Development of a Molecular Diagnosing Platform for Monitoring Oral Hygiene in Diabetic Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The change of HbAlC between diabetes mellitus patients, 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. A lot of researches show that periodontal disease is related to diabetes mellitus. Periodontal disease causes rise of blood sugar, and more than 3 times as diabetes mellitus patients as healthy people have serious periodontal disease.In this study, the investigators collect periodontal pocket and saliva samples of participants, and selecting six periodontal disease-associated bacteria strains, including Porphyromonas gingivalis (Pg), Fusobacterium nucleatum (Fn), Actinobacillus actinomycetemcomitans (Aa), Treponema denticola (Td), Prevotella intermedia (Pi) and Tannerella forsythia (Tf) as diagnostic markers. Participants will get bacteriostasis mouthwash at mouth 2. The investigators will compare the differences of blood biochemistry value and oral bacteria strains after using the mouthwash.Using real-time PCR and MALDI Biotyper, the investigators will establish the database of oral microorganisms in diabetes mellitus patients, 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion condition of diabetes:
- •Glucose(AC)≧126 mg/dL
- •2-h PG≧200mg/dL during an OGTT
- •In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose≧200mg/dL
- •Inclusion condition of periodontal disease
- •(1) 16 natural teeths and 6 front teeth at lesat (2) Periodontal pocket≧7 mm, and radiographic bone loss≧30%
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 HbAlC between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
时间窗: 6 month
To compare the value of HbAlC in % with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash.
The change of LDL between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
时间窗: 6 month
To compare the value of LDL in mg/dL with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
The change of HDL between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
时间窗: 6 month
To compare the value of HDL in mg/dL with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
The change of uric acid between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
时间窗: 6 month
To compare the value of uric acid in mg/dL with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
The change of creatinine between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
时间窗: 6 month
To compare the value of creatinine in mg/dL with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
The change of micro-albumin between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
时间窗: 6 month
To compare the value of micro-albumin in mg/L with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
The change of cholesterol total between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
时间窗: 6 month
To compare the value of cholesterol total in mg/dL with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
The change of hs-CRP between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
时间窗: 6 month
To compare the value of hs-CRP in mg/dL with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
The change of glucose (AC) between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
时间窗: 6 month
To compare the value of glucose (AC) in mg/dL with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash.
The change of triglyceride between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
时间窗: 6 month
To compare the value of triglyceride in mg/dL with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
The change of GPT between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
时间窗: 6 month
To compare the value of GPT in U/L with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
次要结局
未报告次要终点