Role of Infected Blood Dendritic Cells in Heart Disease Risk

Chronic Periodontitis Clinical Trial

Official title:

Peripheral Blood Dendritic Cells and Periodontitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568944
• Other study ID #: R21DE020916
• Secondary ID: Pro00000394R21DE
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: September 2014

Study information

• Verified date: April 2020
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• Oral Antibiotic and Oral Rinse
PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID

Procedure:
• Standard Treatment
Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers

Locations

Country	Name	City	State
United States	GHSU-CDM Clinical Research Center	Augusta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Augusta University	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Zeituni AE, Carrion J, Cutler CW. Porphyromonas gingivalis-dendritic cell interactions: consequences for coronary artery disease. J Oral Microbiol. 2010 Dec 21;2. doi: 10.3402/jom.v2i0.5782. — View Citation

Zeituni AE, McCaig W, Scisci E, Thanassi DG, Cutler CW. The native 67-kilodalton minor fimbria of Porphyromonas gingivalis is a novel glycoprotein with DC-SIGN-targeting motifs. J Bacteriol. 2010 Aug;192(16):4103-10. doi: 10.1128/JB.00275-10. Epub 2010 Jun 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Serum Cytokine Response	serum CCL20 in pg/ml by ELISA will be measured after 30 days	30 days
Secondary	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
Secondary	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
Secondary	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