Interventional Study Targeting Oral Infections in Patients With Chronic Kidney Disease
NCT ID: NCT02357199
Last Updated: 2015-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
93 participants
INTERVENTIONAL
2015-01-31
2015-08-31
Brief Summary
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Detailed Description
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The aim is to examine if a focused oral care procedure to reduce oral infection will be mirrored in reduction of systemic inflammatory parameters in chronic renal disease patients.
Specific research questions:
Can oral infection and systemic inflammatory parameters in chronic renal disease patients be reduced by 1 month of professional oral care and individual prophylactic instruction and can a potential reduction of inflammation be continuously achieved at a 3 months follow-up.
Study design:
Randomized, double-blinded (investigator, outcomes assessor), controlled study. For Eligibility Criteria and Outcome Measures, please see elsewhere in the ClinicalTrials.gov Protocol Registration System.
Participants:
A: Hemodialysis patients, inclusion n=34, B: Hemodialysis patients on a kidney transplant waiting list, inclusion n=34, C: Patients who have had a kidney transplant (1-1½ years after transplantation), inclusion n=34. D: Gender- and age-matched healthy control group.
Number of included patients is estimated from a hypothesis-generating pilot study, a statistical power analysis and the estimated loss to follow-up based on experience from previous research projects in the Nephrology Department.
Intervention and control:
The intervention consists of professional oral care (addressing periodontal and oral mucosal infections, salivary gland dysfunction and caries prevention) and a didactic approach to individual instruction in oral hygiene/prophylactic measures performed by a dental hygienist at three visits: baseline, 2 weeks after baseline and 1 month after baseline.
The research data will be registered by a blinded investigator before the first visit at the dental hygienist and after 3 months.
The control group will follow best-clinical-practice procedures currently implemented in the hospital.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Intensive oral care & didactic training
Professional (dental hygienist) intensive oral care intervention and individual patient training/didactic instruction to promote patient compliance and patient capability of oral preventive measures in a long-term perspective.
Intensive oral care & didactic training
Professional (dental hygienist) intensive oral care intervention and individual patient training/didactic instruction to promote patient compliance and patient capability of oral preventive measures in a long-term perspective.
Standard oral care
Standard oral care protocol consisting of referral by staff in the Department of Nephrology to general dental practitioner followed by patient self-administration of tooth brushing, fluoride toothpaste and oral lubricants.
No interventions assigned to this group
Interventions
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Intensive oral care & didactic training
Professional (dental hygienist) intensive oral care intervention and individual patient training/didactic instruction to promote patient compliance and patient capability of oral preventive measures in a long-term perspective.
Eligibility Criteria
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Inclusion Criteria
* Dentate patients (\>10 teeth)
* Age \>18 years
* Danish language
Exclusion Criteria
* Legally unavailable
* Need of antibiotic prophylaxis with dental treatment
* Heart valve surgery
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Danish Council for Independent Research - Medical Sciences
UNKNOWN
The Danish Dental Association
UNKNOWN
University of Copenhagen
OTHER
Responsible Party
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Siri Beier Jensen
Associate Professor, DDS, PhD
Principal Investigators
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Siri B Jensen, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen
Locations
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Department of Odontology, Faculty of Health Sciences, University of Copenhagen
Copenhagen, , Denmark
Countries
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References
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Kato S, Chmielewski M, Honda H, Pecoits-Filho R, Matsuo S, Yuzawa Y, Tranaeus A, Stenvinkel P, Lindholm B. Aspects of immune dysfunction in end-stage renal disease. Clin J Am Soc Nephrol. 2008 Sep;3(5):1526-33. doi: 10.2215/CJN.00950208. Epub 2008 Aug 13.
McIntyre C, Harper I, Macdougall IC, Raine AE, Williams A, Baker LR. Serum C-reactive protein as a marker for infection and inflammation in regular dialysis patients. Clin Nephrol. 1997 Dec;48(6):371-4.
Thorman R. Oral health in patients with chronic kidney disease. Stockholm, Sweden: Karolinska Institutet; 2009
Other Identifiers
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102-2084/14-3000
Identifier Type: -
Identifier Source: org_study_id