Kidney and Periodontal Disease Study
Condition: Chronic Kidney Disease; Periodontal Disease
MeSH terms: Periodontal Diseases; Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

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.
    

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 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.
    

Intervention name(s): Scaling and root planing; Minocycline
Intervention type(s): Procedure; Drug
Intervention description(s): non-surgical periodontal disease treatment; antibiotic microspheres
Other intervention name(s): Deep cleaning; Subgingival cleaning; Arestin
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic kidney disease progression; periodontal disease; intensive periodontal disease treatment