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临床试验/NCT03048175
NCT03048175已完成不适用

Systemic Inflammation After Wisdom Tooth Removal: a Case-control Study

University of Pisa0 个研究点目标入组 40 人开始时间: 2007年4月19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
主要终点
Changes in C-reactive protein (CRP)

研究概览

简要总结

Third molar (wisdom teeth) extraction is one of the most frequent intervention in dentistry. Nevertheless, little is known about the level of general body inflammation of subjects with impacted or semi-impacted third molars. Moreover, The possible effects of surgical removal of wisdom teeth on the overall health are not known.

Thus, a study in which 40 subjects has been designed. Twenty subjects were affected by bilateral wisdom tooth pathology necessitating for extraction of both teeth. Control group comprised 20 subjects with absence of wisdom teeth or completely erupted wisdom teeth without pathology associated to or history of previous extraction of both wisdom teeth.

In both groups a medical and dental examination will be performed at the baseline and 3 months after baseline for the control group or after the second third molar extraction in the control group. Blood will be also withdrawn to assess systemic inflammation and other systemic parameters.

Parameter were evaluated via high sensitive c reactive protein (CRP), lipids, fibrinogen, oxidative stress and endothelial function analysis.

详细描述

Third molar extraction is one of the most frequent intervention in dentistry. Nevertheless, little is known about the systemic aspect of subjects with impacted or semi-impacted third molars and the possible effects of surgical removal on their systemic parameters. A case-control study of 40 subjects has been designed to evaluate i) the overall systemic inflammation and metabolism of subjects with bilateral third molars compared to subjects with no third molars and ii) the effect of bilateral removal in the immediate and medium postsurgical period. Systemic parameters are evaluated via high sensitive c reactive protein (CRP), lipids, fibrinogen, oxidative stress and endothelial function analysis.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Code was assigned to each participant. No info on whether they belong to cases or control was given to researchers and statistician.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •cases: bilateral wisdom tooth pathology.
  • •control: agenesia/previous extraction/no symptoms of the lower third molars.

排除标准

  • •younger than 18 years and older than 65 years;
  • •pregnant or lactating females;
  • •females using contraceptive methods;
  • •suffering from any systemic illness;
  • •undergoing any pharmacological treatment within 30 days prior to the inclusion
  • •patients affected by periodontal disease (radiographic diagnosis of vertical bone defects or bone resorption equal to 20% of the root length);
  • •patients with periapical and periradicular radiolucent areas X-ray detectable;
  • •patients unable to participate to study.

研究组 & 干预措施

Cases: wisdom tooth pathology

Experimental

Subjects affected by bilateral wisdom tooth pathology, undergoing surgical removal

干预措施: Wisdom tooth removal (Procedure)

Controls: no wisdom tooth pathology

No Intervention

Subjects showing agenesia/previous extraction/no symptoms of the lower third molars.

结局指标

主要结局

Changes in C-reactive protein (CRP)

时间窗: baseline, 24 and three months after the second extraction

High-Sensitive plasmatic C-reactive protein

次要结局

  • Changes in plasma malondialdehyde (MDA)(baseline, 24 and three months after the second extraction)
  • Changes in lipoperoxides (LOOH)(baseline, 24 and three months after the second extraction)
  • Changes in ferric-reducing antioxidant power (FRAP)(baseline, 24 and three months after the second extraction)
  • Changes in endothelial flow-mediated dilation (FMD) calculated as maximal percentual increase in diameter of the blood vessel above baseline(baseline, 24 and three months after the second extraction)

研究者

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

Filippo Graziani, DDS MClinDent PhD

Associate Professor

University of Pisa

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