Top

Published in:

22-08-2022 | Oral and Maxillofacial Surgery | Original Article

A survey regarding the organizational aspects and quality systems of in-house 3D printing in oral and maxillofacial surgery in Germany

Authors: Alexander-N. Zeller, Elisabeth Goetze, Daniel G. E. Thiem, Alexander K. Bartella, Lukas Seifert, Fabian M. Beiglboeck, Juliane Kröplin, Jürgen Hoffmann, Andreas Pabst

Published in: Oral and Maxillofacial Surgery | Issue 4/2023

Abstract

Purpose

The aim of the study was to get a cross-sectional overview of the current status of specific organizational procedures, quality control systems, and standard operating procedures for the use of three-dimensional (3D) printing to assist in-house workflow using additive manufacturing in oral and maxillofacial surgery (OMFS) in Germany.

Methods

An online questionnaire including dynamic components containing 16–29 questions regarding specific organizational aspects, process workflows, quality controls, documentation, and the respective backgrounds in 3D printing was sent to OMF surgeons in university and non-university hospitals as well as private practices with and without inpatient treatment facilities. Participants were recruited from a former study population regarding 3D printing; all participants owned a 3D printer and were registered with the German Association of Oral and Maxillofacial Surgery.

Results

Sixty-seven participants answered the questionnaires. Of those, 20 participants ran a 3D printer in-unit. Quality assurance measures were performed by 13 participants and underlying processes by 8 participants, respectively. Standard operating procedures regarding computer-aided design and manufacturing, post-processing, use, or storage of printed goods were non-existent in most printing units. Data segmentation as well as computer-aided design and manufacturing were conducted by a medical doctor in most cases (n = 19, n = 18, n = 8, respectively). Most participants (n = 8) stated that “medical device regulations did not have any influence yet, but an adaptation of the processes is planned for the future.”

Conclusion

The findings demonstrated significant differences in 3D printing management in OMFS, especially concerning process workflows, quality control, and documentation. Considering the ever-increasing regulations for medical devices, there might be a necessity for standardized 3D printing recommendations and regulations in OMFS.

https://www.fda.gov/medical-devices/products-and-medical-procedures/3d-printing-medical-devices, last online access June 24, 2022.

Serrano C, van den Brink H, Pineau J, Prognon P, Martelli N (2019) Benefits of 3D printing applications in jaw reconstruction: a systematic review and meta-analysis. J Craniomaxillofac Surg 47:1387–1397. https://doi.org/10.1016/j.jcms.2019.06.008CrossRefPubMed

Derksen W, Wismeijer D, Flugge T, Hassan B, Tahmaseb A (2019) The accuracy of computer-guided implant surgery with tooth-supported, digitally designed drill guides based on CBCT and intraoral scanning A prospective cohort study. Clin Oral Implants Res 30(10):1005–1015. https://doi.org/10.1111/clr.13514CrossRefPubMed

Li L et al (2021) Research on the dimensional accuracy of customized bone augmentation combined with 3D-printing individualized titanium mesh: a retrospective case series study. Clin Implant Dent Relat Res 23:5–18. https://doi.org/10.1111/cid.12966CrossRefPubMed

Nyberg EL et al (2017) 3D-printing technologies for craniofacial rehabilitation, reconstruction, and regeneration. Ann Biomed Eng 45:45–57. https://doi.org/10.1007/s10439-016-1668-5CrossRefPubMed

Ettinger KS, Alexander AE, Morris JM, Arce K (2020) Novel geometry of an extended length chimeric scapular free flap for hemimandibular reconstruction: nuances of the technique streamlined by in-house virtual surgical planning and 3D printing for a severely vessel-depleted neck. J Oral Maxillofac Surg 78:823–834. https://doi.org/10.1016/j.joms.2020.01.012CrossRefPubMed

Shah P, Chong BS (2018) 3D imaging, 3D printing and 3D virtual planning in endodontics. Clin Oral Investig 22:641–654. https://doi.org/10.1007/s00784-018-2338-9CrossRefPubMed

Oberoi G et al (2018) 3D printing-encompassing the facets of dentistry. Front Bioeng Biotechnol 6:172. https://doi.org/10.3389/fbioe.2018.00172CrossRefPubMedPubMedCentral

McAllister P, Watson M, Burke E (2018) A Cost-effective, in-house, positioning and cutting guide system for orthognathic surgery. J Maxillofac Oral Surg 17:112–114. https://doi.org/10.1007/s12663-017-1067-yCrossRefPubMed

Martelli N et al (2016) Advantages and disadvantages of 3-dimensional printing in surgery: a systematic review. Surgery 159:1485–1500. https://doi.org/10.1016/j.surg.2015.12.017CrossRefPubMed

10.

