Role of Infected Blood Dendritic Cells in Heart Disease Risk
- Conditions
- Chronic Periodontitis
- Interventions
- Drug: Oral Antibiotic and Oral RinseProcedure: Standard Treatment
- Registration Number
- NCT01568944
- Lead Sponsor
- Augusta University
- Brief Summary
The investigators hypothesize that blood dendritic cells harbor pathogens from the oral cavity in chronic periodontitis and disseminate these pathogens to atherosclerotic plaques.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- generalized moderate to severe chronic periodontitis
- diabetes
- 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
- smoker
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral Antibiotic and Oral Rinse 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 Oral Antibiotic and Oral Rinse Standard Treatment 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 Standard Treatment Standard Treatment Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
- Primary Outcome Measures
Name Time Method Frequency of Blood Dendritic Cells From Baseline 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)
- Secondary Outcome Measures
Name Time Method Serum Cytokine Response 30 days serum CCL20 in pg/ml by ELISA will be measured after 30 days
Probing Attachment Levels 30 days Probing attachment levels (distance from the cemento-enamel junction to the base of the periodontal pocket in mm at 6 sites p\[er tooth) will be monitored after 30 days
Probing Depths 30 days Probing depths (distance from the free gingival margin to the base of the pocket in mm at six sites per tooth) will be monitored after 30 days
Plaque Index 30 days Plaque index of Silness and Loe will be monitored at buccal and lingual surfaces of all teeth after 30 days:
0 no visible microbial plaque
1. thin film of visible microbial plaque in sulcus
2. moderate accumulation of plaque in sulcus
3. large amount of plaque in sulcus or along free gingival marginGingival Index 30 days Gingival index of Loe and Silness on facial, lingual and mesial surfaces of all teeth will be monitored after 30 days:
0 Normal, no inflammation
1. Mild inflammation, slight color change and edema, no bleeding
2. Moderate inflammation, redness, edema, bleeds on probing
3. Severe inflammation, marked redness and edema ulceration, spontaneous bleeding
Trial Locations
- Locations (1)
GHSU-CDM Clinical Research Center
🇺🇸Augusta, Georgia, United States