Exploring the potential of reconstructed human epithelial tissue models for safety assessment of intraoral medical devices.

Medical devices are integral to a wide array of medical interventions and are increasingly utilized in both clinical and home settings. Within the oral cavity, intraoral medical devices are employed for various applications, to improve quality of life and maintain oral health and hygiene. However, the dynamic and complex environment of the oral cavity, characterized by the influence of factors, such as saliva composition, fluctuating pH, and microbial flora presents a challenge to ensure the safety of end-users. In this paper, we investigate the feasibility of utilization of 3D reconstructed human tissue models for the assessment of biocompatibility of intraoral medical devices. Building upon experiences drawn from the development and validation of ISO 10993-23 and from the development of a protocol for ocular irritation and photo-irritation, we suggest a new protocol for buccal mucosa irritation testing. The methodology is based on the viability assessment and analysis of cytokine release into media. By addressing intraoral medical devices biocompatibility testing, we aim to contribute to the advancement of biocompatibility assessment methodologies and increase the applicability of ISO 10993-23.