Mouth Diseases, Renal Insufficiency, Chronic
Conditions
Keywords
Mouth Diseases, Renal Insufficiency, Chronic, Intervention Studies
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.
Interventions
OTHERIntensive 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.
Sponsors
Rigshospitalet, Denmark
Danish Council for Independent Research - Medical Sciences
The Danish Dental Association
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Periodontal disease | Change from baseline examination (before oral care intervention) at 3-months follow-up examination | Measurement of attachment level |
| Whole saliva flow rate, unstimulated | Change from baseline examination (before oral care intervention) at 3-months follow-up examination | Sialometry |
| Whole saliva flow rate, stimulated | Change from baseline examination (before oral care intervention) at 3-months follow-up examination | Sialometry |
| 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 |
| Saliva composition: Total calcium | Change from baseline examination (before oral care intervention) at 3-months follow-up examination | Sialochemistry |
| 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 |
| Saliva composition: Albumin | Change from baseline examination (before oral care intervention) at 3-months follow-up examination | Sialochemistry |
| Saliva composition: Amylase activity | Change from baseline examination (before oral care intervention) at 3-months follow-up examination | Sialochemistry |
| Saliva composition: Secretory IgA | 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: Erythrocytes | 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 |
| Hematologic status: Thrombocytes | Change from baseline examination (before oral care intervention) at 3-months follow-up examination | Blood sample |
| Hematologic status: Transferrin | 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 |
| Phosphate metabolism | 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 |
| 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 |
| 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 |
| Oral Health Impact Profile | Change from baseline examination (before oral care intervention) at 3-months follow-up examination | Quality of life questionnaire |
| Medical Outcomes Study Short Version | Change from baseline examination (before oral care intervention) at 3-months follow-up examination | Quality of life questionnaire |
| Hematologic status: Hemoglobin | Change from baseline examination (before oral care intervention) at 3-months follow-up examination | Blood sample |
| Dental bacterial plaque | Change from baseline examination (before oral care intervention) at 3-months follow-up examination | Measured by plaque index |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dental caries | Baseline examination (before oral care intervention), 3-months follow-up examination | Clinical registration of dental caries |
Countries
Denmark
Outcome results
None listed