Role of Infected Blood Dendritic Cells in Heart Disease Risk

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Christopher Cutler, Georgia Regents University
ClinicalTrials.gov Identifier:
NCT01568944
First received: March 28, 2012
Last updated: January 27, 2015
Last verified: January 2015
  Purpose

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


Condition Intervention
Chronic Periodontitis
Drug: Oral Antibiotic and Oral Rinse
Procedure: Standard Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Official Title: Peripheral Blood Dendritic Cells and Periodontitis

Resource links provided by NLM:


Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • Change in frequency of blood dendritic cells from baseline [ Time Frame: 7, 8, 30 days ] [ Designated as safety issue: No ]
    The frequency of blood dendritic cells at baseline will be compared to that after 7 days of PO antibiotics/mouthrinse therapy, 24 hours after Scaling and root planing (day 8) and 4-6 weeks after scaling and root planing


Secondary Outcome Measures:
  • probing attachment levels [ Time Frame: after 7 days, 24 hours, 4-6 weeks ] [ Designated as safety issue: No ]
    Probing attachment levels will be monitored at baseline, 7 days after antibiotics, 24 hours after scaling and root planing and 4-6 weeks after scaling

  • serum response [ Time Frame: 7 days, 24 hours and 4-6 weeks ] [ Designated as safety issue: No ]
    serum markers will be measured at baseline, after 7 days of antibiotics, 24 hours after scaling and root planing and 4-6 weeks after scaling

  • probing depths [ Time Frame: after 7 days, 24 hours, 4-6 weeks ] [ Designated as safety issue: No ]
    Probing depths will be monitored at baseline, 7 days after antibiotics, 24 hours after scaling and root planing and 4-6 weeks after scaling

  • plaque index [ Time Frame: after 7 days, 24 hours, 4-6 weeks ] [ Designated as safety issue: No ]
    Plaque index of Silness and loe will be monitored at baseline, 7 days after antibiotics, 24 hours after scaling and root planing and 4-6 weeks after scaling

  • gingival index [ Time Frame: after 7 days, 24 hours, 4-6 weeks ] [ Designated as safety issue: No ]
    gingival index of loe and silness will be monitored at baseline, 7 days after antibiotics, 24 hours after scaling and root planing and 4-6 weeks after scaling


Enrollment: 19
Study Start Date: March 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568944

Locations
United States, Georgia
GHSU-CDM Clinical Research Center
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Georgia Regents University
Investigators
Principal Investigator: Christopher Cutler, DDS GHSU-College of Dental Medicine
  More Information

Publications:
Responsible Party: Christopher Cutler, Assoc. Dean Dental Medicine, Dept. Chair Periodontics, Georgia Regents University
ClinicalTrials.gov Identifier: NCT01568944     History of Changes
Other Study ID Numbers: R21 DE020916, Pro00000394, R21DE020916
Study First Received: March 28, 2012
Last Updated: January 27, 2015
Health Authority: United States: Federal Government

Keywords provided by Georgia Regents University:
periodontal
disease
dendritic
cells
antibiotics

Additional relevant MeSH terms:
Chronic Periodontitis
Periodontitis
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Lansoprazole
Anti-Infective Agents
Anti-Ulcer Agents
Antitubercular Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2015