A Randomized Controlled Trial of Intensive Periodontal Therapy on Metabolic and Inflammatory Markers in Patients With ESRD: Results of an Exploratory Study

Periodontitis is a novel risk factor for inflammation and cardiovascular disease in the dialysis population. Limited information about the impact of periodontal therapy in patients receiving dialysis exists

A Randomized Controlled Trial of Intensive Periodontal Therapy on Metabolic and Inflammatory Markers in Patients With ESRD: Results of an Exploratory Study

BACKGROUND: Periodontitis is a novel risk factor for inflammation and cardiovascular disease in the dialysis population. Limited information about the impact of periodontal therapy in patients receiving dialysis exists. 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 following study completion for control group patients. OUTCOMES: Outcomes were feasibility (screening, recruitment, enrollment, adverse events and study withdrawal/completion), clinical periodontal parameters [probing depth (PD), clinical attachment level, bleeding on probing, gingival index (GI), and plaque index] and serum albumin and interleukin 6 levels at 3 and 6 months postintervention. RESULTS: A total of 342 dialysis patients were approached for participation: 53 were randomized, with 26 participants assigned to immediate treatment and 27 to a control arm for treatment after 6 months. 51 patients completed baseline appointments; 46 were available for 3 month follow up and 45 were available for 6 month follow up examinations. 43 participants 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 PD (p=0.008), extent PD ≥ 4 mm (p=0.02), and extent GI ≥1 (p=0.01). By 6 months, however, the difference between groups was no longer present for any variable except PD ≥ 4 mm (p=0.04). There was no significant difference between the groups for serum albumin or high-sensitivity interleukin 6 at any time point, 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