Effects of Omega-3 Plus Low-dose Aspirin as Adjunct to Periodontal Debridement for Chronic Periodontitis in Diabetics
2016年11月22日 更新者：Nídia Cristina Castro dos Santos、Universidade Estadual Paulista Júlio de Mesquita Filho
Effects of Omega-3 Polyunsaturated Fatty Acids Daily Supplementation Plus Low-dose Aspirin as Adjunct to Full-mouth Periodontal Ultrasonic Debridement for the Treatment of Chronic Periodontitis in Type 2 Diabetics: Randomized Clinical Trial
Therefore, the aim of this study is to investigate the effectiveness of daily supplementation of omega-3 polyunsaturated fatty acids and low-dose aspirin as adjunct therapy to one-stage full-mouth periodontal ultrasonic debridement for the treatment of chronic periodontitis in type 2 diabetic patients through a superiority randomized clinical trial.
研究概览
地位
未知
详细说明
Diabetes mellitus (DM) has become a global epidemic.
Its complications can have a significant impact on quality of life, longevity, and costs in public health.
The World Health Organization (WHO) estimates that by 2040, 642 million people will suffer from diabetes, around 10% of the world adult population (WHO, 2015).
Periodontal Diseases are considered the sixth complication of DM.
This close relationship between both diseases is characterized by mutual influence.
Thus, an appropriate control of periodontal disease may facilitate the DM control, improving quality of life on diabetic patients.
Besides that, the presence of DM might impair prognosis of diverse dental treatments due to its inflammatory nature, negative influence on wound healing, on bone biology, and the establishment of infections.
As a host modulatory therapy (HMT), the daily supplementation of omega-3 polyunsaturated fatty acids and low-dose aspirin has been proposed as adjunct therapy to the treatment of chronic periodontitis, showing good clinical and metabolic results in normoglycemic patients.
Therefore, the aim of this study is to investigate the effectiveness of daily supplementation of omega-3 polyunsaturated fatty acids and low-dose aspirin as adjunct therapy to one-stage full-mouth periodontal ultrasonic debridement for the treatment of chronic periodontitis in type 2 diabetic patients through a superiority randomized clinical trial.
研究类型
介入性
注册 (预期的)
75
阶段
- 不适用
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
-
-
SP
-
São José dos Campos、SP、巴西、12245-000
- 招聘中
- UNESP
-
接触：
- Nidia C Santos, MS
- 电话号码：5512991021346
- 邮箱：nidia.santos@ict.unesp.br
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接触：
- Mauro P Santamaria, PhD
- 电话号码：551239479379
- 邮箱：mauro.santamaria@ict.unesp.br
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副研究员：
- Cássia F Araujo, DDS
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首席研究员：
- Nídia C Santos, MS
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首席研究员：
- Mauro P Santamaria, PhD
-
-
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
35年 至 75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:
- a) Age ≥35 b) diagnosis of type 2 DM for ≥5 years c) DM treatment with oral hypoglycemic agents or insulin supplementation and diet d) glycated hemoglobin (HbA1c) levels from 6.5% to 11% e) at least 15 teeth (excluding third molars and teeth indicated for extraction) f) moderate to severe generalized chronic periodontitis (Armitage, 1999) g) agree and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who is not a member of the study (Resolution number 196 - October, 1996, and Ethics and Code of Professional Conduct in Dentistry - CFO179/93).
Exclusion Criteria:
- a) medical conditions that required prophylactic antimicrobial coverage b) scaling and root planing in the previous 6 months c) antimicrobial therapies in the previous 6 months d) anti-inflammatory therapies in the previous 6 months e) systemic conditions, other than DM, that could affect the progression of chronic periodontitis f) current use of medication that could interfere with periodontal response to treatment g) pregnancy or lactation h) smoking
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Control Group
Full-mouth periodontal debridement and placebo
|
One-stage full-mouth periodontal ultrasonic debridement plus placebo intervention
|
|
有源比较器：Test 1
Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days after periodontal therapy
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Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days after periodontal therapy
其他名称：
|
|
有源比较器：Test 2
omega-3 plus aspirin before periodontal therapy
|
Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days before periodontal therapy
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Periodontal pockets with mean probing depth (PD) ≥5mm
大体时间：Baseline, 90 days, 180 days
|
Baseline, 90 days, 180 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Probing depth (mm)
大体时间：Baseline, 90 days, 180 days
|
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
|
Baseline, 90 days, 180 days
|
|
Clinical attachment level (mm)
大体时间：Baseline, 90 days, 180 days
|
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
|
Baseline, 90 days, 180 days
|
|
Gingival recession (mm)
大体时间：Baseline, 90 days, 180 days
|
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
|
Baseline, 90 days, 180 days
|
|
Bleeding on probing (%)
大体时间：Baseline, 90 days, 180 days
|
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
|
Baseline, 90 days, 180 days
|
|
Plaque index (%)
大体时间：Baseline, 90 days, 180 days
|
Using a manual periodontal probe (North Carolina, HuFriedy, Chicago, IL, USA)
|
Baseline, 90 days, 180 days
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
糖化血红蛋白
大体时间：基线，180 天
|
基线，180 天
|
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：Mauro P Santamaria, PhD、UPECLIN HC FM Botucatu Unesp
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
- El-Sharkawy H, Aboelsaad N, Eliwa M, Darweesh M, Alshahat M, Kantarci A, Hasturk H, Van Dyke TE. Adjunctive treatment of chronic periodontitis with daily dietary supplementation with omega-3 Fatty acids and low-dose aspirin. J Periodontol. 2010 Nov;81(11):1635-43. doi: 10.1902/jop.2010.090628. Epub 2010 Jun 23.
- Dos Santos NC, Araujo CF, Andere NMRB, Miguel MMV, Westphal MRA, Van Dyke T, Santamaria MP. Omega-3 Fatty Acids and Low-Dose Aspirin in the Treatment of Periodontitis and Metabolic Syndrome: Case Report. J Int Acad Periodontol. 2020 Oct 1;22(4):223-230.
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
2016年6月1日
初级完成 (预期的)
2018年12月1日
研究完成 (预期的)
2018年12月1日
研究注册日期
首次提交
2016年6月10日
首先提交符合 QC 标准的
2016年6月10日
首次发布 (估计)
2016年6月15日
研究记录更新
最后更新发布 (估计)
2016年11月23日
上次提交的符合 QC 标准的更新
2016年11月22日
最后验证
2016年11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.