Role of Infected Blood Dendritic Cells in Heart Disease Risk

Augusta University

Status

Completed

Conditions

Chronic Periodontitis

Treatments

Drug: Oral Antibiotic and Oral Rinse

Procedure: Standard Treatment

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01568944

Pro00000394 (Other Identifier)

R21DE020916 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The investigators hypothesize that blood dendritic cells harbor pathogens from the oral cavity in chronic periodontitis and disseminate these pathogens to atherosclerotic plaques.

Full 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.

Enrollment

18 patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

18 participants in 2 patient groups

Oral Antibiotic and Oral Rinse

Experimental group

Description:

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

Treatment:

Procedure: Standard Treatment

Drug: Oral Antibiotic and Oral Rinse

Standard Treatment

Other group

Description:

Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers

Treatment:

Procedure: Standard Treatment