Louvrier A et al (2017) How useful is 3D printing in maxillofacial surgery? J Stomatol Oral Maxillofac Surg 118:206–212. https://doi.org/10.1016/j.jormas.2017.07.002CrossRefPubMed

11.

Tejo-Otero A, Buj-Corral I, Fenollosa-Artés F (2020) 3D Printing in medicine for preoperative surgical planning: a review. Ann Biomed Eng 48:536–555. https://doi.org/10.1007/s10439-019-02411-0CrossRefPubMed

12.

Moe J et al (2021) An in-house computer-aided design and computer-aided manufacturing workflow for maxillofacial free flap reconstruction is associated with a low cost and high accuracy. J Oral Maxillofac Surg 79:227–236. https://doi.org/10.1016/j.joms.2020.07.216CrossRefPubMed

13.

Ganguli A et al (2018) 3D printing for preoperative planning and surgical training: a review. Biomed Microdevices 20:65. https://doi.org/10.1007/s10544-018-0301-9CrossRefPubMed

14.

Uygur EITU, Ozturan B, Poyanli O (2020) The role of 3D modeling in education of orthopedic trainees for the treatment of foot deformities. Acta Chir Orthop Traumatol Cech 87, 346–349

15.

Pugliese L et al (2018) The clinical use of 3D printing in surgery. Updates Surg 70:381–388. https://doi.org/10.1007/s13304-018-0586-5CrossRefPubMed

16.

Weidert S et al (2019) 3D printing in orthopedic and trauma surgery education and training : Possibilities and fields of application. Unfallchirurg 122:444–451. https://doi.org/10.1007/s00113-019-0650-8CrossRefPubMed

17.

Lioufas PA, Quayle MR, Leong JC, McMenamin PG (2016) 3D printed models of cleft palate pathology for surgical education. Plast Reconstr Surg Glob Open 4:e1029. https://doi.org/10.1097/gox.0000000000001029CrossRefPubMedPubMedCentral

18.

Abo Sharkh H, Makhoul N (2020) In-house surgeon-led virtual surgical planning for maxillofacial reconstruction. J Oral Maxillofac Surg 78:651–660. https://doi.org/10.1016/j.joms.2019.11.013CrossRefPubMed

19.

Thienpont E, Quaglio G, Karapiperis T, Kjaersgaard-Andersen P (2020) Guest editorial: new medical device regulation in Europe: a collaborative effort of stakeholders to improve patient safety. Clin Orthop Relat Res 478:928–930. https://doi.org/10.1097/CORR.0000000000001154CrossRefPubMedPubMedCentral

20.

Byrne RA (2019) Medical device regulation in Europe - what is changing and how can I become more involved? EuroIntervention 15:647–649. https://doi.org/10.4244/EIJV15I8A118CrossRefPubMed

21.

Meglioli M, Naveau A, Macaluso GM, Catros S (2020) 3D printed bone models in oral and cranio-maxillofacial surgery: a systematic review. 3D Print Med 6:30. https://doi.org/10.1186/s41205-020-00082-5CrossRefPubMedPubMedCentral

22.

Pabst A et al (2021) How is neck dissection performed in oral and maxillofacial surgery? Results of a representative nationwide survey among university and non-university hospitals in Germany. Clin Oral Investig, https://doi.org/10.1007/s00784-020-03622-9

23.

Pabst A et al (2021) 3D printing in oral and maxillofacial surgery: a nationwide survey among university and non-university hospitals and private practices in Germany. Clin Oral Investig, https://doi.org/10.1007/s00784-021-04073-6

24.

Gross BC, Erkal JL, Lockwood SY, Chen C, Spence DM (2014) Evaluation of 3D printing and its potential impact on biotechnology and the chemical sciences. Anal Chem 86:3240–3253. https://doi.org/10.1021/ac403397rCrossRefPubMed

25.

Hughes B, Wilson G (2015) 3D/additive printing manufacturing: a brief history and purchasing guide. 75, 18–21

26.

