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Completed

NCT Number: NCT01568944

Role of Infected Blood Dendritic Cells in Heart Disease Risk

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

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GHSU-CDM Clinical Research Center

Augusta, Georgia, 30912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Peridex/Flagyl/Amoxil/lansoprazole

Standard treatment

Procedure

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

Other names: Scaling, Root planing

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. Serum Cytokine Response

    Time frame: 30 days

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

  3. 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

  4. 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

    • 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

  5. 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

    • 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

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

Peripheral Blood Dendritic Cells and Periodontitis

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 2, 2012
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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