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A randomized controlled trial of intensive periodontal therapy on metabolic and inflammatory markers in patients With ESRD: results of an exploratory study.

ABSTRACT: Periodontitis is a novel risk factor for inflammation and cardiovascular disease in the dialysis population. Limited information exists about the impact of periodontal therapy in patients receiving dialysis.Randomized controlled trial to assess feasibility and gather preliminary data.Dialysis patients with moderate/severe chronic periodontitis.Intensive treatment, consisting of scaling and root planing, extraction of hopeless teeth, and placement of local-delivery antibiotics, was performed at the baseline visit for treatment-group patients and after study completion for control-group patients.Outcomes were feasibility (screening, recruitment, enrollment, adverse events, and study withdrawal/completion), clinical periodontal parameters (probing depth, clinical attachment level, bleeding on probing, gingival index, and plaque index), and serum albumin and interleukin 6 levels at 3 and 6 months postintervention.342 dialysis patients were approached for participation: 53 were randomly assigned, with 26 participants assigned to immediate treatment and 27 assigned to a control arm for treatment after 6 months. 51 patients completed baseline appointments; 46 were available for 3-month follow-up, 45 were available for 6-month follow-up examinations, and 43 completed all visits. At 3 months, there was a statistically significant improvement for the treatment group compared to the control group for 3 periodontal parameters: mean probing depth (P = 0.008), extent of probing depth ?4 mm (P = 0.02), and extent of gingival index ?1 (P = 0.01). However, by 6 months, the difference between groups was no longer present for any variable except probing depth ?4 mm (P = 0.04). There was no significant difference between groups for serum albumin or high-sensitivity interleukin 6 level at any time when adjusted for body mass index, diabetic status, and plaque index.Small sample size and relatively healthy population, imbalance in diabetes.This small trial demonstrates successful cooperation between dentists and nephrologists and successful recruitment, treatment, and retention of dialysis patients with periodontitis. Larger studies with longer follow-up are needed to determine whether treatment can improve markers of inflammation and morbidity.

SUBMITTER: Wehmeyer MM

PROVIDER: S-EPMC3578050 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature

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A randomized controlled trial of intensive periodontal therapy on metabolic and inflammatory markers in patients With ESRD: results of an exploratory study.

Wehmeyer Meggan M H MM Kshirsagar Abhijit V AV Barros Silvana P SP Beck James D JD Moss Kevin L KL Preisser John S JS Offenbacher Steven S

American journal of kidney diseases : the official journal of the National Kidney Foundation 20121220 3

<h4>Background</h4>Periodontitis is a novel risk factor for inflammation and cardiovascular disease in the dialysis population. Limited information exists about the impact of periodontal therapy in patients receiving dialysis.<h4>Study design</h4>Randomized controlled trial to assess feasibility and gather preliminary data.<h4>Setting & participants</h4>Dialysis patients with moderate/severe chronic periodontitis.<h4>Intervention</h4>Intensive treatment, consisting of scaling and root planing, e ...[more]

PMID: 23261122

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Project description:Rationale & objectiveObservational 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 designSingle-center, unmasked, intention-to-treat, randomized, controlled, pilot trial with 2:1 allocation to the treatment and comparison groups.Setting & participantsEnglish- 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.InterventionImmediate intensive nonsurgical periodontal treatment versus rescue treatment for progressive disease at baseline and 4, 8, and 12 months.OutcomesFeasibility and process outcomes. Levels of biomarkers of kidney function, kidney injury, and systemic inflammation obtained at baseline and 4 and 12 months.ResultsKAPD 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.LimitationsNo true control group.ConclusionsThis 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.FundingNational 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 registrationNCT01802216.

Project description:BackgroundInflammation is a common feature in patients with type 2 diabetes mellitus (T2DM). This meta-analysis aimed to assess the influence of thiazolidinedione (TZD) therapy on the circulating levels of inflammatory markers in patients with T2DM.Methods and resultsWe searched the databases Medline, Embase, ScienceDirect, Web of Science, SpringerLink, and the Cochrane Library for randomized controlled trials (RCTs) that examined the effects of thiazolidinedione vs. a placebo on patients with T2DM. The main outcomes were absolute changes in levels of circulating inflammatory markers. Twenty-seven RCTs were included and data were analyzed using a fixed-effect model or a random-effect model based on heterogeneity. Pooled results indicated that circulating levels of high-sensitivity C reactive protein (hsCRP; SMD = -0.65, 95% CI = -0.98 to -0.32, p < 0.01), monocyte chemoattractant protein-1 (MCP-1; WMD = -54.19, 95% CI = -73.86 to -34.52, p < 0.01), von Willebrand factor% (vWF%; WMD = -8.18, 95% CI = -13.54 to -2.81, p 0.01), fibrinogen (SMD = -0.26, 95% CI = -0.41 to -0.11, p < 0.01) and E-selectin(WMD = -3.57, 95% CI = -5.59 to -1.54, p <0.01) were significantly decreased after TZD therapy. However, interleukin-6 (IL-6), matrix metalloproteinase-9 (MMP-9), soluble CD40 ligand, plasminogen activator inhibitor 1 (PAI-1) and intercellular adhesion molecule (ICAM-1) were not significantly affected. Subgroup analyses of PAI-1, vWF% and fibrinogen in terms of trial drugs showed significant reductions for rosiglitazone (all p valuses< 0.05), but not pioglitazone treatment. Conversely, the E-selectin (p < 0.01) lowering effect only existed in the pioglitazone group. Further, rosiglitazone and pioglitazone treatment reduced serum hsCRP and MCP-1 but had no marked effects on MMP-9, IL-6 and ICAM-1.ConclusionsLimited evidence suggested that TZD therapy had anti-inflammatory property that might contribute to its beneficial effect on inflammatory state in patients with type 2 diabetes.

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A randomized controlled trial of intensive periodontal therapy on metabolic and inflammatory markers in patients With ESRD: results of an exploratory study.

Publications

A randomized controlled trial of intensive periodontal therapy on metabolic and inflammatory markers in patients With ESRD: results of an exploratory study.

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