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516 วารสารการแพทย์แผนไทยและการแพทย์ ทางเลือก       ปีที่ 21  ฉบับที่ 3  กันยายน-ธันวาคม 2566




           betes) at the study entry; patients who had   dexamethasone solution) or patients who had
           used any other prophylactic mouthwashes     C. albicans colonies in the oral cavity of over

           within the last month, patients who required   400 CFU/ml at week 2 after the treatment (re-
           use of any form of treatment/medicaments    ceived 0.1% nystatin suspension)
           (such as antibiotics, analgesics, etc.); patients

           who were recently treated with antifungal,   2. Method
           antibacterial, chemotherapeutic and immu-       2.1 Study design
           nosuppressive agents within the last month;      The trial design was a single-centre,

           patients who had dryness of the oral cavity   randomized controlled, parallel arm trial. The
           with a score of 4 or more (assessed by Chal-  study took place at the Faculty of Dentistry,
           lacombe scale) or patients who were allergic   Prince of Songkla University, Hat-Yai, Thailand

           to or should not take anything with curcumin,   between February 2019 and April 2021. The
           chitosan or triamcinolone acetonide.        sample size was calculated according to the

                Subject withdrawal criteria included   formula described by Kelsey et al (1996) for
                                                                         [17]
           patients who had a site activity score of 7   clinical trial studies  as shown below and
                                                                                 [6]
           or more (received artificial saliva), patients   a study by Laxmi et al (2015)  which found
           who had an increased severity of site activity   that 0.1% TA caused a disease relapse of 20%
           score at week 2 after the treatment (received   whereas a low-level laser therapy caused a

           0.1% fluocinolone acetonide paste or 0.1%   disease relapse of 5% within 6 months.

                N  =



                   =


                Level of significance = 5%, Power = 80%, P = (P0=P1)/2 = (0.05+0.2)/2 = 0.125


                Thus 10 patients per group were enrolled   pad.com/quickcalcs, GraphPad Software, Inc.
           allowing for a dropout rate of 20% for the pres-  The block randomization size was 4 and the

           ent pilot study.                            allocation ratio between the two groups was
                A total of 20 patients were randomized   1:1. Five milliliters of each intervention was

           and allocated to two different interventions in-  given to the patient to be used for 2 min, four
           cluding 0.1% CHI-CUR or 0.1% TA mouthwash   times a day at 8 am, 12 pm, 4 pm and before
           using online software from http://www.graph-  bed for four weeks.
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