ClinicalTrials.gov
ClinicalTrials.gov Menu

Integrated Microfluidic System for Oral Diagnostics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00277745
Recruitment Status : Completed
First Posted : January 16, 2006
Last Update Posted : December 14, 2015
Sponsor:
Collaborators:
Sandia National Laboratories
National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
William Giannobile, University of Michigan

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.

Condition or disease Intervention/treatment
Healthy Periodontitis Device: miniaturized microfluidic system

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 (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.

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Integrated Microfluidic System for Oral Diagnostics
Study Start Date : June 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : June 2007

Intervention Details:
  • Device: miniaturized microfluidic system
    Subjects will provide appropriate periodontal treatment as needed.


Primary Outcome Measures :
  1. Proof of principle study to determine ability of device to predict disease activity in patients at high and low risk for disease. [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
Saliva, serum, dental plaque and gingival crevicular fluid


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
100 Adult subjects comprised of two populations: 1) disease susceptible (n=50) and 2) low-risk disease (n=50)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277745


Locations
United States, Michigan
Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Sandia National Laboratories
National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: William V Giannobile, DDS, DMedSc Director of MCOHR

Publications of Results:
Other Publications:
Responsible Party: William Giannobile, William Giannobile, D.D.S., D.Med.Sc., University of Michigan
ClinicalTrials.gov Identifier: NCT00277745     History of Changes
Other Study ID Numbers: H03-00003522
U01DE014961-01 ( U.S. NIH Grant/Contract )
First Posted: January 16, 2006    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015

Keywords provided by William Giannobile, University of Michigan:
periodontitis
microfluidics
saliva diagnostics

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases