journal article·2024-10-08Open access

Complete Digital Workflow for Manufacturing Presurgical Orthodontic Palatal Plates in Newborns and Infants with Cleft Lip and/or Palate

Christina Weismann, Alexander B. Xepapadeas, Marit Bockstedte, Bernd Koos, Michael Krimmel, Christian F. Poets, Maite Aretxabaleta

Journal of Functional Biomaterials· Volume 15· Issue 10

Abstract

Deciding on the implementation or modification of steps in daily clinical care is a nuanced process that demands careful evaluation. This is crucial not only for selecting the most appropriate solution but also for achieving the best treatment outcome. Thus, implementing a workflow for treating cleft lip and/or palate patients with a presurgical orthodontic cleft-covering plate needs to consider objective factors, prioritized from most to least important: safety and quality level, user-friendliness, feasibility, and, finally, efficiency and cost. The goal of this workflow is to integrate CAD/CAM technologies into daily clinical routine to enhance technical and clinical efficiency, reduce the burden of cleft care, and simplify the implementation of these technologies in other facilities. To achieve this, a methodology based on intraoral scanning and additive manufacturing is employed to produce patient-specific passive palatal plates. The approach describes possible pitfalls and their resolution within the routine of a cleft centre, along with an exemplary case scenario. Comparative analysis between the digital workflow and the conventional process demonstrated the digital approach to be safer, higher in quality, more user-friendly, feasible, and cost- and time-effective than the conventional process.
Source: crossref · Quality: baseline

Research context

OpenAlex topics: Cleft Lip and Palate Research · Craniofacial Disorders and Treatments · Tracheal and airway disorders

SciVX discovery tags are terminology-based. OpenAlex topics are source-provided classifications.

Affiliations

Department of Orthodontics, University Hospital Tübingen, Osianderstr, 2-8, 72076 Tübingen, Germany

Centre for Cleft Lip, Palate and Craniofacial Malformations, University Hospital Tübingen, Osianderstr, 2-8, 72076 Tübingen, Germany

Department of Oral and Maxillofacial Surgery, University Hospital Tübingen, Osianderstr, 2-8, 72076 Tübingen, Germany

Department of Neonatology, University Hospital Tübingen, Calwerstr, 7, 72076 Tübingen, Germany

References (79)

