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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
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