Role of Infected Blood Dendritic Cells in Heart Disease Risk

Study Overview
=================
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.

Official Title
-----------------
Peripheral Blood Dendritic Cells and Periodontitis

Conditions
-----------------
Chronic Periodontitis

Intervention / Treatment
-----------------
* Drug: Oral Antibiotic and Oral Rinse
* Procedure: Standard Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: generalized moderate to severe chronic periodontitis Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Antibiotic and Oral Rinse<br>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 | Drug: Oral Antibiotic and Oral Rinse<br>* PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID<br>* Other names: Peridex/Flagyl/Amoxil/lansoprazole;Procedure: Standard Treatment<br>* Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers<br>* Other names: Root planing;|
| Other: Standard Treatment<br>Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers | Procedure: Standard Treatment<br>* Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers<br>* Other names: Root planing;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Blood Dendritic Cells From Baseline | 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) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing Attachment Levels | 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 | 30 days | 
| Serum Cytokine Response | serum CCL20 in pg/ml by ELISA will be measured after 30 days | 30 days | 
| Probing Depths | 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 | 30 days | 
| Plaque Index | 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 thin film of visible microbial plaque in sulcus moderate accumulation of plaque in sulcus large amount of plaque in sulcus or along free gingival margin | 30 days | 
| Gingival Index | 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 Mild inflammation, slight color change and edema, no bleeding Moderate inflammation, redness, edema, bleeds on probing Severe inflammation, marked redness and edema ulceration, spontaneous bleeding | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
periodontal, disease, dendritic, cells, antibiotics