Peripheral Blood Dendritic Cells and Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Frequency of Blood Dendritic Cells From Baseline
研究概览
简要总结
The investigators hypothesize that blood dendritic cells harbor pathogens from the oral cavity in chronic periodontitis and disseminate these pathogens to atherosclerotic plaques.
详细描述
To address this hypothesis, a clinical study in humans with moderate to severe chronic periodontitis has been designed. This is an interventional study involving scaling and root planing and two arms: 1. treatment with PO amoxocillin/metronidazole plus chlorhexidine oral rinse; 2. no antibiotics or oral rinse. It is expected that the antibiotics plus chlorhexidine will prevent the dendritic cell response to infection (bacteremia) elicited by scaling and root planing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •generalized moderate to severe chronic periodontitis
排除标准
- •antibiotics treatment within 3 months
- •treatment with steroids, phenytoin, cyclosporin, coumadin
- •presence of conditions requiring prophylactic antibiotics per AHA
- •cancer, HIV, hepB, lupus, prediagnosed heart disease, renal disease
研究组 & 干预措施
Oral Antibiotic and Oral Rinse
Each subject will received oral Amoxicillin/Amoxil/lansoprazole/Flagyl 250 mg of each three times a day for 8 days. Subjects will also rinse their mouths with 2 ounces of 0.12% chlorhexidine/peridex mouthrinse two times per day. Subjects will also receive mechanical debridement at the baseline visit. Intervention Amoxicillin/Amoxil/lansoprazol 500 mg/ Metronidazole/Flagyl 250 mg
干预措施: Oral Antibiotic and Oral Rinse (Drug)
Oral Antibiotic and Oral Rinse
Each subject will received oral Amoxicillin/Amoxil/lansoprazole/Flagyl 250 mg of each three times a day for 8 days. Subjects will also rinse their mouths with 2 ounces of 0.12% chlorhexidine/peridex mouthrinse two times per day. Subjects will also receive mechanical debridement at the baseline visit. Intervention Amoxicillin/Amoxil/lansoprazol 500 mg/ Metronidazole/Flagyl 250 mg
干预措施: Standard Treatment (Procedure)
Standard Treatment
Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
干预措施: Standard Treatment (Procedure)
结局指标
主要结局
Frequency of Blood Dendritic Cells From Baseline
时间窗: 30 days
The frequency of blood dendritic cells, i.e. % CCR6+CD1a+ DCs by flow cytometry 30 days after treatment with 7 day regimen of antibiotics, mouthrinse therapy and scaling and root planing (SRP) will be compared to those who did not receive the antibiotics, but did receive mouthrinse and scaling and root planing (SRP)
次要结局
- Serum Cytokine Response(30 days)
- Probing Attachment Levels(30 days)
- Probing Depths(30 days)
- Plaque Index(30 days)
- Gingival Index(30 days)
研究者
Christopher Cutler
Assoc. Dean Dental Medicine, Dept. Chair Periodontics
Augusta University