Show source-provided references
1. The complex genetics of cleft lip and palate10.1093/ejo/26.1.7 ↗
2. Section III. Orofacial growth and dentistry
3. Berkowitz, S. (2006). Cleft Lip and Palate, Springer.10.1007/3-540-30020-1 ↗
4. Orthodontic procedures in the treatment of congenital cleft palate
5. The analysis of facial growth10.1016/0002-9416(58)90083-6 ↗
6. The Early Orthodontic Treatment of Alveolar Clefts
7. A new concept in the early orthopedic treatment of cleft lip and palate10.1016/0002-9416(69)90049-9 ↗
8. A Long-Term Retrospective Outcome Assessment of Facial Growth, Secondary Surgical Need, and Maxillary Lateral Incisor Status in a Surgical-Orthodontic Protocol for Complete Clefts10.1097/01.PRS.0000037680.39989.74 ↗
9. Orthognathic Surgery in Cleft Patients Treated by Early Bone Grafting10.1097/00006534-199105000-00003 ↗
10. Early Maxillary Orthopedics, Orthodontia and Alveolar Bone Grafting in Complete Clefts of the Palate10.1097/00006534-196206000-00001 ↗
11. Orthopaedic Growth Guidance and Stimulation For Patients With Cleft Lip and Palate
12. Comprehensive care of cleft lip and palate children at Zürich University: A preliminary report10.1016/0002-9416(76)90274-8 ↗
13. Effects of early maxillary orthopaedics in coordination with delayed surgery for cleft lip and palate10.1016/S0301-0503(79)80041-7 ↗
14. Pre-and early postoperative growth-guidance in cleft lip and palate cases by maxillary orthopedics (an alternative procedure to primary bone-grafting)
15. Early Utilization of Prosthetic Appliances in Cleft Palate Patients10.1097/00006534-196412000-00010 ↗
16. Harkins, C.S. (1960). Principles of Cleft Palate Prosthesis: Aspects in the Rehabilitation of the Cleft Palate Individual, Temple University Publications.
17. Presurgical changes in unilateral cleft palate subjects
18. Treatment procedures in cleft lip and palate cases
19. Improved Primary Surgical and Dental Treatment of Clefts10.1097/00006534-199011000-00006 ↗
20. Preoperative columella lengthening in bilateral cleft lip and palate
21. Effect of Presurgical Infant Orthopedics on Facial Esthetics in Complete Bilateral Cleft Lip and Palate10.1597/1545-1569_1994_031_0068_eopioo_2.3.co_2 ↗
22. Is Taping Alone an Efficient Presurgical Infant Orthopedic Approach in Infants with Unilateral Cleft Lip and Palate? A Randomized Controlled Trial10.1177/1055665620944757 ↗
23. Present and future for technologies to develop patient-specific medical devices: A systematic review approach10.2147/MDER.S215947 ↗
24. A review on computer-aided design and manufacturing of patient-specific maxillofacial implants10.1080/17434440.2020.1736040 ↗
25. Aretxabaleta, M., Roehler, A., Poets, C.F., Xepapadeas, A.B., Koos, B., and Weise, C. (2022). Automation of Measurements for Personalized Medical Appliances by Means of CAD Software—Application in Robin Sequence Orthodontic Appliances. Bioengineering, 9.10.3390/bioengineering9120773 ↗
26. A Report on the Hazards Encountered When Taking Neonatal Cleft Palate Impressions (1983–1992)10.1179/bjo.22.4.299 ↗
27. Unnoticed aspiration of palate plate impression material in a neonate: Diagnosis, therapy, outcome10.1002/ppul.23710 ↗
28. Caring for cleft lip and palate infants: Impression procedures and appliances in use10.4103/0972-4052.55248 ↗
29. Respiratory arrest during an orthodontic impression of a cleft palate, in a baby with Brachmann-de Lange syndrome
30. Intraoral scanning of neonates and infants with craniofacial disorders: Feasibility, scanning duration, and clinical experience10.1093/ejo/cjab068 ↗
31. Aretxabaleta, M., Unkovskiy, A., Koos, B., Spintzyk, S., and Xepapadeas, A.B. (2021). Accuracy evaluation of additively and subtractively fabricated palatal plate orthodontic appliances for newborns and infants—An in vitro study. Materials, 14.10.20944/preprints202107.0317.v1 ↗
32. Xepapadeas, A.B., Weise, C., Frank, K., Spintzyk, S., Poets, C., Wiechers, C., Arand, J., and Koos, B. (2020). Technical note on introducing a digital workflow for newborns with craniofacial anomalies based on intraoral scans-part I: 3D printed and milled palatal stimulation plate for trisomy 21. BMC Oral Health, 20.10.1186/s12903-020-1001-4 ↗
33. Xepapadeas, A.B., Weise, C., Frank, K., Spintzyk, S., Poets, C., Wiechers, C., Arand, J., and Koos, B. (2020). Technical note on introducing a digital workflow for newborns with craniofacial anomalies based on intraoral scans—Part II: 3D printed Tübingen palatal plate prototype for newborns with Robin sequence. BMC Oral Health, 20.10.1186/s12903-020-01159-7 ↗
34. Comparison of additive and subtractive CAD/CAM materials for their potential use as Tübingen Palatal Plate: An in-vitro study on flexural strength
35. Aretxabaleta, M., Xepapadeas, A.B., Poets, C.F., Koos, B., and Spintzyk, S. (2021). Fracture load of an Orthodontic appliance for Robin Sequence Treatment in a digital workflow. Materials, 14.10.3390/ma14020344 ↗
36. Zarean, P., Zarean, P., Thieringer, F.M., Mueller, A.A., Kressmann, S., Erismann, M., Sharma, N., and Benitez, B.K. (2022). A Point-of-Care Digital Workflow for 3D Printed Passive Presurgical Orthopedic Plates in Cleft Care. Children, 9.10.3390/children9081261 ↗
37. Fully digital workflow for presurgical orthodontic plate in cleft lip and palate patients
38. Intraoral iTero scanning for an infant with cleft lip and palate10.1016/j.ajodo.2020.12.012 ↗
39. Das Castillo Morales-Konzept10.1055/a-1398-4448 ↗
40. Die Behandlung von Kau-, Schluck-und Sprechstörungen bei behinderten Kindern mit der orofazialen Regulationstherapie nach Castillo-Morales: Aufgabe für Pädiater und Zahnarzt
