Status:
COMPLETED
Kidney and Periodontal Disease Study
Lead Sponsor:
University of California, San Francisco
Conditions:
Chronic Kidney Disease
Periodontal Disease
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief Summary
The purpose of this study is (1) to determine whether a 12-month trial of patients from underserved communities with clinically significant gum disease and kidney disease randomly assigned to intensiv...
Detailed Description
This is a randomized controlled pilot trial to two intention-to-treat treatment arms: intensive periodontal therapy or control-delayed periodontal therapy. The investigators' goals are to test the fea...
Eligibility Criteria
Inclusion
- Age 20-75 years
- Speaks English or Spanish
- At least two measurements of estimated glomerular filtration (eGFR) rate 15-59 ml/min/1.73m2 within the preceding 12 months
- No eGFR increase by \>= 50% in the preceding 6 months
- Moderate/severe periodontal disease in accordance with the Centers for Disease Control and Prevention/American Academy of Periodontology definition
Exclusion
- General Exclusion Criteria. Subjects must NOT be:
- Under age 20 or over age 75
- Unable to understand and provide informed consent
- Receiving current immunosuppressant therapy.
- Receiving current anticoagulation therapy resulting in an elevated prothrombin time or an International Normalized Ratio (INR) greater than 2.0
- Pregnant.
- Oral Exclusion Criteria. Subjects must NOT:
- Have fewer than 6 natural teeth
- Requires antibiotic prophylaxis for dental procedures as defined by the 2007 American Heart Association guidelines (patients with prosthetic heart valves, those with prosthetic material used for cardiac valve repair, those who have had a history of infective endocarditis, or those with congenital heart defects repaired with prosthetic material).
- Have severe dental disease defined as deep dental caries, endodontic involvement of one or more teeth, presence of abscesses of periodontal or endodontic origin, or dental conditions requiring immediate treatment.
- Have any hard or soft tissue lesion requiring further evaluation and/or treatment.
- Have known allergy to minocycline, tetracyclines, or polyglycolide polymers.
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01802216
Start Date
February 1 2014
End Date
September 1 2017
Last Update
April 30 2019
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.