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临床试验/NCT03791099
NCT03791099Unknown4 期

Preparation and Analysis of Material, Biological and Clinical Parameters of Metronidazole-loaded Porous Matrices for Local Periodontitis Treatment

Wroclaw Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年4月23日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

发起方
Wroclaw Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Malgorzata Szulc

Assistant Professor in Periodontology Department

Wroclaw Medical University

研究点 (1)

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