Kidney and Periodontal Disease Study

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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 intensive gum disease treatment or delayed treatment is feasible and (2) to determine the variability of various tests of kidney function and inflammation in response to intensive gum disease treatment.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Minocycline

Criteria

Inclusion Criteria:

1. Age 20-75 years

2. Speaks English or Spanish

3. At least two measurements of estimated glomerular filtration (eGFR) rate 15-59 ml/min/1.73m2 within the preceding 12 months

4. No eGFR increase by >= 50% in the preceding 6 months

5. Moderate/severe periodontal disease in accordance with the Centers for Disease Control and Prevention/American Academy of Periodontology definition

Exclusion Criteria:

General Exclusion Criteria. Subjects must NOT be:

1. Under age 20 or over age 75

2. Unable to understand and provide informed consent

3. Receiving current immunosuppressant therapy.

4. Receiving current anticoagulation therapy resulting in an elevated prothrombin time or an International Normalized Ratio (INR) greater than 2.0

5. Pregnant.

Oral Exclusion Criteria. Subjects must NOT:

1. Have fewer than 6 natural teeth

2. 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).

3. 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.

4. Have any hard or soft tissue lesion requiring further evaluation and/or treatment.

5. Have known allergy to minocycline, tetracyclines, or polyglycolide polymers.