NCT00937976

Treatment for Periodontal Disease in Dialysis Patients

Impact of Periodontal Therapy on Metabolic and Inflammatory Markers in Chronic Kidney Disease Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to test the hypothesis that periodontal intervention in dialysis patients who have both periodontal disease and a historically high burden of cardiovascular disease will result in a reduction of inflammatory markers and improvement markers of nutrition health like albumin. Patients will be randomized to one of two treatment arms: intensive periodontal therapy or control-delayed periodontal therapy. Eligible patients will have 5 study visits over 7 to 12 months.

Detailed description

The burden of cardiovascular disease (CVD) is well known to those taking care of patients with chronic kidney disease (CKD). Myocardial infarction, sudden death, or stroke, remain leading causes of death and disability, especially for those patients receiving dialysis therapy (Foley 2003). Traditional risk factors (Wilson, D'Agostino et al. 1998) only partially explain the burden of CVD (Longenecker, Coresh et al. 2002). Our research team has been studying the potential role of periodontal disease in explaining the excess burden of CVD in the CKD population. Periodontitis is an inflammatory disease caused by an infection of predominately gram negative organisms (Pihlstrom, Michalowicz et al. 2005) and has been well-studied in other populations as a CVD risk factor (DeStefano, Anda et al. 1993; Mattila, Valtonen et al. 1995; Beck, Garcia et al. 1996; Joshipura, Rimm et al. 1996; Morrison, Ellison et al. 1999; Hujoel, Drangsholt et al. 2000; Wu, Trevisan et al. 2000; Howell, Ridker et al. 2001; Hujoel, Drangsholt et al. 2001; Hung, Willett et al. 2003; Joshipura, Hung et al. 2003; Tuominen, Reunanen et al. 2003; Hung, Joshipura et al. 2004; Pussinen, Alfthan et al. 2004; Pussinen, Nyyssonen et al. 2005; Saremi, Nelson et al. 2005). It has also been demonstrated to accelerate preclinical and clinical atherosclerosis (Loesche, Schork et al. 1998; Arbes, Slade et al. 1999; Genco 1999). In an observational cohort of 168 patients receiving maintenance hemodialysis followed for 18 months, severe and moderate periodontitis was strongly associated with death of cardiovascular causes independent of traditional risk factors (unpublished data). A very high prevalence of periodontal disease in patients with various stages of CKD has been observed. In this population, periodontal disease was associated with a low serum albumin and malnutrition (Kshirsagar, Craig et al. 2007). We present a randomized interventional small exploratory study to assess study feasibility and to determine whether the treatment of periodontal disease in maintenance dialysis patients reduces markers of inflammation and improves markers of nutrition. The existent data support an intervention trial, rather than additional observational studies. There are a multitude of epidemiological studies, including our studies, which confirm an association of periodontal disease and cardiovascular disease (DeStefano, Anda et al. 1993; Mattila, Valtonen et al. 1995; Beck, Garcia et al. 1996; Joshipura, Rimm et al. 1996; Morrison, Ellison et al. 1999; Hujoel, Drangsholt et al. 2000; Wu, Trevisan et al. 2000; Howell, Ridker et al. 2001; Hujoel, Drangsholt et al. 2001; Hung, Willett et al. 2003; Joshipura, Hung et al. 2003; Tuominen, Reunanen et al. 2003; Hung, Joshipura et al. 2004; Pussinen, Alfthan et al. 2004; Pussinen, Nyyssonen et al. 2005; Saremi, Nelson et al. 2005). Thus, the time is right for conducting a hypothesis-driven intervention trial.

Conditions

• Periodontal Disease

Interventions

Type	Name	Description
PROCEDURE	Periodontal Scaling and Root Planing	Participants will take antibiotics prior to dental treatment. Periodontal treatment or a deep cleaning (with local anesthesia or numbing) will be performed to remove plaque and tartar around the teeth and gums. A small amount of antibiotics (minocycline) will be placed around the gums to help fight bacteria and inflammation.

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2009-07-13
• Last updated: 2012-05-07

Locations

1 site across 1 country: United States