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临床试验/NCT03083444
NCT03083444撤回不适用

Early P Gingivalis Oral Infection and Ultrasound Detection of Intimamedia Thickening in Radial Arteries of Young Children

Creighton University1 个研究点 分布在 1 个国家开始时间: 2017年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Arterial wall thickness

研究概览

简要总结

To determine if there is an association between Porphyromonas gingivalis infection of dental gingiva during primary tooth eruption and thickening of the radial artery intimamedial layers. Thickening of these layers in infants could be a promoting factor for later development of atherosclerosis.

详细描述

Specific Aim 1. To determine the presence of Pg in the mouth of edentulous pre-eruption and then teething infants.

Over a 9-month period 15 normal babies will be recruited for a prospective pilot study from Creighton University students. Cotton swabs of the tongue mucosa and dental plaque will be made to detect the presence of Pg by DNA analysis.

Specific Aim 2. To determine the daily temperature of infants. Daily child temperatures will be recorded by the parent. Specific Aim 3. To measure the thickness of the radial artery using a 50 MHz ultrasound probe.

A 50 MHz ultrasound scan will be made by a trained dental hygienist of the left radial artery at an initial visit and at 3-monthly intervals to measure IMT.

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
4 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Pre-primary tooth eruption infants in the range of 4-8 months -

排除标准

  • No erupted teeth. No diabetes, obesity, chronic inflammatory disorders, hyperlipidemia, -

结局指标

主要结局

Arterial wall thickness

时间窗: 9 months

Increase in thickness of intimamedia layers

次要结局

未报告次要终点

研究者

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

Douglas K Benn DDS, PhD

Professor

Creighton University

研究点 (1)

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