Interventional Study Targeting Oral Infections in Patients With Chronic Kidney Disease

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.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency, Chronic; Mouth Diseases
• Intervention / Treatment: Other: Intensive oral care & didactic training

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, DK-2200
    • Department of Odontology, Faculty of Health Sciences, University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival inflammation	Gingival inflammation measured by gingivitis index	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
C-reactive protein, plasma	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental bacterial plaque	Measured by plaque index	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Periodontal disease	Measurement of attachment level	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Whole saliva flow rate, unstimulated	Sialometry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Whole saliva flow rate, stimulated	Sialometry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Sodium	Sialochemistry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Chloride	Sialochemistry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Potassium	Sialochemistry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Total calcium	Sialochemistry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Inorganic phosphate	Sialochemistry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Total protein	Sialochemistry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Albumin	Sialochemistry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Amylase activity	Sialochemistry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Secretory IgA	Sialochemistry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Oral candidiasis	Smear test	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Hematologic status: Erythrocytes	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Hematologic status: Hemoglobin	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Hematologic status: Leukocytes	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Hematologic status: Thrombocytes	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Hematologic status: Transferrin	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Hematologic status: Iron	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Calcium metabolism	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Phosphate metabolism	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Renal function: Carbamide	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Renal function: Bicarbonate	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Renal function: Creatinine	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Renal function: Albumin	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Renal function: Potassium	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Renal function: Sodium	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Oral Health Impact Profile	Quality of life questionnaire	Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Medical Outcomes Study Short Version	Quality of life questionnaire	Change from baseline examination (before oral care intervention) at 3-months follow-up examination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental caries	Clinical registration of dental caries	Baseline examination (before oral care intervention), 3-months follow-up examination

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Rigshospitalet, Denmark; Danish Council for Independent Research - Medical Sciences; The Danish Dental Association
• Investigators: Principal Investigator: Siri B Jensen, DDS, PhD, University of Copenhagen

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: January 28, 2015
• First Submitted That Met QC Criteria: February 2, 2015
• First Posted (Estimate): February 6, 2015

Study Record Updates

• Last Update Posted (Estimate): August 31, 2015
• Last Update Submitted That Met QC Criteria: August 28, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Intervention Studies; Renal Insufficiency, Chronic; Mouth Diseases
• Additional Relevant MeSH Terms: Urologic Diseases; Stomatognathic Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Mouth Diseases
• Other Study ID Numbers: 102-2084/14-3000