Changes in mechanical properties, surface morphology, structure, and composition of Invisalign material in the oral environment.

Introduction: The mechanical properties of Invisalign material have rarely been explored because of the inaccessibility of the patent-protected raw material. The purpose of this study was to systematically evaluate the Invisalign thermoformed aligner material before and after clinical application, including mechanical properties, surface morphology, internal structure, and chemical composition changes.

Methods: Twenty sets of "as-received" (0-week) and retrieved (2-week; worn for 2 weeks, 20 ± 2 hours per day) Invisalign aligners were randomly collected from 4 different patients. Tensile tests, stress relaxation, and creep tests were carried out with a dynamic mechanical analyzer to characterize the changes in the mechanical properties of this material, Fourier transform infrared spectroscopy was used to capture the molecular changes on the surface of these aligners, scanning electron microscopy and transmission electron microscopy were used to observe the changes in surface morphology and internal structure, and scanning transmission electron microscopy-energy dispersive x-ray analysis was used to detect any changes in the chemical composition of this material before and after clinical application.

Results: The elastic modulus of 0-week and 2-week samples were 842 ± 63 MPa and 806 ± 19 MPa, respectively, with no significant difference. In addition, the relative stress after stress relaxation of 2 hours was 19.89 ± 2.25% and 15.91 ± 6.04% for 0-week and 2-week groups, respectively, with no significant difference. Scanning electron microscopy observations showed voids and signs of delamination on the surface of the 2-week samples, and scanning transmission electron microscopy-energy dispersive x-ray analysis indicated the possible release of trace elements during clinical use, such as aluminum. Results of Fourier transform infrared spectroscopy analysis, and transmission electron microscopy observations were quite stable, indicating that the molecular structure on the surface and the internal structure of this material were relatively stable under the oral environment.

Conclusions: The surface morphology showed some defects after the clinical use of 2 weeks; however, there was no significant difference in mechanical properties. Trace elements may release out during clinical use and may pose a specific danger to allergic patients.