Integrated Microfluidic System for Oral Diagnostics

December 11, 2015 updated by: William Giannobile, University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Michigan Center for Oral Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
Sandia National Laboratories

Investigators

  • Principal Investigator: William V Giannobile, DDS, DMedSc, Director of MCOHR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (Estimate)

January 16, 2006

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 11, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H03-00003522
  • U01DE014961-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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