbfae3cf4a3813bb72f82712be1a6d550db8772d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>3-D printers</topic><topic>Additive manufacturing</topic><topic>Anesthesia</topic><topic>Bioceramics</topic><topic>Biomedical materials</topic><topic>Boron oxides</topic><topic>CAD</topic><topic>CAM</topic><topic>Clinical outcomes</topic><topic>Clinical trials</topic><topic>Computed tomography</topic><topic>Computer aided design</topic><topic>Computer aided manufacturing</topic><topic>Defects</topic><topic>Evaluation</topic><topic>FDA approval</topic><topic>Glass ceramics</topic><topic>Image reconstruction</topic><topic>Medical equipment</topic><topic>Patients</topic><topic>Phosphorus pentoxide</topic><topic>Safety</topic><topic>Sintering</topic><topic>Surgeons</topic><topic>Surgery</topic><topic>Surgical implants</topic><topic>Three dimensional printing</topic><topic>Titanium</topic><topic>Transplants & implants</topic><topic>Wire</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lee, Ui-Lyong</creatorcontrib><creatorcontrib>Lim, Jun-Young</creatorcontrib><creatorcontrib>Park, Sung-Nam</creatorcontrib><creatorcontrib>Choi, Byoung-Hun</creatorcontrib><creatorcontrib>Kang, Hyun</creatorcontrib><creatorcontrib>Choi, Won-Cheul</creatorcontrib><collection>CrossRef</collection><collection>Engineered Materials Abstracts</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Technology Collection</collection><collection>Materials Science & Engineering Collection</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Technology Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Materials Science Collection</collection><collection>ProQuest Central Korea</collection><collection>SciTech Premium Collection</collection><collection>Materials Research Database</collection><collection>Materials Science Database</collection><collection>Materials Science Collection</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Materials</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lee, Ui-Lyong</au><au>Lim, Jun-Young</au><au>Park, Sung-Nam</au><au>Choi, Byoung-Hun</au><au>Kang, Hyun</au><au>Choi, Won-Cheul</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Clinical Trial to Evaluate the Efficacy and Safety of 3D Printed Bioceramic Implants for the Reconstruction of Zygomatic Bone Defects</atitle><jtitle>Materials</jtitle><date>2020-10-12</date><risdate>2020</risdate><volume>13</volume><issue>20</issue><spage>4515</spage><pages>4515-</pages><issn>1996-1944</issn><eissn>1996-1944</eissn><abstract>The purpose of this study was to evaluate the clinical efficacy and safety of patient-specific additive-manufactured CaOSiO2-P2O5-B2O3 glass-ceramic (BGS-7) implants for reconstructing zygomatic bone defects at a 6-month follow-up. A prospective, single-arm, single-center, clinical trial was performed on patients with obvious zygoma defects who needed and wanted reconstruction. The primary outcome variable was a bone fusion between the implant and the bone evaluated by computed tomography (CT) at 6 months post surgery. Secondary outcomes, including implant immobilization, satisfaction assessment, osteolysis, subsidence of the BGS-7 implant, and safety, were assessed. A total of eight patients were enrolled in the study. Two patients underwent simultaneous reconstruction of the left and right malar defects using a BGS-7 3D printed implant. Cone beam CT analysis showed that bone fusion at 6 months after surgery was 100%. We observed that the average fusion rate was 76.97%. Osteolysis around 3D printed BGS-7 implants was not observed. The mean distance displacement of all 10 implants was 0.4149 mm. Our study showed no adverse event in any of the cases. The visual analog scale score for satisfaction was 9. All patients who enrolled in this trial were aesthetically and functionally satisfied with the surgical results. In conclusion, this study demonstrates the safety and promising value of patient-specific 3D printed BGS-7 implants as a novel facial bone reconstruction method.</abstract><cop>Basel</cop><pub>MDPI AG</pub><pmid>33053855</pmid><doi>10.3390/ma13204515</doi><orcidid>https://orcid.org/0000-0002-4786-8734</orcidid><orcidid>https://orcid.org/0000-0003-2844-5880</orcidid><oa>free_for_read</oa></addata></record> |
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| source | Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central Open Access; MDPI - Multidisciplinary Digital Publishing Institute; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | 3-D printers Additive manufacturing Anesthesia Bioceramics Biomedical materials Boron oxides CAD CAM Clinical outcomes Clinical trials Computed tomography Computer aided design Computer aided manufacturing Defects Evaluation FDA approval Glass ceramics Image reconstruction Medical equipment Patients Phosphorus pentoxide Safety Sintering Surgeons Surgery Surgical implants Three dimensional printing Titanium Transplants & implants Wire |
| title | A Clinical Trial to Evaluate the Efficacy and Safety of 3D Printed Bioceramic Implants for the Reconstruction of Zygomatic Bone Defects |
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