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.