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Biocompatibility of Orthodontic Aligner Materials in the Digital Workflow: A Quantitative In Vitro Comparison of Thermoformed, Directly Printed, and Polyamide-12 Systems

Journal of Dentistry 2026
Andrea Carganico, Luca Levrini, Piero Antonio Zecca, Arianna Mosca, Alessandro Deppieri, Stefano Saran, Nicola Giannotta, Marina Borgese

Summary

Scientists tested how different clear aligner materials—including newer 3D-printed types—affect human cells when tiny plastic particles wear off during use. Traditional thermoformed aligners and a polyamide-based system held up better in lab tests, while some 3D-printed materials showed more cell damage at higher doses and longer exposure times. This suggests that as 3D-printed aligners become more popular, manufacturers need better testing and quality controls to ensure they're safe for long-term wear in your mouth.

Polymers
Study Type In vitro

INTRODUCTION/OBJECTIVES: Directly 3D-printed aligners (DPAs) have recently emerged as a promising development in orthodontics, offering greater design flexibility and in-office manufacturing. However, their biological safety remains incompletely characterised, particularly regarding the release of micro- and nanoplastics (MNPs) during clinical use. This study evaluated the in vitro cytocompatibility of eight orthodontic aligner materials, including thermoformed systems, directly 3D-printed resins, and a polyamide-12 (PA-12) device, using MTT cell-viability assays on human dental pulp stem cells (hDPSCs). METHODS: Standardised specimens were prepared according to manufacturer-recommended protocols, while MNP suspensions were generated by controlled abrasion and sonication. Cells were exposed to material eluates at concentrations of 500, 1000, and 5000 ng/100 µL for 24 to 96 hours. RESULTS: Cell viability and morphological analyses revealed marked material-, dose-, and time-dependent differences. Thermoformed materials and the polyamide-12 system generally exhibited more stable profiles, with viability frequently above 70% and preserved cell morphology. A subset of materials showed non-linear responses suggestive of a hormetic-like effect. By contrast, several directly 3D-printed resins showed greater reductions in viability, approaching moderate cytotoxicity at higher concentrations and longer exposure. CONCLUSIONS: Within the limitations of this in vitro study, thermoformed materials and polyamide-12 showed more consistent cytocompatibility than some directly printed materials. CLINICAL SIGNIFICANCE: These findings highlight the need for systematic biocompatibility evaluation of orthodontic aligner materials and indicate that adherence to standardised post-curing protocols and rigorous material qualification workflows is essential to minimise potential biological risks during clear aligner therapy.

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