Preparation and Analysis of Material, Biological and Clinical Parameters of Metronidazole-loaded Porous Matrices for Local Periodontitis Treatment
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- PBI
研究概览
简要总结
Aim of the study is the efficiency assessment of porous Metronidazole loaded matrix based on gelatin/hydroxyethylcellulose blend in treatment of deep periodontal pockets resulting from severe chronic periodontitis. The matrix was invented and produced in Department of Drug Form Technology, Wroclaw Medical University.
The porous metronidazole (MTZ) loaded matrix was fabricated by the freeze-drying technique. The morphology, mechanical properties, in vitro degradation, MTZ release from dried sponge were evaluated and also the clinical trials were performed.
Patients suffering from chronic periodontitis are examined. To evaluate oral hygiene API (Approximal Plaque Index) and the gum inflammation BOP (Bleeding on Probing) and PBI (Papilla Bleeding Index) indices are used. The clinical examination is performed 3 times. On the first visit the output indicators are defined. The subgingival scaling is performed and Metronidazol on porous matrix is applied to the selected periodontal pockets. 2 control tests of periodontal indices are carried out after one week and one month from the application.
In the control group after scaling/root planing procedure, there is no application of metronidazole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •non-smokers
- •suffering from chronic periodontitis
排除标准
- •any antibiotics taken systematically or locally in the preceding six months
研究组 & 干预措施
Metronidazole
19,8 mg of metronidazole in one polymer matrix
干预措施: Metronidazole (Drug)
结局指标
主要结局
PBI
时间窗: 4 weeks after the first visit
Papilla bleeding index
API
时间窗: 4 weeks after the first visit
Approximal Plaque Index
BoP
时间窗: 4 weeks after the first visit
Bleeding of probing
PD
时间窗: 4 weeks after the first visit
Periodontal pocket depth
次要结局
未报告次要终点
研究者
Malgorzata Szulc
Assistant Professor in Periodontology Department
Wroclaw Medical University
