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临床试验/NCT03268473
NCT03268473已完成不适用

Effect of Non-surgical Periodontal Treatment on Oxidative Stress and Antioxidant Status in Obstructive Sleep Apnea Syndrome (OSAS)

Bezmialem Vakif University2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2017年7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
40
试验地点
2
主要终点
Serum Oxidative Stress Index (OSI) level : TOS/TAS

研究概览

简要总结

The main objective of this study is to compare the effect of the non-surgical periodontal treatment on serum and saliva oxidative stress parameters in patients with periodontitis and obstructive sleep apnea syndrome (OSAS) and in patients with periodontitis only.

详细描述

There is evidence supporting that OSAS is an independent risk factor for cardiovascular and cerebrovascular diseases such as hypertension, congestive heart failure, myocardial infarction, cardiac-arrhythmia, and stroke.Gender, age, smoking, obesity and diabetes, which are risk factors for periodontitis,It is also common in OSAS at the same time.In addition to common risk factors, both OSAS and periodontitis have been shown to be associated with increased oxidative stress markers.

The investigators aimed to investigate whether non-surgical periodontal treatment on serum and saliva oxidative stress parameters in patients with periodontitis and obstructive sleep apnea syndrome (OSAS) and in patients with periodontitis only.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • aged ≥18 years old
  • having more than 16 teeth
  • BMI>25 kg/m2

排除标准

  • patients with a history of diabetes mellitus or respiratory diseases
  • patients who were under any medication that was known to influence periodontal tissues
  • patients with a history of any periodontal treatment in the past 6 months
  • patients with hormonal changes such as pregnancy or lactation; and 5) patients having fixed dentures or removable prothesis
  • OSAS treatment started (using OSAS therapy device or undergoing surgical operation)

研究组 & 干预措施

Experimental: Non-surgical periodontal therapy in patient with OSAS and Periodontitis

Experimental

Non-surgical periodontal therapy consisted of scaling and root planing and supportive periodontal therapy during 3 months Individuals: with both OSAS and periodontitis Intervention: Procedure: Non-surgical periodontal therapy

干预措施: Experimental (Other)

Control: non-surgical periodontal therapy in Periodontitis

Active Comparator

Non-surgical periodontal therapy consisted of scaling and root planing and supportive periodontal therapy during 3 months Individuals: only periodontitis Intervention: Procedure: Non-surgical periodontal therapy

干预措施: Control (Other)

结局指标

主要结局

Serum Oxidative Stress Index (OSI) level : TOS/TAS

时间窗: 3 months

Changes in serum and salivary oxidative stress parameters

Saliva Thiol/disulfid (millimolar per liter (mmol /L))

时间窗: 3 months

Changes in serum and salivary oxidative stress parameters

Serum Total Antioxidant Status (TAS) level (millimolar per liter (mmol /L))

时间窗: 3 months

Changes in serum and salivary oxidative stress parameters

Saliva Total Oxidant Status (TOS) level (mikromolar per liter (µmol /L))

时间窗: 3 months

Changes in serum and salivary oxidative stress parameters

Saliva Oxidative Stress Index (OSI) level : TOS/TAS

时间窗: 3 months

Changes in serum and salivary oxidative stress parameters

Serum Total Oxidant Status (TOS) level (mikromolar per liter (µmol /L))

时间窗: 3 months

Changes in serum and salivary oxidative stress parameters

Serum Native Thiol (mikromolar per liter (µmol /L))

时间窗: 3 months

Changes in serum and salivary oxidative stress parameters

Saliva Total Antioxidant Status (TAS) level (millimolar per liter (mmol /L))

时间窗: 3 months

Changes in serum and salivary oxidative stress parameters

Serum Thiol/disulfid (millimolar per liter (mmol /L))

时间窗: 3 months

Changes in serum and salivary oxidative stress parameters

Saliva Native Thiol (mikromolar per liter (µmol /L))

时间窗: 3 months

Changes in serum and salivary oxidative stress parameters

次要结局

  • Bleeding on probing (BOP)(3 months)
  • Clinical attachment loss(CAL)(3 months)
  • Plaque Index (PI)(3 months)
  • Probing pocket depth (PD)(3 months)
  • Gingival Index (GI)(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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