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临床试验/NCT04473209
NCT04473209已完成不适用

The Effect of Non-surgical Periodontal Therapy on Serum Resistin Level in Chronic Periodontitis Patients With or Without Type 2 Diabetes Mellitus

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
serum resistin

研究概览

简要总结

non-surgical periodontal debridement was performed for diabetic patients with chronic periodontitis as well as for non-diabetic patients but also with chronic periodontitis. Serum resistin level was assessed in the two groups before and after periodontal therapy and also was compared to a healthy control group.

详细描述

Background: Resisitin is a recognized marker for chronic inflammatory conditions that could be directly linked with type 2 diabetes mellitus. The aim of this study was to assess serum resistin level in type 2 diabetic patients with chronic periodontitis.

Methods: Forty individuals were recruited in this study and were divided into three groups, diabetic group consisted of 15 diabetic patients (type 2 diabetes mellitus) with moderate to severe chronic periodontitis, non-diabetic group consisted of 15 non-diabetic patients with moderate to severe chronic periodontitis and healthy group consisted of 10 non-diabetic individuals with healthy periodontium. Non-surgical periodontal therapy with supra and subgingival debridement was performed for the diabetic and non-diabetic groups. Pocket depth, clinical attachment level, plaque index, gingival index, serum Resistin and high sensitivity C-Reactive Protein assay were recorded for both groups before and after treatment, while HbA1c was recorded for the diabetic group.

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
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •diagnosed with moderate to severe chronic periodontitis.
  • •Presence of a minimum of 15 natural teeth
  • •Presence of at least four teeth with one or more sites with probing pocket depth (PPD) ≥5mm and clinical attachment level (CAL) ≥4mm
  • •agreement to participate in the study and sign a written informed consent

排除标准

  • •Patients who received any periodontal treatment or professional scaling and root planing of the teeth for at least 6 months prior to the study initiation
  • •A history of antibiotics therapy and anti-inflammatory drugs within the previous 6 months
  • •Pregnancy or use of contraceptives or any medication related to diabetes
  • •former or current smokers ˂ 5 years.

研究组 & 干预措施

diabetic group

Active Comparator

diabetic patients with chronic periodontitis

干预措施: non-surgical periodontal therapy (Procedure)

non-diabetic group

Active Comparator

non diabetic patients with chronic periodontitis

干预措施: non-surgical periodontal therapy (Procedure)

结局指标

主要结局

serum resistin

时间窗: 3 months

ng/ml

次要结局

  • probing pocket depth(3 months)
  • C-reactive protein(3 months)
  • clinical attachment loss(3 months)

研究者

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

Weam Ahmed Elbattawy

Dr. Principal Investigator

Cairo University

研究点 (1)

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