Text Size

Role of Infected Blood Dendritic Cells in Heart Disease Risk

This study is currently recruiting participants.
Verified April 2012 by Georgia Regents University
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
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
History of Changes
  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: Amoxicillin-Metronidazole combination plus oral rinse
Device: scaling and root planing

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:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

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


Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PO antibiotics plus oral rinse
This arm is expected to prevent the DC response to scaling and root planing
 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
no antibiotics or mouthrinse
no antimicrobial control
 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

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

Contacts
Contact: Christopher Cutler, DDS, PhD 7067212442 chcutler@georgiahealth.edu
Contact: Cristiano Susin, DDS, PhD 7067212442 csusin@georgiahealth.edu

Locations
United States, Georgia
GHSU-CDM Clinical Research Center Recruiting
Augusta, Georgia, United States, 30912
Contact: Christopher Cutler, DDS     706-721-2442     chcutler@georgiahealth.edu    
Contact: Marlena Smith     7067212442     msmith@georgiahealth.edu    
Sub-Investigator: Jack O'neill, DDS            
Sub-Investigator: Aaron Rawlings, DDS            
Sponsors and Collaborators
Georgia Regents University
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Christopher Cutler, DDS GHSU-College of Dental Medicine
  More Information

Publications:

Responsible Party: 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: April 3, 2012
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Amoxicillin
Anti-Bacterial Agents
Metronidazole
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on June 18, 2013