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J Thai Trad Alt Med Vol. 21 No. 3 Sep-Dec 2023 517
2.2 Efficacy and safety evaluation The dryness of the oral cavity was
2.2.1 Outcome Measures: assessed using the Challacombe dryness scale
Primary outcome : Complete relief of ery- of 0-3.
thematous lesions, pain Pain was assessed before the treat-
and dryness of the oral ment (W0) and at W2 and W4 after the treat-
cavity ment using a Visual Analog Pain scale (VAS;
: Reduction in the number patient reporting scale of 0-10).
of C. albicans colonies An evaluation form was given to the
present in the oral cavity family or the patient to record all aspects and
: Disease relapse possible side effects associated with the study
Secondary outcome: Patient safety drug. Detailed interviews and evaluations were
Demographic data and medical his- conducted to analyze safety and any possible
tory were collected through anamnesis on the side effects of the drug.
first day. The diagnosis of OLP was performed Disease relapse was evaluated by
through clinical evaluation by an oral medicine telephone interviews at the 6-month follow-up
specialist on the first day (W0), two weeks time
after the first examination (W2) and 4 weeks 2.3 Candida infection investigation [18]
after the first examination (W4). Erythematous Patients were asked to rinse 10 ml of
lesions (site activity score) and the dryness sterile phosphate buffer saline 0.01 M pH 7.2 for
of the oral cavity were assessed on W0, W2 1 min and then spit out the saliva in the sam-
and W4 using the Challacombe scale. A site pling bottle (whole mouth method). The saliva
activity score was obtained according to the samples were collected before the treatment
Challacombe scale by multiplication of two (W0) and at W2 and W4 after the treatment
scores; the site score and activity score. The (Figure 1). Samples were taken three times for
site and activity scores were calculated by the every patient. After inoculation on sabouraud
following criteria. dextrose agar (SDA) and tryticase soy agar
Site score: 0 = no lesion at the site, 1= (TSA) medium, respectively, the cultures were
less than 50% of area affected, and 2 = greater incubated at 35˚C for 2 to 3 days. Biochemical
than 50% of area affected. reactions were used to identify different fungi.
Activity score: 0 = reticular, 1 = mild 2.4 Statistical analysis
erythema, 2 = marked erythema, and 3 = ul- Wilcoxon’s matched-pairs signed-ranks
ceration. test was used for the comparison between the