Integrated Microfluidic System for Oral Diagnostics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proof of principle study to determine ability of device to predict disease activity in patients at high and low risk for disease.
研究概览
简要总结
This study is being conducted to test the ability and accuracy of a new instrument in the diagnosis of periodontitis (gum disease) by using fluids from the mouth. The diagnosis instrument will test two types of fluids, gingival crevicular fluid (GCF) and saliva. GCF is the fluid that accumulates between your teeth and gum tissue. The fluids will be collected in three ways: 1. Direct GCF sampling 2. GCF rinse sampling and 3. Whole saliva. A total of 100 adult patients will participate in this study. These subjects will be of two patient populations: 1) diseased population, with active gum disease; and 2) a low-risk disease population, with no active gum disease. Patients will be seen 6 times over the course of the study over a period of approximately 12 months. At each visit the patient will undergo oral fluid collection, as previously described, and thorough examinations of the mouth, including the taking of measurements for study purposes. Patients will also have radiographs taken at baseline, month 6, and end of study visits.
详细描述
The ultimate goal of this investigation is to validate the ability of the prototype platform (miniaturized microfluidic device that can rapidly (within 15 minutes) measure small volumes of oral fluids (on the order of nanoliters of fluid) and identify biomarkers of disease such as mediators of inflammation (interleukins -1 and -6; C-reactive protein (CRP), and a marker of bone resorption (ICTP). This analysis will aid in the diagnosis of active periodontal (gum) disease as well as diseases involved in systemic inflammation (e.g., cardiovascular disease) or systemic bone loss (osteoporosis). This project will have two specific goals: 1. To validate the ability of the diagnostic to measure the designated mediators from oral fluids; and 2. Determine the ability of the multiplexed format of mediator analysis to predict disease activity (future bone loss) in patients at high and low risk for disease. This proposed feasibility study will then aid in providing the impetus for sample size and other design requirements for larger, more expanded human clinical trial testing and subsequent technology transfer.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must possess at least 20 teeth and not have received periodontal treatment or antibiotic-related therapy for medical or dental reasons 3 months prior to study inclusion.
- •Low-risk inclusion: < 3 mm of attachment loss, no pockets > 4 mm, possess no radiographic bone loss, and < 20 sites with bleeding on probing (BOP). Low-risk cohort will be comprised of at least > 50% of the subjects above age 35 in order to exam low risk patients in other age strata (so as to decrease potential bias towards a younger population in the low risk cohort).
- •Disease-susceptible inclusion: Exhibit at least 4 sites with evidence of radiographic bone loss, mean attachment loss > 3 mm, pocket depths (PD) > 4 mm and BOP.
排除标准
- •Long-term use of medications known to affect periodontal status such as anti-inflammatory drugs (NSAIDS and aspirins)
- •History of metabolic bone diseases such as rheumatoid arthritis or post-menopausal osteoporosis.
结局指标
主要结局
Proof of principle study to determine ability of device to predict disease activity in patients at high and low risk for disease.
时间窗: 2 years
次要结局
未报告次要终点
研究者
William Giannobile
William Giannobile, D.D.S., D.Med.Sc.
University of Michigan