DEVELOPMENT OF A NOVEL DESIGN FOR A CUSTOM REMINERALIZATION TRAY MANUFACTURED BY ADDITIVE MANUFACTURING: VALIDATION AND CLINICAL EFFICACY

Objective: To develop and clinically evaluate an original design of a personalized remineralization tray fabricated using additive manufacturing in patients undergoing active orthodontic treatment with fixed appliances. Methodology: The study included 32 patients (aged 18–35 years, of both sexes) undergoing active orthodontic treatment with a fixed bracket system and exhibiting signs of initial enamel demineralization. The personalized dental tray was produced using CAD/CAM technologies and 3D-printed from a biocompatible photopolymer on individual digital jaw models with the fixed orthodontic appliance in place. Clinical efficacy of the original design of the personalized dental tray was assessed by the Remineralization Index (RI), oral hygiene (simplified oral hygiene index, OHI-S / Greene-Vermillion). Results: After completion of the remineralization course, which lasted 14 days, areas of initial demineralization disappeared completely in 93.5% of patients and were markedly reduced in the remainder. Statistically significant improvements were observed in all measured parameters: the Remineralization Index decreased from 2.15 ± 0.25 to 1.03 ± 0.18 (p < 0.001); OHI-S decreased from 2.35 ± 0.41 to 0.85 ± 0.29 (p < 0.001). The proposed original design of the personalized dental tray did not compromise the integrity or bonding of the fixed orthodontic hardware, and patient compliance remained high. Conclusions: The developed and clinically evaluated proposed original design of the personalized dental tray is an effective means of remineralization therapy for patients undergoing active orthodontic treatment with fixed bracket appliances at all stages of treatment. The proposed design ensures prolonged and uniform exposure of the remineralizing agent to sites of initial enamel demineralization. Individualized CAD/CAM 3D-design, subsequent 3D-digital modelling, and final photopolymer 3D-printing ensure precise retention and stabilization of the device intraorally.