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Trial record 32 of 46 for:    gum disease | NIH

Role of Infected Blood Dendritic Cells in Heart Disease Risk

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ClinicalTrials.gov Identifier: NCT01568944
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : January 28, 2015
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Christopher Cutler, Augusta University

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

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: Oral Antibiotic and Oral Rinse Procedure: Standard Treatment Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Official Title: Peripheral Blood Dendritic Cells and Periodontitis
Study Start Date : March 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in frequency of blood dendritic cells from baseline [ Time Frame: 7, 8, 30 days ]
    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 :
  1. probing attachment levels [ Time Frame: after 7 days, 24 hours, 4-6 weeks ]
    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

  2. serum response [ Time Frame: 7 days, 24 hours and 4-6 weeks ]
    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

  3. probing depths [ Time Frame: after 7 days, 24 hours, 4-6 weeks ]
    Probing depths will be monitored at baseline, 7 days after antibiotics, 24 hours after scaling and root planing and 4-6 weeks after scaling

  4. plaque index [ Time Frame: after 7 days, 24 hours, 4-6 weeks ]
    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

  5. gingival index [ Time Frame: after 7 days, 24 hours, 4-6 weeks ]
    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



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568944


Locations
United States, Georgia
GHSU-CDM Clinical Research Center
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Augusta University
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Christopher Cutler, DDS GHSU-College of Dental Medicine

Publications:
Responsible Party: Christopher Cutler, Assoc. Dean Dental Medicine, Dept. Chair Periodontics, Augusta University
ClinicalTrials.gov Identifier: NCT01568944     History of Changes
Other Study ID Numbers: R21DE020916 ( U.S. NIH Grant/Contract )
Pro00000394 ( Other Identifier: GHSU-HAC )
R21DE020916 ( U.S. NIH Grant/Contract )
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: January 28, 2015
Last Verified: January 2015

Keywords provided by Christopher Cutler, Augusta University:
periodontal
disease
dendritic
cells
antibiotics

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontitis
Chronic Periodontitis
Anti-Bacterial Agents
Amoxicillin
Antibiotics, Antitubercular
Chlorhexidine gluconate
Lansoprazole
Dexlansoprazole
Anti-Infective Agents
Antitubercular Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Dermatologic Agents