Interventional Study Targeting Oral Infections in Patients With Chronic Kidney Disease

Aim:

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.

Inclusion criteria

• Patients on a kidney transplant waiting list or patients who have had a kidney transplant (1-1½ year previously)
• Dentate patients (>10 teeth)
• Age >18 years
• Danish language

Exclusion criteria

• Patients not capable of following the research protocol
• Legally unavailable
• Need of antibiotic prophylaxis with dental treatment
• Heart valve surgery