Interventional Study Targeting Oral Infections in Patients With Chronic Kidney Disease

Renal Insufficiency, Chronic Clinical Trial

Official title:

Interventional Study Targeting Oral Infections in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02357199
• Other study ID #: 102-2084/14-3000
• Status: Completed
• Phase: N/A
• First received: January 28, 2015
• Last updated: August 28, 2015
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Diseases
• Mouth Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Odontology, Faculty of Health Sciences, University of Copenhagen	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
University of Copenhagen	Danish Council for Independent Research - Medical Sciences, Rigshospitalet, Denmark, The Danish Dental Association

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. Review. — View 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. — View Citation

Thorman R. Oral health in patients with chronic kidney disease. Stockholm, Sweden: Karolinska Institutet; 2009

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dental caries	Clinical registration of dental caries	Baseline examination (before oral care intervention), 3-months follow-up examination	No
Primary	Gingival inflammation	Gingival inflammation measured by gingivitis index	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Primary	C-reactive protein, plasma	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Dental bacterial plaque	Measured by plaque index	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Periodontal disease	Measurement of attachment level	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Whole saliva flow rate, unstimulated	Sialometry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Whole saliva flow rate, stimulated	Sialometry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Saliva composition: Sodium	Sialochemistry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Saliva composition: Chloride	Sialochemistry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Saliva composition: Potassium	Sialochemistry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Saliva composition: Total calcium	Sialochemistry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Saliva composition: Inorganic phosphate	Sialochemistry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Saliva composition: Total protein	Sialochemistry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Saliva composition: Albumin	Sialochemistry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Saliva composition: Amylase activity	Sialochemistry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Saliva composition: Secretory IgA	Sialochemistry	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Oral candidiasis	Smear test	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Hematologic status: Erythrocytes	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Hematologic status: Hemoglobin	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Hematologic status: Leukocytes	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Hematologic status: Thrombocytes	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Hematologic status: Transferrin	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Hematologic status: Iron	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Calcium metabolism	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Phosphate metabolism	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Renal function: Carbamide	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Renal function: Bicarbonate	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Renal function: Creatinine	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Renal function: Albumin	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Renal function: Potassium	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Renal function: Sodium	Blood sample	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Oral Health Impact Profile	Quality of life questionnaire	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No
Secondary	Medical Outcomes Study Short Version	Quality of life questionnaire	Change from baseline examination (before oral care intervention) at 3-months follow-up examination	No