Health and environmental hazards of shape memory polymer used in orthodontic aligners – a scoping review

Authors

  • Sweety Agrawal Department of Orthodontics and Dentofacial Orthopaedics, Yenepoya Dental Orthodontics College, Yenepoya (Deemed to be University), Mangalore, Karnataka, India
  • Mithun K. Naik Department of Orthodontics and Dentofacial Orthopaedics, Yenepoya Dental Orthodontics College, Yenepoya (Deemed to be University), Mangalore, Karnataka, India
  • Dilshad Umar Department of Orthodontics and Dentofacial Orthopaedics, Yenepoya Dental Orthodontics College, Yenepoya (Deemed to be University), Mangalore, Karnataka, India
  • Sandeep Shetty Department of Orthodontics and Dentofacial Orthopaedics, Yenepoya Dental Orthodontics College, Yenepoya (Deemed to be University), Mangalore, Karnataka, India

DOI:

https://doi.org/10.2340/biid.v13.45225

Keywords:

Clear aligners, shape memory aligners, SMP, 3D-printing aligner, orthodontic aligners, digital orthodontics, biocompatibility, cytotoxicity, environmental impact

Abstract

Background: Shape memory polymers (SMPs) are gaining traction in orthodontics, particularly in clear aligners, due to their stimulus-responsive behavior and potential to improve treatment outcomes. However, their use in biomedical devices raises questions about biocompatibility and environmental sustainability.

Objectives: This scoping review aims to map current evidence on the health and environmental risks of SMPs used in orthodontic aligners, identify knowledge gaps, and guide future research.

Search methods: A systematic search of PubMed, Scopus, Web of Science, Embase, ProQuest, and Cochrane databases was conducted, focusing on studies from the past decade. Search terms included SMPs, orthodontic aligners, toxicity, biodegradability, and environmental impact.

Selection criteria: Eligible studies involved original in vitro, in vivo, clinical, or environmental research related to SMPs in orthodontic applications.

Data collection and analysis: Key information from each study was extracted using a standardized Excel spreadsheet by one reviewer (SA) and validated by another (MKN). Extracted data included study design, polymer type, health and environmental risks, and conclusions. Due to heterogeneity, results were synthesized narratively.

Results: Sixteen studies met the inclusion criteria. Evidence on SMP biocompatibility is emerging but limited. Certain SMP formulations released residual monomers and degradation products with potential cytotoxic or systemic effects. Environmental concerns included low degradability, accumulation of polymer waste, and lack of recycling strategies. Notably, there was a lack of long-term clinical data and environmental life-cycle analyses.

Conclusions: While SMPs offer promise in orthodontics, their safety and environmental impacts are insufficiently studied. Future research should focus on standardized toxicological testing, long-term evaluations, and sustainable material development.

Registration and Conflicts: This scoping review was prospectively registered in PROSPERO (ID: CRD42022308725). The authors report no conflicts of interest.

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References

Elshazly TM, Keilig L, Alkabani Y, Ghoneima A, Abuzayda M, Talaat S, et al. Primary evaluation of shape recovery of orthodon- tic aligners fabricated from shape memory polymer (a typodont study). Dent J. 2021 Mar 10;9(3):31. https://doi.org/10.3390/dj9030031 DOI: https://doi.org/10.3390/dj9030031

Lee SY, Kim H, Kim HJ, Chung CJ, Choi YJ, Kim SJ, et al. Thermo- mechanical properties of 3D printed photocurable shape mem- ory resin for clear aligners. Sci Rep. 2022 Apr 15;12(1):6264. https://doi. org/10.1038/s41598-022-09831-4 DOI: https://doi.org/10.1038/s41598-022-09831-4

Elshazly TM, Keilig L, Alkabani Y, Ghoneima A, Abuzayda M, Talaat W, et al. Potential application of 4D technology in fabrication of ortho- dontic aligners. Front Mater. 2022 Jan 28;8:794536. https://doi.org/10.3389/ fmats.2021.794536 DOI: https://doi.org/10.3389/fmats.2021.794536

