Integrated Microfluidic System for Oral Diagnostics

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Integrated Microfluidic System for Oral Diagnostics

Conditions
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Healthy, Periodontitis

Intervention / Treatment
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* Device: miniaturized microfluidic system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: miniaturized microfluidic system|Subjects will provide appropriate periodontal treatment as needed.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proof of principle study to determine ability of device to predict disease activity in patients at high and low risk for disease. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontitis, microfluidics, saliva diagnostics