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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02357199
Other study ID # 102-2084/14-3000
Secondary ID
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


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
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