Clinical trial NCT02357199: Interventional Study Targeting Oral Infections in Patients With Chronic Kidney Disease
Official title: Interventional Study Targeting Oral Infections in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mouth Diseases
Renal Insufficiency, Chronic
Keywords: Mouth Diseases
Renal Insufficiency, Chronic
Intervention Studies
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Danish Council for Independent Research - Medical Sciences
name: The Danish Dental Association
First posted: 2015-02-06
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gingival inflammation
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: C-reactive protein, plasma
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Secondary outcomes:
measure: Dental bacterial plaque
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Periodontal disease
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Whole saliva flow rate, unstimulated
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Whole saliva flow rate, stimulated
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Saliva composition: Sodium
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Saliva composition: Chloride
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Saliva composition: Potassium
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Saliva composition: Total calcium
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Saliva composition: Inorganic phosphate
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Saliva composition: Total protein
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Saliva composition: Albumin
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Saliva composition: Amylase activity
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Saliva composition: Secretory IgA
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Oral candidiasis
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Hematologic status: Erythrocytes
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Hematologic status: Hemoglobin
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Hematologic status: Leukocytes
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Hematologic status: Thrombocytes
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Hematologic status: Transferrin
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Hematologic status: Iron
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Calcium metabolism
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Phosphate metabolism
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Renal function: Carbamide
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Renal function: Bicarbonate
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Renal function: Creatinine
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Renal function: Albumin
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Renal function: Potassium
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Renal function: Sodium
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Oral Health Impact Profile
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
measure: Medical Outcomes Study Short Version
timeFrame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Other outcomes:
measure: Dental caries
timeFrame: Baseline examination (before oral care intervention), 3-months follow-up examination
Locations:
city: Copenhagen
country: Denmark
facility: Department of Odontology, Faculty of Health Sciences, University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Siri B Jensen, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Thorman R. Oral health in patients with chronic kidney disease. Stockholm, Sweden: Karolinska Institutet; 2009