Nonsurgical Periodontal Therapy in CKD: Findings of the Kidney and Periodontal Disease (KAPD) Pilot Randomized Controlled Trial

Vanessa Grubbs, Faviola Garcia, Eric Vittinghoff, Bonnie L Jue, Mark Ryder, David H Lovett, Steven Offenbacher, George Taylor, Peter Ganz, Kirsten Bibbins-Domingo, Neil R Powe, Vanessa Grubbs, Faviola Garcia, Eric Vittinghoff, Bonnie L Jue, Mark Ryder, David H Lovett, Steven Offenbacher, George Taylor, Peter Ganz, Kirsten Bibbins-Domingo, Neil R Powe

Abstract

Rationale & objective: Observational studies have suggested that periodontal disease may be a modifiable risk factor for chronic kidney disease (CKD). The Kidney and Periodontal Disease (KAPD) Study was designed to determine the feasibility of conducting a periodontal disease treatment trial among a high-risk (mostly poor and racial/ethnic minority) population and estimate the magnitude and variability of kidney and inflammatory biomarker levels in response to intensive periodontal treatment.

Study design: Single-center, unmasked, intention-to-treat, randomized, controlled, pilot trial with 2:1 allocation to the treatment and comparison groups.

Setting & participants: English- and Spanish-speaking individuals aged 20 to 75 years receiving primary care within the San Francisco Community Health Network with evidence of both moderate to severe periodontal disease and CKD.

Intervention: Immediate intensive nonsurgical periodontal treatment versus rescue treatment for progressive disease at baseline and 4, 8, and 12 months.

Outcomes: Feasibility and process outcomes. Levels of biomarkers of kidney function, kidney injury, and systemic inflammation obtained at baseline and 4 and 12 months.

Results: KAPD randomly assigned 51 participants to the immediate (34 participants) or rescue (17 participants) groups. 14% dropped out of the study (4 immediate, 3 rescue) and 80% completed all 4 visits of the 12-month protocol (28 immediate, 13 rescue). Fewer than half the teeth recommended for extraction were extracted and 40% of immediate group visits were outside the protocol window. Bleeding on probing and probing depth improved more in the immediate group than in the rescue group; there was no significant separation in periodontal status. Levels of markers of vascular endothelial and systemic injury declined in both groups.

Limitations: No true control group.

Conclusions: This 12-month, pilot, randomized, controlled trial successfully recruited and retained a high-risk population but was less successful observing treatment adherence, treatment effect, and variability of biomarker levels. Although KAPD did not meet all of its goals, important lessons learned can be applied to future studies.

Funding: National Institute of Diabetes and Digestive and Kidney Disease (Bethesda, MD; grant number 1K23DK093710-01A1) and Harold Amos Medical Faculty Development Program of the Robert Wood Johnson Foundation, Princeton, NJ. Funders had no role in study design; collection, analysis, or interpretation of data; writing the report; or the decision to submit the report for publication.

Trial registration: NCT01802216.

Keywords: Chronic kidney disease; non-surgical periodontal disease treatment; periodontal disease; periodontitis.

© 2019 The Authors.

Figures

Graphical abstract
Graphical abstract
Figure 1
Figure 1
Kidney and Periodontal Disease Study design. Reproduced from Grubbs et al with permission from Elsevier.
Figure 2
Figure 2
Kidney and Periodontal Disease Study consort diagram. Abbreviation: eGFR, estimate glomerular filtration rate. *Not considered enrolled until attended baseline visit. **Clinically inappropriate: deceased, n = 143; residential facility, n = 106; active drug/alcohol abuse, n = 101; homeless/no telephone, n = 85; limited life expectancy, n = 80; unstable mental disorder, n = 25; transferred care, n = 20; assaultive behavior, n = 14; edentulous, n = 4; and other unable to participate in study, n = 71.
Figure 3
Figure 3
Change in periodontal status defined by (A) pocket probing depth (PD), (B) attachment loss (AL), or (C) bleeding on probing (BOP) by Kidney and Periodontal Disease (KAPD) Study visit and treatment group. Percent examined sites with (A) pocket PD ≥ 5 mm, (B) AL ≥ 4 mm, and (C) BOP.
Figure 4
Figure 4
Biomarker levels by Kidney and Periodontal Disease (KAPD) Study visit and treatment group show mean and standard deviation for estimated glomerular filtration rate (eGFR) and asymmetrical dimethylarginine (ADMA) values, median and interquartile range for urinary albumin-creatinine ratio (UACR), serum neutrophil gelatinase-associated lipocalin (NGAL), urinary NGAL excretion, and high-sensitivity C-reactive protein (hsCRP) levels.

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Source: PubMed

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