The aim of this study was to compare the efficacy of PBM (660nm) and corticosteroid therapy
with clobetasol propionate 0.05% in the treatment of OLP. This is a protocol for a
randomized, controlled, double blind clinical trial. Fourty-four patients will be randomized
in two experimental groups. Control group will be treated with clobetasol propionate 0.05%
for 30 consecutive days and with placebo PBM twice a week. The experimental group will be
treated with placebo gel for 30 consecutive days to mask the treatment and patients will
receive PBM twice a week during 1 month (laser λ = 660±10 nm; power 100mW; radiant energy
177J/cm2; 5-s exposure time per point and 0.5J of energy per point. The primary variable
(pain) and the secondary variables including clinical scores and functional scores as well as
patient anxiety and depression (The Hospital Anxiety and Depression Scale-HADS), will be
evaluated at the baseline, once a week during treatment and after 30 and 60 days of follow
up. Evaluation of clinical resolution will be performed at the end of the treatment (30
days). Evaluation of recurrence will be performed after 30 and 60 days of follow up. Serum
and salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated at baseline and
at the end of treatment (30 days). Quality of life will be evaluated by OHIP-14 questionnaire
at baseline, at the end of treatment and after 30 and 60 days of follow up. The chi-square
test, Student's t-test and ANOVA will be used and the level of significance of 5% will be
considered (p < 0.05).