Interventional Study Targeting Oral Infections in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- C-reactive protein, plasma
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients not capable of following the research protocol
- •Legally unavailable
- •Need of antibiotic prophylaxis with dental treatment
- •Heart valve surgery
结局指标
主要结局
C-reactive protein, plasma
时间窗: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Blood sample
Gingival inflammation
时间窗: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Gingival inflammation measured by gingivitis index
次要结局
- Periodontal disease(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Saliva composition: Sodium(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Saliva composition: Chloride(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Saliva composition: Potassium(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Whole saliva flow rate, stimulated(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Saliva composition: Amylase activity(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Whole saliva flow rate, unstimulated(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Dental bacterial plaque(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Saliva composition: Inorganic phosphate(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Saliva composition: Total protein(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Hematologic status: Transferrin(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Renal function: Carbamide(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Saliva composition: Total calcium(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Saliva composition: Albumin(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Oral candidiasis(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Hematologic status: Hemoglobin(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Hematologic status: Leukocytes(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Renal function: Bicarbonate(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Renal function: Creatinine(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Renal function: Albumin(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Oral Health Impact Profile(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Saliva composition: Secretory IgA(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Phosphate metabolism(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Hematologic status: Erythrocytes(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Hematologic status: Thrombocytes(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Hematologic status: Iron(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Calcium metabolism(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Renal function: Potassium(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Renal function: Sodium(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
- Medical Outcomes Study Short Version(Change from baseline examination (before oral care intervention) at 3-months follow-up examination)
研究者
Siri Beier Jensen
Associate Professor, DDS, PhD
University of Copenhagen