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临床试验/NCT01641757
NCT01641757Unknown2 期

Effect of Non-Surgical Periodontal Therapy on Serum Albumin Levels of Patients on Maintenance Hemodialysis Therapy, A Randomized Control Trial

University of the Punjab2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
2 期
入组人数
160
试验地点
2
主要终点
serum albumin levels

研究概览

简要总结

Periodontitis is a destructive chronic infection of the gums, ligaments, and bone, predominantly caused by Gram-negative bacteria. Individuals with periodontal disease are at increased risk of systemic diseases. Increased prevalence of periodontal disease has been reported in patients with chronic kidney disease, especially in dialysis patients. Chronic kidney disease (CKD) is the progressive loss of kidney function over time. When kidneys loose their 85-90 % function, dialysis is performed. Efficacy of dialysis is checked by serum albumin levels. Lower-than-normal levels of serum albumin may be a sign of kidney diseases. Hypoalbuminemia has been demonstrated to be a strong predictor of death in chronic renal failure. A proposed mechanism for the effect of periodontitis on the development of kidney disease is systemic inflammation. The deleterious effects of systemic inflammation on kidney function could occur during the period of active periodontal infection and accumulate during the life time of the individual. This randomized control trial is designed to observe the effect of non-surgical periodontal therapy on serum albumin levels of patients on maintenance hemodialysis therapy. Patients will undergo periodontal examination and their serum albumin levels will be checked. Then they will be randomly divided in two groups. One group will be given non surgical periodontal treatment and second group will be offered late treatment. After 6 weeks 1st group will be reevaluated by serum albumin level and periodontal examination to observe the effect of non-surgical periodontal therapy. Statistical analyses shall be performed using SPSS software. T tests and Chi-sq tests shall be used to test differences according to periodontal status for continuous and categorical variables, respectively. The level of significance is set at p<0.05.

详细描述

Periodontitis is a destructive chronic infection of the gums, ligaments, and bone, predominantly caused by Gram-negative bacteria residing in biofilm surrounding the teeth. Biofilm is an aggregate of microbes with a distinct architecture. This biofilm contains clusters of bacterial species that are found commonly below the gingiva and are associated reproducibly with periodontal disease. These bacteria involved in periodontitis causes destruction of tissues which leads to formation of a periodontal pocket. This space becomes a site for further bacterial colonization and possible entry route of bacteria in blood stream.

It is evident from the data that periodontal health of the Pakistani nation is very poor with only 28% of the 12 year old having healthy gums and more than 93% of the 65 year old have some gum or periodontal disease . These results indicate that periodontal disease including inflammation of gums and calculus is endemic in Pakistan . Like caries, the level of gingival and periodontal disease is higher in the rural population of the Pakistan.

There is an increasing evidence that individuals with periodontal disease are at increased risk of cardiovascular disease, preterm delivery of low birth weight infants, pulmonary diseases, diabetes, osteoporosis, rheumatoid arthritis, alzheimer's disease & kidney diseases. The factors predisposing to periodontal disease and accelerating its progression are clearly evident in chronic renal failure. They encompass hyposalivation and xerostomia, impaired immunity and wound healing, alveolar bone destruction due to renal osteodystrophy, bleeding diathesis, diabetes mellitus, malnutrition and a state of general disability impairing oral hygiene. There is evidence for increased prevalence of periodontal disease in patients with renal disease, especially in dialysis patients.

Chronic kidney disease (CKD) is the progressive loss of kidney function over time. Normal renal functions are normally evaluated by glomerular filtration rate (GFR). Normal results range from 90 - 120 mL/min/1.73 m2.

The loss of kidney function usually takes months or years to occur. The final stage of chronic kidney disease is called end-stage renal disease (ESRD) after which kidneys no longer function and the patient needs dialysis or a kidney transplant .

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Chronic Kidney Disease patients, who are receiving hemodialysis therapy for >3 months. of all ages and both gender and are able to give informed consent.
  • Have at least 14 teeth (excluding third molars) in oral cavity shall be included in study.

排除标准

  • Patients have had periodontal therapy <1 year.
  • Diabetes Mellitus
  • Liver disease

结局指标

主要结局

serum albumin levels

时间窗: 6 months

serum albumin levels are considered to be strong predictor of death in dialysis patients. in this trial we want to see the effect of non surgical periodontal therapy on serum albumin levels of patients on maintenance dialysis therapy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Arsalan Wahid

Principal Investigator

University of the Punjab

研究点 (2)

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