Page 33 - Acrobat J Trad-21-3-2566
P. 33
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.