Role of Infected Blood Dendritic Cells in Heart Disease Risk

April 30, 2020 updated by: Christopher Cutler, Augusta University

Peripheral Blood Dendritic Cells and Periodontitis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • GHSU-CDM Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing Attachment Levels
Time Frame: 30 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
30 days
Serum Cytokine Response
Time Frame: 30 days
serum CCL20 in pg/ml by ELISA will be measured after 30 days
30 days
Probing Depths
Time Frame: 30 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
30 days
Plaque Index
Time Frame: 30 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
30 days
Gingival Index
Time Frame: 30 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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

  • Principal Investigator: Christopher Cutler, DDS, GHSU-College of Dental Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 28, 2012

First Submitted That Met QC Criteria

March 29, 2012

First Posted (Estimate)

April 2, 2012

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

April 30, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21DE020916 (U.S. NIH Grant/Contract)
  • Pro00000394 (Other Identifier: GHSU-HAC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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