Trial record 2 of 3 for:    periodontal dendritic cells

Role of Infected Blood Dendritic Cells in Heart Disease Risk

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Georgia Regents University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Georgia Regents University
ClinicalTrials.gov Identifier:
NCT01568944
First received: March 28, 2012
Last updated: April 3, 2012
Last verified: April 2012

March 28, 2012
April 3, 2012
March 2012
March 2013   (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: Amoxicillin-Metronidazole combination plus oral rinse
    PO Amoxicillin 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID
  • Device: scaling and root planing
    all subjects will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
    Other Names:
    • deep cleaning
    • local debridement
  • Experimental: PO antibiotics plus oral rinse
    This arm is expected to prevent the DC response to scaling and root planing
    Interventions:
    • Drug: Amoxicillin-Metronidazole combination plus oral rinse
    • Device: scaling and root planing
  • no antibiotics or mouthrinse
    no antimicrobial control
    Intervention: Device: scaling and root planing

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
March 2014
March 2013   (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
Yes
Contact: Christopher Cutler, DDS, PhD 7067212442 chcutler@georgiahealth.edu
Contact: Cristiano Susin, DDS, PhD 7067212442 csusin@georgiahealth.edu
United States
 
NCT01568944
R21 DE020916, Pro00000394, R21DE020916
Yes
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
April 2012

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