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Treatment for Periodontal Disease in Dialysis Patients (KPU)

This study has been completed.
Sponsor:
Collaborator:
OraPharma
Information provided by (Responsible Party):
Michael Stella, DDS, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00937976
First received: July 9, 2009
Last updated: May 4, 2012
Last verified: May 2012

July 9, 2009
May 4, 2012
August 2008
June 2010   (final data collection date for primary outcome measure)
Serum Albumin, IL-6, CRP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00937976 on ClinicalTrials.gov Archive Site
HbA1c, periodontal probing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment for Periodontal Disease in Dialysis Patients
Impact of Periodontal Therapy on Metabolic and Inflammatory Markers in Chronic Kidney Disease Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Periodontal Disease
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.
  • Control-delayed periodontal therapy
    Intervention: Procedure: Periodontal Scaling and Root Planing
  • Intensive Periodontal Therapy
    Intervention: Procedure: Periodontal Scaling and Root Planing
Wehmeyer MM, Kshirsagar AV, Barros SP, Beck JD, Moss KL, Preisser JS, Offenbacher S. A randomized controlled trial of intensive periodontal therapy on metabolic and inflammatory markers in patients With ESRD: results of an exploratory study. Am J Kidney Dis. 2013 Mar;61(3):450-8. doi: 10.1053/j.ajkd.2012.10.021. Epub 2012 Dec 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Presence of 12 or more teeth
  • Presence of moderate to severe periodontal disease (2 or more teeth with at least 6 mm Clinical Attachment Loss and at least 1 site with Probing Depth > 5 mm)
  • Receiving dialysis for at least 3 months
  • English speaking
  • Ability and willingness to give written informed consent for participation in the study
  • Age 18 to 80 years
  • Twelve or more teeth

Exclusion Criteria:

  • Any severe co-morbid conditions likely to affect life expectancy within 1 year (for example, metastatic cancer)
  • Any condition that would, in the judgement of the clinician, be a contraindication to dental treatment
  • Dementia
  • Pregnancy or lactation
  • Inability to take oral medications
  • Allergy or intolerance to minocycline, tetracyclines or polygycolate polymers
  • Allergy to both penicillin and clindamycin
  • Severe dental caries, pulpal or mucosal disease that would interfere with periodontal therapy
  • Inability or unwillingness to follow the study protocol
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00937976
KPU082008
No
Michael Stella, DDS, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
OraPharma
Principal Investigator: Steven Offenbacher, DDS, PhD UNC Chapel Hill
University of North Carolina, Chapel Hill
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP