Role of Infected Blood Dendritic Cells in Heart Disease Risk

NCT01568944 | Completed Results DMC

• 2 other identifiers: R21DE020916Pro00000394
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Keywords

periodontal; disease; dendritic; cells; antibiotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Probing Attachment Levels

  30 days

• Serum Cytokine Response

  30 days

• Probing Depths

  30 days

• Plaque Index

  30 days

• Gingival Index

  30 days

Study Arms (2)

Oral Antibiotic and Oral Rinse

EXPERIMENTAL

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; Procedure: Standard Treatment

Standard Treatment

OTHER

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

Procedure: Standard Treatment

Interventions

Oral Antibiotic and Oral Rinse DRUG

PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID

Also known as: Peridex/Flagyl/Amoxil/lansoprazole

Oral Antibiotic and Oral Rinse

Standard Treatment PROCEDURE

Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers

Also known as: Scaling, Root planing

Oral Antibiotic and Oral Rinse; Standard Treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• generalized moderate to severe chronic periodontitis

You may not qualify if:

• 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

Sponsors & Collaborators

• Augusta University: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

GHSU-CDM Clinical Research Center

Augusta, Georgia, 30912, United States

Location

Related Publications (2)

• 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.

  PMID: 20562309 BACKGROUND

• 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.

  PMID: 21523219 BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis; Disease

Interventions

Anti-Bacterial Agents; Mouthwashes; chlorhexidine gluconate; Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Biomedical and Dental Materials; Specialty Uses of Chemicals; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Results Point of Contact

• Title: chairman
• Organization: Dental College of Georgia

chcutler@augusta.edu

706-7212442

Study Officials

• Christopher Cutler, DDS

  GHSU-College of Dental Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Dean Dental Medicine, Dept. Chair Periodontics

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 2, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 12, 2020
• Results First Posted: May 12, 2020

Record last verified: 2020-04

Locations

US (1)