Status:
COMPLETED
Treatment for Periodontal Disease in Dialysis Patients
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
OraPharma
Conditions:
Periodontal Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
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 resul...
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 de...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00937976
Start Date
August 1 2008
End Date
June 1 2010
Last Update
May 7 2012
Active Locations (1)
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1
GO Health Center, School of Dentistry, University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States, 27599