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Role of Infected Blood Dendritic Cells in Heart Disease Risk

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral Antibiotic and Oral Rinse
Standard Treatment
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Periodontitis focused on measuring periodontal, disease, dendritic, cells, antibiotics

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • GHSU-CDM Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Oral Antibiotic and Oral Rinse

Standard Treatment

Arm 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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
March 28, 2012
Last Updated
April 30, 2020
Sponsor
Augusta University
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT01568944
Brief Title
Role of Infected Blood Dendritic Cells in Heart Disease Risk
Official Title
Peripheral Blood Dendritic Cells and Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
periodontal, disease, dendritic, cells, antibiotics

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Antibiotic and Oral Rinse
Arm Type
Experimental
Arm 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
Arm Title
Standard Treatment
Arm Type
Other
Arm Description
Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
Intervention Type
Drug
Intervention Name(s)
Oral Antibiotic and Oral Rinse
Other Intervention Name(s)
Peridex/Flagyl/Amoxil/lansoprazole
Intervention Description
PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID
Intervention Type
Procedure
Intervention Name(s)
Standard Treatment
Other Intervention Name(s)
Scaling, Root planing
Intervention Description
Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
Primary Outcome Measure Information:
Title
Frequency of Blood Dendritic Cells From Baseline
Description
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)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Probing Attachment Levels
Description
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
Time Frame
30 days
Title
Serum Cytokine Response
Description
serum CCL20 in pg/ml by ELISA will be measured after 30 days
Time Frame
30 days
Title
Probing Depths
Description
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
Time Frame
30 days
Title
Plaque Index
Description
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
Time Frame
30 days
Title
Gingival Index
Description
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
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Cutler, DDS
Organizational Affiliation
GHSU-College of Dental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
GHSU-CDM Clinical Research Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20562309
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.
Results Reference
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PubMed Identifier
21523219
Citation
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.
Results Reference
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Role of Infected Blood Dendritic Cells in Heart Disease Risk

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