Atta I, Bourauel C, Alkabani Y, Mohamed N, Kim H, Alhotan A, et al. Physiochemical and mechanical characterisation of orthodontic 3D printed aligner material made of shape memory polymers (4D aligner material). J Mech Behav Biomed Mater. 2023 Dec 25;150:106337–7. https://doi.org/10.1016/j.jmbbm.2023.106337 DOI: https://doi.org/10.1016/j.jmbbm.2023.106337

Tricco AC, Lillie E, Zarin W, O’Brien KK, Colquhoun H, Levac D, et al. PRISMA extension for scoping reviews (PRISMA-ScR): checklist and explanation. Ann Intern Med. 2018 Sep 4;169(7):467–73. https://doi. org/10.7326/M18-0850 DOI: https://doi.org/10.7326/M18-0850

Ouzzani M, Hammady H, Fedorowicz Z, Elmagarmid A. Rayyan – a web and mobile app for systematic reviews. Syst Rev. 2016 Dec;5(1):210. https://doi.org/10.1186/s13643-016-0384-4 DOI: https://doi.org/10.1186/s13643-016-0384-4

Pratsinis H, Papageorgiou SN, Panayi N, Iliadi A, Eliades T, Kletsas D. Cytotoxicity and estrogenicity of a novel 3-dimensional printed orthodontic aligner. Am J Orthod Dentofacial Orthop. 2022;162(3):e116-e122. https://doi.org/10.1016/j.ajodo.2022.06.014 DOI: https://doi.org/10.1016/j.ajodo.2022.06.014

Erbe C, Ludwig B, Bleilöb M. Unlocking the biological insights of 3D printed aligners: a look at current findings. Semin Orthod. 2024;31(1):139-143. https://doi.org/10.1053/j.sodo.2024.10.001 DOI: https://doi.org/10.1053/j.sodo.2024.10.001

‌Caelli C, Tamburrino F, Brondi C, Razionale AV, Ballarino A, Barone S. Sustainability in healthcare sector: the dental aligners case. Sustainability. 2023;15(24):16757. https://doi.org/10.3390/su152416757 DOI: https://doi.org/10.3390/su152416757

Niu C, Li D, Zhang Y, Wang Y, Ning S, Zhao G, et al. Prospects for 3D-printing of clear aligners – a narrative review. Fronti Mater. 2024 Jul 30;11:1438660.. https://doi.org/10.3389/fmats.2024.1438660 DOI: https://doi.org/10.3389/fmats.2024.1438660

Kim GT, Go HB, Yu JH, Yang SY, Kim KM, Choi SH, et al. Cytotoxicity, colour stability and dimensional accuracy of 3D printing resin with three different photoinitiators. Polymers. 2022 Feb 28;14(5):979. https://doi.org/10.3390/polym14050979 DOI: https://doi.org/10.3390/polym14050979

Campobasso A, Ariano A, Battista G, Posa F, Migliorati M, Drago S et al. Comparison of the cytotoxicity of 3D-printed aligners using different post-curing procedures: an in vitro study. Aust Orthod J. 2023 Jul 1;39(2):49–56. https://doi.org/10.2478/aoj-2023-0026 DOI: https://doi.org/10.2478/aoj-2023-0026

Iodice G, Ludwig B, Polishchuk E, Petruzzelli R, Di Cunto R, Soboh Husam, et al. Effect of post‐printing curing time on cytotoxicity of direct printed aligners: a pilot study. Orthod Craniofac Res. 2024;27(Suppl. S2):141–6. https://doi.org/10.1111/ocr.12819 DOI: https://doi.org/10.1111/ocr.12819

Willi A, Patcas R, Zervou S-K, Panayi N, Schätzle M, Eliades G et al. Leaching from a 3D-printed aligner resin. Eur J Orthod. 2023;45(3):244–9. https://doi.org/10.1093/ejo/cjac056 DOI: https://doi.org/10.1093/ejo/cjac056

