Feasibility Study of a Novel Stent‐Based Low‐Level Laser Therapy Device for Reducing Severe Radiation‐Induced Oral Mucositis

Objectives Radiation‐induced oral mucositis (RIOM) is a severe complication of radiotherapy (RT) for head and neck cancers, impairing quality of life and treatment adherence. Low‐level laser therapy (LLLT) shows promise for reducing RIOM severity, but operator‐dependent devices limit practicality. This feasibility study assessed the safety and efficacy of a novel intraoral stent‐based LLLT device designed for consistent laser delivery. Materials and Methods This prospective, single‐arm, multicenter study enrolled 15 patients receiving curative RT for head and neck cancers. The stent‐based device delivered laser light to 43 oral cavity points at three wavelengths (670, 830, and 910 nm) during 20‐min sessions, five times weekly. The primary end point was the incidence of Grade 3 or higher RIOM (WHO oral mucositis scale). Pain severity was a secondary end point (Numeric Pain Rating Scale [NPRS]). Results Grade 3 or higher RIOM occurred in 6.6% of patients, significantly lower than historical rates (30%–40%). No patients reported severe pain (NPRS ≥ 8). The device was well‐tolerated with no adverse effects, and all patients completed RT as planned. Conclusions The intraoral stent‐based LLLT device is a safe and potentially effective intervention for reducing severe RIOM. Randomized trials are warranted to confirm these findings. Trial Registration This study was a prospective, single‐arm feasibility trial and was not registered in a clinical trial registry, as it did not meet the criteria for mandatory registration at the time of its initiation.