Interventional Study Targeting Oral Infections in Patients With Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Interventional Study Targeting Oral Infections in Patients With Chronic Kidney Disease

Conditions
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Mouth Diseases, Renal Insufficiency, Chronic

Intervention / Treatment
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* Other: Intensive oral care & didactic training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive oral care & didactic training<br>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<br>* 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.<br>|
| No Intervention: Standard oral care<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Insufficiency, Chronic, Mouth Diseases, Intervention Studies