KPU: Treatment for Periodontal Disease in Dialysis Patients

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT00937976

Collaborator

OraPharma (Industry)

Enrollment

Location

Arms

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Periodontal Disease	Procedure: Periodontal Scaling and Root Planing	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: Control-delayed periodontal therapy	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.
Other: Intensive Periodontal Therapy	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.

Arm

Intervention/Treatment

Other: Control-delayed periodontal therapy

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.

Other: Intensive Periodontal Therapy

Procedure: Periodontal Scaling and Root Planing

Outcome Measures

Primary Outcome Measures

Serum Albumin, IL-6, CRP [6 months]

Secondary Outcome Measures

HbA1c, periodontal probing [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GO Health Center, School of Dentistry, University of North Carolina-Chapel Hill	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

University of North Carolina, Chapel Hill
OraPharma

Investigators

Principal Investigator: Steven Offenbacher, DDS, PhD, UNC Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Stella, DDS, DDS, University of North Carolina, Chapel Hill

ClinicalTrials.gov Identifier:

NCT00937976

Other Study ID Numbers:

KPU082008

First Posted:

Jul 13, 2009

Last Update Posted:

May 7, 2012

Last Verified:

May 1, 2012

Keywords provided by Michael Stella, DDS, DDS, University of North Carolina, Chapel Hill

Hemodialysis and peritoneal dialysis

Additional relevant MeSH terms:

Periodontal Diseases

Study Results

No Results Posted as of May 7, 2012