Integrated Microfluidic System for Oral Diagnostics
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery, Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | June 2005 |
| End Date: | June 2007 |
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.
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.
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.
(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.
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.
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