Oxidative Stress Markers Evaluation Before and After Periodontal Treatment of Diabetics Type 2 Patients
2011年11月16日 更新者:Luiz Antonio Pugliesi Alves de Lima、University of Sao Paulo
Oxidative Stress Markers Evaluation Before and After Periodontal Treatment of Diabetics Type 2 Patients With Generalized Chronic Periodontitis and Healthy Periodontium
Abstract Diabetes mellitus and periodontal diseases are both chronic inflammatory disorders that have a major impact on the health and well being of millions of individuals worldwide.
Periodontal diseases are among the most common diseases in humans, therefore, if the presence of periodontal diseases plays any role in overall systemic health, the public health impact may be substantial.
An important factor that can be involved in the progression of the periodontal disease is the production of Reactive Oxygen Species (ROS).
The imbalance between oxidative stress induced by ROS and the concentrations (or activity) of the antioxidant may result in tissue damage.
The ROS induce the activity of lipid peroxidation-Tbars, myeloperoxidase (MPO), peroxidase and arginase, whose mechanisms reflect the severity of the periodontal disease and it may offer the basis for a patient specific diagnostic test for periodontitis and could have therapeutic significance.
The aim of this study is to investigate quantitatively the levels of oxidative stress markers (Myeloperoxidase, Peroxidase, Lipid Peroxidation and Arginase) in saliva and in gingival crevicular fluid (GCF) of diabetes type 2 subjects with generalized chronic periodontitis and periodontally healthy individuals, and systematically healthy individuals with generalized chronic periodontitis and periodontally healthy individuals, before and after periodontal treatment.
Unstimulated whole saliva will be collected for 5 min as well as GCF of 25 diabetes type 2 with generalized chronic periodontitis, 25 diabetes type 2 periodontally healthy individuals as controls, 25 systematically healthy individuals with generalized chronic periodontitis and 25 periodontally healthy individuals before and after treatment.
The following clinical parameters will be evaluated: probing pocket depth, probing attachment level, plaque index and the gingival index.
The activity of stress markers in saliva and GFC will be analyzed by spectrophotometry.
Adequate statistical analysis will be carried out with a p-value set at p < 0.05.
研究概览
研究类型
介入性
注册 (预期的)
200
阶段
- 第一阶段早期
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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SP
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São Paulo、SP、巴西、05508-000
- 招聘中
- University of Sao Paulo
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接触:
- Luiz Antônio Pugliesi Alves de Lima, PhD
- 电话号码:55-11-30917833
- 邮箱:lapalima@usp.br
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接触:
- Ana Paula Sassá Benedete
- 电话号码:55-11-30917833
- 邮箱:abenedete@gmail.com
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
30年 至 70年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients with type 2 diabetes and chronic periodontitis(more than 30% of the sites involved, AAP, 1999)
- Patients with type 2 diabetes and periodontally healthy (AAP, 1999)
- Patients systemically healthy with chronic periodontitis (more than 30% of the sites involved)
- Patients systemically and periodontally healthy
- Patients with at least 15 natural teeth (excluding 3rd molars).
- At least 30% of sites with probing pocket depth (PD)> 5 mm and a maximum of 60% sites with PS <7 mm
- Clinical attachment level (CAL)> 4 mm
- Visible plaque and bleeding on probing (BOP)
- Patients with type 2 diabetes have to bear the disease for at least five years and have to show a blood percentage of glycated hemoglobin between 6.5% to 8% (UKPDS 1998) at baseline
Exclusion Criteria
- Individuals with periodontal pockets deeper than 7 mm
- Patients with any other systemic disease (except diabetes type 2)
- Patients who have used medications such as anticoagulants, contraceptives or antidepressants in the past 6 months
- Patients who have used antibiotic and anti-inflammatory drugs in the last 3 months before the of the study
- Smoking
- Pregnancy
- Patients who have received periodontal treatment in the last six months before the start of this study.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:chronic periodontitis
Saliva and GCF samples will be evaluated before and after treatment from patients treated of chronic periodontitis.
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scaling and root planning
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安慰剂比较:periodontally healthy individuals
Saliva and GCF samples will be evaluated from periodontally healthy individuals at baseline.
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Periodontally healthy patients will receive oral hygiene instructions and prophylaxis.
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有源比较器:chronic periodontitis with diabetes type 2
Saliva and GCF samples will be evaluated before and after treatment from patients with diabetes type 2 treated of chronic periodontitis
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scaling and root planning
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安慰剂比较:periodontally healthy individuals with diabetes type 2
Saliva and GCF samples will be evaluated from periodontally healthy individuals with diabetes type 2 at baseline
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Periodontally healthy patients will receive oral hygiene instructions and prophylaxis.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluate level change of oxidative stress biomarkers in crevicular gingival fluid and whole saliva on diabetes type 2 individuals
大体时间:baseline and 4 weeks after periodontal treatment
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The participants will be followed for an expected average of 4 weeks after periodontal treatment.
The samples of saliva and crevicular gingival fluid will be evaluated at baseline and four weeks after periodontal treatment.
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baseline and 4 weeks after periodontal treatment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任:Luiz A Lima, PhD、University of Sao Paulo
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年8月1日
初级完成 (预期的)
2011年12月1日
研究完成 (预期的)
2013年8月1日
研究注册日期
首次提交
2011年8月22日
首先提交符合 QC 标准的
2011年11月16日
首次发布 (估计)
2011年11月21日
研究记录更新
最后更新发布 (估计)
2011年11月21日
上次提交的符合 QC 标准的更新
2011年11月16日
最后验证
2011年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.