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Integrated Microfluidic System for Oral Diagnostics
This study is currently recruiting patients
Verified by University of Michigan January 2006
| Sponsored by: |
University of Michigan
Sandia National Laboratories
National Institutes of Health (NIH) |
| Information provided by: |
University of Michigan |
| ClinicalTrials.gov Identifier: |
NCT00277745 |
Purpose
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.
| Condition |
Intervention |
Phase |
| Healthy Individuals or Moderate to Severe Periodontitis
|
Procedure: Subjects will provide appropriate periodontal treatment as needed. |
Phase I |
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Efficacy Study
Official Title: Integrated Microfluidic System for Oral Diagnostics
Further study details as provided by University of Michigan:
Primary Outcomes: Proof of principle study to determine ability of device to predict disease activity in patients at high and low risk for disease.
Expected Total Enrollment:
100
Study start: June 2005
Last follow-up: January 2006
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.
Eligibility
Ages Eligible for Study:
18 Years
-
80 Years,
Genders Eligible for Study:
Both
Accepts Healthy Volunteers
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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Location
and Contact
Information
Please refer to this study by ClinicalTrials.gov identifier
NCT00277745
Amy S Kim, DDS
734-998-1468
Amy.S.Kim@umich.edu
Joel J Joshua, BSE
734-998-1435
Jjoshua@umich.edu
MichiganMichigan Center for Oral Health Research, Ann Arbor,
Michigan,
48106,
United States; Recruiting
Amy S Kim, DDS
734-998-1468
Amy.S.Kim@umich.edu
Joel J Joshua, BSE
734-998-1435
Jjoshua@umich.edu
Study chairs or principal investigators
William V Giannobile, DDS, DMedSc, Principal Investigator, Director of MCOHR
More Information
Study ID Numbers:
2004-01; U01 DE14961-01
Last Updated:
January 12, 2006
Record first received:
January 12, 2006
ClinicalTrials.gov Identifier:
NCT00277745Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-09-29
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