Kidney and Periodontal Disease Study

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 feasibility of conducting this trial among an underserved (mostly poor
and low literacy) population and to determine the variability of renal and inflammatory
biomarkers in response to intensive periodontal therapy over a 12 month period among
participants with both chronic kidney disease (CKD) and significant periodontal disease.

Randomization will be restricted with respect to diabetes (a strong risk factor for
causing/aggravating both CKD and periodontal disease) to prevent an imbalance between the
two arms. The investigators will recruit 51 patients from the San Francisco General Hospital
(SFGH) Renal Clinic. Participants will be assigned 2:1 to the intervention group for the
intensive periodontal treatment protocol (n=34) or to the control/delayed treatment group
for rescue periodontal treatment only with intensive treatment at the end of the study
(n=17).

Hypothesis:

A large scale randomized controlled trial of intensive periodontal treatment among the
underserved will be feasible (with respect to enrollment, randomization, adherence and
variability in clinical outcomes).

Specific Aims:

1. To assess the feasibility of recruiting patients to this pilot trial.

2. To determine the variability of kidney biomarkers in response to periodontal disease
treatment.

Statistical Analysis:

The investigators will calculate descriptive statistics (mean, standard deviation) of each
clinical outcome which will include a traditional marker of kidney function (serum
creatinine), markers of kidney structure [as glomerular injury (albuminuria) and tubular
injury (neutrophil gelatinase-associated lipocalin (NGAL))]; a marker of vascular
endothelial injury (asymmetrical dimethylarginine (ADMA)); and markers of systemic
inflammation (IL-6 and C-reactive protein) measured at baseline, study month 4, and study
month 12. The investigators will use repeated-measures generalized estimating equations
(GEE) to compare changes in clinical outcomes over time within each treatment group and to
compare differences between treatment groups taking individual change over time into
account.

Sample Size Calculation:

This is a pilot study. To the investigators' knowledge, there are no existing data of the
anticipated effect size of periodontal treatment to inform sample size calculations.
However, because a primary aim is to determine the variability of various renal and
inflammatory biomarkers, the investigators seek to enroll at least 30 subjects in the
intervention arm of the trial.

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.