Seifert LB et al (2020) 3D printed patient individualised models versus cadaveric models in an undergraduate oral and maxillofacial surgery curriculum: comparison of students’ perceptions. Eur J Dent Educ 24:809–810. https://doi.org/10.1111/eje.12550CrossRefPubMed

27.

Werz SM, Zeichner SJ, Berg BI, Zeilhofer HF, Thieringer F (2018) 3D printed surgical simulation models as educational tool by maxillofacial surgeons. Eur J Dent Educ 22:e500–e505. https://doi.org/10.1111/eje.12332CrossRefPubMed

28.

Kim PS et al (2019) Obtaining informed consent using patient specific 3D printing cerebral aneurysm modeL. J Korean Neurosurg Soc 62:398–404. https://doi.org/10.3340/jkns.2019.0092CrossRefPubMedPubMedCentral

29.

Zhuang YD et al (2019) Effectiveness of personalized 3D printed models for patient education in degenerative lumbar disease. Patient Educ Couns 102:1875–1881. https://doi.org/10.1016/j.pec.2019.05.006CrossRefPubMed

30.

Jacobs CA, Lin AY (2017) A New Classification of three-dimensional printing technologies: systematic review of three-dimensional printing for patient-specific craniomaxillofacial surgery. Plast Reconstr Surg 139:1211–1220. https://doi.org/10.1097/PRS.0000000000003232CrossRefPubMed

31.

Honigmann P et al (2021) In-hospital 3D printed scaphoid prosthesis using medical-grade polyetheretherketone (PEEK) biomaterial. Biomed Res Int 2021:1301028. https://doi.org/10.1155/2021/1301028CrossRefPubMedPubMedCentral

32.

Hull CW (1984) Apparatus for production of three-dimensonal objects by stereo thography. 19 2,908,54510/1

33.

Auhl, Dietmar Rohnstock, Falk Löschke, Oliver Schäfer, Konstanze Wang, Peng Wagner, Manfred H (2019) 3D-printing quality in relation to melt flow and fusion behavior of polymer materials2107:030004. https://doi.org/10.1063/1.5109498

34.

van Noort R (2012) The future of dental devices is digital. Dent Mater 28:3–12. https://doi.org/10.1016/j.dental.2011.10.014CrossRefPubMed

35.

Wickramasinghe S, Do T, Tran P (2020) FDM-based 3D printing of polymer and associated composite: a review on mechanical properties, defects and treatments. Polymers (Basel) 12, https://doi.org/10.3390/polym12071529

36.

Msallem B et al (2020) Evaluation of the dimensional accuracy of 3D-printed anatomical mandibular models using FFF, SLA, SLS, MJ, and BJ printing technology. J Clin Med 9, https://doi.org/10.3390/jcm9030817

37.

Seifert LB et al (2020) 3D-printed patient individualised models vs cadaveric models in an undergraduate oral and maxillofacial surgery curriculum: Comparison of student's perceptions. Eur J Dent Educ, https://doi.org/10.1111/eje.12522

38.

Msallem B, Beiglboeck F, Honigmann P, Jaquiéry C, Thieringer F (2017) Craniofacial reconstruction by a cost-efficient template-based process using 3D printing. Plast Reconstr Surg Glob Open 5:e1582. https://doi.org/10.1097/gox.0000000000001582CrossRefPubMedPubMedCentral

39.

Laneve E et al (2019) Sterilisation in dentistry: a review of the literature. Int J Dent 2019:6507286. https://doi.org/10.1155/2019/6507286CrossRefPubMedPubMedCentral

40.

Rutala WA, Weber DJ (1998) Clinical effectiveness of low-temperature sterilization technologies. Infect Control Hosp Epidemiol 19:798–804. https://doi.org/10.1086/647730CrossRefPubMed

41.

Rutala WA, Weber DJ (2004) Disinfection and sterilization in health care facilities: what clinicians need to know. Clin Infect Dis 39:702–709. https://doi.org/10.1086/423182CrossRefPubMed

42.

Bank TL et al (2008) Effects of gamma-sterilization on the physico-chemical properties of natural sediments. Chem Geol 251:1–7. https://doi.org/10.1016/j.chemgeo.2008.01.003CrossRef

43.

Tallarico M et al (2021) In vitro evaluation of bioburden, three-dimensional stability, and accuracy of surgical templates without metallic sleeves after routinely infection control activities. Clin Implant Dent Relat Res. https://doi.org/10.1111/cid.12986

44.

