Interventional Study Targeting Oral Infections in Patients With Chronic Kidney Disease

University of Copenhagen

Status: Completed

Conditions: Mouth Diseases; Renal Insufficiency, Chronic

Treatments: Other: Intensive oral care & didactic training

Study type: Interventional

Funder types: Other

Identifiers

NCT02357199

102-2084/14-3000

Details and patient eligibility

About

This study aims to investigate the prevalence of oral infection in chronic renal disease patients and to examine whether a focused oral hygiene intervention can reduce oral infection leading to reduced systemic inflammatory parameters in chronic renal disease patients in hemodialysis, chronic renal disease patients waiting for kidney transplantation, and chronic renal disease patients who has been transplanted 1-1½ year previously. The results will be compared to a gender- and age-matched healthy control group.

Full description

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.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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93 participants in 2 patient groups

Intensive oral care & didactic training

Experimental group

Description:

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.

Treatment:

Other: Intensive oral care & didactic training

Standard oral care

No Intervention group

Description:

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.