Photodynamic Therapy Fiber-Optic Device for Localized Ablation of Superficial Oral Premalignant Lesions

Oral premalignant lesions carry an inherent risk of malignant transformation, and conventional surgical excision may cause scarring, functional impairment and aesthetic defects in the oral cavity. Photodynamic therapy serves as a non-surgical alternative, yet existing light delivery systems are mostly designed for large-area irradiation and lack precise confinement to irregular lesion boundaries. This study designs a flexible fiber-optic photodynamic therapy device with a side-emitting optical fiber and a custom 3D-printed light-shielding template. The template is fabricated according to intraoral scanning data to match the lesion contour, so that excitation light is restricted exclusively to target tissues while protecting adjacent normal mucosa. The output light intensity is calibrated in real time to maintain a stable radiant exposure. In a clinical cohort of oral leukoplakia patients, the device achieves high lesion clearance rates with minimal injury to surrounding healthy tissues. The main drawback is the requirement for individualized template fabrication, which extends the preoperative preparation cycle. This customized fiber-optic light delivery device improves the spatial selectivity of oral photodynamic therapy.