미노클린첨부제의 지치주위염에 대한 유효성및 안전성평가를 위한 위약대조 이중맹검 제3상 비교임상시험

Abstract

This clinical study was designed to determine the clinical and microbiological outcomes and safety of using minocycline loaded polycaprolactone strip for pericoronitis patients. 64 patients showing symptoms and signs of pericoronitis were enrolled according to the inclusion criteria in this double blind study. They were randomly assigned to two groups. 32 patients comprised control group and they received only polycaprolactone films in pericoronal spaces, and another 32 patients comprised experimental group and they received polycaprolactone films loaded with 30% minocycline. Informed consent was obtained from all the participants before beginning the study. At the initial visit, gingival index(GI), papillary bleeding index(PBI), amount of gingival crevicular fluid(GCF) were recorded, and microbiological sampling was done. Then, loaded or unloaded polycaprolactone film was inserted into the pericoronal spaces. No drug was prescribed excepting this film. After one week, clinical and microbiological exam was repeated. Presence of any side effects or inconveniences were checked. Chi-square test and t-test was performed to compare outcomes. At baseline, there were no significant differences in all the criteria between experimental group and control group. Experimental group showed significant improvement compared with control group both in GI(p<0.01) and PBI(p<0.01). The amount of GCF of the experimental group was significantly decreased compared with the control group(p<0.01) and baseline(p<0.01). In microbiological study, percentage of motile rod was prominently decreased in the experimental group. Also, aerobic(p<0.001), anaerobic(p<0.001) and black pigmented(p<0.01) bacteria were significantly decreased from the baseline. Furthermore, no side effects or inconveniences was reported in the experimental group. From this study, it was concluded that insertion of polycaprolactone film with 30% minocycline into the pericoronal spaces would be effective and safe treatment for pericoronitis.