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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Augusta University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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