Clinical Trial: Kidney and Periodontal Disease Study

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Kidney and Periodontal Disease Study

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 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 Summary:

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 de
Sponsor: University of California, San Francisco

Current Primary Outcome: Number of participants completing study protocol [ Time Frame: conclusion of study (month 12) ]

The investigators will determine the number of participants who complete baseline, month 4, month 8, and month 12 study visits.


Original Primary Outcome:

  • Number of participants completing study protocol [ Time Frame: conclusion of study (month 12) ]
    The investigators will determine the number of participants who complete baseline, month 4, month 8, and month 12 study visits.
  • serum creatinine [ Time Frame: baseline ]
    The investigators will measure serum creatinine as a traditional biomarker of kidney function.
  • change in serum creatinine [ Time Frame: baseline and study month 4 ]
    The investigators will measure change in serum creatinine (a traditional biomarker of kidney function) from baseline to study month 4.
  • change in serum creatinine [ Time Frame: study month 4 and 12 ]
    The investigators will measure change serum creatinine (a traditional biomarker of kidney function) from study month 4 to 12.
  • albuminuria [ Time Frame: baseline ]
    The investigators will measure urine albumin to creatinine ratio as a marker of glomerular injury.
  • change in albuminuria [ Time Frame: baseline and study month 4 ]
    The investigators will measure change in urine albumin to creatinine ratio (a marker of glomerular injury) from baseline to study month 4.
  • change in albuminuria [ Time Frame: study month 4 and 12 ]
    The investigators will measure change in urine albumin to creatinine ratio (a marke

    Current Secondary Outcome: Change in estimated glomerular filtration rate [ Time Frame: baseline to 12 month ]

    Using the creatinine-based CKD-EPI equation, the investigators will determine change in estimated glomerular filtration rate from baseline to 12 month by individual and treatment group


    Original Secondary Outcome:

    • serum IL-6 [ Time Frame: baseline ]
      The investigators will measure serum IL-6 as a biomarker of systemic inflammation.
    • change in serum IL-6 [ Time Frame: baseline and study month 4 ]
      The investigators will measure change in serum IL-6 (a biomarker of systemic inflammation) from baseline to study month 4.
    • change in serum IL-6 [ Time Frame: study month 4 and 12 ]
      The investigators will measure change in serum IL-6 (a biomarker of systemic inflammation) from study month 4 to 12.
    • serum hsCRP [ Time Frame: baseline ]
      The investigators will measure serum highly sensitive C-reactive protein (hsCRP) as a biomarker of systemic inflammation.
    • change in serum hsCRP [ Time Frame: baseline and study month 4 ]
      The investigators will measure change in serum highly sensitive C-reactive protein (hsCRP) (a biomarker of systemic inflammation) from baseline to study month 4.
    • change in serum hsCRP [ Time Frame: study month 4 and 12 ]
      The investigators will measure change in serum highly sensitive C-reactive protein (hsCRP) (a biomarker of systemic inflammation) from study month 4 to 12.


    Information By: University of California, San Francisco

    Dates:
    Date Received: February 15, 2013
    Date Started: February 2014
    Date Completion: September 2017
    Last Updated: October 25, 2016
    Last Verified: October 2016