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Role of Infected Blood Dendritic Cells in Heart Disease Risk

Not Applicable
Completed
Conditions
Chronic Periodontitis
Interventions
Drug: Oral Antibiotic and Oral Rinse
Procedure: 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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Oral Antibiotic and Oral RinseOral Antibiotic and Oral RinseEach 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 RinseStandard TreatmentEach 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 TreatmentStandard TreatmentSubjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
Primary Outcome Measures
NameTimeMethod
Frequency of Blood Dendritic Cells From Baseline30 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
NameTimeMethod
Serum Cytokine Response30 days

serum CCL20 in pg/ml by ELISA will be measured after 30 days

Probing Attachment Levels30 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 Depths30 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 Index30 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 margin

Gingival Index30 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

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