跳至主要内容
临床试验/NCT03345329
NCT03345329已完成不适用

Development of a Molecular Diagnosing Platform for Relieving Periodontal Symptoms

General Biologicals Corporation0 个研究点目标入组 100 人开始时间: 2015年10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
100
主要终点
The change of PSR score, GI, PI, and oral bacteria strains between periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash

研究概览

简要总结

More than ninety percent of adults in Taiwan are suspected to carry periodontal disease, which causes bad breath, swollen and bleeding gums, plaque and even tooth loss. Half of the patients, however, are ignorance these clinical syndromes because of no obvious pain. In this study, the investigators selected six periodontal disease-associated bacteria strains, including Porphyromonas gingivalis (Pg), Fusobacterium nucleatum (Fn), Actinobacillus actinomycetemcomitans (Aa), Tannerella forsythia (Tf), Treponema denticola (Td) and Prevotella intermedia (Pi) as diagnostic markers. Using real-time PCR and MALDI Biotyper, the investigators will establish the database of oral microorganisms in Taiwanese people, providing periodontal disease clinical markers of high-risk groups and the basis for personal medicine of therapy in the future.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 3≦periodontal screening and recording≦4
  • 16 natural teeths and 6 front teeth at lesat

排除标准

  • People who have oral lesion, dental braces, denture, mouthwash allergy, or serious systemic disease
  • People who have ever eaten antibiotics and Anti-inflammatory drugs over the last 6 months
  • People who have ever eaten Immunosuppressive drugs, antiepileptic drugs, antihypertensive drugs, or anticoagulant
  • Pregnant women or the woman who eat birth control pills

结局指标

主要结局

The change of PSR score, GI, PI, and oral bacteria strains between periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash

时间窗: 9 month

To compare the value of PSR score (0-4 point), GI (0-4 point), and PI (0-5 point) with periodontal disease patients older than 60 years of age, periodontal disease patients younger than 60 years of age and healthy people after receiving periodontal therapy and using mouthwash. Oral bacteria strains are also compared with these groups.

次要结局

未报告次要终点

研究者

发起方
General Biologicals Corporation
申办方类型
Industry
责任方
Sponsor

相似试验