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临床试验/NCT03513627
NCT03513627Unknown不适用

Comparison of Microvascular Reactivity Assessed by Post-occlusive Reactive Hyperaemia Test in Gingiva at Natural Tooth and at Implant Borne Crown

Semmelweis University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年5月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Magnitude of the hyperemia after PORH test

研究概览

简要总结

Apply LSCI method for follow-up changes in regional blood flow after compression of the gingiva in order to compare the vascular reactivity of the attached gingiva at implant versus at tooth.

详细描述

This study will examine the effects of implantation and peri-implant soft tissue shaping on the circulation and the regeneration processes of the human gingiva.

The primary aim is to determine the effect of a short term disruption of the blood flow in the gingiva next to an implant and the contralateral tooth, in order to compare the functionally active collateral circulation in the attached gingiva at these respective regions. Using Laser Speckle Contrast Imaging technique (LSCI), which provides blood perfusion data, the investigators will have the possibility to detect functional alterations in gingival microcirculation during and after a short term compression of the gingiva. The secondary aim is to assess and compare the time course of the restoration of the circulation on the affected areas. Further aims are to observe if the compensation capability of the circulation is influenced by gingival thickness (biotype) and patient's gender.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with single dental implant installed in the front region of the jaw at least 6 months ago. On the contralateral side a natural tooth is located.

排除标准

  • systemic disease
  • alcohol abuse
  • pregnancy
  • gingivitis
  • periodontitis

结局指标

主要结局

Magnitude of the hyperemia after PORH test

时间窗: 5min

Blood flow changes are measured by LSCI before (baseline), during and after gingiva compression. The scale is an arbitrary unit (0-3000 LSPU); relative changes to the baseline measurement will be calculate.

次要结局

  • Longevity of the hyperemia after PORH test(20min)
  • Difference in the magnitude and longevity of hyperemia induced by PORH test next to an implant born crown between women and men.(20 min)
  • Size of the hyperemia after PORH test(20 min)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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