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临床试验/NCT02901743
NCT02901743已完成4 期

"Efficacy of Nonsurgical Periodontal Therapy in Patients With Chronic Renal Disease and Periodontitis: A Biochemical and Microbiological Assay"

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre0 个研究点目标入组 40 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
40
主要终点
Levels of Microbiological and Biochemical Parameters

研究概览

简要总结

The main aim and objective of this study was to evaluate the effects of Non- surgical periodontal therapy on the subgingival microbiota and biochemical parameters in patients with chronic kidney disease and chronic periodontitis.

详细描述

The study was designed as a Non randomized prospective, interventional clinical trial. The sample size for the study was 40 individuals aged between 35-75 years, equally divided into two groups.

Group I--- Patients with Chronic kidney disease and chronic periodontitis (Test) Group II--- Patients with Chronic periodontitis only (Controls) At baseline both the groups were analyzed for clinical, microbiological and also biochemical parameters and underwent Non-surgical Periodontal treatment (i.e. scaling and root planning). All parameters were reassessed again after 3 months.

A total of 20 patients attending the outpatient wing of Hyderabad Kidney Centre , Malakpet,Hyderabad who were diagnosed clinically with Chronic Kidney disease and willing to participate in the study were included in the study.

Another 20 patients attending the outpatient wing of Department of periodontics, Panineeya Mahavidyalaya Institute of Dental Sciences & Hospital, Hyderabad, diagnosed with Chronic Periodontitis and willing to participate in the study were taken.

Biochemical parameters considered included -serum creatin & urinary albumin: creatin ratio.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A total of 20 patients diagnosed with Chronic kidney disease, (having abnormal Glomerular filtration rate(GFR) and serum Creatinine levels.) and chronic periodontitis (with at least 15 teeth remaining, and with the presence of ≥4 sites in 3 different teeth having clinical attachment loss (CAL) of ≥ 4mm and bleeding on probing). (Group I)
  • 20 patients diagnosed with chronic periodontitis only. (GroupII)

排除标准

  • Patients with HIV infection, pregnancy, lupus erythematosus, rheumatoid arthritis, any systemic disorder, periodontal therapy in the preceding 6 months, or on any course of antibiotic prophylaxis for periodontal procedures were excluded from the study

结局指标

主要结局

Levels of Microbiological and Biochemical Parameters

时间窗: Change in levels of Microbiological and Biochemical parameters were assessed at baseline and 3 months after scaling and rootplaning

Microbiological assay was done by PCR test i.e., pooled plaque samples were taken from both predialysis as well as chronic periodontitis patients at baseline and 3 months after scaling and root planing. Supragingival plaque was removed carefully with a sterile scaler to prevent the contamination of the samples.Sample was harvested from the same site with a sterile Gracey curet 5-6 with one single vertical stroke on the root surface. Biochemical assay was done by Modified Jaffe's reaction to assess the levels of Serum Creatinine and urine samples were taken to assess the Albumin:Creatinine ratio

次要结局

  • Clinical parameter -Gingival Index (GI)(Change in the GI was assessed at baseline and 3 months after Scaling and rootplaning)
  • Clinical Parameters-Probing depth(PD) and Clinical attachment levels (CAL)(Change in Pd was assessed at baseline and 3 months after scaling and rootplaning)
  • Clinical Parameter- Clinical attachment levels(CAL)(Change in CAL was assessed at baseline and 3 months after scaling and rootplaning)

研究者

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

Dr.Thirumalesh

Post Graduate

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

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