Taher BB, Rasheed TA. The impact of adding chitosan nanoparticles on biofilm formation, cytotoxicity, and certain physical and mechanical aspects of directly printed orthodontic clear aligners. Nanomaterials. 2023 Sep 26;13(19):2649–9. https://doi.org/10.3390/nano13192649 DOI: https://doi.org/10.3390/nano13192649

Raszewski Z, Chojnacka K, Kulbacka J, Mikulewicz M. Mechanical properties and biocompatibility of 3D printing acrylic material with bioactive components. J Funct Biomater. 2022 Dec 23;14(1):13. https://doi.org/10.3390/jfb14010013 DOI: https://doi.org/10.3390/jfb14010013

Ahamed SF, Kumar SM, Kumar V, Kanna A, Indrapriya Dharshini K. Cytotoxic evaluation of directly 3D printed aligners and Invisalign. Eur J Mol Clin Med. 2020 Dec 4;7(5):1129–40.

Kim JE, Mangal U, Yu JH, Kim GT, Kim H, Seo JY, et al. Evaluation of the effects of temperature and centrifugation time on elimination of uncured resin from 3D-printed dental aligners. Sci Rep. 2024 Jul 2;14(1):15206. https://doi.org/10.1038/s41598-024-66150-6 DOI: https://doi.org/10.1038/s41598-024-66150-6

Guttridge C, Shannon A, O’Sullivan A, O’Sullivan KJ, O’Sullivan LW. Effects of post-curing duration on the mechanical properties of complex 3D printed geometrical parts. J Mech Behav Biomed Mater. 2024 Aug;156:106585. https://doi.org/10.1016/j.jmbbm.2024.106585 DOI: https://doi.org/10.1016/j.jmbbm.2024.106585

Moradinezhad M, Abbasi Montazeri E, Hashemi Ashtiani A, Pourlotfi R, Rakhshan V. Biofilm formation of Streptococcus mutans, Streptococcus sanguinis, Staphylococcus epidermidis, Staphylococcus aureus, Lactobacillus casei, and Candida Albicans on 5 thermoform and 3D printed orthodontic clear aligner and retainer materials at 3 time points: an in vitro study. BMC Oral Health. 2024 Sep 18;24(1):1107. https://doi.org/10.1186/s12903-024-04893-4 DOI: https://doi.org/10.1186/s12903-024-04893-4

Simunovic L, Maric AJ, Bacic I, Haramina T, Mestrovic S. Impact of UV light exposure during printing on thermomechanical properties of 3D-printed polyurethane-based orthodontic aligners. Appl Sci. 2024 Oct 21;14(20):9580. https://doi.org/10.3390/app14209580 DOI: https://doi.org/10.3390/app14209580

Bleilöb M, Welte-Jzyk C, Knode V, Ludwig B, Erbe C. Biocompatibility of variable thicknesses of a novel directly printed aligner in orthodontics. Sci Rep. 2025 Jan 25;15(1):3279. https://doi.org/10.1038/s41598-025-85359-7 DOI: https://doi.org/10.1038/s41598-025-85359-7

Riester O, Laufer S, Deigner HP. Direct 3D printed biocompatible microfluidics: assessment of human mesenchymal stem cell differentiation and cytotoxic drug screening in a dynamic culture system. J Nanobiotechnol. 2022 Dec 27;20(1):540. https://doi.org/​10.1186/s12951-022-01737-7‌ DOI: https://doi.org/10.1186/s12951-022-01737-7

Additional Files

Published

2026-01-07

How to Cite

Agrawal, S., Naik, M. K., Umar, D., & Shetty, S. (2026). Health and environmental hazards of shape memory polymer used in orthodontic aligners – a scoping review. Biomaterial Investigations in Dentistry, 13(1), 15–20. https://doi.org/10.2340/biid.v13.45225