Interventional Study Targeting Oral Infections in Patients With Chronic Kidney Disease
- Conditions
- Mouth DiseasesRenal Insufficiency, Chronic
- Interventions
- Other: Intensive oral care & didactic training
- Registration Number
- NCT02357199
- Lead Sponsor
- University of Copenhagen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
- 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
- Patients not capable of following the research protocol
- Legally unavailable
- Need of antibiotic prophylaxis with dental treatment
- Heart valve surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intensive oral care & didactic training 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.
- Primary Outcome Measures
Name Time Method C-reactive protein, plasma Change from baseline examination (before oral care intervention) at 3-months follow-up examination Blood sample
Gingival inflammation Change from baseline examination (before oral care intervention) at 3-months follow-up examination Gingival inflammation measured by gingivitis index
- Secondary Outcome Measures
Name Time Method Periodontal disease Change from baseline examination (before oral care intervention) at 3-months follow-up examination Measurement of attachment level
Saliva composition: Sodium Change from baseline examination (before oral care intervention) at 3-months follow-up examination Sialochemistry
Saliva composition: Chloride Change from baseline examination (before oral care intervention) at 3-months follow-up examination Sialochemistry
Saliva composition: Potassium Change from baseline examination (before oral care intervention) at 3-months follow-up examination Sialochemistry
Whole saliva flow rate, stimulated Change from baseline examination (before oral care intervention) at 3-months follow-up examination Sialometry
Saliva composition: Amylase activity Change from baseline examination (before oral care intervention) at 3-months follow-up examination Sialochemistry
Whole saliva flow rate, unstimulated Change from baseline examination (before oral care intervention) at 3-months follow-up examination Sialometry
Dental bacterial plaque Change from baseline examination (before oral care intervention) at 3-months follow-up examination Measured by plaque index
Saliva composition: Inorganic phosphate Change from baseline examination (before oral care intervention) at 3-months follow-up examination Sialochemistry
Saliva composition: Total protein Change from baseline examination (before oral care intervention) at 3-months follow-up examination Sialochemistry
Hematologic status: Transferrin Change from baseline examination (before oral care intervention) at 3-months follow-up examination Blood sample
Renal function: Carbamide Change from baseline examination (before oral care intervention) at 3-months follow-up examination Blood sample
Saliva composition: Total calcium Change from baseline examination (before oral care intervention) at 3-months follow-up examination Sialochemistry
Saliva composition: Albumin Change from baseline examination (before oral care intervention) at 3-months follow-up examination Sialochemistry
Oral candidiasis Change from baseline examination (before oral care intervention) at 3-months follow-up examination Smear test
Hematologic status: Hemoglobin Change from baseline examination (before oral care intervention) at 3-months follow-up examination Blood sample
Hematologic status: Leukocytes Change from baseline examination (before oral care intervention) at 3-months follow-up examination Blood sample
Renal function: Bicarbonate Change from baseline examination (before oral care intervention) at 3-months follow-up examination Blood sample
Renal function: Creatinine Change from baseline examination (before oral care intervention) at 3-months follow-up examination Blood sample
Renal function: Albumin Change from baseline examination (before oral care intervention) at 3-months follow-up examination Blood sample
Oral Health Impact Profile Change from baseline examination (before oral care intervention) at 3-months follow-up examination Quality of life questionnaire
Saliva composition: Secretory IgA Change from baseline examination (before oral care intervention) at 3-months follow-up examination Sialochemistry
Phosphate metabolism Change from baseline examination (before oral care intervention) at 3-months follow-up examination Blood sample
Hematologic status: Erythrocytes Change from baseline examination (before oral care intervention) at 3-months follow-up examination Blood sample
Hematologic status: Thrombocytes Change from baseline examination (before oral care intervention) at 3-months follow-up examination Blood sample
Hematologic status: Iron Change from baseline examination (before oral care intervention) at 3-months follow-up examination Blood sample
Calcium metabolism Change from baseline examination (before oral care intervention) at 3-months follow-up examination Blood sample
Renal function: Potassium Change from baseline examination (before oral care intervention) at 3-months follow-up examination Blood sample
Renal function: Sodium Change from baseline examination (before oral care intervention) at 3-months follow-up examination Blood sample
Medical Outcomes Study Short Version Change from baseline examination (before oral care intervention) at 3-months follow-up examination Quality of life questionnaire
Trial Locations
- Locations (1)
Department of Odontology, Faculty of Health Sciences, University of Copenhagen
🇩🇰Copenhagen, Denmark