Role of Infected Blood Dendritic Cells in Heart Disease Risk

This study has been completed.
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
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

March 28, 2012
January 27, 2015
March 2012
September 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01568944 on ClinicalTrials.gov Archive Site
  • 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
  • clinical response [ Time Frame: after 7 days, 24 hours, 4-6 weeks ] [ Designated as safety issue: No ]
    the clinical indices 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
Not Provided
Not Provided
 
Role of Infected Blood Dendritic Cells in Heart Disease Risk
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.
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Chronic Periodontitis
  • 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
  • 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
    Interventions:
    • Drug: Oral Antibiotic and Oral Rinse
    • Procedure: Standard Treatment
  • Standard Treatment
    Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
    Intervention: Procedure: Standard Treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
40 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01568944
R21DE020916, Pro00000394, R21DE020916
Yes
Not Provided
Not Provided
Christopher Cutler, Georgia Regents University
Georgia Regents University
National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Christopher Cutler, DDS GHSU-College of Dental Medicine
Georgia Regents University
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP