Impact of local and systemic photobiomodulation on the salivary status of patients with Sjögren's disease

Abstract

Objective: To compare the efficacy of local photobiomodulation alone and local photobiomodulation combined with ILIB on salivary flow and composition in patients with Sjögren's disease (SD) by assessing unstimulated and stimulated salivary flow, salivary pH, buffering capacity, and sali-vary calcium and phosphate concentrations.

Methods: Randomized, longitudinal, single-blind, crossover clinical trial. Participants will be randomly assigned to four groups: local photobiomodulation, local placebo, local photobio-modulation combined with ILIB, and combined placebo. Baseline assessments will include sialometry and salivary biochemical analysis. Following the first treatment phase, assess-ments will be repeated and, after a washout period, the crossover will be performed, allowing all participants to receive the corresponding active intervention. Comparisons will include local photobiomodulation versus local placebo, combined therapy versus combined place-bo, and local photobiomodulation alone versus local photobiomodulation combined with ILIB. Statistical analyses will include non-parametric paired tests, bootstrap permutation tests, and clustering methods.

Expected Results: Photobiomodulation is expected to increase salivary flow and improve overall salivary status with the combination of local therapy and ILIB producing greater benefits than local treatment alone. The findings may contribute to the development of innovative therapeutic pro-tocols for the management of salivary dysfunction in patients with Sjögren's disease.