Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00277745
Status:
COMPLETED
Last Update Posted:
2015-12-14
First Post:
2006-01-12
Brief Title:
Integrated Microfluidic System for Oral Diagnostics
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Integrated Microfluidic System for Oral Diagnostics
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01DE014961-01 | NIH | None | httpsreporternihgovquickSearchU01DE014961-01 |