Treatment for Periodontal Disease in Dialysis Patients
Condition: Periodontal Disease
MeSH terms: Periodontal Diseases
Study type: Interventional

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      independent of traditional risk factors (unpublished data).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.
    

Intervention name(s): Periodontal Scaling and Root Planing
Intervention type(s): Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemodialysis and peritoneal dialysis