Clinical and Microbiological Evaluation of Periodontal Treatment of Diabetic Patients: A Longitudinal Study
2015年12月30日 更新者：Eduardo Aleixo Figueira
Clinical and Microbiological Evaluation of Non-surgical Periodontal Treatment of Diabetic and Non-diabetic Patients: A Longitudinal Study
The purpose of this study is to determine whether periodontal treatment improves the periodontal clinical parameters in the periodontal patients with diabetes regarding non-diabetics: two years follow-up.
研究概览
详细说明
All the subjects in the study will receive non surgical periodontal treatment in one session (full-mouth scaling and root planing).
Clinical parameters will be assessed in all teeth (except third molars) by one experienced and trained examiner before treatment and every 3 months for 2 years.
Visible plaque index (VPI) will be represented a mean percentage of sites with visible plaque calculated for all teeth analyzed (four sites per tooth).
Others parameters will be assessed at six sites per tooth using a manual periodontal probe (15mm).
Bleeding on probing (BOP) will be represented the mean percentage of sites with bleeding (up to 15 seconds after probing) calculated for all teeth analyzed.
Probing depth (PD - distance between the gingival margin and the bottom of the sulcus/pocket), gingival recession (GR - distance between the cementoenamel junction and gingival margin) and clinical attachment level (CAL - distance between the cementoenamel junction and the bottom of the sulcus/pocket) will be represented a mean distance calculated per site for all teeth analyzed.
For blood parameters, an outside laboratory will perform all blood analysis.
It will be requested for each subject with diabetes (DG) at baseline, each 3 months post-treatment.
Fasting plasma glucose (FPG) will be expressed in milligrams per deciliter and HbA1c will be expressed as a percentage.
Statistical analysis will be performed using an available software program and the patient will be considered as the unit of analysis.The data will be processed and analyzed by descriptive and inferential statistics, probably nonparametric.
研究类型
介入性
注册 (预期的)
144
阶段
- 阶段2
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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-
Rio Grande do Norte
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Natal、Rio Grande do Norte、巴西、59056-000
- 招聘中
- Departamento de Odontologia; Universidade Federal do Rio Grande do Norte
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接触：
- Bruno CV Gurgel, Doctor
- 电话号码：+558432154136
- 邮箱：bcgurgel@yahoo.com.br
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接触：
- Eduardo A Figueira, Doctor
- 电话号码：+5584999521370
- 邮箱：edufigueira@yahoo.com.br
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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
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Clinical diagnosis of chronical periodontitis according to Lopez et al. 2002 (one or more teeth with at least one site with PD >= 4mm or CAL >= 3mm);
- And have at least 8 natural teeth (excluding third molars), and older than 18 years and of both genders.
Exclusion Criteria:
- Any systemic diseases or complications (except Type 2 Diabetes Mellitus) such as cardiovascular disease, Alzheimer's, lung or brain diseases and metabolic syndrome;
- Use of antibiotics or periodontal treatment within the past 6 months;
- Long-term administration of anti-inflammatory or/and immunosuppressive agents;
- Current smoker or former smoker for the past 5 years;
- Pregnant or breastfeeding;
- And presence of orthodontic appliances.
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Diabetic group
Subjects with Chronic Periodontitis and Type 2 Diabetes Mellitus treated with non surgical periodontal therapy (Full Mouth Scaling and Root Planing)
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This procedure was performed as described by Quirynen et al. 2005 with some modifications
|
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实验性的：Nondiabetic group
Subjects with Chronic Periodontitis and without Type 2 Diabetes Mellitus treated with non surgical periodontal therapy (Full Mouth Scaling and Root Planing)
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This procedure was performed as described by Quirynen et al. 2005 with some modifications
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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 |
|---|---|---|
|
Percentage of bleeding on probing
大体时间：Baseline
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The mean percentage of periodontal sites with bleeding on probing
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Baseline
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Percentage of bleeding on probing
大体时间：at three months
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The mean percentage of periodontal sites with bleeding on probing
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at three months
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Percentage of bleeding on probing
大体时间：at six months
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The mean percentage of periodontal sites with bleeding on probing
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at six months
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Percentage of bleeding on probing
大体时间：at nine months
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The mean percentage of periodontal sites with bleeding on probing
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at nine months
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Percentage of bleeding on probing
大体时间：at twelve months
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The mean percentage of periodontal sites with bleeding on probing
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at twelve months
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Percentage of bleeding on probing
大体时间：at eighteen months
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The mean percentage of periodontal sites with bleeding on probing
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at eighteen months
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Percentage of bleeding on probing
大体时间：at twenty four months
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The mean percentage of periodontal sites with bleeding on probing
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at twenty four months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of visible plaque index
大体时间：Baseline and at three, six, nine, twelve, eighteen and twenty four months
|
The mean percentage of periodontal sites with visible plaque
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Baseline and at three, six, nine, twelve, eighteen and twenty four months
|
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Probing depth (mm)
大体时间：Baseline and at three, six, nine, twelve, eighteen and twenty four months
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The mean of probing depth in millimeters calculated for periodontal sites.
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Baseline and at three, six, nine, twelve, eighteen and twenty four months
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Clinical attachment level (mm)
大体时间：Baseline and at three, six, nine, twelve, eighteen and twenty four months
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The mean of clinical attachment level in millimeters calculated for periodontal sites.
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Baseline and at three, six, nine, twelve, eighteen and twenty four months
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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
- 首席研究员：Bruno CV Gurgel, Doctor、Universidade Federal do Rio Grande do Norte
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Quirynen M, Bollen CM, Vandekerckhove BN, Dekeyser C, Papaioannou W, Eyssen H. Full- vs. partial-mouth disinfection in the treatment of periodontal infections: short-term clinical and microbiological observations. J Dent Res. 1995 Aug;74(8):1459-67. doi: 10.1177/00220345950740080501.
- Lopez NJ, Smith PC, Gutierrez J. Periodontal therapy may reduce the risk of preterm low birth weight in women with periodontal disease: a randomized controlled trial. J Periodontol. 2002 Aug;73(8):911-24. doi: 10.1902/jop.2002.73.8.911.
- Almeida ML, Duarte PM, Figueira EA, Lemos JC, Nobre CMG, Miranda TS, de Vasconcelos Gurgel BC. Effects of a full-mouth disinfection protocol on the treatment of type-2 diabetic and non-diabetic subjects with mild-to-moderate periodontitis: one-year clinical outcomes. Clin Oral Investig. 2020 Jan;24(1):333-341. doi: 10.1007/s00784-019-02927-8. Epub 2019 May 17.
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
2013年1月1日
初级完成 (预期的)
2016年10月1日
研究完成 (预期的)
2017年10月1日
研究注册日期
首次提交
2015年12月28日
首先提交符合 QC 标准的
2015年12月30日
首次发布 (估计)
2015年12月31日
研究记录更新
最后更新发布 (估计)
2015年12月31日
上次提交的符合 QC 标准的更新
2015年12月30日
最后验证
2015年12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.