跳至主要内容
临床试验/NCT03090282
NCT03090282已完成不适用

Subgingival Microbiome Following Mechanical Treatment and it's Effect on Peri-implant Sub-mucosa in Aggressive Periodontitis Patients

Peking University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
changes of prevalence and abundance of OTUs

研究概览

简要总结

The investigators planed to observe the microbiome of an aggressive periodontitis patient, during mechanical treatment, surgery(if indicated) and implant placement. The investigators designed to observe the changes after mechanical treatment.Then, the investigators will compare the sub-mucosa microbiome of implant and the subgingival community. The investigators expected a different community after treatment, and there could be similarity between implant and nature teeth.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects were between 18-35 years old and diagnosed with generalized aggressive periodontitis (GAgP) according to the 1999 International Classification of Periodontal Diseases (Armitage 1999);
  • At least 20 teeth in the first appointment and at least 3 teeth(other than first molars and central incisors)with a probing depth(PD) ≥ 6mm, clinical attachment level (CAL)≥5mm;
  • The clinical diagnosis was confirmed by evidence of inter-proximal bone loss on full-mouth periapical radiographs;
  • Family history of aggressive periodontitis.

排除标准

  • Uncontrolled systemic conditions including diabetes and hypertension;
  • Pregnant or lactating;
  • Received periodontal treatment within the previous 6 months or antibiotic medication during the previous 3 months.

结局指标

主要结局

changes of prevalence and abundance of OTUs

时间窗: before implantation, 1 months after second stage surgery, and every month after prosthetic treatment until 2 years.

compute and compare the prevalence and abundance of OTUs

changes of diversity of subgingival community (compare the sub-mucosa microbiome of implant and the subgingival community)

时间窗: before implantation, 1 months after second stage surgery, and every month after prosthetic treatment until 2 years.

the diversity of submucosa community before and after implatation

次要结局

  • changes of bleeding index(Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.)
  • clinical attachment loss(Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.)
  • changes of probing depth(Baseline, 6 weeks after mechanical treatment, before implantation, 1 months after second stage surgery, every month after prosthetic treatment until 2 years.)

研究者

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

Liu guojing

Principal Investigator

Peking University

研究点 (1)

Loading locations...

相似试验