41. Ganzheitliche Behandlung–Castillo Morales10.1055/a-1379-4579 ↗
42. Digital impressions from newborns to preschoolers with cleft lip and palate: A two-centers experience10.1016/j.bjps.2022.08.015 ↗
43. Trueness and precision of digital impressions obtained using an intraoral scanner with different head size in the partially edentulous mandible10.1016/j.jpor.2018.01.003 ↗
44. Accuracy and precision of 3 intraoral scanners and accuracy of conventional impressions: A novel in vivo analysis method10.1016/j.jdent.2017.12.006 ↗
45. Three-dimensional differences between intraoral scans and conventional impressions of edentulous jaws: A clinical study10.1016/j.prosdent.2019.04.004 ↗
46. Intraoral scanning of the edentulous jaw without additional markers: An in vivo validation study on scanning precision and registration of an intraoral scan with a cone-beam computed tomography scan10.5624/isd.20220131 ↗
47. Comparison of conventional impression making and intraoral scanning for the study of unilateral cleft lip and palate10.1111/cga.12499 ↗
48. Evaluation of the effects of cheiloplasty on maxillary arch in UCLP infants using three-dimensional digital models10.1177/1055665619835090 ↗
49. Mangano, F.G., Veronesi, G., Hauschild, U., Mijiritsky, E., and Mangano, C. (2016). Trueness and precision of four intraoral scanners in oral implantology: A comparative in vitro study. PLoS ONE, 11.10.1371/journal.pone.0163107 ↗
50. Conventional Vs Digital Impressions: Acceptability, Treatment Comfort and Stress Among Young Orthodontic Patients10.2174/1874210601812010118 ↗
51. Comparison of digital and conventional impression techniques: Evaluation of patients’ perception, treatment comfort, effectiveness and clinical outcomes10.1186/1472-6831-14-10 ↗
52. Intraoral 3D Scanning or Dental Impressions for the Assessment of Dental Arch Relationships in Cleft Care: Which is Superior?10.1597/15-036 ↗
53. Three-dimensional digital evaluation of maxillary arch changes after using nasoalveolar molding devices in unilateral complete cleft lip and palate patients
54. Three-dimensional changes of maxillary alveolar morphology after using modified nasoalveolar molding in patients with complete unilateral cleft lip and palate10.1177/10556656221086816 ↗
55. Comparative study on cleft palate morphology after passive presurgical plate therapy in unilateral cleft lip and palate10.1016/j.bjps.2024.03.001 ↗
56. Neurotrophic Processes in Orofacial Growth10.1177/00220345710500062301 ↗
57. The Passive Role of Nasal Septal Cartilage in Mid-Facial Growth10.1097/00006534-196806000-00004 ↗
58. Presurgical orthopaedic treatment using hard plates10.1016/S1010-5182(89)80027-7 ↗
59. Comparison Between Palatal Configurations in UCLP Infants with and without a Hotz Plate Until Four Years of Age10.1597/1545-1569_2000_037_0185_cbpciu_2.3.co_2 ↗
60. The early management of cleft lip and palate deformities10.1111/j.1834-7819.1973.tb03469.x ↗
61. Pre-surgical orthopedics and bone grafting for infants with cleft lip and palate: A dissent
62. A randomised prospective clinical trial into the effect of infant orthopaedics on maxillary arch dimensions in unilateral cleft lip and palate (Dutchcleft)10.1034/j.1600-0722.2001.00056.x ↗
63. Infant Orthopedics and Facial Growth in Complete Unilateral Cleft Lip and Palate Until 6 Years of Age (Dutchcleft)10.1597/08-034.1 ↗
64. Prahl, C. (2007). The Effects of Infant Orthopedics in Patients with Cleft Lip and Palate. [Doctor Thesis, Radboud University Nismegen Medical Centre].
65. Infant Orthopedics in UCLP: Effect on Feeding, Weight, and Length: A Randomized Clinical Trial (Dutchcleft)10.1597/03-111.1 ↗
66. A Follow-Up Study of Cleft Children Treated with Primary Bone Grafting: I
67. A study of the effects of early bone-grafting in complete clefts of the lip and palate—Five year study10.1016/S0007-1226(72)80055-9 ↗
68. Early Palatal Changes in Complete and Incomplete Cleft Lip and/or Palate10.1159/000147308 ↗
69. Timing of Cleft Palate Closure Should Be Based on the Ratio of the Area of the Cleft to That of the Palatal Segments and Not on Age Alone10.1097/01.PRS.0000161673.31770.23 ↗
70. Presurgical Cleft Management of Infants: A Survey of ACPA Approved and International Cleft Palate and Craniofacial Teams10.1177/10556656221109416 ↗
71. The Eurocleft Project 1996–2000: Overview10.1054/jcms.2001.0217 ↗
72. Nasoalveolar Molding: Assessing the Burden of Care10.1097/SCS.0000000000007026 ↗
73. Comparative Study of Maxillary Growth in Patients With Unilateral Cleft Treated With and Without Pre-Surgical Orthopedics10.1177/10556656221149784 ↗
74. A digital assessment of the maxillary deformity correction in infants with bilateral cleft lip and palate using computer-aided nasoalveolar molding10.1097/SCS.0000000000003812 ↗
75. Presurgical nasoalveolar molding for cleft lip and palate: The application of digitally designed molds10.1097/PRS.0000000000001286 ↗
76. Pitfalls and solutions in virtual design of nasoalveolar molding plates by using CAD/CAM technology—A preliminary clinical study10.1016/j.jcms.2016.01.008 ↗
77. Analysis of computer-aided techniques for virtual planning in nasoalveolar moulding10.1016/j.bjoms.2015.03.002 ↗
78. Ogino, S., Kawanabe, H., Fukui, K., Sone, R., and Oyama, A. (2023). Effect of Pre-Surgical Orthopedic Treatment on Hard and Soft Tissue Morphology in Infants with Cleft Lip and Palate. Diagnostics, 13.10.3390/diagnostics13081444 ↗
79. A virtual noninvasive way of constructing a nasoalveolar molding plate for cleft babies, using intraoral scanners, CAD, and prosthetic milling10.1177/1055665619886476 ↗