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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| Danish Council for Independent Research - Medical Sciences | UNKNOWN |
| The Danish Dental Association | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive oral care & didactic training | Experimental | 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. |
|
| Standard oral care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive oral care & didactic training | Other | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Dental caries | Clinical registration of dental caries | Baseline examination (before oral care intervention), 3-months follow-up examination |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siri B Jensen, DDS, PhD | University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Odontology, Faculty of Health Sciences, University of Copenhagen | Copenhagen | DK-2200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18701615 | Background | 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. | |
| 9438096 | Background | 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. |
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| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| 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 |
| Background | Thorman R. Oral health in patients with chronic kidney disease. Stockholm, Sweden: Karolinska Institutet; 2009 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |