염화세틸피리디늄 분말의 치태제거와 치은염 완화 효과에 관한 임상시험

Abstract

To evaluate the effect of cetylpyridinium chloride in a powder form when used concomitantly with a commercial flouride containing tooth paste on inhibition of plaque formation, on gingivitis, and on irritation of oral mucosa, a double--blind, randomized parallel study was set up. Cetylpyridinium chloride was incorporated into a ligh brown colored powder with menthol added for scent. There were no diffemces between the active agent and the placebo which did not contain cetylpyridinium chloride in appearance, color, smell, taste, or dispenser. 98 healthy volunteers were assigned to one of two groups: brushing 3 times a day with flouride toothpaste and cetylpyridinium chloride powder, or brushing 3 times a day with flouride toothpaste and placebo. Before the test period, the subjects received through tooth cleaning and polishing. At basteline, GI, PI, BOP, and GCF of the Ramfjord teeth were measured in the experimental and placebo groups including 58 and 42 subjects repectively, After 4 weeks, GI, PI, BOP, GCF, compliance, irritation of the oral mucosa(redness, pus drainage, edema) and adverse reactions were measured. The PI, GI, and BOP of the experimental group recorded at baseline are 0.190.19, 0.420.31, and 0.080.15. These scores showed significant decrease after 4 weeks of test period(0.110.15, 0.220.24, 0.020.09 repectively at the end of the study) and inhibition of plaque accumulation and resolution of gingival inflammation could be observed. GCF shoed slight increase but this was not statistically different. Comparison of changes in measured scores of control and experimental groupshow GI, PI of the test indices have decreased. Test group showed significantly greater decrease in gingivitis and plaque accumulation after 4 weeks. GCF and BOP also showed greater decrease thant the control group but this difference was not statistically significant. At no time of the study period did any of the subjects show signs of irritation of the oral mucosa or adverse reactions. Following conclusions could be obtained from this study. The combined use of cetl powder and flouride toothpaste showed greater inhibition of plaque accumulation and greater decrease of gingivitis than use of flouride toothpaste with placebo agent.