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

Abstract

Background: 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.

Study design: Randomized controlled trial to assess feasibility and gather preliminary data.

Setting & participants: Dialysis patients with moderate/severe chronic periodontitis.

Intervention: 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: 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.

Results: 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.

Limitations: Small sample size and relatively healthy population, imbalance in diabetes.

Conclusions: 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.

Trial registration: ClinicalTrials.gov NCT00937976.

Copyright © 2013 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1

CONSORT Study Flow Diagram

Figure 2

Status of Screened Subjects and Reasons for Ineligibility (n=262). PD, probing depth.

Figure 3

Mean (SE) Clinical Measures for Each Time Point by Treatment Group(PD= probing depth, BOP= bleeding on probing, PI= plaque index, GI= gingival index, CAL= clinical attachment level) *significant at p≤0.05