Additive manufacturing and artificial intelligence are entering the clinical practice of dentistry, shaping a new paradigm of digital transformation based on the integration of hardware and software solutions aimed at increasing the predictability and quality of treatment.
This review pays attention to key clinical and regulatory aspects — standardization, validation, traceability, ethics-by-design and human oversight are considered as components of a coordinated strategy for the implementation of AM/AI in dentistry.
Additive manufacturing is transforming clinical workflows in dentistry through the integration of CAD/CAM solutions, precision additive printing and post-processing, which reduces variability and increases the reproducibility of restorations and prosthetic constructions.
Practical requirements include documented traceability of material batches, equipment qualification, validation of operating parameters and statistical process control — this becomes the basis of a quality system oriented towards the prevention of clinical complications and the early detection of anomalies.
Quality control in AM should cover validation of fillers and powders, calibration of scanners and printers, monitoring of printing parameters in real time and recording of manufacturing cycle metadata; all these elements are necessary for reproducibility and for investigation of incidents during post-marketing surveillance.
The integration of AI into AM requires adherence to principles of algorithmic transparency, verification of models on representative clinical data and protocoling of software and model versions, which ensures the possibility of auditing and clinical validation of decisions.
Clinicians and dental technicians remain responsible for therapeutic decisions — therefore workflows must provide an option to override automated recommendations, documenting the reasons and recording clinical outcomes for subsequent analysis of effectiveness and safety.
Protection of confidential data and proper informed consent must be combined with technical measures — encryption, access management, anonymization of data for model training; it is important to document the level of risk and inform patients about control mechanisms and the possibility of human review of results.
Continuing professional education plays a key role in the safety of implementation — curricula should include practical work with CAD, design optimization algorithms, validation protocols and risk management, as well as training in documentation and traceability.
Transnational initiatives and symposia form unified competencies — validation of educational programs should rely on clinically confirmed courses and simulations; more than 1 500 specialists who participated in specialty forums testify to the demand for such formats, and 2,5 миллиона issued certificates demonstrate the scale of the transformation of the educational model.
When using metals, ceramics, polymer-metal composites and hydrogels for bioprinting, clinical evaluation of long-term biocompatibility, assessment of regenerative potentials and monitoring of possible side effects in the long term are required.
In bioprinting regulatory validation and ethical review have particular importance — informed patient consent, clinical trials with appropriate control groups, documenting assumptions, software versions and the evidence base throughout the product life cycle.
Recommendations include: implementing systems for quality control of the manufacturing process, verifying algorithms on local data before clinical application, documenting software versions and materials, organizing procedures for informed consent and post-marketing surveillance to assess outcomes.
Technical implementation should provide for integration of monitoring of printing parameters, rollback procedures and expert review of results, as well as mechanisms for cross-checking between clinical and laboratory data for reproducibility and risk management.
Holding specialized congresses and symposia in Milan and similar centers provides a platform for exchange of clinical data, interdisciplinary alliances between clinicians, software developers and regulators, — this accelerates the harmonization of standards and the development of joint protocols for the implementation of new technologies.
The focus of conferences should be not only demonstrational but also practical — case discussions, incident analyses, development of guidelines and agreed standards for clinical and laboratory practice.
The ethical integration of AI and additive manufacturing emphasizes the need for a systemic approach: standardization, validation, traceability, education and regulatory cooperation form the basis for safe and reproducible implementation of innovations in dentistry.
For clinicians this means active participation in the validation of technologies and in documenting clinical outcomes, for laboratories — implementation of strict quality and traceability protocols, for regulators — development of flexible but transparent requirements for risk and effectiveness assessment.
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