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临床试验/NCT04131283
NCT04131283已完成不适用

Evidence of Spreading Vasoconstriction in Human Gingiva

Semmelweis University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2019年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
Blood flow change after application of epinephrine

研究概览

简要总结

The aim of this study is to observe the mechanism of spreading vasoconstriction in human healthy gingiva. Epinephrine solution is applied on the attached gingiva in group "A" and on the surface of the tooth next to the ginvial sulcus in group "B". The different placement of the solution causes different effect in the microcirculation.

详细描述

Spatial regulation of gingival microcirculation has not been revealed yet. Although this could be an important mechanism to protect gingiva as it is exposed to mechanical, chemical, thermal etc. irritation during whole life. It is especially important during flap surgery. Laser Speckle Contrast Imaging (LSCI) is novel non-invasive method with high spatio-temporal resolution, therefore it allows us to study remote effect of local vasoconstriction such as spreading vasoconstriction in human gingiva.

The epinephrine is a daily used vasoconstrictor material in dentistry and it will be used to trigger remote effect on gingiva. Epinephrine in 1 mg/ml concentration. Solution will be dropped on the gingiva at tooth 12 in a fabricated leakage proof well attached to 2mm above the marginal gingiva in group "A". The solution will be dropped on the surface of tooth 12 next to the sulcus into the well in case of group "B". The changes of the blood flow will be monitor at the test side with surrounding gingival area by LSCI. The control side in each case will be - appropriately to the test side - at tooth 21 with phisiologocal saline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • at least 5 mm keratinized gingiva at the upper front teeth
  • general health

排除标准

  • pregnancy, breast-feeding
  • any medication
  • smoking, gingivitis, caries and coronal restoration with insufficient marginal integrity

研究组 & 干预措施

Epinephrine effect throught keratinized ginigva

Experimental

1 mg/ml epniephrine vs physiologocal saline

干预措施: Epinephrine (Drug)

Epinephrine effect throught gingival sulcular epithelium

Experimental

1 mg/ml epniephrine vs physiologocal saline

干预措施: Epinephrine (Drug)

结局指标

主要结局

Blood flow change after application of epinephrine

时间窗: 30 minutes

The change in blood flow will be measured after locally applied epinephrine at the site fo application and at the remote sites

次要结局

  • Comparsion of the change in blood flow between genders(30 minutes)

研究者

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

Dr. Vag Janos

Principal Investigator

Semmelweis University

研究点 (1)

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