Torok G et al (2020) Effects of disinfection and sterilization on the dimensional changes and mechanical properties of 3D printed surgical guides for implant therapy - pilot study. BMC Oral Health 20:19. https://doi.org/10.1186/s12903-020-1005-0CrossRefPubMedPubMedCentral

45.

Aguado-Maestro I, De Frutos-Serna M, González-Nava A, Merino-De Santos AB, García-Alonso M (2020) Are the common sterilization methods completely effective for our in-house 3D printed biomodels and surgical guides? Injury, https://doi.org/10.1016/j.injury.2020.09.014

46.

Shea GK et al (2020) A review of the manufacturing process and infection rate of 3D-printed models and guides sterilized by hydrogen peroxide plasma and utilized intra-operatively. 3D Print Med 6:7. https://doi.org/10.1186/s41205-020-00061-wCrossRefPubMedPubMedCentral

47.

Ferras-Tarrago J et al (2021) Security of 3D-printed polylactide acid piece sterilization in the operating room: a sterility test. Eur J Trauma Emerg Surg, https://doi.org/10.1007/s00068-020-01564-1

48.

Bosc R et al (2021) Bacteriological and mechanical impact of the Sterrad sterilization method on personalized 3D printed guides for mandibular reconstruction. Sci Rep 11:581. https://doi.org/10.1038/s41598-020-79752-7CrossRefPubMedPubMedCentral

49.

Shaheen E, Alhelwani A, Van De Casteele E, Politis C, Jacobs R (2018) Evaluation of dimensional changes of 3D printed models after sterilization: a pilot study. Open Dent J 12:72–79. https://doi.org/10.2174/1874210601812010072CrossRefPubMedPubMedCentral

50.

Sharma N et al (2020) Effects of steam sterilization on 3D printed biocompatible resin materials for surgical guides-an accuracy assessment study. J Clin Med 9(5):1506. https://doi.org/10.3390/jcm9051506CrossRefPubMedPubMedCentral

51.

Chen JV, Tanaka KS, Dang ABC, Dang A (2020) Identifying a commercially-available 3D printing process that minimizes model distortion after annealing and autoclaving and the effect of steam sterilization on mechanical strength. 3D Print Med 6:9. https://doi.org/10.1186/s41205-020-00062-9CrossRefPubMedPubMedCentral

52.

Nikoyan L, Patel R (2020) Intraoral scanner, three-dimensional imaging, and three-dimensional printing in the dental office. Dent Clin North Am 64:365–378. https://doi.org/10.1016/j.cden.2019.12.004CrossRefPubMed

53.

Meglioli M, Naveau A, Macaluso GM, Catros S (2020) Correction to: 3D printed bone models in oral and craniomaxillofacial surgery: a systematic review. 3D Print Med 6:36. https://doi.org/10.1186/s41205-020-00088-zCrossRefPubMedPubMedCentral

Title: A survey regarding the organizational aspects and quality systems of in-house 3D printing in oral and maxillofacial surgery in Germany
Authors: Alexander-N. Zeller
Elisabeth Goetze
Daniel G. E. Thiem
Alexander K. Bartella
Lukas Seifert
Fabian M. Beiglboeck
Juliane Kröplin
Jürgen Hoffmann
Andreas Pabst
Publication date: 22-08-2022
Publisher: Springer Berlin Heidelberg
Keywords: Oral and Maxillofacial Surgery
Oral and Maxillofacial Surgery
Published in: Oral and Maxillofacial Surgery / Issue 4/2023
Print ISSN: 1865-1550
Electronic ISSN: 1865-1569
DOI: https://doi.org/10.1007/s10006-022-01109-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

A survey regarding the organizational aspects and quality systems of in-house 3D printing in oral and maxillofacial surgery in Germany

Abstract

Purpose

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

Please log in to get access to this content

Other articles of this Issue 4/2023

Tissue response to different incision tools in animal model

Clinical outcome following conservative treatment of 58 mandibular ameloblastoma patients: a retrospective study

Characteristics and surgical management of pure trapdoor fracture of the orbital floor in adults: a 15-year review

Utility of preoperative colour flow Doppler assessment of perforator anatomy in medial sural artery perforator (MSAP) free flaps

Is it necessary to use bone grafts to prevent defects at the lower border of the mandible after mandibular advancement?—a systematic review

Impact of different anesthetic approaches on the outcomes of temporomandibular joint arthrocentesis: a systematic review